Aktiebolaget Hassle & Anor v Alphapharm

[2002] HCATrans 193

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
  Sydney  No S287 of 2001

B e t w e e n -

AKTIEBOLAGET HÄSSLE

First Appellant

ASTRA PHARMACEUTICALS PTY LIMITED

Second Appellant

and

ALPHAPHARM PTY LIMITED

Respondent

GLEESON CJ
GAUDRON J
McHUGH J
GUMMOW J
KIRBY J
HAYNE J
CALLINAN J

TRANSCRIPT OF PROCEEDINGS

AT CANBERRA ON THURSDAY, 30 MAY 2002, AT 10.21 AM

(Continued from 29/5/02)

Copyright in the High Court of Australia

GLEESON CJ:   Yes, Dr Emmerson.

MR EMMERSON:   If the Court pleases, I propose to deal with some matters which were raised by members of the Court in argument and which, on reviewing the transcript, I see I have not dealt with as completely as I should.

At page 15, line 608 of the transcript, your Honour Justice McHugh, in the course of dealing with the notional addressee for the purposes of the test for obviousness, said this:

So, this mundane test of this unimaginative worker with a complete recall of all the knowledge in the field but incapable of any inspiration himself really seems very fictitious.  He or she does not exist in the real world.

I dealt with the point about complete recall but on looking at the transcript I find I did not deal with the rest.  We would say, with respect, it is not so much being incapable of any inspiration but certainly without exercise of any inspiration.  Subject to that rider, the intention of the test as we would see it is that he or she does, in fact, exist in the real world, the sort of person good at their job who exist in the real world, though one cannot deny that such a person is placed in rather artificial circumstances for the purposes of the test.

KIRBY J:   If they do not have access to the Internet, they are in very artificial circumstances, today – very artificial circumstances.

MR EMMERSON:   Yes.  It is not so much a matter, with respect, your Honour, of not having access to the Internet any more than it was a matter in the old days of not having access to documents which you might find by a diligent search.  It is more that the test is to be applied against the background of the general knowledge of such a person and if such a person has to find additional information, whether it be from a library or from the Internet, then that is outside the scope of common general knowledge.

Your Honour Justice Callinan at page 21, line 878 – perhaps I should take the Court to the top of the page.  Your Honour referred to my submission at page 53 in paragraph 85 and in particular:

their opinion as to the kinds of literature searches which would be made.

Now, that is a reference to page 53 of the Court book.  It deals with a number of different matters.  I see ongoing through the transcript that I had taken up the point about Dr Marshall but I had not, I think, clearly answered your Honour’s question so far as the opinion as to the kinds of literature searches which would be made.  In fact, his Honour, as we understand it, did not come back precisely to that issue.  He did, at page 62 and 63 in paragraph 104, start an analysis of evidence which gives some light as to how he approached the matter.  He also, at page 64 in paragraph 107, dealt with some of the problems that arise in the nature of this evidence.  But as we would see it, it would be a fair statement, as your Honour put it to me, that his Honour did not precisely deal with the list of matters which were the subject of submission, and to which he referred at page 53, paragraph 85.

Your Honour Justice Gaudron put to me a number of questions relating to the application to the present case of what, in our submission, is the test to be applied.  The Court will recall that, stated compendiously, we say that the test to be applied is that the notional skilled worker is informed of the problem, is equipped with common general knowledge, and against that, you ask the question, “Was the solution to the problem obvious?” 

Implicit in this, I should add, is that we are talking about the type of invention which lends itself to a problem solution analysis.  Not all types of invention do this, but the present case is a problem solution type of case, and that is why we use this particular formulation.  Now, in dealing with the nature of the problem, the position that we take is that the notional skilled worker is informed of the physical and chemical characteristics of omeprazole, and out of those arises everything else that follows.  We say that the notional skilled worker is not informed of what might be discovered by certain specific tests which one can lay down.  The reason why we say that the true approach demands that sort of analysis is this:  the physical and chemical properties of omeprazole are properties of omeprazole itself; they are something which can be ascertained and known. 

When you start to take the matter a step further and say, “Well, knowing what I know about omeprazole, I will try to formulate it in such and such a way, specifying ingredients, methods and so on”, then you have strayed into the area of attempting to solve the problem rather than the area of stating the problem.  We say that attempts to solve the problem which had not become part of common general knowledge are not part of the information that the notional skilled worker in the art uses for the testing of obviousness.

Now, a related reason is this.  As the Court has heard, the case gives rise, from the point of view of the formulator, to a complex of problems and different formulators might decide to try different approaches.  As the evidence makes clear, at almost every stage of any hypothetical attempt, however you try to formulate it, there are multiple choices.  What will actually happen depends on what the actual skilled worker does in respect of those multiple choices.

So while the Court has held that the notional skilled worker would eventually have got there, it does not follow and, indeed, is contrary, we would to say, to the evidence and the findings of the Court that everyone got there in the same way.  Both at first instance and on appeal the courts accepted the proposition that the research was complex with dead ends and so on. 

Now, it therefore, in our respectful submission, in the circumstances of the present case, makes no sense to choose a single hypothetical set of tests which might have been performed because there is no reason to suppose that what one chooses would be those chosen by any particular formulator or formulators in general.  For that reason also, we say the distinction must be carefully preserved between a statement of the problem and an attempt to provide a solution.

It has also occurred to me that in a couple of places I used a phrase which may be open to misconstruction.  It occurs first on page 66 at line 2965.  I refer in a compendious way to “various instabilities of omeprazole and its low solubility in water”.  I should make it clear that when I referred to instabilities there, I was concerned with the physical and chemical properties of omeprazole, including the fact that it breaks down in the presence of moisture, that it breaks down in the presence of acid, that it breaks down in the presence of heat.  I was not intending there to refer to instabilities of any form of omeprazole as actually formulated.

Equally, at the following page, page 67, at line 2981, where I referred to:

Depending on what formulation was tried, there was sometimes instability during the process of formulation –

I was there referring to omeprazole in the environment provided by the rest of the formulation, but I was considering the instability of omeprazole itself.

At page 73, your Honour Justice Kirby put to me a question about whether there was a policy reason to loosen up the 3M test in the light of modern scientific developments.  I dealt with that in part, but I would wish to add this, that this is a matter which, in our respectful submission, has been dealt with by statute.  The Patents Act 1990, in section 7(2) and (3), enlarges the scope of the prior art which is available for consideration on the issue of obviousness. But that is a statutory development and, in our submission, it is not one which, we respectfully say, lends itself to being incorporated by way of a common law development into the old statute.

Parliament has altered the law in this respect with regard to patents granted under the 1990 Act, and subsequently, but it has not altered it with regard to patents granted under earlier Acts.

We would also note in the context of that particular matter that the actual change that was introduced by Parliament is not, of course, the sort of change which we say is inherent in the approach adopted by the courts below in the present case.  This is another reason why as a matter of public policy one would submit that it is inappropriate that by way of statutory interpretation one should read into the 1952 Act the matters which, in our submission, were read into it by the courts below.

If the Court pleases, if there are no further questions, those are the submissions for the appellants in this matter.

GLEESON CJ:   Thank you, Dr Emmerson.  Yes, Dr Bennett.

MRS BENNETT:   May it please the Court.  Your Honours, the words of the section that we are construing or dealing with here are, as your Honours have been taken to, whether or not the invention as claimed was “obvious and did not involve an inventive step”, having regard to what was known or used in Australia at the priority date.  That is a compendious expression, “obvious and did not involve an inventive step”.  One could say it was a hendiadys.  It is certainly an expression that has been considered by this Court and by other courts, in particular in a number of unanimous decisions of the Full Federal Court, as to what that conveys, drawing upon the historical development that led to that terminology being inserted in the 1952 Act.

There are a set of well‑developed principles as to what that conveys and what is required to fulfil the requirement of inventive step or lack of obviousness.  The propositions being put by the appellants in this case are in complete contradiction to every aspect of the development of that expression.  It is not a principle, as they have put it, that has been adopted in any court in this country so far as we are aware.  It is certainly antithetical to the development of the law here and to the development of the law overseas in other jurisdictions, as we will be taking your Honours to.

Further, what the appellant is seeking to do is to reargue in this Court the decision of Wellcome v VR Laboratories which is, of course, a unanimous decision of the Court and none of the conditions that they would need to fulfil as referred to in John v Federal Commissioner of Taxation have been complied with.  It is a unanimous decision.  It has been applied by, as we will show your Honours and we have referred to some of them in our written submission, it has been followed by a number of unanimous Full Federal Courts, a number of single judges.  It is described as a “routine” test, if I can call it that, in effect, in the Patent Office manual.  It is certainly in accordance with the test in textbooks and it mirrors, in effect, the development in the United Kingdom.

What I propose to do, your Honours, is to take you through a number of individual headings some of which, of course, will coalesce, to develop what we say in this case.  The first will be to look at the law of obviousness and lack of inventive step as it has been developed and applied.  We will then look at the question of the nature of the art and the skill of the calling of the hypothetical addressee.  We will then take your Honours to the patent itself which, as we note, is a matter that we put before this Court.  The appellant did not choose to even present that in the appeal books, as they have chosen not to put in the evidence.  We will take your Honours through that and the problem that the patent says it is seeking to address.  We remind your Honours that this patent is not the patent for omeprazole.  Omeprazole was the subject – which is a very worthwhile drug – is the subject of a separate patent, what was referred to as the compound patent.  It has had a full 20 years monopoly during which time, as your Honours will see from the judgments, there has been what can only be described as very large remuneration to the appellants in respect of the invention.

CALLINAN J:   Doctor, in relation to the expiration of that patent, when did your clients first seek to market their product?

MRS BENNETT:   Your Honour, first reminding your Honour that nobody could do anything with omeprazole at all while the compound patent was current.

CALLINAN J:   That is why I want to know when it expired.  When did the patent expire?

MRS BENNETT:   The patent expired in 1999.  It was because our client was proposing to market it and put in submissions to the requisite authorities in Australia that this matter was brought on as a matter of such urgency.

CALLINAN J:   That is what we want to know.  When, in relation to the expiration, did your clients put in submissions then?

MRS BENNETT:   Expiration?

CALLINAN J:   Yes, expiration.

MRS BENNETT:   The compound patent was due to expire I think in March or April.

KIRBY J:   Of which year?

MRS BENNETT:   Of 1999.

CALLINAN J:   I just wanted the chronology.  When was the application for the patent made by the appellants?

MRS BENNETT:   This patent was originally filed in 1979 I think, your Honour.

CALLINAN J:   No, no.

MRS BENNETT:   This patent?

CALLINAN J:   This patent, the one in suit.

MRS BENNETT:   The patent in suit was filed in, sorry, 1986.

CALLINAN J:   1986.  The patent for the actual drug itself expired in 1999.  When did your client make the first step, or take the first steps towards ‑ ‑ ‑

MRS BENNETT:   It would have been 1998.

CALLINAN J:   1988.  When the expiration of the other patent was imminent.

MRS BENNETT:   Was due to happen.  We should add there is another matter in the chronology and that is that 10 years after the grant of this patent, the patent in suit, the appellant sought the amendments that we have put into the supplementary appeal book.  So 10 years after the grant of this patent, they sought substantial amendments and did not commence proceedings until a very short time, I think a matter of weeks, after those amendments were granted.  They waited until then to commence proceedings and that then led to the urgency before Justice Lehane that he referred to in his reasons.

Your Honours, the next subject matter that I will deal with as I go through is the law as it is and as it exists and the effect of it, of the lack of relevance of the steps taken by the inventor.  It is a primary principle in patent law, as it has been developed to date, that the actual steps taken by the inventor are not relevant to the determination of the question of obviousness and inventive step, unless, as here, one can see that the steps taken by the inventor reinforce the evidence of the hypothetical skilled addressee and help the revoker to establish a lack of inventive step and obviousness.

The next area that I will deal with is the way the case has been run by the appellant.  Your Honours will see that there has been a marked shift in the way the appellant has presented its case.  For example, to Justice Lehane the appellant proposed that the appropriate test was the “routine steps” test that was set out at page 286 of Wellcome.  They then appealed to the Full Court – and I will come back to this in more detail – on the basis that his Honour failed to apply the principles of both 3M and Wellcome and it is only in this Court that they have now fallen back to ignoring Wellcome, saying that that was wrong and that your Honours should apply a more rigid test that they say arises from what we will call 3M, which is the Minnesota Mining Case.

I then propose to deal shortly with the facts of the case.  Of course your Honours will appreciate that not only those concurrent findings of fact but, as your Honours will see from the reasons below, they were unchallenged.  The only evidence that was called before Justice Lehane with respect to the hypothetical skilled worker was the evidence called by Alphapharm.  Astra did not seek to, or could not, bring evidence from a practical formulator in Australia to say that there was anything inventive or non‑routine about this alleged invention at all, and that the assertions of the Alphapharm witnesses – and I will deal with the various ways in which the test of obviousness was established in fact – were not challenged, and in the Full Court that was set out in some detail.

I will then take your Honours to the reasoning of Justice Lehane and of the Full Court and, with great respect, it is necessary to do so because one thing, in our respectful submission, one must be careful of ‑ and your Honours would see it more often than I – is not to take individual sentences from a judgment out of context, because when one looks at the totality of the reasons below, both of the first instance judge and the unanimous decision in the Full Court, your Honours will see that there was no misapplication of principle.

GLEESON CJ:   Is the essence or the bottom line of your argument that this represents an impermissible attempt to extend the patent for omeprazole by getting patent for a combination that will deliver it to the gut?

MRS BENNETT:   Well, it is an impermissible attempt because – yes, because it is a mere formulation that they are seeking to strap up, if I can call it that.

McHUGH J:   There is nothing to stop you from inventing another combination patent different from the patent in suit which makes omeprazole efficient?

MRS BENNETT:   Your Honour, there are reality reasons why one does not do that.

McHUGH J:   Commercial?

MRS BENNETT:   It is not only commercial.  Your Honours will be aware that after patents expire generic formulations do come to the market.  They are, as a matter of fact, the subject of a great deal of news and relevant so far as the PBS is concerned.  In order to get a generic product accepted by the Australian Drug Evaluation Committee my understanding is that you have to show the same bioavailability and matters such as that as what is called ethical compound that has gone through.

So, practically speaking, one needs really to deal with formulations as to which there has been safety and efficacy testing established, and the sort of matters, I think, Justice Hayne referred to yesterday – what is in America called FDA approval – so that realistically and practically, generics tend to follow the same formulations.  So that does not mean, with great respect, that it necessarily leads to a question of – it does not shed any light on the questions of obviousness and inventive step.

Your Honours will then go to the overseas position, and deal not only with the way in which this patent has been dealt with in other jurisdictions.  Applying the same analysis, as was applied by the courts here, and that is looking at the question of whether the hypothetical skilled worker would, as a matter of routine steps, have arrived at the invention.  We did set up a schedule of that in our submissions and there has been a response.  We will give your Honours the various decisions.

While there has been different findings of fact in some of the jurisdiction, the test is relevant and we will take your Honours to the fact that, in fact, we would be out of kilter with the rest of the world including what has developed to be our “TRIPS” position if your Honours were to take the more restricted test suggested by the appellant.

We will also deal, in that regard, with our notice of contention which really deals with the question of whether or not the basic results of a literature search that would, as a matter of fact, have been conducted as the first step by the hypothetical skilled formulator using the Internet is relevant to the question of obviousness and we will take your Honours to a recent English decision where the exact issue has been dealt with.  Then we will deal with some matters of policy, those that have not been dealt with by implication during the previous subjects, and then I will deal with an area that I am calling “odds and ends” which are matters that my friend has raised that I will not have otherwise have specifically dealt with during the course of my submissions.

If I can take your Honours now to the question of the law of obviousness and lack of inventive step, as it has been developed and applied.  We do point to two things in the words of the statute itself.  We have already referred your Honours to the fact that it is a compendious expression.  Our learned friends seek to restrict the word “obvious” to the most narrow meaning possible – that is not the way it has been dealt with – and our friends ignore the fact that it is a compendious concept ‑ ‑ ‑

McHUGH J:   Well, you say that, but if you go back to the late 19^th century, where Lord Herschell described obviousness in the sense that he would see the solution – “at once” was the phrase he used – “at once”. 

MRS BENNETT:   Your Honour, in some particular examples, when you are looking to see what constitutes obviousness in that context – for example, if it is something remembered from a dream or a mechanical combination that one puts together in one go, yes, one can look to see whether it was “at once”.  But in an experimental art – and this is what Sir Keith Aickin was dealing with in Wellcome – that is simply not appropriate. 

What the courts have developed – and I will take your Honours to it ‑ is the fact that one must look at the test and adapt it to the particular subject matter.  So that while sometimes, in one particular case, yes, one could look at it as at once, there are other ways of looking at it that must be used, with respect, to see whether – because what we are looking to see is whether there is an inventive step; whether or not what the patentee has done is sufficiently beyond the skill of the calling to give that person a monopoly for 20 years for something that simply might be new but might not contribute anything in the sense of crossing a barrier.  I will develop that, your Honour. 

That submission has been put to the English Court of Appeal in the case of General Tire, as to the meaning of the word “obvious”.  I should say this – and I will come to that case now, after one more sentence, if I may, just to pick up something else in the statute.  The other expression, of course, is it is having regard to what was known or used.  As I think I said earlier, that does not mean simply “compared to”, but having regard to not only what was known but what was done.  I think your Honour Justice Kirby mentioned yesterday the expression “known or used”.  In the 1990 Act that has been divided up in the definition of prior art base into publications and acts done. 

McHUGH J:   But one thing we have to be wary of, as Justice Kirby often points out, we have to give effect to the parliamentary term and not the judicial glosses on it.  Merely because English courts put a gloss on terms, or if statutory terms just do not work too well in particular fields because of developments in that field, is really by the way, is it not?  We cannot be changing the meaning of Acts of Parliament. 

MRS BENNETT:   We are not asking your Honours to change the meaning of Acts of Parliament.  The word “obvious”, standing alone, is not restricted to the meaning that our learned friends have put – and I will develop that. 

McHUGH J:   Nothing strikes me, Dr Bennett, as being obvious, or something does not strike me as obvious, if you go along one path and you find, no, I could not find my terminus there, and then I come back and I go down another blind alley, and then I come back, and then finally I get there.  That does not seem to me to be obvious. 

MRS BENNETT:   As the test is applied of obvious and lack of inventive step, the test that has been – your Honours can rewrite the law of 3M and Wellcome, of course, with respect, but the test that has been applied dealt with, developed and applied, in looking at how the expression “obvious and inventive step” came into the statute.  Now, that is a decision of which Justice Gummow was a part initially in Werner v Bailey.  I will take your Honours to that.  We have referred to it in our submissions.

But just taking the point about the dead end and retracing of steps, which I can see has been picked up, of course, by our learned friends and mentioned a few times, one has to look at that when applied to the skill of the worker in the art.  Now, your Honours, with great respect, when you look at any realistic experimental program of any sort, one inevitably in the real word gets oneself into a position of what could be described as a dead end and retracing of steps. 

Let me give you an example.  I may have a compound.  I may believe that it can be dissolved in, let us say, one of three different solvents.  A tri‑solvent I might take a long time to extract it.  I might have to sit around on my machine for three or four hours or a day to see if the peaks come out to show that I have succeeded in extracting it and it is not there.  That is a dead end.  I then go back to my compound.  I extract it in a separate solvent.  It does not work.  Again, it is a dead end and a retracing of steps.  That can be done without there being any invention or any inventive step in the course that I am taking. 

If I can draw a little bit on what was put yesterday, without wishing to take the analogy with lawyers too far, I can look at a judgment and see that a number of cases are cited in that in support of a proposition.  So I can leave my chambers.  I can walk to the Supreme Court library, look up one of the cases cited and see that it does not, in fact, support the proposition that was put.  That is a dead end.  I then walk back.  That is a literal retracing of my steps.  Then I start again and I find the next case. 

One has to look at what the skill of the art is, what is the nature of the art first.  The nature of the art is experiment.  Not every series of experiments is worthy of a patent.  One has to look and see what the nature of skill of the art is and, bearing in mind the application of that art, whether or not there was truly something beyond the skill of the calling.

McHUGH J:   This argument logically seems to lead to a conclusion that, contrary to the prevailing learning, there is a difference between inventive step and obviousness and that non-obviousness is not a synonym for inventive step.

MRS BENNETT:   Your Honour, if truly it is a hendiadys, then one has a concept that is being dealt with overall in the expression, the expression being “obviousness and inventive step” together.  Your Honour, I appreciate ‑ ‑ ‑

CALLINAN J:   I will tell you my problem about that expression, taking up what Justice McHugh has just asked you.  “Obvious” seems to qualify the manner of new manufacture, using the definition.  “Invention” is defined as manner of new manufacture.  “Obvious” seems to qualify that, whereas “inventive” seems to qualify a step or steps. 

Now, the meaning that presents itself to me, just reading those words without the instruction of the judicial gloss on them, is that the manner of new manufacture might in itself perhaps be obvious, but that there may be a step in reaching that manner of new manufacture or in the manner of manufacture which itself is inventive, leaving aside any authority on it at all, and therefore revocation would not be available.

MRS BENNETT:   Your Honour, part of the answer is in looking to see how the words came into the statute and what development of the law led them to be there and part of that analysis is that what used to be called absence of subject matter – there used to be a concept of new and novelty and then the courts developed the concept of absence of subject matter, and it was ‑ ‑ ‑

McHUGH J:   Want of subject matter is the ‑ ‑ ‑

MRS BENNETT:   Or want of subject matter, sorry, your Honour.

HAYNE J:   But to conduct the debate at that level is to conduct it at a level of abstraction that obscures more than illuminates.  The invention with which we are presently concerned, or the subject matter which we are presently concerned, seems to me to have three elements:  core with alkaline reacting compound, inert sub‑coat, plus enteric coating, and the invention is said to lie in the combination of those three elements.  Now if we speak either in the metaphor of dead-end and retracing steps, that has no utility unless we know whether the dead-end and retracing of steps is in relation to choosing a particular form of inert sub‑coat one over another.  That, I can understand, is something that might well occupy the time of a formulator, but be not instantly relevant to the question of whether the combination of core with alkaline reacting compound, plus inert sub‑coat, plus an enteric coat, is an invention.

MRS BENNETT:   Well, perhaps I can deal with that in two ways, your Honour.  The first is this:  certainly, on the facts as found, part of this discussion maybe unnecessary, because if one looks at the nature of the problem in the patent, which is that after you have a conventional formulation of an enteric coat on an alkaline reacting core, there was a problem.  That is what the patent says; there was a problem on long‑term stability.  Everything else was okay, but they have got a problem on long‑term stability.  The evidence is clear that the solution to that problem was obvious in even the most narrow sense to the hypothetical formulator, because as soon as that problem was presented to the hypothetical formulator, in each case he immediately said, “Well then I would assume there is an interaction between the two and I would separate it.”

HAYNE J:   The interposition of the inert sub‑coat is said to be the obvious step ‑ ‑ ‑

MRS BENNETT:   That is right.

HAYNE J:    ‑ ‑ ‑but therefore the critical step in this case becomes, does it not, the identification of the problem that is to be given to the notional addressee, not a debate about the history of the law or where it comes from or the meaning to be assigned to general tags commonly employed in the field.

MRS BENNETT:   Your Honour, with respect, we would adopt that up to this point and then say that in any event we are still okay and it is this way:  certainly if one takes the findings of fact as found, if one talks in the terms of the Full Court, that the first two integers were a given, yes, then that is the answer.  The first two integers were a given, the only problem arose with a third.  Yes, as a matter of fact, when applying any test, that is obvious and the test is satisfied.  In any event, however, even if one goes from the very beginning of the act of formulation, we say that the test is still satisfied, even if one says that the problem is starting from the very beginning with omeprazole, we do not concede it is because we say that, on any view of the facts it is not, but we say that no matter whichever problem one takes as the starting point, it is quite clear that the trial judge initially and in the Full Court in relooking at the facts, where the requirement is for the judge to be satisfied that the hypothetical worker would, as a matter of routine, get from the prior art to the invention, then that test has been satisfied without doubt, whichever the starting point is.

KIRBY J:   I take Justice Hayne’s point about levels of abstraction, but for my own part it would be helpful to have just perhaps a short reference to the history.  I can see why as a matter of policy obviousness is there.  Answer:  it is there because if it is obvious you should not get a monopoly right for an extended period.  But it would be helpful to me at least to have reference to what Justice Gummow said in that case and to know the history of how it came in, not necessarily at any length but just a thumbnail sketch of how it came in, whether it has been common to our Acts going back to the earliest legislation and whether it is the common feature of international patent law, as I understand it is.

MRS BENNETT:   Your Honour, perhaps to deal partly with this meaning of “obvious”, first we have referred in our written submissions to the fact that both here and in the United Kingdom the word has not been given even as a word the meaning attributed to it by the appellants, the narrow meaning.  Justice Burchett originally in the Tidy Tea Case, then sitting in a Full Court in Elconnex and then again in the Nappies Case, Kimberley‑Clark, of which I do not have such happy memories, used the expression “obvious” in the sense of lying in the way, the idea of it being on a road to an end, citing a Latin derivation. 

The appellants have pointed out that according to the dictionaries that meaning is obsolete, but it is certainly a meaning that has been applied in looking at what is meant by the word “obvious” in this sense.  It is also a meaning that has been applied by the British courts in Philips’ (Bosgra’s) Patent that we have referred to in our submissions, and recently again by the English Court of Appeal in the Genentech Case, again looking at the word “obvious” in that sense as a word alone.

McHUGH J:   The Genentech Case, a judgment of Lord Justice Mustill back in 1989.

MRS BENNETT:   I cannot recall if it was Lord Justice Mustill.  I think it might have been Lord Justice Dillon.

McHUGH J:   Where he spoke about it being like a bet on a horse.  It stuck in my mind.

MRS BENNETT:   I cannot recall that exact expression, your Honour, but the majority in that case dealt to some extent with – it was one of the first cases that ever dealt with molecular biology in the context.  Of course, one can see how the word “obvious” in that narrow sense would be totally inapplicable to the nature of an art like molecular biology.  Let me come back for a moment to the case ‑ ‑ ‑

KIRBY J:   Is that the point, that the statute, even the 1952 Act, has to, as it were, adapt to the changing nature of the science to which it has to apply, the technology to which it has to apply?

MRS BENNETT:   Your Honour, in fact it has been adapted that way.  It has always been construed that way, in a way that allows it to adapt and it has adapted since its introduction to many different areas of technology, because it is not just looking at the word “obvious”.  One could argue it the other way, with respect, and say, “Let’s look at the words ‘inventive step’.  Let’s see what that connotes”.  If, as is accepted by the appellants – and, with great respect, I understand what your Honours are saying, that there are two words there, but if “obviousness” is the antithesis of “inventive step”, then one needs from the very fact that it is a composite expression to take the broader view of the meaning of the word “obvious”.  That is in a way what the Court of Appeal did in the well‑known English case of General Tire.

McHUGH J:   General Tire is a case where it was already known that polyesters for electrical insulation could be made from reagents that were members of a particular chemical series and it said there was no inventive step if you worked out that there were substitutes in that series.

MRS BENNETT:   Your Honour, what I would seek to do for the moment is to take the Court to where this particular point of the word “obvious” and what the expression means, in the same expression in the 1949 Act. I think your Honours should have it, it is at [1972] RPC 457. If I can take your Honours to page 497.

McHUGH J:   I am sorry, I had in mind the General Electric Case.

MRS BENNETT:   Your Honours will see that the expression in the English Act is the same.  Much has been said about the difference, or my learned friends pointed out there has been some difference in the development of the English law, and I will come to that when dealing with the Cairnstores decision, but the fact is that the only changes in the English law relevantly are to the nature of the prior art base.  The law as to what constitutes obviousness and inventive step itself, other than what you can bring to bear on it, remain the same.

Your Honours will see under the heading “OBVIOUSNESS” at page 497 the section is referred to, then at line 25 this is said:

In relation to the word “obvious” we were assisted by Sir Lionel Heald reminding us as to how this word came to be introduced into patent law –

They then refer to Vickers v Siddell:

There were also cited to us a considerable number of cases in which the meaning of this word was discussed in relation to particular facts.  We agree, however, with what was said by Diplock, L.J. (as he then was) and Willmer, L.J. in the Johns‑Manville case . . . at 493 and 496 deprecating “coining” phrases which may later be suggested to be of general application.  “Obvious” is, after all, a much‑used word and it does not seem to us that there is any need to go beyond the primary dictionary meaning of “very plain”.

When head (f) is invoked it is, of course, as previously indicated, for whoever seeks revocation of a patent to show that the alleged inventive step was obvious to a normally skilled addressee in the art.  On the way to that end there are here a number of preliminary questions to be resolved.

Pausing there, in our respectful submission, what the court is doing is drawing a distinction between the mere word “obvious” and its presence in section 32(1)(f).

These include the common general knowledge to be imputed to that addressee; whether what had to be done to achieve the step was truly a matter of inventive experiment or merely a matter of that type of trial and error which forms part of the normal industrial function of such an addressee; what documents he would find in the course of such researches as he would be expected to make; and how he would regard those documents in the light of common general knowledge.  Then finally one has to consider whether the step is properly described as a new combination of integers or merely as a collocation of old ones. None of these questions, some of which inevitably overlap, is easy to resolve, and on each it is for the appellants to establish their contentions.

As regards obviousness as a whole, the trial judge approached the matter correctly when he said:

“The question of obviousness is seldom easy to decide.  It has been said to be a kind of jury question and, in the days when patent actions were tried before a judge and jury, was treated so.  The decision is ultimately one for the court which cannot let its function in this respect be usurped by the witnesses, though undoubtedly the evidence of the witnesses may help the court to arrive at its decision.  It must be decided objectively and, being a jury question, it is right that all the relevant circumstances of the case should be taken into account.  That this is the correct view of the matter is clear both from the old cases and the new.”

CALLINAN J:   When were cases first tried by the Privy Council, patent cases?  They were tried by the Privy Council for a long time were they not?

MRS BENNETT:   I am afraid I cannot answer that, your Honour.

CALLINAN J:   It ceased to be a jury question a long time ago.

MRS BENNETT:   No, your Honour.  With respect, it has not ceased to be – sorry, in terms of being tried by a jury?

CALLINAN J:   Yes.

MRS BENNETT:   I do not know when that ceased, but there has been continuing reference to the concept of obviousness being a jury question and indeed Sir Keith Aickin referred at that specifically in the Wellcome Case.

GUMMOW J:   There is a case in the 1890s in England which says the practice should stop.  No more juries.

MRS BENNETT:   No more juries, yes, of course.  Part of the problem is in the United States that the juries continue to hear patent cases.

GUMMOW J:   It continues in the United States to this day.

MRS BENNETT:   Yes, it does.

KIRBY J:   That is for constitutional reasons, presumably.

MRS BENNETT:   It also makes it very difficult to argue for some of the concepts in the patent cases and the technologies.

KIRBY J:   Yes, but it might be contribute to finality.

MRS BENNETT:   We say that it contributes to finality in this case because of the concurrent findings of fact.  Bearing in mind, we would submit, that it is ultimately a finding of fact in that sense as to whether or not there was obviousness and lack of inventive step in this case.  As such, it is a matter with which, with respect, this Court should not interfere under the principle of Louth v Diprose.  We also of course refer to what was said by Lord Hoffmann in Biogen v Medeva which of course was a patent case where his Lordship specifically referred to the fact that obviousness is a jury question and therefore not one with which courts of appeal should lightly interfere with the decision of the trial judge.

CALLINAN J:   Doctor, to say that an alleged inventive step was obvious seems to me to be tautological.

MRS BENNETT:   They are antithetical.

CALLINAN J:   Tautology.  If it is inventive, it is not obvious.

MRS BENNETT:   That is so.  That is why we say it is a compendious expression, seeking to deal ‑ ‑ ‑

CALLINAN J:   It seems to be tautological to me, on the way in which you would have it construed.  It really does not give “inventive step” any work to do.

MRS BENNETT:   We say it does give “inventive step” the work to do because in fact the question that first needs to be assessed is whether or not there was an inventive step and then, if there was not an inventive step, one can say it was obvious.

CALLINAN J:   That would be the end of it, if there is no inventive step.  You do not need any reference in the section to “obvious”.

MRS BENNETT:   Your Honour, perhaps ‑ ‑ ‑

CALLINAN J:   It may be, as you say, it is simply the outcome of the history of all the glosses upon the statute of monopolies.

MRS BENNETT:   Your Honour, it is a complex expression and ‑ ‑ ‑

CALLINAN J:   It seems to me to be a very plain expression.

MRS BENNETT:   It is a complex concept, but perhaps the best way to deal with it is to look at the way it has been developed and dealt with by courts who probably, with respect to them, have dealt with it more clarify than I, then I will come back to any residual questions that your Honour may have.

CALLINAN J:   The authorities are there and I am bound by them.

MRS BENNETT:   Your Honour, what we did in our written submissions was refer generally, quite broadly, at paragraph 33, to some of the cases that have dealt with the question of what is required to establish obviousness.  Probably the first case that dealt with it quite fully – although we have not put out a list of authorities because we did not realise ‑ ‑ ‑

CALLINAN J:   Well, just give me the reference to them.  I will not take up your time.

MRS BENNETT:   It is Werner v Bailey – in the decision of Werner v Bailey which was primarily a decision of both Justices Lockhart and Gummow, the question of the development of the law of obviousness was looked to and is development from the concept of want of subject matter. 
Justice Lockhart in an expression that has been oft cited since that time said that there must be “some barrier crossed” for the concept of obviousness –or non-obviousness ‑ “some barrier crossed”.  Your Honours will see at paragraph 33:

There must in fact be “difficulties to be overcome” requiring what is called invention, or there must be some ingenuity in the mode of making the adaptation” ‑

That is the older decision of Riekmann v Thierry ‑

“Novelty alone will not sustain a patent.  There must in addition be some difficulty overcome, some barrier crossed” ‑

from Justice Lockhart –

the claimed invention must be “beyond the skill of the calling” –

that was an expression used in the United States that was adopted by a unanimous Federal Court in Allsop v Bintang, to which I will come, and has been cited frequently as a test of obviousness –

there must be an exercise of inventive faculties to produce the claimed invention, determined by the person ‑ ‑ ‑

GUMMOW J:   We can all read these passages, surely.  It is a quarter past 11.  It seems to me, sooner or later, we have to get down to some specifics.

MRS BENNETT:   Your Honour, I appreciate that.  I have been asked to deal with the development of the law of obviousness.

GUMMOW J:   His Honour asked you to give him a reference, without reading out pages.

GUMMOW J:   Just me the references.

MRS BENNETT:   Very well, your Honours, if I can refer your Honour to the cases that have been referred to in paragraph 33.  We would also refer your Honours to the decisions of the Full Court which in each case were unanimous decisions in Allsop v Bintang which I think is on our learned friend’s list of authorities ‑  and I may come back to that very shortly – to Grace v Asahi, a unanimous decision of Justices Northrop, Lockhart and Cooper in 25 IPR 481 and in ICI v Lubrizol (2000) 106 FCR 214, a unanimous decision of Justices Lee, Heerey and Lehane.

GUMMOW J:   Looking at General Tire at page 497 which you took us to, is there any evidence in the present case as to what form the normal industrial function of an addressee being a formulator?

MRS BENNETT:   Yes, your Honour, there was a finding as to the skills of the hypothetical skilled formulator.

GUMMOW J:   No, no, the normal industrial function when faced with a problem?

MRS BENNETT:   Your Honour, the evidence was that the normal function of a ‑ ‑ ‑

GUMMOW J:   Any finding on it, to be more precise?

MRS BENNETT:   Yes, that an Australian formulator was a person skilled in the art of generic formulation, because there are no major pharmaceutical companies here, and that the normal work involved in formulation was complex of its own nature and was rarely something as a matter of every day formulation ‑ if I can call it that ‑ that was straightforward.  If I can refer your Honours to page 63 of the appeal book at paragraph 104.  This deals with some of the specific matters.

GUMMOW J:   This seems to me to be the starting – well, the second point.  The first point is the problem.  This is the second point; what would you do about it?

MRS BENNETT:   Yes, your Honour.

GUMMOW J:   You are running an obviousness case in this area.  Now is there a finding on this?

MRS BENNETT:   I beg your pardon, your Honour? 

GUMMOW J:   Is there a finding? 

MRS BENNETT:   This is under the heading of “Discussion”, so it is basically Justice Lehane’s reasoning.  His Honour says at page 63, lines 7, 8: 

The evidence also leaves no room for doubt that formulators working in Australia before the priority date knew that a compound which tended to degrade in acid or neutral media –

et cetera.  Then he goes on to the claimed combination.  The Full Court dealt particularly with the statement of Professor Rees, who was a witness called by the respondent, as to the general nature of formulations.  So part of the normal industrial function was to fulfil that formulation, and that was ‑ ‑ ‑

GUMMOW J:   But how do they go about doing it?  That is what I am trying to find out. 

MRS BENNETT:   I beg your pardon? 

GUMMOW J:   How do they go about doing it?  What is their ordinary function? 

MRS BENNETT:   The ordinary function is to take ‑ ‑ ‑

GUMMOW J:   What is the evidence, and what is the finding?  If there is not one, just say so.  If there is one, tell us.  I do not think there is. 

MRS BENNETT:   I beg your pardon? 

GUMMOW J:   I do not think there is, at the moment, but there may be.  That is why I am asking you. 

MRS BENNETT:   His Honour Justice Lehane discussed the evidence that was given by each of the formulators as to what that formulator would normally do in getting a new generic drug – which is the skill of the formulator in Australia in getting that to formulate.  In a general case, his Honour accepted the evidence of Dr Rowe, in particular – we will start with him – that the first thing that he would do would be a routine literature search against the word “omeprazole”. 

GUMMOW J:   Now, where do we see it? 

MRS BENNETT:   Yes, your Honour. 

GUMMOW J:   It is no good telling me.  I have to see it myself. 

MRS BENNETT:   All right.  If I can take your Honour to appeal book, page 44, paragraph 64: 

Dr Rowe described the steps which, he said, he would have taken to formulate a dosage form of omeprazole before the priority date using only the knowledge and materials that he had, or to which he would have had access, before the priority date. 

He then refers to a literature search; he then says, over at page 45, at line 10: 

He would then have conducted pre-formulation studies on omeprazole. 

He then said: 

that he would have learnt from Pilbrant and Cederberg (or by standard laboratory testing) –

which is important.  That he would have done standard laboratory testing to ascertain the characteristics of omeprazole –

That would have meant that an enteric coated dosage form would have been ideal because, once it had passed through the stomach, it would dissolve rapidly and be bioavailable.  Formulators had, before the priority date, experience in enteric coating acid labile drugs (that is, drugs which degrade or decompose in an acidic environment):  in this respect, to work with omeprazole, though different in detail and degree, would be similar to working with any other acid labile –

drug.  “The next step”, paragraph 66, would be to test it for stability.  Refers to the “standard test”: 

If the tests revealed diminution in potency, it would have been obvious either that the drug was unstable in the solid state on its own or that it was interacting with something in the formulation. 

He would have conducted further tests, he would have considered a reaction with the enter coated film – the most likely problem – and the “obvious answer” would be: 

“to coat the core material with a water soluble film – ”

Then over the page, at page 46, in the first line: 

Knowing that the drug was most stable in an alkaline environment, Dr Rowe would have considered the addition of a basic (alkaline) compound to the core before coating. 

KIRBY J:   The problem with this is that his Honour then goes on to describe what Dr Story would do, and then what Dr Marshall would do.  Now, does he ever come to a synthesis in his own findings ‑ ‑ ‑

MRS BENNETT:   Yes, he does. 

KIRBY J:    ‑ ‑ ‑ as to what he says he finds is what would be expected of an Australian operative? 

MRS BENNETT:   Yes, he does.  Your Honour, if I could just lead into that with this, without reading out obviously everything that his Honour says.  He then deals with – the evidence was called by different hypothetical formulators given different tasks.  All his Honour had to do was to be satisfied himself that a hypothetical formulator would, as a matter of routine, have gone from the prior art or common general knowledge to the invention.  As that is a key matter of the test to be applied, I will have to come back to that and deal with the law on that in due course.  So he accepts the evidence of Dr Rowe.  He then refers to ‑ ‑ ‑

GAUDRON J:   Where does he accept that and does he accept all of it?  I am just looking at page, I think it was 44.  He was asked to give his opinion of what he believed formulators in Australia would have done if faced with that task, which seems to me to be the question that is raised in General Tire, the normal industrial function.

MRS BENNETT:   Yes, your Honour.

GAUDRON J:   Did he give that evidence as well, not just what he would have done, what others in Australia would have done?

MRS BENNETT:  Yes, his evidence was framed in those terms and, indeed, at page 45 in paragraph 65, line 20 his Honour refers broadly to it in part, where he says, “Formulators had”, so he is talking broadly about formulators.  The evidence of both Drs Rowe and Story was couched in terms of what they would have done and gives the reasons why they could speak broadly for formulation.  Dr Story then, your Honours will see at page 46 in paragraph 68 at line 43 ‑ ‑ ‑

KIRBY J:   Is not the finding at page 63 in paragraph 104 where he says ‑ ‑ ‑

MRS BENNETT:   It goes on from there.

KIRBY J:   ‑ ‑ ‑ that:

The evidence also leaves no room for doubt that formulators working in Australia before the priority date knew –

this and that, and “No doubt I may take it” he starts in 105.  Is this where he actually comes to having reviewed the testimony to his own conclusion?

MRS BENNETT:   Yes, it is, your Honour.  If I can just before moving to that just answer one more point for Justice Gaudron.  At page 46 in the evidence of Dr Story you will see at line 44, in his evidence he said:

this reinforced my view that this opinion would be shared by other –

formulators, in talking about whether or not it would be obvious.  He then goes on to talk about:

The need –

generally –

to take into account the physico-chemical characteristics of the active compound, and the ‘problems’ –

and at page 47 at paragraph 69:

Dr Story described his approach to formulation (and the approach which he said he would have adopted in formulating omeprazole) in terms –

similar to Dr Rowe, and then goes on at line 16 to talk about:

and based on my experience, every ‘hands on’ formulator –

and so there is specific evidence going to that.  Dr Marshall – if I can just before I go with respect to the conclusions.  So we have those two different formulators that the judge and others, Drs Thiel and Ashley that were referred to as well, that gave evidence as to what the hypothetical formulator would do.  So we have more than one of them.  Your Honours will appreciate or I can tell your Honours that in every case of which I am aware the test for the hypothetical formulator has been a test of taking the appropriately skilled person in the art and asking them to take the steps hypothetically.  That is what most of the witnesses in this case did.

To my knowledge for the first time in this case we put in another kind of witness.  We took Dr Marshall, who was cocooned.  He was not given the formulation patent.  He was simply asked to go right back to the very beginning and apply whatever he knew at the priority date and start from scratch.  I will come to his evidence in due course.  He did not take six goes to get there.  He wrote six reports, because the first one was, “Well, this is very generally what I do.”  In fact he got there in six very simple reports and he got there in one go when the problem was presented to him.  I will come back to that.  But what Justice Lehane used Dr Marshall for was to fortify his conclusions based upon the standard hypothetical test.  That is what it is.  It is for the judge to be satisfied, as Justice Lehane was and as the Full Court was – the individual judges or the judges unanimously – that that test was satisfied and that as a matter of fact that the hypothetical formulator with the skill in the art in Australia would get there.

HAYNE J:   Dr Bennett, let there be no misunderstanding.  One of the difficulties I confront in this case is being persuaded that at trial and at the Full Court the judges asked the right question.  I need therefore to know where you say, at trial and in the Full Court, the judges addressed the right question.  That is not answered by telling me what evidence was there.

MRS BENNETT:   Well, your Honour, I was seeking to deal with the evidence because that was what I was asked to deal with at this stage ‑ ‑ ‑

GUMMOW J:   No, you were asked if there was a finding.

MRS BENNETT:   Well, the findings commence at page 62 – and I will come back to the tests, your Honour, because that is based upon Wellcome v VR.  At page 62, in the commencement of a discussion and in a passage, with respect, referred to earlier by Justice Kirby at page 63:

The evidence also leaves no room for doubt that formulators working in Australia before the priority date knew –

those factors.  Then his Honour turns to the fact that that:

does not advance matters far, because the question is, was the claimed combination obvious?

So he is asking, with respect, the correct question, at that level.  He then goes on and looks at the manufacturers’ literature, which he does take into account, because he accepts that it would have been dealt with as a routine step.  However, he says at page 64 at 106:

The matter may be approached from a somewhat different direction.  Dr Ashley gave evidence –

in effect, if your Honours go to line 28:

I would expect an Australian undergraduate pharmacy student as at the Priority Date to appreciate that an interaction –

that is, an interaction between an acid and an alkali –

would occur.

HAYNE J:   And his Honour rejects that, does he not, at 107?

MRS BENNETT:   No, he does not reject it as such, your Honour.  He does comment that the scientific team at Astra spent a lot of time and resources.

HAYNE J:   Solving a problem that an undergraduate pharmacy student in Australia would have seen.  Now, if that is not rejection, what is it, Dr Bennett?

MRS BENNETT:   Your Honour, his Honour is dealing with the assertions of the Astra team and as to what they did.  There are two answers to that.  The first is that the evidence of what the inventor did is absolutely not relevant.  It does not look to the test.  Secondly, the inventors were coming at it from a different area.  Third, his Honour found as a finding of fact that the inventors got caught up with what were called “the twin problems” and that those matters would not have been considered by the hypothetical formulator in Australia, as a matter of fact, and that is what led Astra astray.

At paragraph 110 his Honour sets out the test.  He accepts that at the commencement of the whole exercise, that is, the attempt to formulate omeprazole from scratch:

the combination claimed in the patent was not obvious.

He then sets out the test in the terms of Wellcome v VR.  He says then at page 66 at line 5:

I accept the general descriptions given by Dr Story and Dr Rowe of the way in which they would go about the formulation of a new drug.  Nor do I see any reason to doubt the evidence of Dr Story, Dr Rowe and Dr Thiel about . . . the manufacturers’ literature . . . That was evidence of factual matters within the knowledge and experience of the witnesses and which no one, with experience of the practice of formulators in Australia, was called to contradict.

He then refers to the submissions made by Astra and then says at 112:

What is important, however, is the steps which the hypothetical formulator would have taken and where those steps would have led.  I have no difficulty with the proposition that a formulator asked, in April 1986, to formulate omeprazole would have done a literature search at least in order to discover what learning there was about omeprazole itself and its characteristics.  Clearly enough such a search would have uncovered the compound patent, the omeprazole salts patent and Pilbrant and Cederberg.  Pilbrant and Cederberg both indicated a number of the characteristics of omeprazole and pointed the formulator in a particular direction:  an enteric coated dosage form seemed most likely to be the best possibility.  That being so, there can be no surprise that the witnesses would have first tried directly enteric coating an omeprazole core, or that the particular “controlled release” dosage form that Dr Marshall would have tried was an enteric coated one.  I accept also that that is what the hypothetical formulator would have done.  I accept also that the process which would then have followed would have been a complex, detailed and laborious . . . and it is easy to fall into the twin traps of hindsight and over simplification.  But there is no reason to doubt that the hypothetical formulator would, having tried the first simple formulation, have done substantially what Astra did:  submitted it to appropriate tests, including tests for stability on manufacture and on storage and for acid resistance.

It is difficult then to resist the force of Dr Storey’s observation that –

then they would have had the same results:

The Astra tests showed immediate discolouration, on coating, of a core to which no “alkaline reacting” substance had been added; there was no suggestion that the core was formulated or made in any other than a well known way, that is a way in which the hypothetical skilled formulator might well have chosen.  Dr Rowe’s evidence (and similarly to Dr Ashley’s) was that there was nothing unusual about the use of an alkaline substance to stabilise an acid labile drug; and, as I have mentioned, Dr Marshall included an alkali in his formulation of the cores.

And that was from the beginning.

McHUGH J:   It seems to me that the problem from your point of view is the first sentence in paragraph 113, which really does not answer the question whether it is obvious.  I mean even in England where, I think, it is arguable there is a much more liberal test as to what constitutes obviousness, the courts do not say that it is obvious simply because it is possible to explore numerous laborious paths to achieve the result that the inventor did.  They have drawn back from that.  They use expressions which, itself, are glossed, like “obvious to try”.  But it is not enough, is it, to say that they would have produced the same results as Astra.  That does not mean it is obvious.

MRS BENNETT:   No, your Honour, that is not what his Honour is getting at in that sentence, with respect.  What he is saying is accepting that the formulators would have taken those steps, experimentally they would have seen the same result which would have led to the problem.  In other words, if they had ‑ ‑ ‑

McHUGH J:   What his Honour is saying ‑ excuse me, Dr Bennett – that accepting that they would have tried the first simple formulation and done substantially what Astra did, submitted it to the appropriate tests, then, ultimately, they would have produced results not substantially different from those of Astra.

MRS BENNETT:   No, your Honour.  What he is saying, if you look at what he is saying through that passage, he says, “I accept” that they would have “tried the first simple formulation” of an enteric coat directly on an alkaline protected core.  Having done that, as a matter of experimental science, it is inevitable that they would have seen the discolouration.  That is what his Honour is saying.  Having seen the discolouration, he then says, “I accept their evidence”; that having seen that discolouration which they must have got, that independently their evidence is that they would then have realised that there was an interaction between the alkali of the core and the acidity of coat and separated them with the sub‑coat.

McHUGH J:   Yes, I know, but the passage that you quickly skipped over – did not read at all ‑ his Honour says:

I accept also that the process which would then have followed would have been a complex, detailed and laborious one, involving a good deal of trial and error, dead ends and the retracing of steps –

MRS BENNETT:   Yes, precisely the route ‑ ‑ ‑

McHUGH J:   How is that obvious?

MRS BENNETT:   Because it is absolutely the routine skill of the formulator and it would have been solved by the application of routine skill.

McHUGH J:   Routine in a sense that you know that there are a thousand possibilities and you are only going to pursue a thousand of them.  That does not make it obvious.

MRS BENNETT:   Your Honour, with respect, this is an experimental art.  As has been said in a number of cases, including Wellcome, and again and again, there is no prevision in chemistry.

McHUGH J:   Yes, I know, but you are trying to make the statute fit the art.

MRS BENNETT:   No, I am not.

McHUGH J:   Maybe the art has to fit the statute.

MRS BENNETT:   Your Honour, perhaps if I can pick up that point and then go back to the matter that Justice Hayne raised.  Bearing in mind that the case that was applied primarily, or the tests that were applied by Justice Lehane – he referred specifically and applied the tests in 3M and Wellcome v VR – so I can take your Honours, first, to the decision in 3M.  What we submit to the Court is this:  in 3M Sir Keith Aickin was dealing primarily with the question with what constitutes common general knowledge.  That is what he was being asked to look at and that is what he did look at.  If your Honours go to page 292, about point 6 or 7 on the page, halfway down the paragraph commencing “Justice Williams did not deal expressly”, he says:

The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade.  It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.

Then he deals with the making of “mosaic”:

I do not with respect think that it is correct to describe that process as the making of a mosaic –

He says:

The process of applying such common general knowledge to the solution of a problem is not a process of picking out individual pieces of information and combining them, including inferences . . . the making of a mosaic prohibited in the case of an allegation of want of novelty is the picking out of individual items of information  . . . and assembling them together –

and at page 293, he says, in the beginning of the first paragraph:

In the case of alleged lack of an inventive step the question of making a mosaic must operate (if at all) in a very different matter.  An allegation of want of inventive step is not made out by saying you may take one or two, or twenty‑one or twenty‑two, prior publications and then select from them appropriate extracts . . . So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness.  The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent –

we are dealing still with common general knowledge.  He then goes on to say:

The proper question is not whether it would have been obvious to the hypothetical addressee who was present with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process.  It is rather whether it would have been obvious to a non‑inventive skilled worked in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination . . . In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers.

Then at the end of that paragraph:

It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious.

So his Honour is not prohibiting the fact that one can select integers and make them part of common general knowledge.  He says you have to do it, but you have to do it in the glare of hindsight.  That is where the case goes in establishing what is the common general knowledge available to the skilled worker in bringing to bear the solution of a problem.  It does not go further than that.

What his Honour then did in the Wellcome Case, if I can take your Honours to that ‑ that case was a short time later and it is of course a unanimous decision of the Court, and it is the same judge who wrote the primary judgment.  It is inconceivable, in our respectful submission, that his Honour would have, without specifically saying so, written reasons that were inconsistent with what he said in the 3M Case.

Your Honour Justice Gummow raised yesterday some of the matters that were relied upon by Justice Handley, and I will come to that.  What is apparent from the reading of the argument before the Court is that the submissions being put by the appellants in this case mirror to a very large extent the submissions put by the appellants in Wellcome v VR, that is that the world starts and ends with 3M.  That one cannot look at any intervening experiments at all because all that is required is for the hypothetical skilled addressee to go straight from the common general knowledge to the claimed invention in one step and that, therefore, experiments are irrelevant.  That was the first point.  The second point was that the inventors’ experiments cannot be relevant.  The third point was that it cannot be relevant because it was experiments carried out in England, not in Australia.

The primary proposition that his Honour was dealing with was whether, in looking at the question of obviousness in an experimental art, bearing in mind what he had said in 3M about common general knowledge, was it relevant to look at experimental detail.  His Honour said yes it was. In the argument at page 263 and 264, your Honours will see, with respect, that they were the matters that were argued.  At page 264 there was an argument put about halfway down the page:

The fact that the research and experiments undertaken to achieve the result were obvious does not render the result obvious.  When obviousness is in issue, the court is concerned with the result and not with the steps leading to it.

A matter such as that were put to the Court.  Mr Handley, as he then was, then put other matters to his Honour.  At page 266 you will see that he said, at about 10 lines down:

It is significant that the specification of the patent in suit refers to experimental work, investigations and research.  Prima facie that is material that makes the patentee’s experimental work relevant to the invention.

At the bottom of the page it is put:

The relevance of that material here is supported by the expert evidence for the defendant that it was a reasonable prediction of the skilled non‑inventive worker in the field that the mixture which is the subject matter of the patent would work and was worth trying.  The history of the patentee’s research might either support or contradict the views of the defendant’s experts –

and he deals with some of those matters.  They are talking about whether or not the material can be relevant.  It is then put, further down that paragraph at about 12 lines down:

The test of obviousness is whether the hypothetical skilled non‑inventive worker in the field would have thought it obvious to try the particular composition.

There two cases were referred to:  Alsop’s Patent and Olin v Biorex.

McHUGH J:   But even “obvious to try” itself seems to be a gloss.  Why is it not a more general workable test simply to ask:  did the invention straightforwardly follow from what was the general knowledge in the trade, profession or industry?

MRS BENNETT:   It depends on how you are putting that, your Honour.  If you are saying, with respect, that any two‑stage process that requires two steps to be taken and you do not know the result of the first step before you move to the second, be those steps ever so routine, then that is good enough for a patent.  That is what the result is of the submission being put by the appellants.

McHUGH J:   What about the test in Olin’s Case:

“Would the notional research group at the relevant date, in all the circumstances . . . directly be led as a matter of course ‑ ‑ ‑

MRS BENNETT:   Yes, “to try”.

McHUGH J:  

‑ ‑ ‑ to try . . . in the expectation that it might well produce a useful alternative –

but “directly be led”.

MRS BENNETT:   We rely on that, your Honour, because when you look about “directly led . . . to try”, that is the case, by the way – it is that line of authority that has actually enlivened the English development of the “obvious to try with reasonable prospects of success”.  What Olin v Biorex says is worthwhile “to try” and, over the page, with reasonable predictability of success or reasonable prospects of success.  But there is another case also that is put to his Honour, and that is Alsop’s Case.

KIRBY J:   Could you just give me a clue as to what your case at trial was and how you represented ‑ ‑ ‑

MRS BENNETT:   The case that we ‑ ‑ ‑

KIRBY J:   No, but in relation to this point, that the appellants took a lot of time and spent a lot of money.  Was your contention that they were just stupid or too slow or not well focused or not up to date in their knowledge?

MRS BENNETT:   No.  There were a number of matters that were raised in regard to that.  First, it is not a question of what the inventors did, and that is absolutely given.

KIRBY J:   I realise that is not the question but, unless they have had a mental blank or they have been chasing – scientists sometimes do doggedly go down the wrong path, and that can be an explanation.

MRS BENNETT:   There were a number of different matters that were relevant to that.  One matter that is not reflected in the reasons – and we sought to have the evidence before the court – Dr Story said that there were a lot of problems in the way they started off with the process, the machinery they used that they probably had in the laboratories.  But importantly, some of the matters that they were dealing with were matters that they needed to establish to get the product to market, for example, toxicology tests, the matters that one needs to go through for approval, safety and efficacy tests, both in‑vitro and in‑vivo.  Then long‑term stability tests of course require long‑term testing, and that takes some time.  There is some evidence to suggest that they saw a slight problem with discolouration between the coat and the core at manufacture but continued working with that without the sub‑coat until they got to the stage of long‑term storage.  The patent itself makes it clear that the formulation with the enteric coat and the core was a conventional formulation and it worked except for long‑term storage.

GLEESON CJ:   Is what is said in paragraph 97 on page 59 relevant to the point you are now making?

MRS BENNETT:   Yes, your Honour.  It is one of the matters that I did try and deal with earlier.

GLEESON CJ:   The point made on the top of page 60, which is related to the point you were just making a moment ago, seems to suggest that the witness, Professor Rhodes, was saying that there is something unfair or unrealistic in considering the position of a generic manufacturer who works on the basis of the benefit of a lot of information made available and obtained only over time and after experimentation by the ethical manufacturer.

MRS BENNETT:   Your Honour, that is what Professor Rhodes was saying.  The evidence that came from the generic formulators was that they approached every compound simply as a generic compound and they were not put off by some of the matters that would put off the person who actually had lived with the drug and was worried about other factors.

McHUGH J:   But your case has to be that any Australian undergraduate in chemistry would have solved this problem, is that not so?

MRS BENNETT:   Your Honour, that was evidence that was referred to by the trial judge, that ‑ ‑ ‑

McHUGH J:   No, but is it not ‑ ‑ ‑

MRS BENNETT:   No, the evidence ‑ ‑ ‑

McHUGH J:   Irrespective of whether there was evidence or not, is that not what it comes down to?  If you talking about the skilled technician or the skilled worker, you have to say that any Australian undergraduate in chemistry would have solved this problem. 

MRS BENNETT:   They actually say, I think, it is pharmaceutical chemistry. 

McHUGH J:   Well, pharmaceutical chemistry. 

MRS BENNETT:   Certainly, that was the opinion of Dr Ashley, who was a lecturer in pharmaceutical chemistry, that he would have expected an undergraduate to have understood that there was a potential problem between an acid and an alkali.  There are three pieces of evidence that I will add to that though, which are all consistent with it.  The first is that as soon as the problem arose – and that is the stage only of long‑term stability – that each of the formulators said that they would immediately appreciate that there was a possibility of interaction.  Dr Marshall proposed that, without the ability to do experiments, as the likely way to resolve each of the scenarios that was put to him.  Each of them, he said, separate them. 

In fact, Astra itself, at the stage at which the problem arose, resolved it at a single session.  When the problem arose, Astra had a single meeting in December of 1981 and proposed two alternative solutions.  One was to change the enteric coat, and the second was to put a sub-coat on.  They did that immediately the problem arose, because the evidence was that there were no problems with the formulation except for long‑term stability.  Indeed, the submission was put to the Food and Drug Administration that the introduction of the sub-coat did not lessen the bioavailability, and they relied upon all the phase 2 studies, which had been done with a two‑stage coat, in order to promote the approval for the three. 

McHUGH J:   Poor old Professor Rhodes must be something of a dummy then.  He said he would not have thought that a water-soluble sub-coat would work.  He thought that what they had done was a brilliant solution. 

MRS BENNETT:   Professor Rhodes was the one who, as the Full Court pointed out, when it was suggested to him that one would use a water‑insoluble coat reacted to that with a great deal of – he rejected the possibility and said that nobody would use a water-insoluble coat.  That is referred to in the Full Court’s reference to Professor Rhodes.  He rejected the possibility of using a water-insoluble coat or a wax coat.  In any event, your Honour will appreciate that Professors Rees and Rhodes were not hypothetical formulators in Australia.  They were not generic ‑ ‑ ‑

McHUGH J:   I know, but the judge accepted their evidence and took it into account in determining what the hypothetical formulator would have done. 

MRS BENNETT:   No, with respect, he did not.  And he could not ‑ ‑ ‑

McHUGH J:   Well, I think he did, did he not?  That was your side’s argument at trial.  I thought the judge said he accepted it. 

MRS BENNETT:   Accepted the hypothetical formulators, not Professors Rees and Rhodes. 

McHUGH J:   No, but he accepted that you could take into account their evidence. 

MRS BENNETT:   He said he accepted that they could not be taken into account for common general knowledge, but said that they could have some relevance in the question of inventive step.  But he rejected completely their philosophy about these twin problems that they said would have stopped them from getting to the solution and said that those twin problems would have had no impact on the hypothetical formulator in Australia. 

McHUGH J:   In paragraph 92, last sentence, he said: 

If appropriately qualified (as they plainly are) they can express opinions as to matters relating to the formulation claimed in the patent which will assist the Court in deciding the question whether, having regard to the state of common general knowledge in Australia, what is claimed was obvious ‑ ‑ ‑

MRS BENNETT:   Yes, they expressed opinions, but he preferred the evidence of the Alphapharm witnesses.  He accepted the evidence of the Alphapharm witnesses in preference.  He took their evidence into account but did not accept it. 

GUMMOW J:   Where does he say he rejects it? 

MRS BENNETT:   If I can take ‑ ‑ ‑

GUMMOW J:   Where is the rejection? 

MRS BENNETT:   At paragraph 110 he expressly accepts the evidence given by Drs Story and Rowe:  

of the way in which they would go about the formulation of the new drug. 

His Honour goes on later to say at 115 ‑ ‑ ‑

McHUGH J:   Well, he says, he accepts: 

the general descriptions given by Dr Story and Dr Rowe of the way in which they would go about ‑ ‑ ‑

MRS BENNETT:   Yes, that is right, not getting involved with these twin problems, that they would have gone directly to the solution.  At paragraph 115 ‑ ‑ ‑

GUMMOW J:   Well, wait a minute.  You took us to paragraph 110.  He said he accepted Dr Story and Dr Rowe, and he said, “Nor do I see any reason to doubt Dr Story ‑ ‑ ‑

MRS BENNETT:   No, Drs Story, Rowe and Thiel “about the importance” ‑ ‑ ‑

GUMMOW J:   Yes.  Where is the rejection?

MRS BENNETT:   I was just about to take the Court to that.  At paragraph 115:

It must be borne in mind that the cause of the gastric resistance problem suggested by the patent “diffusion” of  “water of [sic] gastric juice” was hypothesis, not established fact.  In judging whether the interposition of a water soluble sub-coat involved an inventive step, what the hypothetical formulator would have thought, or surmised, is of greater significance than Astra’s hypotheses.  The experts called by Alphapharm all gave evidence that they would have regarded the problem as resulting, not from permeation of water or acid through a properly applied and intact enteric coat, but because the enteric coat was undermined by interaction, which they would have taken to be occurring, between coat and core.

That was antithetical to the evidence of Professors Rees and Rhodes.

HAYNE J:   What do you say as to paragraph 114, pages 67 to 68, where his Honour records the different view expressed on the one hand by Professors Rhodes and Rees, and on the other by Drs Story and Rowe about the likelihood of interaction being the cause of difficulty?

MRS BENNETT:   Thank you, your Honour, that is exactly where he rejects what was put by the Astra witnesses.  He says they might have identified what our learned friends kept calling “the Scylla and Charybdis identified by the Astra tests” and he goes on to say:

There can be no doubt that the twin problems would have been unexpected:  so much is common ground.  But whereas Professors Rhodes and Rees, particularly, strongly expressed the view that such an interaction was so contrary to experience and to well understood science that the formulator would have thought of other causes . . . Dr Story and Dr Rowe (and Dr Ashley and Dr Thiel as well) expressed the view that a formulator would have suspected interaction ‑ ‑ ‑

HAYNE J:   What does the statement that there can be no doubt that the twin problems would have been unexpected, that that was common ground at trial, say about the case of obviousness?

MRS BENNETT:   What that says is that while they may have been twin problems but that was a hypothesis put forward by Astra, the fact is that the generic formulator would have disregarded all of that and simply said, “I think there is interaction”, and that is an express finding.

HAYNE J:   That is to say, interaction between ‑ ‑ ‑

MRS BENNETT:   The core and the coat.

HAYNE J:    ‑ ‑ ‑ core and coat?

MRS BENNETT:   In other words, would not have been deterred by the theoretical possibilities of what might be occurring in the detail in which the Astra professors were worried about it, but just would have seen the discolouration and said, “I think there is something happening between the two and I am going to separate them”, and that is the finding that he made.  To that extent, he is rejecting the importance of the hypothesis as put by the Astra witnesses and goes on at paragraph 115 that the experts ‑ he says:

In judging whether the interposition of a water soluble sub-coat involved an inventive step, what the hypothetical formulator would have thought, or surmised, is of greater significance than Astra’s hypotheses.  The experts called by Alphapharm all gave evidence that they would have –

simply –

regarded the problem as resulting, not from permeation of water –

and all the twin problems –

but because the enteric coat was undermined by interaction, which they would have taken to be occurring, between coat and core.

If I can return ‑ ‑ ‑

McHUGH J:   But see, part of the problem then comes, is the very next line, is it? 

To a considerable extent, that proposition relied on the use that the witnesses said they would have made it the manufacturers’ literature and, to a lesser extent, the earlier patents. 

In that evidence, the Full Court said, could not be used, did it not?

MRS BENNETT:   No, the Full Court assumed without deciding.  It just did not deal with it.  It did not say it could not be used.  It said, “We will look at it again without using it.”  Our proposition, I should say, your Honours, is that it can be used, because it was a finding of fact.  Two things:  first, that Dr Story, who was the one who said he would use it and whose evidence the trial judge accepted, said, “These are basic matters within my knowledge” and here is the manufacturers’ literature that backs it up.  So it was corroborative of his own common general knowledge.

McHUGH J:   Well, of his common – that is not relevant.

MRS BENNETT:   His Honour, in fact, accepted that that was part of common general knowledge of a skilled hypothetical formulator.

McHUGH J:   What?  What is in the manufacturers’ literature?

MRS BENNETT:   Well, no.  What the manufacturers’ literature discussed was simply cases where one might get a problem with enteric coats on different cores, and his Honour accepted quite clearly that the hypothetical formulator, with or without the literature, would appreciate that there was an interaction.

It is of interest that Dr Marshall, for example, proposed an interaction immediately without any reference to literature, as did Dr Ashley.

If I can return for a moment to Wellcome v VR, because the test that was applied ‑ ‑ ‑

McHUGH J:   Well, you were taking us to Alsop now?

MRS BENNETT:   I was.  That is in Wellcome v VR.  What his Honour did was to apply the test in Wellcome v VR.  Can I say to your Honours this that the test that was applied by Justice Lehane, which is the passage specifically at page 286, has been applied in terms by at least three unanimous Full Courts of the Federal Court, implicitly by another Full Court, by a number of trial judges, including may I say Justice Gummow in the Leonardis v Sartas Case and is described in the Patent Office manual as a basic test to be used for the analysis of obviousness and inventive step.

GUMMOW J:   The question is, what is meant by “routine”?

MRS BENNETT:   Well, first, I need to deal, with respect, unless the Court does not want to hear from me, with our learned friends’ submission that that test is not of itself applicable at all.  Our learned friends say that there is no room for experimental work between common general knowledge and invention.

The primary force of their submission is that all you can bring to bear is common general knowledge.  If you need to do any experiment, no matter how routine, to get an answer – which is the purpose of doing an experiment if you do not know the answer – you cannot have it, and certainly, if you need to do two experiments, you cannot have those, because one would lead to the other.  They are denying completely ‑  and it is clear from their submissions before this Court – the applicability at all, no matter what “routine” means, of the Wellcome test, the ratio of the Wellcome decision at page 286.  They have actually put squarely in their submissions that it should not be applied and the Court should overrule it or should disregard it.

What we point to is the fact that that is the test and it has become the test used in this area of art, that is, in experimental work, it has routinely been applied.

GUMMOW J:   Yes, I know that.  We all know that.  The question is what does it mean?

MRS BENNETT:   Well, the first question is:  is it appropriate to use it, and our friends say no.

GUMMOW J:   Yes, I know that.  Just assume for a moment it is, so we can get on.  What does it mean?  Does it have the content, as Justice McHugh has put to you several times, what was said by Justice Graham in Olin  and, if it does, are you not in trouble?

MRS BENNETT:   Can I just put this to your Honour:  first, it is not just a restatement of what was said by Justice Graham in Olin, although Olin itself, in our respectful submission, can form a basis ‑ ‑ ‑

GUMMOW J:   Well, you disagree with it.  What other content do you give to the word “routine”?  We have to get down to specifics; it is no good chanting mantras like “routine”.

MRS BENNETT:   Well, this is not a statute; this is put in a context, your Honour, and what it means here ‑ ‑ ‑

GUMMOW J:   Well, if you just want to go back to the statute, disregard “routine”, but you want to cling to it, so I do not know where I am at the moment.

MRS BENNETT:   With respect, your Honour, what I am saying is that the word “routine” is not being used in a statute, it is being used in a context.

GUMMOW J:   Of course it is, but it has to have some content.

MRS BENNETT:   Yes.  What is important is that the patent itself should involve an inventive step, whether or not it was consciously taken by the patentee and whether or not it appeared obvious to the patentee himself.  The test is whether the hypothetical addressee, faced with the same problem, would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.  The test is in the terms of the hypothetical addressee, who is a person who has a skill in the art.  Here we know that that hypothetical addressee is a person who is a qualified pharmaceutical chemist with a doctorate and capable of research; that is the level of the unimaginative formulator in Australia.  So, taken in context ‑ ‑ ‑

GUMMOW J:   Well, does that mean, going back to the English Court of Appeal in General Tire, that one has to know in the first place what forms part of the normal industrial function of this hypothetical person, as the starting point, to know what is that person’s routine?

MRS BENNETT:   I will put it another way if I may, your Honour.  One looks to see what is the nature of the art in question or the subject matter of the invention and what are the skills of the hypothetical formulator.  To talk about normal industrial function perhaps is not as useful ‑ ‑ ‑

GUMMOW J:   Well, that may be right, but I want to know what you say instead.

MRS BENNETT:   I say that one looks to see what are the skills of the hypothetical addressee in that art in Australia, and here we know that the ‑ ‑ ‑

GUMMOW J:   Not the skills, what they do.

MRS BENNETT:   Well, what do they do routinely would be how do they apply their skills to solve a problem?  Here we know that they apply their skills to solve the problem of formulating omeprazole in a way that leads them directly from the prior art to the invention within the nature of an experimental art.

GAUDRON J:   Now, I suppose the issue comes down to experimental art.  You mean by that, do you, that they would routinely test the results of what they were doing?

MRS BENNETT:   Yes.

GAUDRON J:   And in that process routinely identify more and more about the nature of the problem that they had to solve.

MRS BENNETT:   Yes, your Honour.

GAUDRON J:   Is there evidence of that?

MRS BENNETT:   Yes, your Honour.  There is evidence ‑ ‑ ‑

GAUDRON J:   Is there a finding about that?

MRS BENNETT:   There is evidence given that the hypothetical formulator would first consider the characteristics of omeprazole, either by doing a literature search or by doing his own experiments, and would thereby find out all the questions of acid lability and matters such as that by routine experiments, because the physico‑chemical characteristics of a compound were the first thing that the hypothetical formulator would routinely ascertain.  Having done that, the hypothetical formulator, knowing that it was acid labile and needed to go through the stomach, would routinely put on an enteric coat.  Further, we know ‑ ‑ ‑

GAUDRON J:   Now, this is the next critical step, this bit.  You have to say that at that stage the formulator would have routinely tested or made observations to see if there was instability.

MRS BENNETT:   Yes, your Honour.  Before we get to that, the formulator routinely would have put, knowing it is acid labile, an alkali buffer into the core.  The evidence was that it was part of the routine step for a formulator to test for stability, both immediately or to look for any instability immediately and to test on long‑term storage, because that is something you have to do as part of the routine steps.  Having seen any instability, the evidence is that the hypothetical formulator would have recognised that there was an interaction occurring between the coat and the core and would have separated them by the sub‑coat.

HAYNE J:   Now, how does that sit with what is said at 109 of the trial judge’s reasons?  It may; it may not.  What I want to know is how does it.  Leave aside the first point that the combination was not obvious to Astra – that is a forensic point against you of some weight, I would have thought, but let us put it aside – what then we see is:

enteric coated dosage form . . . omeprazole presented difficulties in the formulation of such a dosage form, which no other drug, sharing any of its characteristics, had previously presented –

and there were several causes of that problem.

MRS BENNETT:   Yes.  First, your Honour, you say, with respect, to disregard the first sentence.  This, of course, is how Astra put its case.

HAYNE J:   Yes.

MRS BENNETT:   This was not relevantly accepted as something that would have occurred to the hypothetical formulator, but dealing with that, the first point is, just dealing with the word “brainstorming”, that when the problem arose Astra solved it immediately and that was in a single session ‑ ‑ ‑

HAYNE J:   I did ask you to put that aside, Dr Bennett.  If you do not wish to, do not.

MRS BENNETT:   No, I will, your Honour.  If I might continue.  Secondly, I can see what your Honour is pointing to, that:

it became apparent early in the process that an enteric coated dosage form was likely to be appropriate, omeprazole presented difficulties in the formulation of such a dosage form, which no other drug had previously presented ‑ ‑ ‑

HAYNE J:   Yes, I have read it, Dr Bennett.  How does this deal with the proposition you have just advanced?

MRS BENNETT:   It deals with it this way, that the evidence was that to the generic formulator omeprazole simply represented another acid labile drug to be formulated; that the physico‑chemical characteristics, part of which were the nature of the problem itself, such as its acid lability and matters such as that, would have in fact told the formulator to put in the core an alkali to buffer the acid lability and to put on an enteric coat to deal with that same acid lability to get it through the stomach.  Once that was done, the next problem presented itself as an interaction.

So that, in fact, while the case was that omeprazole was difficult to Astra, the evidence was that to the hypothetical formulator they would have treated it as what was put before the judge as basically compound A.  They would have not been deterred by that because that is what the generic formulators in Australia do.  That none of those matters would have deterred the Australian generic formulator from dealing with the properties, many of which were irrelevant to that formulator.  They would not have been concerned with all of the things that Astra said concerned them.  They would have gone much more directly to the correct formulation.

GAUDRON J:   Is it that Astra did not think what to the hypothetical Australian formulator was obvious was obviously worth checking, namely, that there was a reaction between the coating and the core?

MRS BENNETT:   In fact, your Honour, it is interesting because the evidence is that they went straight to it, both because at a single meeting they came to it and ‑ ‑ ‑

GAUDRON J:   But at the beginning, early in the process?

MRS BENNETT:   It did not happen at the beginning.  The problem, did not arise until they got to the stage of long‑term storage and at that point Dr Pilbrant’s evidence was that they immediately thought of an interaction and you will see that from the cross‑examination of Dr Pilbrant that is set out in the Full Court’s decision, but also what in fact happened at the brainstorming session.  His evidence was they had a single meeting after the problem arose and solved it, so that a lot of the other matters were smoke and mirrors.  It did not deter Astra at all once the problem arose, and that is the problem that is said to be the problem in the patent.  The patent says the problem is it was a problem on long‑term storage and that was immediately solved, both by Astra and by the hypothetical formulator.

Your Honours, if I can just return for a moment to what is meant by “routine”.  As well as considering what was said in Biorex, might I hand your Honours a copy of Alsop’s Patent which was the other case that was cited in the argument at exactly the same time as Biorex.  Your Honours will see that that was a claim for a process but what was said in the reasons was that that ‑ ‑ ‑

GUMMOW J:   Sir Stafford Cripps was counsel, was he not?

MRS BENNETT:   I am just trying to find the passage, your Honours, where it is treated as being, effectively, looking at the product.  At 752 at the bottom paragraph Justice Parker says:

In considering the validity of a Patent for a process, it is therefore material to ascertain precisely what the patentee claims to be the result of the process for which the Patent has been granted; the real consideration which he gives for the grant is the disclosure of a process which produces a result, and not the disclosure of a process which may or may not produce any result at all.

If I can then take your Honours to page 759.  At line 24 his Lordship says:

Under these circumstances, I think that any ordinary man with a working knowledge of chemistry would have inferred that the medium disclosed in Andrew’s Specification could be produced electrically.  If he were a cautious man he might probably have thought it well to test by experiment the truth of his inference, not because he would doubt its truth but because the gaseous medium produced by the electric discharge might possibly contain some unexpected constituent which might spoil so sensitive a substance as flour.  There would be no reason to think that there could be any such unexpected constituent, but a chemist, aware as he would be of the extent of the unknown compared with the known in chemistry, would naturally desire to make himself secure.

Then he goes down three lines:

I gather that if Sir William Ramsay, with Andrew’s Specification before him, had been asked whether he could predict the effect on flour of a gaseous medium obtained by subjecting air to a flaming discharge of electricity, he would have said – “Such a medium will almost certainly bleach your flour, but whether it will leave a taint or not –

and he discusses that.  Then he goes down at line 47 and says:

You had better try.  It is certainly worth trying but you must not be disappointed if you do not get a good result.”  If the mere fact that a man who ascertains by experiment that a gaseous medium, the known constituents of which suggest the probability of a certain result, does produce that result, has subject‑matter for a Patent because of the possibility that some unknown factor may prevent the anticipated result being obtained, the field for new Patents would be enormously extended – there might be as many Patents for bleaching flour with oxides of nitrogen in air as there are possible ways of producing nitric oxide; there might be as many Patents for the application of cellulose for a commercial purpose as there are trees from which wood pulp could be obtained.  Any Patent for the application of a chemical substance to a commercial purpose would give rise to a crop of other Patents, the novelty and subject‑matter of which would in each case depend on the fact that prevision in chemical matters is liable to be falsified by the possible existence of some unknown factor, the effect of which cannot be foreseen, and there must always, in the present state of chemical knowledge, be a possibility of unknown factors.

KIRBY J:   A little bit of policy creeping in there. 

MRS BENNETT:   It is, your Honour, but it also is a recognition ‑ ‑ ‑

KIRBY J:   I am not criticising. 

MRS BENNETT:   I know, I appreciate that.  It is in fact a recognition of the very nature of chemistry.  Your Honours, if I can just go back into Justice Aickin’s decision. 

KIRBY J:   Which one? 

MRS BENNETT:   The Wellcome one.  His Honour sets out at page 270 how he says is the question of obviousness.  He said, it: 

involves asking the question whether the invention would have been obvious to a non-inventive worker in the field, equipped with the common general knowledge in that particular field as at the priority date, without regard to documents in existence but not part of such common general knowledge. 

We say that that means you do not take into account documents as part of general knowledge unless you establish that as a fact.  That is what his Honour held in 3M.  I should say, we submit that does not mean that if you then take a routine step and find a document, that that piece of paper must be rejected.  At page 271 his Honour points to the argument by the appellant: 

that, because of this fundamental characteristic of the nature of obviousness, experiments or investigations made by the inventor were irrelevant to that issue because they threw no light on the manner in which a non-inventive skilled worker would have approached the problem.  For this basic proposition, they relied on Crane v Price. 

At page 272, in a passage that he repeats later – or the concept he repeats later – that has been frequently cited, in the first main paragraph: 

It remains true that a valid patent may be “the result of long experiments and profound research” or of “some sudden and lucky thought or of mere accidental discovery” notwithstanding the development of the objection of obviousness. 

At page 274, in continuing to deal with the decision of Riekmann v Thierry, two pages earlier, he says, in discussing Lord Davey, with whom Lord Macnaghten agreed: 

referred to the evidence of experiments.  His Lordship said: 

“I must say one word, my Lords, on the point which was so much pressed upon us by the learned Counsel for the Respondents, that the subject of the respondents’ patent was, in fact, the result of prolonged study and experiments.  My Lords, I am not impressed by this argument –

It then goes on, at the bottom of the page: 

“It is not enough that the purpose is new or that there is novelty in the application, so that the article produced is in that sense new, but there must be some novelty in the mode of application.  By that I understand, that in adapting the old contrivance to the new purpose, there must be difficulties to be overcome, requiring what is called invention, or there must be some ingenuity in the mode – ” 

of application.  In the next passage, he cites Justice Maugham in IG Farbenindustrie, and, dealing with that passage, the first part of it is: 

“In a sense it is still true to say that there is no prevision in chemistry . . . There is no short cut to knowledge of this kind.  A laborious and systematic investigation of a long series of combinations becomes necessary –

Then it is a question of fact, your Honours, whether that set of experimentation is inventive or not.  At the bottom of the page, and continuing with the citation from IG Farbenindustrie, he says: 

“The Court is concerned, so far as subject-matter is concerned, only with the results.  The invention must, of course, add something of a substantial character to existing knowledge; but the Courts do not inquire into the way in which the conquest was achieved.” 

That is, the courts do not look at how the inventor came to it.  His Honour then stops at 276 with what he takes from IG Farbenindustrie.  We would seek conveniently to hand up to your Honours the continuation of that passage which should be at page 322. 

Your Honours will see that the passage cited by Sir Keith Aickin finished at about line 26 or 27 after the reference to Lancashire Explosives but then Justice Maugham continues:

On the other hand, as I have indicated, it must remembered that the result achieved must not be obvious even to persons skilled in the art and well acquainted with the published information in regard to the problem with which the –

patent –

is concerned

So again he brings in the concept of what cannot be obvious to a person skilled in the art. 

Going back to Wellcome at page 277, after referring at point 7 to the observation by Lord Porter in EMI v Lissen, the passage there cited includes about six lines up from the bottom of the page:

It is easy for one not skilled in the art to see invention in a device which to the skilled mind is obvious.

KIRBY J:   Where is that, I am sorry?

MRS BENNETT:   That is on page 277, about six lines up from the bottom in the citation from EMI V Lissen ‑ seven lines up.  Then at page 279, his Honour reminds us that the test is objective and a reference to Surface Silos at about 10 lines down from the top.  Then in citing the passage from Dow Corning, about six lines into that citation, he says:

Was an invention in the legal sense, that is, regarding the matter objectively, made by him, having regard to the existing state of knowledge?

Then again, at the bottom of the page:

It is, however, undoubtedly the law that the test of obviousness is objective and not subjective and as stated recently by Sachs, LJ –

The question is a practical one to be answered objectively without enquiring into the particular mind of the inventor and it has always been held to be in essence a jury question –

In the citation of Lord Justice Edmund Davies from Woven Plastic there is a reference again to “a real inventive step”.  Then in the paragraph at the bottom of page 280, his Honour says:

In present case it was admitted by the respondent that the test of obviousness was an objective one, but it was argued that evidence of a subjective character was admissible.  That is no doubt true in some cases because expert witnesses are often properly asked whether they found a particular invention “surprising” to them.  That however does not answer the question whether evidence of the steps which the patentee took is relevant and therefore admissible.  Evidence of what was in the patentee’s mind may be admissible as evidence of the state of the art, but could seldom be otherwise admissible.  Evidence of what he did by way of experiment may be another matter.  It might show that the experiments devised for the purpose were part of an inventive step.  Alternatively it might be shown that the experiments –

and I know it is not a statute but it is a plural –

were of a routine character which the uninventive worker in the field would try as a matter of course.  The latter could be relevant though not decisive in every case.  It may be that the perception of the true nature of the problem was the inventive step which, once taken, revealed that straightforward experiments will provide the solution.  It will always be necessary to distinguish between experiments leading to an invention and subsequent experiments for checking and testing –

Having considered all of the authorities and having pointed to the fact that there was very little authority in Australia, which explained why he went to the UK, his Honour noted – I will come back in a moment ‑ at page 284 at the bottom of the page he again refers to the fact that:

What must be proved is common general knowledge in Australia and the inventiveness or otherwise of the alleged invention judged against that background.

At 285 at the bottom of that page, his Honour having gone through what he describes as:

the area of conflict in the authorities and the absence of examination of the divergent expressions of opinion, it is necessary to consider the issue in this appeal as a matter of principle.

That is when he comes to the passage at 286, about five lines down:

In more recent authorities discovery has been ordered to enable those attacking the patent to search for material which may suggest that all that the inventor actually did was to take a series of routines steps to make a series of routine experiments.

He then reiterates that:

It is still correct to say that a valid patent may be obtained for something stumbled upon by accident, remembered from a dream or imported from abroad, if it otherwise satisfies the requirement of the legislation.

Over and above either being a series of complex experiments:

What is important is that the patent itself should involve an inventive step, whether or not it was consciously taken by the patentee –

so it is not enough that you have research and experimentation.  There is an additional requirement that there be an inventive step.

In the context, what his Honour is talking about then is the way one tests it is by the hypothetical addressee, faced with the same problem, and the question is what would that hypothetical addressee have done.  The expression used is a matter of routine, but that is not limited to a statement that says that, irrespective of the art, irrespective of the iterative nature of the art in question, such as the steps taken to formulate a compound, that you can only take a single unvarying route if, in fact, the nature of that art routinely involves taking a route where only one route is available.

GLEESON CJ:   My difficulty at the moment is in seeing the direct opposition in an experimental art between “routine” and “invention”.  In an experimental art, as a matter of routine, you experiment.  What is it that distinguishes between a step that is inventive and the step that is routine?

MRS BENNETT:   Something that the hypothetical formulator would not have done when faced with that problem.  If the hypothetical formulator ‑ and one normally takes care of looking at hindsight, and Justice Lehane did very carefully, or with Dr Marshall where there was no hindsight, one looks to see, allowing for that, for example, a hindsight, whether one accepts that the hypothetical formulator would have taken that series of steps, would have done those experiments.  When the test has been applied in the way it has, in looking at what the hypothetical addressee has done, in some cases the court find that there has been an inventive step, because they do not accept that the hypothetical formulator would, in fact, have taken the next step.

GLEESON CJ:   That seems pretty close to the point that Dr Emmerson was attributing to you.  That seems to be saying that if the problem would have been solved, there is no invention present, but we are only here because the problem was solved.

MRS BENNETT:   The problem was solved, your Honour, we say, as a matter of routine.  There are problems that are solved by not a matter of routine.  What happens is, one looks to see what would be the normal approach, I suppose, faced with the problem, would the hypothetical formulator have got there?  Now, that is in the context that what we are assessing is whether or not what the patentee did, objectively looked at, was sufficient ingenuity – not sufficient in a quantitative, but qualitative sense – was it beyond the skill of the calling?  Was there some barrier crossed?  Was there something that was beyond what the normal person skilled in the art would have come to without the exercise of inventive ingenuity.  There are cases, a lot of cases, where the courts make that finding, that despite the evidence they do not accept that as a fact.  In some of the cases where the Full Court has used the test, in some cases despite all of the evidence, after cross‑examination of the witnesses and matters such as that, the court either accepts or does not accept that the hypothetical addressee would have come to it without the exercise of inventive ingenuity, without that spark.

KIRBY J:   That must be so in every case where this issue is in contest.  Somebody is saying, “Oh, this was a wonderfully bright and imaginative and brilliant idea”, and the other person is saying, “Easy; every undergraduate could do it.”

MRS BENNETT:   And that is a matter the judge has to assess as a matter of fact.

KIRBY J:   That is definitely in your favour so long as the judge and the judges have applied the right test?

MRS BENNETT:   That is right.

KIRBY J:   That is what we have to decide.

MRS BENNETT:   It has often been said to be a matter of degree.  What the judge did in this case was to make it very clear that he took great care to allow for hindsight, and hindsight is the normal attack.

KIRBY J:   Well, they keep saying that, and Justice Lehane in particular, but what is suggested is that, despite their best endeavours, they were really infected by hindsight.

MRS BENNETT:   Well, in that regard, having taken great care and having observed the evidence and the cross-examination – or in some cases the lack thereof - of Drs Rowe and Story, his Honour accepted their evidence and said that in that regard he was fortified by the evidence of Dr Marshall, as to which no allegation of hindsight could be made because he did not know the solution.

GLEESON CJ:   Is the opposing idea that you do not have to be inventive to solve this problem; you just have to be thorough?

MRS BENNETT:   Yes, in a way that the ordinary formulator is thorough.

McHUGH J:   But that means you cannot get a patent for a better mouse trap if a person skilled in the trade could have produced it sooner or later by a series of trial and error experiments.

MRS BENNETT:   Your Honour, there are some areas of art where the normal experimentation can take time.

McHUGH J:   Well, that does not seem like - it is obvious, Dr Bennett.  It just seems to me to give a most unusual content to the term “obvious”.

KIRBY J:   Your answer is that that is because you are not a chemical experimenter, you are a lawyer, and therefore you have to test it not by a lay person’s reaction or a lawyer’s reaction but what the hypothetical formulator ‑ ‑ ‑

MRS BENNETT:   We do say that, your Honour, and that is exactly what was said in Wellcome, that one has to be careful not to judge something as inventive because one is not in that field.

McHUGH J:   You are much more familiar with the cases than I am, but it seems to me that adopting the approach that you advocate, that in England patents in fields of microbiology, genetics and cell biology are all at risk on this theory of “obviousness”.

MRS BENNETT:   With respect, they are not, your Honour.  Your Honour is balancing them – there is a balance between two concepts.  Your Honour puts to me that you could have a situation where a series of experiments was held to be obvious in a circumstance where one would wish it not to be.  But the alternative proposition which is being advanced here that any series of experiments, any series of experiments at all, means that there is a patent.  We have the same sort of concept as in Alsop.

What we have is a situation that is being advanced here, that if the skilled worker, irrespective of the art, needs to do a series of experiments to find out, as one normally does – you do an experiment, you find out the answer, you do the next experiment – that irrespective of the routine nature of that, according to our learned friends, that person is entitled to a patent.  That would mean that any formulation that requires any experiment to be done is patentable, which would give every person who discovered a new compound 40 years of patent monopoly without more.

GUMMOW J:   Maybe both of you are too extreme.

GLEESON CJ:   That is right; you seem to be attributing to Dr Emmerson the proposition that for the hypothetical skilled addressee you substitute blind Freddie.

MRS BENNETT:   Dr Emmerson has said that the hypothetical skilled addressee can only be a mechanical plodder.  He denies the nature of this art, which is a person with a doctorate and experienced in the art of genetic formulation.  It is Dr Emmerson who is taking, with respect, the extreme view of saying that no series of experiments can be allowed to the hypothetical formulator, because that means that that person cannot jump directly from common general knowledge to the claimed invention.

What we say is that the test that is applied is a jury question test in looking at the facts, looking at the competing evidence ‑ here there was no competing evidence, of course.  Normally there is – look at competing evidence, look at the cross‑examination and see whether the judge is satisfied that in the circumstances of this case that the steps that were taken were no more than the routine application of the skill of the art.  In this case, as a finding of fact, both on the application of the test in Wellcome, directly, and on the application of the test as the Biorex Case has developed in the UK in a way that is not affected by the differences in English law, there can be a finding in both cases, and there was, that there was nothing here that was beyond the skill of the calling.  Now that is a finding that has been made and the findings of fact are not challenged.  Those assertions were made and accepted and there was no appeal, either to the Full Court or to this Court, as to those findings of fact.

The only appeal that was made to the Full Court – there were two grounds of appeal.  One was that his Honour used the word “might” in one part of his judgment.  Of course we say in context it was quite clear that he applied the correct test.

GLEESON CJ:   I thought he firmed up on that a couple of paragraphs later.

MRS BENNETT:   Both before and after.  He said beforehand “The test is would the person have done it?”  The exact word of course in Wellcome is “might” and his Honour used that word, but later he said, “I come to that with a considerable degree of firmness.”  So we say ‑ ‑ ‑

GAUDRON J:   What is the significance of “might” in the Wellcome passage?  It seemed to me to suggest that in a sense you are looking at the subjective thought processes of the hypothetical formulator.

MRS BENNETT:   I think what his Honour was saying was that one looks at whatever steps got there.  They do not have to be the steps of the inventor.  So in this case, or in many cases, you have it that, for example, if something was remembered from a dream, it does not necessarily mean that a person would not have got there by the mere application of routine steps.

GAUDRON J:   It seemed to me to be a more elegant way of repeating what the hypothetical formulator might say to himself, “I think this will work.  I think this might work.”

MRS BENNETT:   And then try it.  Take it as a step.  Yes, your Honour.  It is very much a question of assessing what the skilled formulator, bringing the skill of his or her art, would do in seeking to solve the problem.  Now, when we get to the question of the nature of the problem – and I will take your Honours to the patent – when one looks to the assessment of the problem then one can see that the problem only arose, and if you look at what my friend says is the appropriate problem solution approach in this case, the problem only arose after the first two integers of the combination were already in, and there was discolouration of omeprazole observed which meant that there was instability.  It was that problem that on any view of the evidence was immediately solved.

The complexity here is that what the appellant is seeking to do, despite the problem in the invention, is to take us right back to the very beginning of the formulation, when we also satisfy that test, and then put into it the experiments that Astra did or did not do in getting to that stage.

Your Honour Justice McHugh raised with me the English cases.  There are two differences only with respect to the way English law has developed relevantly in this regard, broadly speaking.  One is in the different nature of the literature that can be made available as common general knowledge, what sort of public information or what publications can be taken into account and the second is ‑ ‑ ‑

KIRBY J:   Is that in the statute, is it?

MRS BENNETT:   Yes, and the second is that they have taken from the words of Olin v Biorex in the language of “obvious to try with reasonable prospects of success”, as Sir Keith Aickin took those words to formulate the test at page 286 or going further from the cases he referred to, which included Johns‑Manville, which is the classic case that applies the expression “obvious to try with reasonable prospects of success”.         The English courts tend to have stuck with that language but it is really another way of looking at the same question.

We should say that it is not Sir Keith Aickin alone who has taken the concepts that he has taken and enunciated in Wellcome.  First, the recognition of the changing nature of the person of ordinary skill was specifically referred to by Justice Windeyer in the Sunbeam Case where he said that, for example, it can be a trained engineer or scientist.  So he has recognised that times move on and it is not just the mechanical plodder.

McHUGH J:   But where does the skilled workman or the skilled addressee stand in the spectrum?  You referred earlier to the Biogen Case.  Was it not that case where Lord Hoffmann contemplated a situation where the defence of obviousness might be rejected where a less skilled person may have thought it obvious but a highly skilled person might have thought there were so many problems that it was not worth trying and, therefore, it was not obvious to a person with great skill.  So where do you draw the line?

MRS BENNETT:   One draws the line at the findings of fact.

McHUGH J:   No, but how do you get to the findings of fact?

MRS BENNETT:   You get to the findings of fact by ascertaining what is the nature of the hypothetical skilled person.  In this case there was no dispute, and it was found as a fact, that as far as Australia is concerned, the hypothetical skilled person was a generic formulator with a doctorate and a capacity, which in self‑imported ‑ ‑ ‑

McHUGH J:   I asked that question because I wondered whether or not that sort of issue may not arise here.  I mean, Lord Hoffmann seemed to contemplate a situation where somebody who does not see all the problems can get to the solutions straight away; that is somebody who is highly skilled ‑ ‑ ‑

KIRBY J:   Like lawyers who come at problems with a lot of baggage because of their knowledge of the glosses.

MRS BENNETT:   Well, I hope that is not directed at me.

KIRBY J:   Sometimes there is a duty in coming unencumbered.

McHUGH J:   Justice Kirby is contrasting himself with me.

MRS BENNETT:   One would imagine that they will be matters that would be put to an expert in cross‑examination to elucidate that sort of factual matter, if that were the case.  But if you wanted to put that in fact that to the person of ordinary skill, the problems would have been prohibitive, then one would put that to the witnesses and then one would evaluate whether to accept that or not.

GLEESON CJ:   Now you claim in this case to have actually produced a skilled person?

MRS BENNETT:   We produced a number of them; we produced ‑ ‑ ‑

GLEESON CJ:   Dr Marshall.

MRS BENNETT:   We produced a number of them; they were all skilled persons, but one of them, in fact, could not have been said to be tainted in any way with hindsight, because that one was not given the solution to the problem at all.

McHUGH J:   Did he not give a little bit of a hint?

MRS BENNETT:   It was held by Justice Lehane ‑ there was an allegation that he was nudged, with respect, to one question.  Justice Lehane said, even accepting that that might have been called a nudge, it is irrelevant, and I accept that Dr Marshall would have come to the invention.

HAYNE J:   Did he ever get to a water soluble sub‑coat?

MRS BENNETT:   We say he did.

HAYNE J:   Did the judge find that he did?

MRS BENNETT:   Yes, it was one of the alternatives that he put in his last report and time ran out because of the exigencies of the case to get another report, but the judge accepted that that meant that to the hypothetical formulator, bearing in mind that Dr Marshall was not able to carry out the experiments that were the nature of his calling, and he specifically adverted to that in his evidence that he got there.

KIRBY J:   It is a risky strategy.

GLEESON CJ:   We do not know if any other doctors were called.

CALLINAN J:   Where is that finding?

MRS BENNETT:   You would only do it in the clearest case.

CALLINAN J:   Because it may be a very, very important finding for you.  Where is this finding?

MRS BENNETT:   At paragraph 119.

KIRBY J:   I did not hear the paragraph.

MRS BENNETT:   Sorry, 119 at page 70, probably commencing at page 69.  It is where his Honour says:

I am fortified in that way of viewing the matter by the evidence of Dr Marshall.

He specifically refers to the fact that Astra took a number of factors into account.

McHUGH J:   He did not arrive at the precise combination.

MRS BENNETT:   He says that, ultimately.  What he says is ‑ that is what Astra said.  Astra took comfort in the fact that he did not arrive at the precise confirmation.  That was what Astra’s assertion was.  But then his Honour goes on, at about line 6 on page 70:

despite the limitations of the exercise, several aspects of his report are striking.  He, like all the other witnesses –

by “the limitations” there he meant the limitations of the exercise which meant that he was just asked questions and was not able to conduct his experiments, and in the time frame:

He, like all the other witnesses, thought an enteric coated dosage form was appropriate.  He moved quickly to that position following his initial general comments about the formulation process and about sustained and controlled release; I do not doubt that it was his own independent idea to opt for an enteric coat, not merely the product of a suggestion . . . His formulation of the core included, apparently as a matter of course calling for no particular comment, a strongly alkaline substance (as I have mentioned, he thought it probable that he could successfully apply an enteric coat to that core).  When presented with scenarios, which had to take the place of actual tests but were, I think, a reasonable reflection of the Astra experience, one of the things which he thought might be occurring was an interaction between core and coat and one of the steps which he suggested was the incorporation of a sub‑coat, initially of (water insoluble) ethylcellulose.  Perhaps the question he was then asked, “why ethylcellulose?”, was a “nudge” but, more importantly, when asked to consider what he could do if tests showed poor bioavailability, he suggested changes to the sub‑coat.  Certainly, his preferred (theoretical) solution was a “leaky” sub‑coat comprising a mixture of ethylcellulose and HPMC; but HPMC was among a number of alternative sub‑coating materials which, he suggested, would be considered.

CALLINAN J:   But his preferred solution would not have worked, is that right?

MRS BENNETT:   Because what would have happened, if he had have applied – this is exactly the course that happened ‑ ‑ ‑

CALLINAN J:   No, just answer my question please.

MRS BENNETT:   His initially preferred solution ‑ ‑ ‑

CALLINAN J:   The preferred solution of a leaky sub‑coat, would it or would it not have worked?

MRS BENNETT:   Sorry, using ethylcellulose would have then shown poor bioavailability, and he then gave a series of options, one of which was a leaky sub‑coat comprising a mixture, alternatively HPMC.

HAYNE J:   Now, claim 1 of the patent in suit has as a sub‑coat a water soluble sub‑coat, does it not?

MRS BENNETT:   Water soluble or rapidly disintegrating in water.

HAYNE J:   Yes.

MRS BENNETT:   And HPMC is, in fact, one of the sub‑coats specifically exemplified.

HAYNE J:   Yes, in claim 4.

CALLINAN J:   The leaky sub‑coat would not have worked, is that right?  Surely it is yes or no.

MRS BENNETT:   We do not know the actual answer because it was a mixture of ethylcellulose and HPMC.  It is likely that that would have been rapidly disintegrating in water.  It was not solely water soluble, but the claim says water soluble or rapidly disintegrating.

CALLINAN J:   Dr Bennett, I will ask the question once more.  Is it not likely that a leaky sub‑coat would not have worked?

MRS BENNETT:   We say it is more likely that it would have worked, your Honour.

CALLINAN J:   It would have worked.

GAUDRON J:   The tests were not done.

MRS BENNETT:   No.

GAUDRON J:   He was asked to assume that it would have been leaky or that it would have ‑ ‑ ‑

MRS BENNETT:   No.

GAUDRON J:   He was asked to assume, was he not, that there would be poor bioavailability with that?

MRS BENNETT:   That was before that.  When he used ethylcellulose, which was not water soluble, and he was told that that would show poor bioavailability – and that is because it would not rapidly disintegrate and allow the omeprazole to be released in the intestine – he then gave a number of alternatives.  One was a mixture of ethylcellulose and HPMC or HPMC alone.  There is no direct finding, but seeing that the test was either water soluble or rapidly disintegrating in water, it is just as likely that that mixture would have worked.

GLEESON CJ:   Is that a convenient time?

MRS BENNETT:   Yes, your Honour.

GLEESON CJ:   We will adjourn until 2.00 pm.

AT 12.45 PM LUNCHEON ADJOURNMENT

UPON RESUMING AT 2.02 PM:

GLEESON CJ:   Yes, Dr Bennett. 

MRS BENNETT:   Your Honours, just a couple of matters.  Just to give your Honours the reference to a couple of cases that I mentioned before lunch.  I did refer to Winner v Ammar.  That is relevant to two aspects of our case.  The first is a general discussion, after Werner v Bailey, of the concept of obviousness and inventive step and the requirements for it.  Also, in the reasons of Justice Cooper, it is another case that goes into our footnote 18, which is a case where the precise passage of Wellcome at 286 is directly applied. The reference to that case is 113 ALR 63.

I also did refer to Sunbeam v Morphy-Richards 180 CLR 98. Again, I do not propose to go to that case in detail, but we specifically refer to page 112. We do have copies of Winner v Ammar that we can hand up to the Court for its convenience. 

KIRBY J:   I know intellectual property lawyers love these Australian cases and so on but, for my own part, I will be more influenced – keeping always steadily in mind the difference in legislation – to see how other final courts have dealt with this problem.  It may be that there is no lesson to be learned from them because you may say, in the end, it is a question of fact in every case, but it may be that we would not want to let ourselves be out of step with other countries of the world which are dealing with very similar questions. 

MRS BENNETT:   That is certainly a matter I will come to and perhaps if I can deal with it at the time in looking at the question of how courts have treated the various experimental steps that are dealt with in the question of obviousness.

GUMMOW J:   Looking at United States authorities in that ‑ ‑ ‑

MRS BENNETT:   We have referred to the United States authorities only to the extent of saying that the test there is, in effect, “obvious to try” with a reasonable expectation of success.

Your Honours, before I just move on, may I just also refer your Honours to another decision to which Sir Keith Aicken was referred in the Wellcome Case and it is another decision of this Court, which is Washex Machinery Corporation v Burton 49 ALJR 12. We do have copies of that case for your Honours. That is a decision of his Honour Justice Stephen.

KIRBY J:   This is to make what point?

MRS BENNETT:   This is to make the point that another judge of this Court has considered the concept of “obvious to try” and, in slightly different terminology, adopting two cases to support what his Honour said, one was Johns-Manville Corporation and the other was Olin v Biorex.

GUMMOW J:   Did this not go on appeal?  Did Washex go on appeal?

MRS BENNETT:   I do not think it did, your Honour.  If I can take your Honours to page 16, in the second column, his Honour deals at the top with the fact – you see, “the three features in question” and he goes down between D and E and says:

The question for me is, therefore, whether to a person skilled in the art the effecting of a change from a hard to a soft mount below soft mounted critical speed would, in 1964, have been regarded as a possible solution justifying investigation and trial –

And the he goes on to say:

In my view this would have been apparent to the hypothetical skilled but unimaginative technician –

and refers to Technograph –

because of the “common general knowledge in the art which must be presumed to be a part of his skilled equipment”.  It would, I think, have readily suggested itself to a person –

and goes through, and then also refers to Hill Hoists, which was in our list of authorities where the concept was also referred to in broad terms of “obvious to try” by Justice Wyndeyer.

Your Honours raised with me beforehand the question of the difficult of having a test such as this apply.  There are two things we say in relation to that, or a number of further things if I could add to what I said before the adjournment.  First, bearing in mind that there are two kinds of invention:  one is remembered from a dream; and the other one that is said to be as the result of research.  So what this test is apposite for is assessing whether an assertion that something that has been done by way of research is worthy of invention.

It is of interest to see – I will not go into the number of cases in which the Wellcome test has been directly applied, and they are referred to in our written submissions, but we would seek to take your Honour to a good example, bearing in mind that it is same concept as being a matter of degree to which the Full Court referred in the Beecham Case.  If we can take your Honours to ICI v Lubrizol in the Full Court. If I can take your Honours to page 240 at paragraph 79. This was a case where the Wellcome test was applied but on the evidence the court held that it was inventive.  I am sorry, I am looking at paragraph 79.  I do not know if your Honours’ copy has paragraph numbers on the ‑ ‑ ‑

GLEESON CJ:   No, what is the first word in the paragraph?

MRS BENNETT:   “In the end” on page 240.

GLEESON CJ:   The first complete paragraph?

MRS BENNETT:   Thank you, your Honour:

In the end, this is one of those difficult cases involving questions of degree – 

referring to Beecham, then:

The question to be asked is whether the hypothetical addressee, faced with the problem that confronted Dr Jolley and equipped with the common general knowledge . . . would have taken as a matter of routine whatever steps might have led from that general knowledge to the invention.”

Then their Honours go on to consider some of the warnings, “of illegitimate use of hindsight” and matters such as that that are set out in Wellcome. 

They consider the evidence and then they go on, after considering other cases that are cited, including the reference to Genentech v Wellcome and the words of Lord Justice Mustill that talk about, “a road to be travelled towards the goal”.  They then say, at the bottom of the page:

The appellants also relied on Coopers Animal Health; but we do not think that the finding that, on the particular evidence of that case, DGBE was a solvent worth trying assists much in providing an answer, on the evidence in this case, to the question whether the skilled worker equipped with the common general knowledge in Australia would have found the class of compounds identified . . . an obvious possibility for the solution of the problem posed.”

They go on and refer to the fact that:

Senior counsel for the applicants relied – 

upon this case, and then distinguish it on the facts.  That is a good example of where the courts apply the test but distinguish it on the facts to find the alleged invention indeed worthy of a patent.

GUMMOW J:   Now, do you accept that Genentech does have the tendencies identified there in paragraphs 80, 81, namely more rigorous than established here?

MRS BENNETT:   More rigorous?

GUMMOW J:   Yes.  That is what is said there.  In other words, it makes it harder for the patentees.

MRS BENNETT:   I must say I should have considered that, your Honour, but I have not.  From my recollection of Genentech, my recollection was that as to the test applied that, having used the word “obvious” and relying on Johns‑Manville and Olin v Biorex – well, the short answer is I cannot really answer it, your Honour, I am sorry.

GUMMOW J:   All right.

MRS BENNETT:   Perhaps if I may, I can put in a written note on that in due course.

KIRBY J:   Their explanation of distinguishing this case was that they say there was good deal of evidence given by workers skilled in the field.  That is what they interpreted this case as turning on.

MRS BENNETT:   Yes.  Well, it does.  That is exactly in support, with respect, of what I put earlier.

KIRBY J:   That supports your proposition.  You see, the anchor for your case is this is said by everyone; it is a jury question;  it is a question of fact; it is determined that there is a line to be drawn; the line is difficult to find; you can have all sorts of judicial formulae; but in the end a judgment has to be made; you have to trust the people to make it and unless they use the wrong criteria, appellate courts have to leave them alone ‑ ‑ ‑

MRS BENNETT:   With respect, yes, your Honour.

KIRBY J:   ‑ ‑ ‑ because you cannot use judicial formulae to make the leap of judgment in the particular case.  So the focus of this case has to be, from first to last, did the Full Court and did Justice Lahane apply the wrong test?

MRS BENNETT:   Exactly, and ‑ ‑ ‑

KIRBY J:   I think that is what Dr Emmerson concentrated on.  He suggested that breaking it down into the components is a wrong approach.

MRS BENNETT:   I propose to come to that, your Honour, precisely.  Might I just add two other matters before I get to the actual facts of this case.  The first is that there are, of course, other criteria that the courts often look to in assessing whether or not something involves an inventive step.  First, there is often evidence called by the patentee from a hypothetical formulator or hypothetical person skilled in the art in Australia to contradict the evidence of the other side.  Here the only Australian person called was a Professor Brown and he did not have any hands-on formulation experience at all and so he was not in the requisite class.

The other sort of matter that the courts may take into account, for example, is where there is a publicly proven long‑felt want in respect of a particular category of exercise and that sort of evidence could be taken into account by the court.  So there are other matters.

The only other thing before I go to the facts of this case is this proposition, your Honours, and that is this.  The simple fact that there are two alternatives that immediately present themselves to the hypothetical formulator does not stop each being a routine step or an obvious step to take.  Each is then obvious and routine.  We say that follows as a matter of logic.  We also rely upon the reasoning of Justice Laddie in a case called Brugger v Medic‑Aid [1996] RPC 635, and I think that was in our list of authorities, your Honours.

Before going into his Honour’s reasons I should say that his Honour’s reasons in this case were specifically supported and approved by the Court of Appeal in England in Pharmacia Corporation v Merck & Co Inc [2002] EWCA 1610 and his Honour’s logic and reasoning has founds it way, with approval, into the CIPA Guide to Patents and also to the recent edition of Terrell.

If I can take your Honours to page 661, in a passage that was cited with approval by the Court of Appeal in England of which Justice Aldous, who was a well‑known patent lawyer, was a member.  At line 6 his Lordship says:

First a route may still be an obvious one to try even if it is not possible to be sure that taking it will produce success, or sufficient success to make it commercially worthwhile.  The latter point is inherent in Johns‑Manville Corporation’s Patent [1967] RPC 479, a decision of the Court of Appeal under the Patents Act, 1949 which is just as relevant to obviousness under the 1977 Act. Secondly, if a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well. If a number of obvious routes exist it is more or less inevitable that a skilled worker will try some before others. The order in which he chooses to try them may depend on factors such as the ease and speed with which they can be tried, the availability of testing equipment, the costs involved and the commercial interests of his employer. There is no rule of law or logic which says that only the option which is likely to be tried first or second is to be treated as obvious for the purpose of patent legislation.

The last small matter before I get to the patent which is really the issue in this case, before we go to the reasons, and that is nothing should be said, with respect, or gleaned or taken as an admission from what I said before lunch, that while we have a general concept of the formulation, we have actually denied infringement, and that is subject to the notice of contention, and we still do deny infringement.  I will not bother your Honours with the reasons for that.

GUMMOW J:   What is the citation of the judgment of Lord Justice Aldous you refer to?

MRS BENNETT:   That was the Pharmacia Case, your Honour, and it was 2002 EWCA 1610.

GUMMOW J:   What is the name of the parties?

MRS BENNETT:   Sorry, Pharmacia Corporation v Merck & Co Inc.

GUMMOW J:   Thank you.

MRS BENNETT:   We have, I should say, put into our list of authorities and without going into the detail of them, we refer your Honours to various textbooks that we have cited including Ricketson, with respect to the law of Australia, Terrell and – Terrell and Halsbury’s Laws of England, both the reissue and the 4^th edition, as to the general applicability and the way in which this sort of test has come into the general law.  We have also referred your Honours to the Australian Patent Office Manual of Practice and Procedure.  I do not know if your Honours were able to get copies of that.  We have copies available.

GLEESON CJ:   Yes, thank you.

MRS BENNETT:   Is that “yes, thank you”, your Honour meaning you have copies?

GLEESON CJ:   We have it, yes, thank you.

MRS BENNETT:   I do not propose to go to that right now, except I can perhaps – if you have the Patent Office Manual I can refer your Honours to the page.  Your Honours will just see that even ‑ ‑ ‑

GLEESON CJ:   “It is so easy that any fool could do it.”  Is that the one?

MRS BENNETT:   There are a number of different tests that are referred to in the manual, your Honour.  In particular, your Honours will see at paragraph 4.1.5 “Test for Inventive Step”.  “There are many tests applied by the court to assess ‘inventive step’”.  They refer to Justice Cooper in Winner v Ammar.  Over the page your Honour will see a distinct reference to Wellcome v VR at 286.

It is really a question of considering the nature of the art or the nature of the invention and choosing the analysis that best assists the judge in determining, on the basis of the evidence, whether or not the invention was obvious and involved an inventive step.  I do not know if your Honours wish me to go to the textbooks, but we have referred to them in our submissions.

Your Honours, perhaps the most convenient way to see the nature of the problem, or the subject matter of the decisions of the trial judge and the Full Court is to go to the patent because that, after all, is where the nature of the problem is presented.  Before doing that though, we should just point out a couple of matters of the way in which this case was run by the appellant.

As I put to your Honours in my outline of what I was going to submit to the Court, the appellants now are saying that this Court should not support or should distinguish or should reject the test of Sir Keith Aickin in Wellcome at page 286.  Indeed, in their written submissions, the appellants say that his Honour Justice Lehane made a radical departure from principle in following that principle in Wellcome, which we say is quite unfair to Justice Lehane.  In fact, in the written submissions that were handed to his Honour – we have only given your Honours the first few pages relevant to “obviousness” because obviously a lot of other matters were dealt with, including the facts – at page 3 of the applicants’ submission on “Inventive Step (Obviousness)”, in paragraph 7, after referring to a passage from General Tire, your Honours will see that the appellants submitted there that the test of obviousness was stated by Justice Aickin in Wellcome at page 270 and then continued to say:

The question is whether it would have been obvious . . . The test is whether the hypothetical addressee –

et cetera.  So that was fairly and squarely put by Astra to Justice Lehane as a basis for making his decision.  We of course put the same test, so that was not in dispute.

The other matter perhaps I can deal with while I am talking about the way in which the case was approached, which puts the judgments into perspective, was to just refer your Honours to the progression, as I put it before, on the notices of appeal.  Your Honours will see when we come to the Full Court that there were only two issues raised before that court.  One was whether as a matter of fact Justice Lehane’s using of the word “might” meant that he had not satisfied the test in Wellcome, not that it was the incorrect test, and secondly, whether or not any document could be used as a routine step.  They were the two issues before the Full Court.

My learned friends refer to the passage in the transcript before the Full Court, where they say that they ‑ ‑ ‑

GUMMOW J:   The notice of appeal to the Full Court ‑ ‑ ‑

MRS BENNETT:   Notice of appeal to the Full Court, which is at page ‑ ‑ ‑

GUMMOW J:     ‑ ‑ ‑ had rather more in it than you might be suggesting, I suggest. 

MRS BENNETT:   I am sorry.  I did not hear that, your Honour. 

GUMMOW J:   Had rather more in it than you might now be suggesting. 

MRS BENNETT:   Well, the point that we refer to – yes, but they were the two issues that the Full Court said squarely raised themselves.  At page 130 of the appeal book – it is really variations on a theme – your Honours will see, at paragraph 4, they say that: 

in failing to apply properly the tests for obviousness enunciated in –

Minnesota and Wellcome.  Of course, now, if you look at the present notice of appeal, you will see that the only reference is to Minnesota Mining.  The other matter was the question of whether or not the appellants conceded that the compound patent would be available to the hypothetical formulator.  Dr Emmerson referred in his submissions to the passage at page 330 of the appeal book, where he was asked a question whether or not that was allowed. 

We have two responses to that – or a number of responses that arise from the way the case was run.  There was no criticism before Justice Lehane at all of the use of the compound patent by the hypothetical formulator.  Secondly, if I can hand up to the Court an extract from the Full Court transcripts.  What in fact happened was that that withdrawal of the right to use the compound patent was only dealt with by senior counsel for the appellant in reply.  That was after Justice Merkel put to him, in reply, that his statement that you cannot have a single piece of paper, because it is prohibited by 3M, and you cannot have it in any shape or form, was inconsistent with the fact that they had not objected to the compound patent. 

If I can take your Honours through some of the extracts, your Honours will see that at page 26, before the Full Court, Dr Emmerson says: 

No doubt you know of the existence of a Omeprazole and you know its properties, but what we object to is taking anything which starts on that point and says, but this document also tells me something about formulation –

They talk about the properties of omeprazole.  Then he says, at the fourth last line: 

I mean one can look at a Omeprazole patent itself which is the main patent of the background and you know something about that.  But what you don’t know about is earlier related attempts –

and then at page 66, Justice Wilcox says: 

if a formulator was asked to provide a formulation for a particular drug and that was a compound which was the subject of a patent, surely as simply part of the instructions the formulator would be given a copy of the patent which would describe what it is that he’s supposed to formulate into a useable product.  Is that not right? 

And Dr Emmerson says: 

So far as Dr Marshall is concerned, in preparing his first report he was given the patent for Omeprazole and we don’t quarrel with that. 

At page 81, Justice Merkel says: 

What Dr Rowe and Dr Story they would have had started with the patent for the drug itself, then the article put out by the two inventors, Dr Pilbrant and Dr Cederberg, that’s what they had.  Then they had access to the ES –

omeprazole salts patent –

search material.  Now what I am suggesting to you is that the patent for the drug itself plus the inventors of the drugs own paper describing the drug is something that you would expect them to be better than their brief. 

Dr Emmerson: 

I would accept the former but not the latter –

so he accepts the compound patent –

The former proposition the patent for the drug itself, yes, that is an account of the drug. 

Then after the passage at page 330, which is in the appellant’s submissions, Justice Wilcox says: 

so he would be dependent for his information on what his employer told him about the characteristics of the drug, is that right? 

Dr Emmerson: 

It doesn’t matter where the information comes from, it is assumed that he knows what the problem is. 

We just raise that to put into perspective the allegation when the Full Court said there was no issue about the compound patent. 

HAYNE J:   Do you accept that the definition of the problem to the hypothetical addressee is sufficiently encompassed by paragraph 9 of the trial judge’s judgment?

MRS BENNETT:   What we say about paragraph 9 of the trial judge’s judgment is that that is taken from his Honour’s discussion of the patent, and I am about to go to that.  We say that it may be sufficient but it does not mean that that is all the hypothetical skilled formulator would have when you look at the nature of the problem, and for a number of different reasons.  I should also point out two things about the Pilbrant and Cederberg article.  That, in fact, was a prior published article.  It was publicly available before the priority date, and it is not unusual, your Honours, for people to publish matters that then interfere with their rights to a patent.

HAYNE J:   Do you accept that the statement of problem to the hypothetical addressee would not – and I emphasise not – encompass information that long‑term storage tests of a directly enteric coated core reveal instability?

MRS BENNETT:   If one takes the nature of the problem as it presents in the patent, that would logically be information given to the hypothetical formulator.  However, in the present case, we do not need that to show lack of inventive step, because the evidence is that they started before that point.  We say that evidence should be given but it is not necessary for the reasons of their Honours to be accepted.

HAYNE J:   Does it then follow that your argument takes as its next step that instability would be revealed by what are properly described as “routine tests” performed in the course of performing the normal industrial function of a pharmaceutical formulator?

MRS BENNETT:   Yes, your Honour.

HAYNE J:   Is the next step in your argument that the solution to the problem thus revealed of instability was an obvious solution?

MRS BENNETT:   Yes, your Honour.

HAYNE J:   Does that in turn require the taking of two separate steps, that is, first identifying that the performance of the tests revealing instability are part of routine and normal industrial function – that is one chain of inquiry; but, second – and it is upon this I want to focus for the moment – that the solution adopted of a water soluble or water fragmenting inert sub-coat was obvious as the solution to the problem thus identified?

MRS BENNETT:   Yes, your Honour.

HAYNE J:   Now, is the second aspect of the answer, that is, the answer that water soluble or water fragmenting inert sub-coat is the obvious answer to the problem of instability, consistent with what is said about these matters at paragraph 114 of the judgment, the reference to “Scylla and Charybdis”, which might be understood as suggesting that there is a larger and more complex problem than suggested by an answer, “I will separate the enteric coat from the active core”, and, secondly, is it consistent with what is said at paragraph 109, which seems to suggest that a water insoluble sub‑coat was, at least the first, perhaps the obvious, answer to the problem identified?

MRS BENNETT:   Taking the second aspect first, at 109, where they are talking about the “brainstorming” session, the fact is that Astra went straight to a water soluble sub‑coat.

HAYNE J:   What I had in mind was what appears at line 39 of paragraph 109 on page 65, “a water soluble sub-coat was an unlikely solution.”

MRS BENNETT:   Yes, that was Astra’s case.  If I can go back then to the first part of it which I need to go to to deal with that.  What his Honour is referring to at paragraph 114 was an expression that was used consistently by counsel for Astra to describe what it called the “twin problems” referred to in the patent.  We put that that was a smoke and mirrors attempt to dress up something that was routine into something that was patentable.

Two other aspects in relation to the so‑called Scylla and Charybdis need to be taken into account, with respect.  The first is his Honour did not accept that the hypothetical Australian formulator would get involved at all in what might be the complex detail of matter that was adverted to by the professors called by Astra.  What his Honour accepted is that that was irrelevant to the formulator who would have seen an interaction and simply separated it with a sub‑coat.  So the Scylla and Charybdis question that Astra kept pursuing was an hypothesis which Astra says it still does not know the answer to which did not prevent the hypothetical formulator from coming to the interaction.  It did not prevent Dr Marshall and, indeed, it did not prevent Astra because, despite the fact that Astra said that they still did not know this very complicated twin problem at all, Dr Pilbrant said that in the “brainstorming” session they went straight to that as one of the two solutions and, indeed, in his cross‑examination he said when they saw the problem, they assumed an interaction and put in a sub‑coat.  So that Scylla and Charybdis question is irrelevant and all of the facts of the case point to the correctness of the evidence of the hypothetical formulators that they would simply have separated them as a practical solution to the problem, without going into the academic theory.

So going back, then, to the passage at paragraph 109 which was Astra’s case on obviousness, his Honour found that the hypothesis referred to at line 37 that Astra postulated was irrelevant.

HAYNE J:   Where do I find that finding.

MRS BENNETT:   Just give me one moment, if I may, your Honour.  Paragraph 115:

It must be borne in mind that the cause of the gastric resistance problem suggested by the patent, “diffusion” of “water of [sic] gastric juice” was hypothesis, not established fact.  In judging whether the interposition of a water soluble sub‑coat involved an inventive step, what the hypothetical formulator would have thought, or surmised, is of greater significance than Astra’s hypotheses.  The experts called by Alphapharm all gave evidence that they would have regarded the problem as resulting, not from permeation of water or acid through a properly applied and intact enteric coat, but because the enteric coat was undermined by interaction, which they would have taken to be occurring, between coat and core.

HAYNE J:   Yes?

MRS BENNETT:   That is saying that the hypothetical formulator would not have got involved with this complex twin problem of diffusion of water of gastric juice, would have assumed that the enteric coat was having a problem because it was then undermined by the interaction between the core and the coat and simply fixed it by separating them so no interaction occurred and hypothesis – sorry.

HAYNE J:   The point to which I am directing your attention and with which I do not think you are grappling is that the solution in fact adopted in the patent is a water soluble or water disintegrating intermediate core, sub‑core.  What is it about adoption of that kind of sub‑coat which is obvious?

MRS BENNETT:   I am sorry, your Honour, I misunderstood the question.  I thought you were going to the sub‑coat as a generic concept.  If one is talking about the water soluble aspect, the answer to that was that if you want to have omeprazole readily bioavailable upon its contact with the intestine when the enteric coat is dissolved by the environment in the small intestine after it passes through the stomach, you want it maximum bioavailability which means you want the omeprazole immediately released which means that you want a water soluble sub‑coat.

HAYNE J:   Where do I find his Honour finding, as a fact, that the adoption of a water soluble sub‑coat was the obvious or an obvious solution to the problem thus identified?

MRS BENNETT:   His Honour dealt with that, to some extent, by reliance upon the manufacturers’ literature which deals specifically with that, and your Honour will see – I am in paragraph 116 ‑ where one of the documents directly suggested that, “a water soluble” – I withdraw that, His Honour was not dealing with it there.  He was dealing with the problems that could have been raised.  At 117, after referring to some of the problems of the manufacturers’ literature, his Honour said:

there is apparent force in the comment made in . . . sub‑coats –

et cetera.  He refers to that.

Nevertheless, if one accepts, as I do, that it was generally known by Australian formulators that there was commonly to be found . . . information relevant to the use of their products . . . particular publications . . . routine steps taken in the course of the formulation process, the force of the comment is significantly weakened . . . accepts . . . Dr Story, that one does not look at documents only for the purpose of finding precise directions . . . one would first try the simpler solutions . . . is not difficult finally to accept that the element of a water soluble sub‑coat, in combination  . . . might –

and that is where he uses the “might” –

have been arrived at by the skilled, though not . . . imaginative, formulator.

To look at the matter in that way is not, I think, to ask the irrelevant question . . . in this context –

et cetera.  Then he goes into Dr Marshall who at the last stage when asked “why ethylcellulose” and if there is a bioavailability problem would have gone to the leaky sub‑coat or HPMC alone, as we referred to before lunch.  The Full Court pointed to different evidence and I can come to that in a moment. 

So, his Honour, in making his decision of satisfaction that the hypothetical formulator would have got there, formed that view on the basis of the evidence we have referred to.  There is another reference, your Honours, that might be of some assistance which is at page 63, line 6 where his Honour says:

leaves no room for doubt that formulators . . . knew that a compound which tended to degrade in acid or neutral media might be stabilised by the  . . . an aqueous solution . . . an alkaline pH . . . enteric coats . . . the existence, properties and some uses of coats made of substances such as ethylcellulose and HPMC.

So they are the matters that his Honour refers to.

I appreciate that is not an answer directly to your Honour’s question.  The Full Court at page 193 refers to Dr Rhodes at paragraph 124:

Dr Rhodes agreed that “the fact that one does not know how something works or . . . if there is more than one mechanism involved, does not stop a formulation being made”.  He also agreed that, if he had been formulating omeprazole, he would first have tried an enteric coat directly on the core . . . known to protect . . . If the result failed bioavailability tests, or proved unstable during storage, he would make tests –

and then over the page at paragraph 126:

In relation to the choice of a water soluble subcoat, it is interesting to note the reaction of Dr Rhodes to a reference in an earlier patent to the use of wax coats.  Dr Rhodes said:

“My concern would be if I had been a formulator in 1986 looking at this patent, my first reaction would have been to say:  Wax coats?  Wax coats are hydrophobic.  They are not water soluble.  I don’t want anything like a wax coat near a drug which I know has got a very low solubility and, therefore, has got a potential bio‑availability problem.”

GUMMOW J:   There is a complaint against you, is there not, a procedural fairness complaint against you, as to the embarking by the Full Court onto this evidentiary finding expedition?

MRS BENNETT:   Yes, your Honour.  There are two answers to – well, there is one big answer to that.  The first is that it was the appellants who raised the question of “might”.  The case went on obviousness alone in the Full Court for four days, during which time their Honours were taken up hill and down dale to the evidence.  The appellants had plenty of time and opportunity and did deal with all of the evidentiary matters that they relied upon to show that his Honour Justice Lehane could not have meant “would” and both oral and written submissions in regard to that were plentiful.

GUMMOW J:   But were you, as it were, by way of contention saying, “Oh well, maybe his Honour did nod when he talked about ‘might’”, but nevertheless you go ahead in the Full Court if you would and that can all be strapped up by some evidentiary finding on your part?

MRS BENNETT:   No, your Honour, our notice of contention, from recollection, in the Full Court related only to the question of common general knowledge and documentary material and we asserted at all times that his Honour’s ‑ ‑ ‑

GUMMOW J:   I am just asking did anybody invite them to embark on this evidentiary finding expedition?

MRS BENNETT:   It was part and parcel of the notice of appeal when the appellants said that they failed to properly apply the test for obviousness and that, in fact, his Honour Justice Lehane’s “might” on the evidence could not mean “could” or “would”.  If your Honour looks at the notice of appeal at pages 130 and following ‑ ‑ ‑

GUMMOW J:   I do not want to take up time with this but ‑ ‑ ‑

MRS BENNETT:   That deals with a number of factual matters that are referred to specifically in the notice of appeal and they were elaborated fully by the appellants during the course of it.  The Full Court was, in fact, directly invited to consider the evidence in order to ascertain whether ‑ ‑ ‑

GUMMOW J:   Invited by whom?

MRS BENNETT:   By the appellants.  We can hand up to your Honours the outline of submissions as well as the transcript if your Honours wish to satisfy yourselves of that.

CALLINAN J:   Dr Bennett, did the Full Court deal with Dr Marshall’s evidence?

MRS BENNETT:   Yes, your Honour.

CALLINAN J:   Whereabouts?

MRS BENNETT:   I am sorry, your Honour.

CALLINAN J:   I do not think the Full Court mentioned it.

MRS BENNETT:   I thought they did.

CALLINAN J:   Unless you can pick it up.  The Full Court seems to have dealt in detail with the evidence of every expert except Dr Marshall.

MRS BENNETT:   They did refer to Dr Marshall at page 200.

CALLINAN J:   Yes, they refer to it, but if you go back to page ‑ ‑ ‑

MRS BENNETT:   No, they do not discuss it in detail.

CALLINAN J:   Whereas they discuss in very great detail, I think I am right to say, beginning at page 179, the evidence of each and every of the experts apart from Dr Marshall.

MRS BENNETT:   Yes, they obviously took the view of what I will call the “classic evidence” of Drs Story and Rowe, which is the classic hypothetical skilled worker evidence, established the position and then as - Justice Lehane’s reasoning, if your Honours will recall, was based primarily on Drs Rowe and Story and he said he was fortified in his view by Dr Marshall.  So the Full Court is simply affirming that, having found that Story and Rowe again get the question of routine steps established, they support the fact that it is supported, as Justice Lehane said, by the practical reactions of Dr Marshall.

CALLINAN J:   Did the trial judge deal with the argument of the appellants that the experts called by your side were, in effect, disqualified because of their previous inventiveness?

MRS BENNETT:   What the appellants put is set out in the summary of the evidence by Justice Lehane.  As to Dr Rowe, they quibbled with the fact that he was not actually in Australia on the priority date and his Honour held he could still give evidence of common general knowledge and certainly of inventive step.  As to Dr Story, they did not quibble with the fact that otherwise Dr Rowe was of the right qualifications and competent to give evidence of inventive step.  They did draw an issue with Dr Story only on the basis that he had been a patentee and what his Honour said was, he can certainly give evidence of common general knowledge and the approach of other formulators, and it is apparent they he did not rely to the same extent upon Dr Story, but there was no complaint made about Dr Marshall or Drs Thiel or Ashley, from recollection.

CALLINAN J:   Thank you.

MRS BENNETT:   The only submissions made on the evidence to his Honour in terms of objections to evidence were made by us because we complained that neither Professors Rees, Rhodes or Brown were hypothetical formulators, and his Honour refers to the fact that we put written submissions in to that effect and we certainly put in submissions on that.  The Full Court noted when evidentiary complaints were made to them that there was no ground of appeal in the Full Court on questions of evidence but that in any event, as we will show your Honours, the Full Court also dealt with the evidence referred, with apparent surprise to the lack of contra evidence or lack of cross‑examination by the appellants, and found again that the assertions of the Alphapharm witnesses were undisputed and unchallenged.  Yes, the reference to Dr Story is at page 38 of the appeal book, how he dealt with Dr Story, at line 20.

Your Honours, if I can now go to the patent, which is usually the starting point for a lot of these cases.  Your Honours will see in the supplementary appeal book that we have put in three versions of the patent, pre‑amendment, post‑amendment and a colour‑coded copy which shows where the amendments were.  We remind your Honours that these amendments were made some 10 years after the grant of the patent in Australia.

GUMMOW J:   Well so what?

MRS BENNETT:   Well it is just of interest, your Honour, that it was obtained on the basis of the pre‑amendment patent, it was left to run for 10 years during which the monopoly was for a right in rem was there.  They then removed from the patent ‑ ‑ ‑

GUMMOW J:   I have sat in cases where the specification has been amended at trial.

MRS BENNETT:   Then, if it is a trial, one then has to satisfy section 105 of the Patents Act, which is actually quite difficult.

GUMMOW J:   Yes, that is right.

MRS BENNETT:   If one amends before any proceedings ‑ ‑ ‑

GUMMOW J:   Now it was easier the way these people did it, but that is what the Act permits, so what?

MRS BENNETT:   Well, our notice of contention in paragraph 2, we submit that, under section 116 of the Patents Act, it is a short section, it says:

The Commissioner or a court may, in interpreting a complete specification as amended, refer to the specification without amendment.

And we say that it is relevant in this case to see what it is, in interpreting what the nature of the invention is said to be, in looking at the pre‑amendment patent, because it is quite interesting to see when one changes something from “it must be obvious” to “further pioneering work is established” ‑ ‑ ‑

GLEESON CJ:   This is at the bottom of 73.

MRS BENNETT:   Yes, your Honour.

GUMMOW J:   But is it some admission against interest?  It is not a question of whether it is interesting; what issue does it go to?

MRS BENNETT:   We say it goes to two things:  to interpreting what is the nature of the problem and the nature of the invention; and, secondly, to the extent that there are admissions by the patentee, we rely on those admissions.

GUMMOW J:   Against interest?  How?

MRS BENNETT:   Against interest, because it establishes a different – there are a number of matters which are conceded to be part of the background or obvious that they have withdrawn.

GUMMOW J:   I do not understand this.

GAUDRON J:   No, I am lost, Dr Bennett.  Are you taking us to the patent for the purposes of identifying the problem with which the hypothetical addressee would have been faced?

MRS BENNETT:   We are taking you to the patent, your Honour, to show first what the nature of the problem truly was and where the problem truly arose and a bit more detail to assist your Honours in seeing how far down the track Astra, in describing the nature of the problem, said that it was not part of the problem.  The first two integers, for example, were never said, in the original patent, to be part of the problem; only the third integer.  So it assists in that regard and in looking to see how difficult it is said some of these steps were to take, we rely upon the concession in the unamended patent as an admission that certain matters were obvious, to anyone.

GAUDRON J:   In any event, it is the combination that has to be obvious, does it not?

MRS BENNETT:   Yes, your Honour, and that is quite clearly what both Justice Lehane and the Full Court considered.

GUMMOW J:   Obviously.  Why would anyone waste time on such a debate?  Just look at claim 1.  It is a combination claim.  That is what has to be obvious.

MRS BENNETT:   Yes, and that is what the court dealt ‑ ‑ ‑

GUMMOW J:   Why do these cases get blown out with these false issues?  It seems to be getting worse and worse.  Anyway, I will not say any more.

MRS BENNETT:   Your Honour, we are dealing with the case that is being made by the appellants.  We say that the courts below did exactly what they are meant to do.  They looked at the combination and determined whether or not the combination was obvious, or involved an inventive step, applying well‑known principles and applying those well‑known principles to incontrovertible fact.

GAUDRON J:   Where I am lost, Dr Bennett, is this.  It does not seem to me to be a matter whether or not there is an implied admission as to the obviousness of any part of this.  I want to know why it is that the Full Court was right, or wrong.  Your case is they were not wrong.  How does the patent help in that exercise other than by identifying the problem that would have been the subject of inquiry to the addressee?

MRS BENNETT:   It is the nature of the problem as to which the solution to this claim is said to address that we are looking at.  So to start with we have to see what the patentee says is the nature of the problem.  Perhaps I can deal with it this way.  If I could take your Honours first to the patent that the courts were considering, which was the patent that appears at page 37, which is post‑amendment, because we lost the argument on section 116.  Your Honours will see that at page 39, as one normally has, a description, “Background of the Invention”.  That is the compound patent.  As a further background we see, at line 16:

Omeprazole is susceptible to degradation/transformation in acid reacting and neutral media.

At line 24:

Thus an oral dosage form of omeprazole should be protected from contact with the acid reacting gastric juice in order to reach the small intestine without degradation –

That supports the Full Court’s decision that that was a given, not only from the concession of the patentee but also on the finding of facts, with regard to the hypothetical formulator.  At page 40, line 16:

Ordinary enteric coatings, are made of acidic compounds.  If covered with such a conventional enteric coating, omeprazole rapidly decomposes by direct or indirect contact with it, with the result that the preparations become badly discolored and lose omeprazole content –

The problem starts at line 21:

It has been found that in order to enhance the storage stability –

so we are the stage not of bioavailability testing, which one gets to with an omeprazole core consisting of an alkaline reacting compound coated by an enteric coat. 

It has been found that in order to enhance the storage stability –

I withdraw that, that is what the patent now says.

the cores which contain omeprazole should also contain alkaline reacting constituents.  When such a core is enteric coated –

you get discolouration, at line 24:

of the coating and the active drug contained in the cores in the proximal part of the small intestine, it also will allow some diffusion of gastric juice –

and this alleged twin problem.  At line 30:

The alkaline solution will interfere with the enteric coating and eventually dissolve it.  In accordance with the present invention this is prevented by the subcoating layer.

So what is asserted here, and it does not make full sense because they have taken so much out, is that we are at the stage of storage stability, not at the initial stage of bioavailability or stability on manufacture.  That is backed up as one goes through the patent.  At page 42 under the heading “Separating layer”, your Honours will see again a reference at the third line, line 4, that we are talking about:

discolouration of omeprazole during the coating process or during storage.

Both of which arise from interaction.  At page 44, line 10:

Without this separating layer the resistance towards gastric juice would be too short and/or the storage stability of the dosage form would be unacceptably short.

At line 20:

It is essential for the long term stability during storage that the water content –

et cetera.  All of it is geared towards storage and, indeed, if your Honours go to page 47 which is one of the examples – and I will not take your Honours through the intricacies of the fact that there is nothing that is actually dealt with all the way through, your Honours will see that in that Table 2, it is all about storage.  if you look at the lines from 14 to 24, you will see that they are talking about storage, at line 17:

Storage for six months under these conditions corresponds to storage at normal temperature for three years.

At page 49 we have Table 4, another storage test, and then just a series of examples of various formulations.  Then under “Discussion” at page 63:

From the results given in Table 5 it can be seen that formulations containing omeprazole with acceptable acid resistance can be prepared by using a conventional enteric coating technique . . . it is also obvious that the storage stability . . . is not acceptable, since a discolouration, showing a degradation of omeprazole, occurs during short storage at . . . already during the enteric coating process –

That, of course, confirms that that is demonstrated by discolouration which is what the hypothetical formulators said, that if they saw discolouration they would assume a problem with stability and act to rectify it.

GUMMOW J:   This is all about explaining best method and so on, is it not?

MRS BENNETT:   Yes, but it is all going to the question of something that is stable on storage.  That is made much clearer when one goes to the patent at page 71 which gives further detail.  You will see at line 12:

Omeprazole is however susceptible to degradation/transformation in acid reacting and neutral media.  However, the half‑life –

et cetera.  At line 16, 17 –

e.g. pH=7 the half-life of omeprazole is about 14 hours, while at higher pH-values the stability in solution is much better –

and there is a reference to Pilbrant and Cederberg.  At line 25:

From what is said about the stability properties of omeprazole, it is obvious that an oral dosage form of omeprazole must be protected from contact with the acid reacting gastric juice in order to reach the small intestine –

They then refer to human pharmacological studies.  I am sorry, I think I may have said the wrong page number, I do not know if I have lost your Honours.  I was on page 73, I was told I said 71 and I apologise for that.

At page 74 now ‑ I do not know if your Honours want me to repeat the passages at 73, but they go through some of the matters that were deleted.  At line 7:

In order to obtain a pharmaceutical dosage form of omeprazole which prevents omeprazole from contact with acidic gastric juice, the cores must be enteric coated.  Ordinary enteric coatings, however, are made of acidic compounds.  If covered with such a conventional enteric coating, omeprazole rapidly decomposes –

this is all, of course, still in the background.

McHUGH J:   Yes, but the problem was that omeprazole is unstable and degrades rapidly in an acid or neutral solution and its stability is also affected by moisture and in order for it to work as an oral medication, it had to be released rapidly when it reached the top of the small intestine, but it must also be able to go through the stomach protected from the gastric juices in the stomach.  Now, that was the problem that had to be solved, was it not?

MRS BENNETT:   Well, it is a question of when the problem arose.  If the problem arose at the very beginning of the formulation, yes, that was the problem, and those factors your Honour mentioned led the hypothetical formulator immediately to stabilise the core with an alkaline reacting compound and to coat it with an enteric coat to get it through the stomach.  So if you start at the beginning of the formulation, if that was the problem, those two were a given, as the Full Court said, or immediately come to, as Justice Lehane said.  Then, when you did that, in the ordinary course you inevitably got a discolouration – certainly, on long‑term storage – and that was the sub-coat. 

Perhaps now the appropriate time to move to it is to go to Justice Lehane and the way in which his Honour dealt with it, not repeating the matters I have already dealt with specifically.  I want to look at the way in which his Honour approached it and the structure of his Honour’s reasons, as well as the Full Court.  His Honour’s reasons start at page 19 of the appeal book.  His Honour deals with some of the background about Astra and the context of the patent, some of the matters that I referred to earlier, in answer to a question from your Honour Justice Callinan, about the timing of the various patents and the benefit to Astra, during the currency of the compound patent, of its sales of Losec; refers to the amendment; and then starts discussing the patent.  I will not ‑ ‑ ‑

GLEESON CJ:   Well, now, you can probably assume that by this time in the proceedings, we have got on top of the reasons for judgment of Justice Lehane and the Full Court.  What you perhaps need to take us to is what you regard as the critical part of the reasoning. 

MRS BENNETT:   Thank you, your Honour.  What I am proposing to do is to go straight to page 32.  His Honour commences his discussion of obviousness, lack of inventive step.  At page 30, he deals with the transitional provisions, and then at paragraph 34 he starts looking at the principles to be adopted.  The principles are well-established.  He cites Wellcome v VR at 270, which is a passage that has been approved in this Court as well.  He then goes into a discussion of Minnesota Mining as to common general knowledge.  I will not go through all the passages he cites, but they are obviously appropriate passages.  He then in paragraph 36 points out that there was: 

no significant dispute as to who was properly to be regarded as the hypothetical “non-inventive worker in the field”:  that person is one who is experienced in the practical work of formulating drugs for therapeutic use. 

He then discusses who the hypothetical formulator was at line 50 and points out: 

The skilled worker for present purposes is a member of that class –

and notes that it should be a not “particularly imaginative or inventive one”, and then cites Allsop v Bintang, which is a unanimous decision of the Federal Court.  He then at paragraph 37 commences an analysis of what constitutes common general knowledge and refers to the way in which the evidence of the witnesses for Alphapharm was set out. 

McHUGH J:   By the way, in the Allsop Case, they used the “at once” formulation, if I remember rightly. 

MRS BENNETT:   They used the 286 test as well.  If your Honour was referring to Allsop v Bintang, our learned friends point to a short passage of their Honours’ reasons where they go through some of the tests of obviousness, one of which they refer to as being the test in Vickers v Siddell. 

McHUGH J:   Vickers v Siddell, yes. 

MRS BENNETT:   But in the overall context, when you look at the whole of their Honours’ reasons in that case, your Honours will see that that is only part of the discussion. In fact, at page 700 – which is in 15 IPR 686, I am sorry – at line 16, the court there says:

The test of obviousness was stated by Aickin J in Wellcome –

cites 270, moves on at line 25 to cite the passage at 286.  That is the way they start.  The approach the test of obviousness in exactly the same way.  Wellcome, page 270, and then because it is an experimental art, 286. 

They then refer at line 46 to what was said by Justice Clark for the Supreme Court of the United States in Graham v John Deere, that it must be beyond the skill of the calling, and notes that: 

“The standard [ie the standard of the law of patents] has remained invariable in this court.  Technology, however, has advanced – and with remarkable rapidity in the last 50 years.  Moreover, the ambit of applicable art in given fields of science has widened by disciplines unheard of a half century ago.  It is but an evenhanded application to require that those persons granted the benefit of a patent monopoly be charged with an awareness of these changed conditions.  The same is true of the less technical, but still useful arts –

and there is the mouse trap, your Honour –

He who seeks to build a better mousetrap today has a long path to tread before reaching the Patent Office. 

McHUGH J:   Emmerson is well read.

MRS BENNETT:   Yes, your Honour.  Then your Honour will see that at line 24 is the crucial point:

although a simple idea may be inventive, it is essential for validity that there be inventiveness.  Though small, it must be present.

Then they cite a number of different matters.  They go back to Graham v John Deere.  They also refer to Vickers v Siddell and then they go on to talk about Werner v Bailey where there has to:

be some difficulty overcome, some barrier crossed . . . whether there is sufficient invention to justify a monopoly –

and then go down, again, to go back to Wellcome, it being a:

jury question . . . The nature of the issue, involving as it does matters of impression, is one in which particular respect and weight should be given to the decision of the trial judge –

and then proceed to deal with it in that composite way of taking all of those different factors, so it was not ‑ ‑ ‑

McHUGH J:   I know there are all these formulations and they refer on page 700 to what Lord Justice Diplock said in Johns‑Manville and did he not say in that case that he doubted whether there was any verbal formulation that was appropriate to all classes of claims?

MRS BENNETT:   That is why there have been various ways in which courts have looked to applying other formulations if necessary to the facts of the case or the nature of the art in that case.  One would apply a different test to a mechanical combination where the idea of the combination itself was the alleged invention.  One applies a different test to that.

KIRBY J:   That is why I take it you actually embrace Justice McHugh’s point because you say that is the answer to Dr Emmerson’s suggestion of unimaginative plodders.  You are just not in the realm of unimaginative plodders when you are dealing with this particular realm of the art of chemistry and pharmaceutics.

MRS BENNETT:   There are two further answers to that, your Honour.  The first is that Justice Windeyer in Sunbeam recognised that a long time ago.

KIRBY J:   You have told us that.

MRS BENNETT:   And, secondly, that there was no dispute as to the characterisation of the correct person in this case.

McHUGH J:   Perhaps the best way of approaching it is the passage I saw in a judgment of, I think it was Lord Justice Aldous, where he said the question really is whether the advance is technically or practically obvious, so ‑ ‑ ‑

MRS BENNETT:   It imports the art.

McHUGH J:   Yes, the particular art.

MRS BENNETT:   It all comes down to working out the best way for the judge to satisfy him or herself that, in fact, there is something there that constitutes an inventive step and is appropriate for a patent, whether there is some barrier crossed, whether – well, no matter how you formulate it, the judge has to decide that, as to whether in this case, or the instant case that he or she is dealing with ‑ ‑ ‑

KIRBY J:   As long you do not get too far away from the statute which is the law that you have to apply.

MRS BENNETT:   But that is what they all come back to and some of these expressions that are used ‑ everyone is very careful to say that these are simply ways of approaching a test of obviousness ‑ ‑ ‑

KIRBY J:   I realise that but these are cases that involve a lot of money and they attract very highly skilled lawyers who then have to try to breathe into all sorts of cases in other contexts of great importance, and points of distinction, points of application, and you spend two days in the High Court of Australia going through it all.

MRS BENNETT:   In the present case, your Honour, the principles applied by Justice Lehane are principles that have been long accepted, deriving from unanimous decisions of the High Court and applied by unanimous Full Federal Courts which, I think, this Court has said on previous occasion, is a court that regularly deals ‑ ‑ ‑

KIRBY J:   Well, unless Justice Lehane has gone wrong in his formulation of the test, or the Full Court more properly, as far as I am concerned I am not going to review a jury verdict.  You have to trust your decision‑makers in these matters.

MRS BENNETT:   We certainly support that, your Honour, and we say that we are going through Justice Lehane now to show the way in which he approached it, to show that there was no misapplication of principle.  So he deals with 3M, he deals with Wellcome, he then talks about a non‑inventive worker in the field, he then talks about the evidence and deals then with common general knowledge – I am sorry, I am on page 34.  He goes through a lot of the authorities on common general knowledge.  He deals with Astra’s submissions at the bottom of page 35 and then at page ‑ ‑ ‑

KIRBY J:   We can read all this, Dr Bennett.  I mean, we are only on page 34 and there are 200 in the book.

MRS BENNETT:   No, your Honour, I will skip through it, your Honour.  Your Honours will see that he rejected the submission that we put that, in the light of the evidence that the computer search was part of common general knowledge, we submitted that the results of that search was also part of common general knowledge and he rejected that submission, but said that that does not mean that the routine literature search cannot be treated as an ordinary routine step.  Now the Full Court did not directly analyse it in that way and we have raised that in our notice of contention.  We say that that is a simple logical proposition that flows from the very concept of the allowance of a routine step.  If that involves a literature search, the result of that search is no different to doing an experiment.

In that regard, and in support of our notice of contention, we refer your Honours to a decision of the English courts in Nutrinova [2001] FSR 42 at page 797. It is a decision of the English Patents Court, his Honour Justice Pumfrey, and we submit that the logic of his Honour in this regard is logic that flows naturally and we urge upon your Honours. And that is at page 825, paragraph 81:

The addressee of this specification is either a single organic chemist or a small group.  A person given the task of finding a commercially acceptable pathway . . . would . . . be a post-doctoral organic chemist with experience of heterocyclic synthesis.  Dr Tennant says, and I accept, that the first thing a chemist charged with such a task would do is to familiarise himself with existing synthetic routes . . . expressed the view that such a chemist would do a literature search and would certainly come up with the review article . . . The German version of this article is referred to on page 6 of the translation of the patent in suit.  If this is what the unimaginative chemist would do, the court must do it as well.  The disclosure of a document is ascertained by looking at the document through the eyes of the unimaginative chemist, and the court must decide what is obvious, or insufficient, in the same way.  This is not to say that the contents of the article amount to common general knowledge.  The Court of Appeal in General Tire . . . described common general knowledge –

and refers then to a recent decision of Beloit.

It is, in essence, the knowledge which the addressee of the specification can be expected to have as part of his ordinary professional knowledge. An organic chemist brings his general skills and knowledge as an organic chemist to the task, but he cannot be expected to know the contents of review articles.  At the same time, he must be expected to discover such articles, since doing a literature search is something which every skilled man in this art would be expected to do.

He then cites a passage from Lord Justice Aldous in Beloit and then says:

There is a category of information which would be accepted generally once discovered and which will certainly be discovered by the skilled unimaginative chemist doing his job, not as a matter of performing a diligent search, following all the leads and cross‑references, but as a matter of identifying the publications which are necessary to use as a starting point for tackling the new problem.  I have no doubt that publications of this sort must be pleaded, if only to avoid surprise, but if it is established that their disclosure would form the basis of the skilled man’s approach to the new problem it seems to me that they will form part of the knowledge with which he will approach other disclosures.  To this extent, the information which they disclose must be treated in the same way as information forming part of the common general knowledge.

Now, his Honour says it is not part of common general knowledge but it has to be taken into account.  We say it should be taken into account here because it can be found as a result of a routine search.  So that is what was dealt with by his Honour Justice Lehane at ‑ ‑ ‑

GAUDRON J:   Do you put any emphasis on “or used in Australia”?

MRS BENNETT:   Yes, your Honour, because what was used in Australia was literature searches.  So it is an act of going in and typing the word “omeprazole’ into a search engine.  The Full Court deal with that as well.

What I wish to put then about the structure of his Honour’s reasons because it has been the subject of comment of your Honours, is this.  What his Honour does is he then describes the Alphapharm witnesses and talks about who they are, what they knew and how they approached the problem.  First he describes who they are, between pages 36 and 39.  He then deals with some of the documents, that I will not trouble your Honours with at the moment, bearing in mind this decision goes to the questions of “novelty” as well as to questions of “obviousness”.

Then at page 44, he starts setting out the evidence of Dr Rowe, Dr Story and Dr Marshall.  I have taken your Honours to a lot of that.  Then he talks about Dr Rowe’s evidence and the steps that he would have taken to formulate it and he goes through that step by step.  He refers to the fact that if there had not been information available by way of a document, that Dr Rowe would have done the experiments for himself and by standard laboratory testing would have come up with the characteristics.  That is at page 45 in paragraphs 64 and 65.  That would have led him directly to an enteric coated dosage form, in paragraph 65.  Then, in paragraph 66:

The next step . . . would have been to test the product for stability.

At line 44:

If the tests revealed diminution in potency –

then he would have ‑ ‑ ‑

GUMMOW J:   We can read all this, Mrs Bennett.  We have been through it several times.

MRS BENNETT:   I was asked earlier to point to some of the specific matters.  I will go faster then, your Honours.

McHUGH J:   If you go any faster we will not be able to hear you.

MRS BENNETT:   The accusation – my learned junior keeps putting a sign up next to me saying, “Slow down”.  I do not think he is talking about, with respect, Justice Gummow, the matters I am referring to, rather the speed at which I am talking.

McHUGH J:   You are getting close to the speed of sound already.

MRS BENNETT:   Then I will have to slow down.  What I am trying to say is that he goes through the evidence, and at page 47 then he gets to Dr Marshall where he goes through the evidence of Dr Marshall in some detail.  It is clear from that evidence that Dr Marshall started right back with a very simple proposition.  So in terms of the six reports they did not all deal with the problem.

KIRBY J:   You told us that.

MRS BENNETT:   Yes, your Honour.  Then I was asked earlier where he links up his statements of the evidence, after going through the Astra evidence, which he said supported the evidence of the Alphapharm experts.  Then at page 66 – rather, he starts his discussion at page 62.  There are some passages there that we have already referred to about the evidence leaves no room for doubt that that had been got to.  Then really the crux of his Honour’s reasoning starts at paragraph 110.  He sets out the test.  Then at page 66 he links back the evidence that he has described earlier.  I think Justice Callinan you asked me for that specific reference earlier.  At page 66 he says:

I accept the general descriptions given by Dr Story and Dr Rowe of the way in which they would go about the formulation of a new drug.

He goes back at paragraph 112 to make it clear he is asking the steps of – or what the formulator would have done.  We have dealt with the passages at page 67 and also his consideration of and rejection of the relevance of the twin problems.  I do not think I have taken your Honours, however, to paragraph 118 at page 69.

KIRBY J:   Somebody has, because I have underlined it four times.

MRS BENNETT:   The only point I wish to make in relation to that paragraph is this.  His Honour made it quite clear that he was not looking at the individual integers but whether the combination was obvious, that that had to be done in context.  Then again at line 30, “given . . . all the expert evidence”, and then he says again at line 36:

The evidence of the formulators suggests, and Astra’s experience confirms, that that view was likely to have been maintained with considerable firmness.

That is the view of whether they would have arrived at it.  At page 70 ‑ ‑ ‑

KIRBY J:   This page is underlined five times, the whole page.

MRS BENNETT:   The only reference I have not made, your Honour, specifically is to note that his Honour specifically noted that he allowed for hindsight, which is one of the criticisms that is often made of judges doing an assessment of obviousness on the basis of routine steps.

KIRBY J:   You have mentioned that three times.  He referred to the insidious effects.  So it was in his mind.

MRS BENNETT:   I am sorry, your Honour.  May I then go to the Full Court, which I do not think I have actually gone to in any detail.

KIRBY J:   I hope you are going to leave enough time for a reply but also deal with the issue of policy and the issue of overseas decisions.

MRS BENNETT:   Yes, I will.

KIRBY J:   Speaking for myself, I would not want in this area for the High Court, statutory variations apart, to be taking a position that is different from that of the thrust of this international doctrine, if there is an international doctrine on this issue.

MRS BENNETT:   I will get to that, your Honour.  I apologise.  I did only get to start a bit later this morning, so ‑ ‑ ‑

KIRBY J:   Dr Emmerson was very thorough and you have been very thorough.  It has been a very thorough two days.

MRS BENNETT:   What the Full Court does is go through, of course, the reasoning of his Honour Justice Lehane.  They deal specifically with the fact that they are looking at a combination in a number of places, in particular at paragraph 25 on page 159, where they note:

The claim is that the combination of these integers is an inventive step.

So one has to understand the purpose of the combination.  They then go through the amended specification and note what it says at paragraphs 26 and following.  Then at page 161 they come to the principles that they are going to apply under the heading, “The law as to ‘inventive step’”.  They note the “scintilla” point but then point out at paragraph 31, line 46:

it is nevertheless essential for the validity of a patent that there be some inventiveness.

They cite the cases that are reasonably classic in that regard.  They deal with the question of obviousness and inventive step at paragraph 32, the antithetical nature of it, and they then refer to the Wellcome passage at 270 in paragraph 33 and to 3M’s assessment of common general knowledge.  The principles are unexceptional.  At paragraph 35 they point out that the issue is whether highlighted:

the combination of the three integers . . . constitutes an inventive step . . . or would have been obvious to the non‑inventive skilled worker in the field of pharmaceutical formulation.

They note that prior publications do not get you there.  They then refer to Beecham – and this is in the context of what the submissions were ‑ ‑ ‑

GUMMOW J:   What is classic about Lord Justice Buckley’s judgment?

MRS BENNETT:   Well, only, I suppose, your Honour, that it has been referred to a number of times.  Beecham’s Case is something that appears on a reasonably regular ‑ ‑ ‑

GUMMOW J:   Anyway, do not waste time on it.  It just does not strike me as classic.

KIRBY J:   It is not old enough to be a classic.  It is only 1980.

MRS BENNETT:   They point to the Beecham Case really for the passage cited which is to deal with the submission put by the appellants that it has to be “clearly predictable” at the outset.  So they refer to that and say:

It is not necessary to establish that its success is clearly predictable.  It will suffice if it is shown that it would appear to anyone skilled in the art but lacking in inventive capacity ‑ ‑ ‑

GUMMOW J:   We can read all this, Mrs Bennett.

MRS BENNETT:   Well, I had not taken your Honours ‑ ‑ ‑

KIRBY J:   It is 38 and on which comes to the issue of integers, which is the target of the first submissions we received.

MRS BENNETT:   Yes.  We do point, however, to the fact that in Lord Justice Buckley’s reasons there is also an interesting statement which accords with ICI v Lubrizol in the fourth-last line:

The question would, I think, be one of degree.

So you can apply the tests but it is a matter of fact and one of degree.  Then at paragraph 38 in a passage that my learned friend cited but did not complete the sentence in:

Alphapharm does not suggest the combination of integers . . . would have been apparent to the skilled worker in the field prior to that worker attempting to formulate omeprazole.

Our submission was not to break down the combination of integers as such.  We were disputing that it had to – we did not suggest that before even looking at omeprazole you would go straight to the combination.  What we did say was that each of the integers was at least worthwhile trying.  Now, in an experimental art where one is going into a combination integer by integer, in our respectful submission, that is an unexceptional approach because that is how it happened.

KIRBY J:   That is a question which we have to answer.

MRS BENNETT:   Yes, your Honour, although not necessarily on the facts of this case because, as I have said before, once you start at the point where the problem arose, then in fact the combination was immediately apparent.  What the Full Court say is that the first two integers are a given, so they do not really go through the complicated exercise of going through it, but the fact remains this was an experimental approach both by Astra – and, as we put in our written submissions, it is inconceivable, with respect, that a patentee can inflict upon the hypothetical formulator the test that you must solve the problem before the problem even presents itself.

At the very beginning of the formulation no one, including Astra, went straight to the combination.  It was not an idea of a combination.  What happened was, it was an iterative process that started with omeprazole and its characteristics and the other integers then presented themselves in a routine fashion.  Their Honours go through the reasoning of Justice Lehane, and I will not go back through that ‑ ‑ ‑

GLEESON CJ:   Just before you pass from the top of page 164, as I understand part of the argument against you, it is that if each of the integers had not been at least worthwhile trying, the question would not have arisen.  So if the fact that each of the integers was worthwhile trying forecloses the issue, there is no room for argument.

MRS BENNETT:   Your Honour, I am not sure I quite understand what your Honour the Chief Justice is putting to me.

GLEESON CJ:   I am looking at the critical question.

MRS BENNETT:   Yes.

GLEESON CJ:   As I understood part of Dr Emmerson’s argument, he said one of the faults with the reasoning process and with your case is, as he put it, that the wrong question was asked, which was, “Could the problem have been solved by a skilled team?”  Now, the sentence that begins with the word “However” and ends with the word “law” which expresses the critical question, according to the Full Court, begins with the proposition that each of the integers was at least worthwhile trying.  We can disregard the possibility, can we not, that each of the integers was not at least worthwhile trying?

MRS BENNETT:   Yes.

GLEESON CJ:   Otherwise we would not be here.

MRS BENNETT:   No.

GLEESON CJ:   But if the fact that each of the integers was at least worthwhile trying means that the combination was obvious, the only competing possibilities seem to be that there is no solution to the problem at all or that the solution is obvious.

MRS BENNETT:   When one looks to see whether it was worthwhile trying, that is a shorthand, of course, for worthwhile trying with reasonable prospects of success, which is the way the English courts have sort of adapted, or have gone in a more direct line from Johns‑Manville rather than the words of Sir Keith Aickin in the Wellcome Case of routine steps.  What the test is that their Honours are saying in shorthand form is whether in this art, to the hypothetical addressee – non‑inventive hypothetical addressee – in a circumstance where you do go integer by integer, whether or not it is established as a fact that each of those integers fulfilled the appropriate test, which is worthwhile trying with reasonable prospects, or would routinely have been found.

Now, that is something that was specifically allowed for and specifically adverted to by Sir Keith Aickin in 3M.  What he pointed out is that what one must do to establish that a combination is obvious is to show that the selection of integers, the individual integers, was obvious in the glare of hindsight which necessarily, as his Honour said, involves the acceptance of some and the rejection of others.  So, where you are not talking about a combination thought of in one go, where you are talking about an art such as this where it is apposite, it is not wrong – indeed, it is probably the only way you can do it – properly to assess whether something is beyond the skill of the calling is to look at the fact that the calling itself deals with a step by step integer process and so you look to see what the unimaginative hypothetical skilled formulator would do and if, in fact, that formulator would, either obvious to try with reasonable prospects or by routine steps, get to the combination in the glare of hindsight, as said in 3M, then, in fact, there is no inventive step and the combination is obvious.

GAUDRON J:   The question is, is it not, what the Full Court meant by the expression “was at least worthwhile trying”?  In this context – and I am talking about working with chemical compounds – would you accept that the test is whether a person would be directly led to try a particular procedure – procedure may not be the right word – with reasonable prospects of success allowing always for the possibility that in chemical compounds there is a possibility that something will operate in a way that is not known?

MRS BENNETT:   Your Honour, we take issue with the expression “as a test of directly led”, because that would suggest that one cannot have two obvious alternatives.  The question is, whether the routine practice of the art would give you, as one alternative, the course, because experiments necessarily go often in two stages and, indeed, “directly led” would give rise to a problem if you had a two‑stage process, because you are directly led to the first and the first leads to the second.

GAUDRON J:   Well each step ‑ ‑ ‑

MRS BENNETT:   Well, it is the one step to get to the integer; it might be two experimental steps to get there.  So, in our respectful submission, the only way that one can really look at it is to look at the hypothetical worker and see what that worker would have done.  Now whether you call that – in some cases it would be a straight line and, in fact, the evidence in this case really is that it was a straight line, because each step was a logical conclusion and Drs Rowe and Story ‑ the acceptance of their evidence establishes that.  But in terms of the broader test, it may not be a single straight line; it might be, I have two choices, each of which are to me perfectly obvious and perfectly routine and each of which will lead me to the integer, but if you only have one choice, then that is not a recognition of what happens in experiments.

GAUDRON J:   Well that may be so, but we need to know, to determine this appeal it seems to me, what the Full Court meant by, “at least worthwhile trying” and we need to know whether, in the context of which we are speaking, namely the formulation of pharmaceutical compounds, that was the correct test.

MRS BENNETT:   What the test was that the Full Court was applying ‑ ‑ ‑

GAUDRON J:   No, but where do we find in the Full Court judgment what they meant by that expression?

MRS BENNETT:   We say, your Honour, it is implicit in the reference to Beecham that they are talking about the British test of “worthwhile trying with reasonable prospects of success”, which is ‑ ‑ ‑

HAYNE J:   Paragraph 83, page 178, is it not?  Is that the statement you are referring to in the Full Court?

McHUGH J:   Line 27.

MRS BENNETT:   Yes, that is out of the ‑ ‑ ‑

HAYNE J:  

worth trying (perhaps amongst many possibilities), it must follow ‑ ‑ ‑

MRS BENNETT:   Yes, your Honour, but the “worth trying” again imports the concept of not just merely thinking about it as a question mark, but with reasonable prospects of success, which is the British test or the verbal description of the British test.

GAUDRON J:   But again, “worth trying”, you see, it just seems to me that that really is circular.  We go back at least worthwhile trying; that seems to me to be merely repetitive.

HAYNE J:   Amplified ‑ ‑ ‑

GAUDRON J:   We talking about something about probabilities in this area, are we not?

MRS BENNETT:   We are talking about fact and I should just add, after going to paragraph 83, your Honours might also go to paragraph 85, where:

Obviousness is not necessarily negated by the fact that the task of the hypothetical formulator would have been “complex, detailed and laborious . . . Depending on the nature of the relevant product, these qualities may be inherent –

again, a reference to Wellcome.  Then they go on at paragraph 86, again:

In a case where the possibilities “worth a try” concern the cheapest –

et cetera, it is going to be “inevitable” that you have research, and:

the critical question is not whether a hypothetical formulator would have needed to undertake complex and laborious work, but

“whether what had to be done to achieve the step was truly a matter of inventive experiment or merely a matter of that type of trial and error which forms part of the industrial function –

So they have brought the test that they have applied back to that and they say:

The answer to that question must depend on the evidence –

and then they look into the evidence.  So the test that they actually apply, when one goes through the whole of their analysis, is the test at paragraph 86.  If I can just say to your Honours – and that is made clear again ‑ ‑ ‑

GAUDRON J:   Can I put to you this.  It does not seem to me that it is that these judicial statements are universally true in every case or could even be universally true in every case.  Must the step taken be one that either you can say will probably lead to a solution or lead to other steps that lead to a solution and, by way of contradistinction, if it does not do that, exclude other steps as ones that would lead to a solution?

MRS BENNETT:   That is really what Sir Keith Aickin is saying in 3M, that the process of selection of an integer necessarily involves the rejection of another.  So where it is an experimental art you may need to do two experiments to accept one and reject the other.  The Full Court specifically says at paragraph ‑ ‑ ‑

GAUDRON J:   But must there be some probability about that?

MRS BENNETT:   Yes, it has to be worthwhile trying with a reasonable expectation of success.  So you look to see what is ‑ ‑ ‑

GAUDRON J:   That it will lead you at least to the right course or the next stage?

MRS BENNETT:   Yes.  Well, the next stage and that will either be the right course or it will tell you that that is the wrong course and then you will know what the right course is, and that is really what was said by Justice Laddie in Brugger. The Full Court make that clear at page 202 where, after dealing with Dr Rees’ assertion about inventive journey and the assertion that it has to be linear, there has to be a linear progression, bearing in mind the facts of this case were as found that formulations are never linear as a matter of the norm, they say:

As we have pointed out at paras 83 to 87 above, obviousness is not confined to –

linear cases.  So they make that finding explicitly and, bearing in mind that the formulator’s art is not linear, that is a reasonable and appropriate decision on the nature of this case and this art which recognises ‑ ‑ ‑

HAYNE J:   When we deal with a formulator, are we to treat the formulator as knowing that there is a solution to the problem?

MRS BENNETT:   No.

HAYNE J:   Surely not.

MRS BENNETT:   I said no.  I agree.

HAYNE J:   Thus the question of obviousness is not to be assessed against there being a finite number of possibilities in which all you must do is eliminate some or all, many of them, to achieve the solution that you know is out there.

MRS BENNETT:   In the nature of this art, that would probably be right.  What you look at here and what the evidence shows is how the formulator moves forward in a sequence of logical progressions based upon the nature of the drug.  In some cases, in Dr Marshall’s case, he proposed three alternatives to explain something that he noted.  In the ordinary course you would do experiments which would verify or show that that step was the correct step, or show that it was the wrong step.  It was like my example earlier about three possible solvents, three known solvents, each of which could dissolve your compound and you have to try it and see.

HAYNE J:   What provoked my question is paragraph 140 lines 23 and following of the Full Court judgment, speaking of Astra’s development of the formulation taking time:

Essentially an exercise in trying out various known possibilities until the correct solution emerged.

Now, is that not a statement which assumes that this is simply a mathematical equation to which there is a single solution achievable by trial and error which would be, it seems to me, I understand you to accept, the wrong starting point against which to assess the question.

MRS BENNETT:   To the extent that the Astra experience is the experience of the hypothetical worker, if as a matter of fact it was accepted that the formulator would inevitably get there without the exercise of inventive capacity as part of the routine skill of the calling, then if it merely was a matter of a series of experiments, then yes, that would mean – if that finding of fact were made – that there would be no inventive step.

CALLINAN J:   Dr Marshall knew at least that there was a solution, did he not?

MRS BENNETT:   No.

CALLINAN J:   Did not know that there was a solution?

MRS BENNETT:   No.  He simply said, “Here is the omeprazole.  Please formulate it.”  He did not have the solution.  The formulator may assume that he would get there ‑ ‑ ‑

CALLINAN J:   But he must have known why he was being asked to do it.

MRS BENNETT:   No, your Honour.  He was simply ‑ ‑ ‑

CALLINAN J:   He knew he was doing it for a patent case, surely.

MRS BENNETT:   He did not know if he was being asked to say that there was one or there was not one.

CALLINAN J:   No, but he was being asked to do it for a patent case, was he not?  He knew that that was the purpose for which he was being asked to do it.

MRS BENNETT:   Your Honour, he did not know which side he was on in that sense.  He did not know whether he was being asked to find a formulation or to say that one was impossible.  He was simply asked to formulate.

CALLINAN J:   He would not have to be very bright to understand that he would not be being asked to embark upon a futility.

MRS BENNETT:   If we were seeking to prove that it could not be formulated, he might be.

GLEESON CJ:   If it could not be formulated, how would there be a patent case? 

CALLINAN J:   Exactly. 

MRS BENNETT:   Well, your Honour, I do not know what was in Dr Marshall’s mind.  He was simply given the compound patent omeprazole and told to show what he would do to formulate that, only taking into account the knowledge at the time.  There is no evidence to suggest that the average formulator, in approaching this task of formulation, would assume that there was no solution.  Indeed, what generic formulators in Australia do is take a compound with which they are unfamiliar – and that is the hypothetical person – and go about seeing if they can formulate it.  That is exactly the skill of the art. 

CALLINAN J:   But in the context of doing it for a case, it is inconceivable to me that he could not have believed that there must have been a solution. 

KIRBY J:   But that must be so in every case.  In every case, there are experts; in every case, they are called; in every case, they would have in the back of their mind that there has been a patent and that is why they are giving evidence.  So that you cannot exclude it altogether, but you agree that it is not a part of the premise upon which ‑ ‑ ‑

MRS BENNETT:   We do not, your Honour ‑ ‑ ‑

KIRBY J:    ‑ ‑ ‑ the formulator operates. 

CALLINAN J:   But he was not your conventional witness, because he was being asked to do more than discuss the literature and matters of that kind.  He was being asked to achieve a result if he could. 

MRS BENNETT:   There are two answers to your Honour on that, apart from the one, with respect, we adopt what was said by his Honour Justice Kirby.  The first is, there was never any suggestion, or cross‑examination, or anything put to Dr Marshall, that his process was affected in any way by any endpoint that he assumed one way or the other.  That is the first point.  The second point is that the normal hypothetical skilled addressee, that has gone through all of the other patent cases, is normally someone who actually knows the solution, and the judges assess the conflicts in the evidence, if there are any, and do it by being careful about hindsight.  In Dr Marshall’s case, what he assumed is not the question.  The fact is that he was a witness that supported the normal sort of witnesses.

CALLINAN J:   Yes, but what happened here assumes a special significance, I think, because of the passage to which Justice Hayne just drew your attention, in the Full Court. 

GUMMOW J:   Yes.  Does that not suggest the infection of hindsight? 

MRS BENNETT:   Well, it was never ‑ ‑ ‑

GUMMOW J:   This is a classic, perhaps, manifestation of it – that approach in paragraph 140. 

MRS BENNETT:   With respect, Justice Lehane first ‑ ‑ ‑

GUMMOW J:   And that links back to what the Chief Justice is putting to you. 

MRS BENNETT:   First, Justice Lehane was careful to deal with hindsight.  Secondly, it was accepted by both parties in the case – and I accept that that does not bind your Honours – that Dr Marshall was one witness who could not be tainted by hindsight.  Thirdly, to the extent that he knew that there might be a solution out there, that is certainly less impact of hindsight in the classical test of someone who know the solution and then seeks to say what the hypothetical task would have been.  So the strength and the force of Dr Marshall’s evidence stands, and was accepted, because his evidence, if it were tainted at all by hindsight – which was never put to him, and never found, and never suggested – was less. 

CALLINAN J:   Well, let me just ask you to pause there.  You say that certain matters were not put to some of the witnesses.  That was a matter that is emphasised by the Full Court at pages 173, 174, 181 and 184.  But that is in the context in which the trial judge did not rule upon a multiplicity of objections, and we do not know what the objections were.  Nobody really knows what evidence should or should not have been in.  I must say that I am not impressed by reliance upon a failure to put something, when I think the issues were clearly joined on the appellant’s own material, and the appellant, in any event, when cross-examining, could not have known what was in evidence or not in evidence. 

MRS BENNETT:   Your Honour, when the Full Court makes comment about what was and what was not challenged, that is in this context.  First, there was no objection by the appellants as to any aspect of the evidence.  That is a small issue, I know, but it is an issue.  More importantly, their Honours went back to the evidence, the cross‑examination ‑ ‑ ‑

CALLINAN J:   No, they seem to be Browne v Dunn points in the Full Court.  You can read them at the pages I have just given to you.

MRS BENNETT:   Can I put that to your Honour is the context of this.  Astra did not call any evidence at all by the relevant person to rebut the assertion.  So in terms that there was no conflict, there was no conflict on the evidence of the person of ordinary skill.

CALLINAN J:   The appellants may have taken the view that they did not have to, having regard to Dr Marshall’s evidence.

MRS BENNETT:   Your Honour, first, Dr Marshall was not the basis ‑ ‑ ‑

CALLINAN J:   Or, I might add, to the respects in which, arguably, the other experts called by your client fell short.

MRS BENNETT:   Your Honour, they were matters that should have been put to his Honour Justice Lehane, if those matters were to be put at all.  The appellant accepted the evidence of Dr Marshall as a witness, untainted by hindsight, and relied simply upon the fact that they said he did not get there finally.  So, that was never submitted.  His Honour Justice Lehane heard all of the evidence and all the cross‑examination and Dr Marshall – he did not base his conclusion totally on the evidence of Dr Marshall, neither did the Full Court.

KIRBY J:   The Full Court hardly mentioned Dr ‑ ‑ ‑

MRS BENNETT:   That is right.  So the totality of the evidence, which was not challenged in cross‑examination – and that is a specific finding to that fact – relevant parts and assertions were simply unchallenged because there was no contradictory evidence and they were not challenged in cross‑examination and those findings of fact were made.  The findings of fact were made on that basis.  We appreciate that the appellants took the view that they did not want the evidence before this Court.

CALLINAN J:   Did his Honour the trial judge’s findings in respect of Dr Story and Dr Rowe go any further than the passage to which you referred us at page 66, that is, of acceptance of the:

general descriptions given by Dr Story and Dr Rowe of the way in which they would go about the formulation of a new drug.

MRS BENNETT:   Yes, it did, your Honour.  First ‑ ‑ ‑

CALLINAN J:   Just give me the passages, please.  Do not worry about reading them to me.  Just tell me where they are.

MRS BENNETT:   It is the passages where he sets out the detail of their evidence, from pages 44 of the appeal book where he talks about the evidence of Drs Rowe, Story and Marshall in some detail until he gets to page 53, and that is what he then says in his discussion that he accepts.  Another thing is at page 39 he specifically says in paragraph 50:

Plainly, in my view, the evidence of Dr Rowe, Dr Story and Dr Marshall is, of the evidence in Alphapharm’s case, of particular significance . . . I shall concentrate on their evidence.

CALLINAN J:   But at those pages you just gave us, at the moment all I can see is a discussion or a narration of a summary of their evidence.

MRS BENNETT:   Yes, your Honour, it is a discussion of the evidence as to the steps ‑ ‑ ‑

KIRBY J:   You say you have to read the passage where he says “I accept the general descriptions” in the light of his understanding of what the general descriptions were?

MRS BENNETT:   Yes, your Honour, and at those pages he sets out the steps that each of them says they would have taken to formulate omeprazole, the routine steps they would have adopted.

GLEESON CJ:   Now, Dr Bennett, we have only half an hour left and we cannot give Dr Emmerson less than a quarter of an hour or 20 minutes to reply.

MRS BENNETT:   All right, your Honours, I appreciate that.  I will not go further then through the – bearing in mind your Honours are going to read the Full Court’s decision – except if I could specifically point your Honours to the fact that they were very careful to make it clear that they were looking at the combination and they do that again and again and in particular at page 203, the conclusion they reach at paragraph 154 and then at 155 they make it clear they are dealing with a combination, they refer to the evidence and reach the same conclusion as Justice Lehane.

The only other paragraph that I would wish just to draw your Honours’ attention to is when they point out and what the contentions were on appeal at pages 169 to 170, which shows that really they took the view of the limit of what they were being asked to consider by way of what the appellants actually submitted in the case; to some extent it puts it into context.

There is one other important matter we wish to refer your Honours to and that is at page 176, bearing in mind I have not gone through the Full Court in detail.  At paragraph 77, leaving aside the documents, referring to the fact that the experiments would have been done anyway, they say:

Our ultimate conclusion of lack of an inventive step does not depend on the contents of manufacturers’ literature; rather, the conclusion is based on expert evidence regarding fundamental concepts known to pharmaceutical formulators prior to the priority date.

GLEESON CJ:   Now, I think you have attached to your written submissions, unless I am mistaken, the overseas experience.

MRS BENNETT:   Yes, your Honour, and what I propose to do now is to hand up to the Court a bundle of those decisions, with two exceptions.  So far as the Spanish case is concerned, which was settled, we have simply put in the defence which was filed and then it was settled.  We do not have a copy of the Israeli decision because we do not have an English translation of it.

GUMMOW J:   Well, do these include the relevant statutory provisions?  If they do not, they are not useful.

MRS BENNETT:   Your Honour, what they are there for is to show first that the way in which the individual courts, old tribunals, dealt with the question, was to look at exactly the question of whether or not the hypothetical worker would or would not have come by a process of routine steps to the invention.

Now, in some cases there was a finding of fact that he would and in some cases there was a finding of fact that he would not, but the approach is what we rely upon and the approach is standard.

GUMMOW J:   …..is not going to help me, because I am not comparing apples with apples.

KIRBY J:   One would hope that the judges would set out somewhere ‑ ‑ ‑

MRS BENNETT:   Your Honours, we would seek leave simply to send up a note of the relevant statutory provisions, if we may do that.

GUMMOW J:   I would be assisted by knowing what the current state is in the United States.  We have been given all these English cases, but the largest and most important common law use of that expression, patent jurisdiction, is in the United States.

MRS BENNETT:   United States has a statutory provision ‑ ‑ ‑

GUMMOW J:   Do not take time with it now.  Just put it in a note.

MRS BENNETT:   We deal broadly with the overseas position in paragraphs ‑ ‑ ‑

GUMMOW J:   I know that.

MRS BENNETT:   Thank you, your Honour.  May we just say then some matters about the overseas position broadly.  I put to your Honours, and we will send up the statutory provision as to the question of “routine steps”, being the way in which it was approached.  We also wish to hand up to your Honours three other documents.  One is the decision by the New Zealand Court of Appeal in the Ancare Case, which shows that they take the same approach.  One is a decision by the European Patent Office in the Astaxanthin Case which shows that it takes the same approach, and the third is what we have referred to in our written submissions, which is a summary of the American position taken from a book called Coopers, which we have referred to in our written submissions.

So far as Cairnstores is concerned, which is the English decision, we will not take your Honours through that case in detail but we would urge your Honours to read it.  That is the decision of Justice Laddie on the same patent.  It is quite clear that Justice Laddie used the same test, and two other matters so far as his Lordship’s decision is concerned.  The first is that his reasoning did not involve any consideration of documentation.  So that aspect of where the English law is different from Australia was irrelevant.  He dealt with that secondarily after he came to the conclusion of lack of inventive step.

The second is when my learned friend was asked a question about Cairnstores by your Honour the Chief Justice, he said it was different in Australia because there were the twin problems.  We have already taken the Court to the fact that Justice Lehane dismissed the twin problems as relevant and therefore Justice Laddie’s decision is on all fours in terms of reasoning.

We seek leave to just refer your Honours to two other matters.  The first is that while it postdates both the 1952 Act and the 1990 Act, in the second reading speech to the 1990 Act there was specific reference to the fact that Australia was about to enter into the “Trips” agreement.  We would seek to hand your Honours a copy of that agreement, the relevant part of that agreement, which is taken out of Lahore, if your Honours wish to look at it in detail.  If your Honours see under the heading “Section 5”, which is the second page, “Patents”, your Honours will see that:

patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.

So the test is “inventive step”, which by footnote 5 says:

For the purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non‑obvious” and “useful” respectively.

So the test is “inventive step” with respect to all countries that have signed “Trips”.  In partial answer to your Honour Justice Gummow, but not a complete answer, all of the jurisdictions as to which we have handed up, certainly the European jurisdictions that we have handed up to your Honours in respect of the overseas decisions ‑ ‑ ‑

GUMMOW J:   We are not worried about them.  I am worried about the United States Court of Appeals of the Federal Circuit at the moment.  There is a case called In re Fine 837 F 2d 1071, a case called O’Farrell in 853 F 2d 894, which seems to suggest that the “obvious to try” notion is not accepted as legitimate in this obviousness area.

MRS BENNETT:   They do expect “obvious to try” if there is an expectation of success, you cannot have obvious ‑ ‑ ‑

GUMMOW J:   Do not go into it now.  I just invited you to put something in about it.  If you do not want to take that up, do not.

MRS BENNETT:   Yes, your Honour, thank you.

GUMMOW J:   But at the moment, it is inadequately dealt with.

MRS BENNETT:   I appreciate that.  We will deal further with the United States.

We do not that one of the bases put to the Court on a special leave application by the appellant was that if this decision were to stand, that Australia would be out of kilter with the rest of the world.  In our respectful submission, we have established that if this decision does not stand, we ‑ ‑ ‑

GUMMOW J:   You have not established it by reason of what I have just been putting to you, so do not exaggerate, please.

MRS BENNETT:   Well, your Honour, in our respectful submission, subject to the United States, certainly the reasoning of the Full Court and Justice Lehane is in accordance with the New Zealand approach, the European approach and the English approach.  We appreciate that we have not dealt with the whole of the world but on special ‑ ‑ ‑

GUMMOW J:   Not the whole of the world, just the most important country in the world in this field, that is all.

MRS BENNETT:   I appreciate that, your Honour, we will deal with that, but our learned friends relied inter alia upon Europe to say that - they said we would be out of kilter with all of the world.  Now, I agree that we have not taken the exact converse but we have dealt with that in part.  The only other aspects with which ‑ ‑ ‑

KIRBY J:   What is the end product of the cases you have handed us?  Have the appellants succeeded in any of the jurisdictions?

MRS BENNETT:   Some of them are still going, in some cases injunctions were not granted because there was a question mark.  I think we put it in our summary to the submissions ‑ ‑ ‑

KIRBY J:   You did give us a schedule.

MRS BENNETT:   There is a schedule.  We say that where the matter has been fully considered, I could be wrong, but the patent has been revoked – I could be wrong on that – except Israel where it was, in effect, run as a litigant in person; the managing director of the company ran the case, not legal representation.  But I do not seek to take away from what is in our summary.

KIRBY J:   There is a very lively intellectual property law in Israel.

MRS BENNETT:   I appreciate that, your Honour, but the case ‑ ‑ ‑

KIRBY J:   They are very knowledgeable about intellectual property law.

MRS BENNETT:   But in the first case, the party in the main case was not legally represented.  In the further schedule put on by the appellants, they refer to another case as to which we have no knowledge, we were not part of it. 

Your Honour, it has been put to me that there may have been something I said to your Honour in response to a question your Honour Justice Hayne asked me about whether the information for the skilled worker should include the results of a stability test after enteric coating was put on the alkaline core.  It is said that I said, “yes”.  The question is, if the problem that is identified in the patent to be solved was whether – if the problem presenting itself to the skilled worker was instability after the enteric coat was put on the core, that is said to be the problem in the patent.  That would not have been presented to the skilled worker.  That is what the skilled worker would have solved immediately. 

The only other policy questions in about the next one minute that I would refer to very broadly, your Honours, are these.  A patent, of course, is a right in rem, and it should be carefully considered.  What is being sought here is a second 20‑year monopoly, in effect, for what has been established by the facts to be a routine formulation for a compound for which Astra has already had a 20‑year monopoly.  Yes, there is a principle to reward patentees or inventors for inventions they give to the public, but yes, there is a balance.  Specifically, section 6 refers to a balance in regards to the public interest.  Lord Hoffmann in Biogen v Medeva has referred to not wanting to stultify further research and development.  The US courts have also looked at the balance between, for example, research and development and breadth of claims.  Basically, what it comes down to is, there is a balance of interest. 

So far as this art or the chemical or experimental arts are concerned, in our respectful submission, as a policy matter, it would be inconceivable if merely by adding an experimental step into a proposed invention that a person would get a patent because the skilled worker is not allowed to apply the art of his or her calling, which is what, in our respectful submission, the appellants are suggesting. 

Finally, your Honour – and I did not get to my odds and ends, but I appreciate I have to stop – we say that the questions that we posed as a response to the appellants’ submissions in paragraph 1 of our own submissions fairly follow, if the appellants’ submissions are accepted, and that would be, in our respectful submission, not – I will not use the word “catastrophic” because it is probably too emotive at this stage of the afternoon – but it would be most unfortunate for the patent system in this country and where it stands in terms of the standard of patents, even under the 1952 Act, that should have been applied when assessing what is properly something that is inventive.  May it please the Court. 

GLEESON CJ:   Thank you, Dr Bennett.  Yes, Dr Emmerson. 

MR EMMERSON:   If the Court pleases, on the matter of foreign proceedings, we have dealt with that in writing in our annexure delivered with our submissions in reply.  I do not propose to add to those now.  

Second, on the issue of Dr Marshall, my learned friend suggested that it was accepted that he was in some sense untainted.  He was not untainted with the knowledge that a pharmaceutical formulation of omeprazole existed and that that was why he was being asked to give evidence.  That appears in the appeal book of the court below.  The letter of instructions dated 28 October 1998 say in these proceedings Astra and Hässle allege that after the expiry of a certain patent Alphapharm intends marketing and that is what it is about.

Question No 1 in cross-examination of Dr Marshall was, “Dr Marshall, you say in your first affidavit at paragraph 10 that you have put knowledge of the product Losec” – that is our omeprazole formulation – “out of your mind in preparing the report annexed to your affidavit.  Do you see that?”  And question No 2, “What knowledge did you have of Losec when you prepared your reports?---Only that I had been prescribed Losec.”  So there is, with respect, not the slightest doubt that Dr Marshall was fully familiar with those matters.

So far as the parts which are said to have been unchallenged and referred to in the judgment of the Full Court, those are matters which we say proceed on a quite erroneous footing, namely, the section of the claim treating the first and third integers as given and asking whether with that background the invention of the sub‑coat was obvious.  There was no unchallenged evidence that the entirety was obvious.

Next point, as to the statements in our specification, we say section 116 is entirely irrelevant.  It deals with the use of an earlier form of a patent specification for the purpose of construction of the specification in suit.  So you look to see its meaning.  You do not look to see whether in some earlier form, prepared in some other country, there was a statement which might be construed under our law as an admission.

So, we would say the earlier forum is irrelevant.  We would say that there is nothing at all sinister in the timing of the commencement of proceedings at the time of the amendment.  The proceedings were commenced when my clients first learnt that our learned friend’s clients were about to put an omeprazole‑containing product on the market and as soon as information was available about that, these proceedings were commenced.  That was the reason for the haste.  There was nothing sinister there at all, in our submission.

As to the chronology of the work done by my clients in preparing omeprazole, could I direct some submissions against the proposition that the moment they knew of the problem they saw the result.  The appeal book at page 53, in paragraph 86 of the learned primary judge’s judgment, sets out the evidence about what had happened.  Four lines from the bottom of the page we have a reference to “in vivo studies”:

These confirmed poor bioavailability results with enteric coated pellets –

so, there was a bioavailability problem –

Improvements to the enteric coat were considered: particularly, ways to make the coat less permeable.  A number of possibilities were tried between April and November 1981.

So, the sequence of events was poor bioavailability found as a problem.  Number of possibilities tried out over an extended period.  Then, on 10 December 1981, the brainstorming meeting took place.  So, we would say, with all respect to our learned friend, that it is simply not a case where we ourselves were led directly to the result.  The matter is referred to by the Full Court at page 186 in paragraphs 113 and 114, dealing with the brainstorming session and it is clear that in the brainstorming session the Full Court says a number of possibilities were discussed.  In relation to tablets, of one of the possibilities, these included:

(i)  a buffered, uncoated tablet –

in which certain alkaline buffering was used, or:

(ii)  a rapidly dissolving core containing omeprazole and an alkaline reacting compound or an alkaline salt of omeprazole, press coated with a neutral coating and then enteric coated – in other words, a subcoated and enteric coated tablet.

So one got to that as a very important part of the inventive idea, but it did not come to the inventors immediately at all.  Further than that, the actual nature of the sub-coating, namely that it should be water soluble, was not something which my clients immediately got to, nor, I might say, was it something that Dr Marshall immediately got to, because he introduced the notion of sub-coating as a barrier layer.

On the issue of witnesses who were called, it is our submission that Professor Brown, who was one of the witnesses called on behalf of my clients, was indeed an Australian formulation expert and, of course, Professor Rhodes and Professor Rees were also formulation experts.  They were not Australian experts and his Honour therefore held that they were not entitled to speak on the subject of common general knowledge and the art in Australia.  We have no quarrel with that, but they were experts and they were formulators.  So any quasi Browne v Dunn point about the evidence of the experts, we say must necessarily fail.

Our learned friend, at one stage I think, suggested that it was our position that the skilled addressee must have no research capacity.  Our position about the skilled addressee is set out in our reply submissions in paragraph 2 of those, which say the appellants accept that in the present case the notional addressee is a highly qualified pharmaceutical chemist usually with a doctorate, a qualification usually associated with a

demonstrated capacity for original research.  However, this fact makes it of critical importance to apply the true test, and we go on to put submissions there.

KIRBY J:   I did not understand Dr Bennett as denying the research capacity.  The notice of contention even goes so far as to say there is no reason to limit the results of the search, and so on, so that I thought that she was saying that they had a very large research capacity, larger than you.  I may have misunderstood it.

MR EMMERSON:   Well, if I have misunderstood my learned friend ‑ ‑ ‑

KIRBY J:   Well, it will all be on the record. 

MR EMMERSON:    ‑ ‑ ‑ my understanding was that the position that was being attributed to myself and this end of the Bar table was that there was no research capacity.  That is not so, but, of course, there is the intellectual tension to which the learned trial judge referred, that you have nevertheless to suppose that the exercise that is being carried on is not a research exercise.  On the issue of normal industrial function, in our submission, there is very little treatment of that in the judgments. 

We say, equally, that that is a phrase which is drawn from a case in particular circumstances.  We say that that is not part of the Act and is not of assistance in a case of this sort, where part of the normal function of the notional addressee is carrying out original research.  This means that to ask, “Is this a normal industrial function?” is simply postponing the problem.  You have to consider such a person, but you have to consider a person when he is not carrying out research.  The question of whether his normal industrial function sometimes involves research and sometimes does not is, in our submission, irrelevant.  If the Court pleases, those are the submissions in reply. 

GLEESON CJ:   Thank you, Dr Emmerson.  We will reserve our decision in this matter, and we will adjourn.

AT 4.12 PM THE MATTER WAS ADJOURNED