Aktiebolaget Hassle & Anor v Alphapharm

[2002] HCATrans 192

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 WEDNESDAY, 29 MAY 2002, AT 10.17 AM

Copyright in the High Court of Australia

MR J.McL. EMMERSON, QC:   If the Court pleases, I appear with my learned friends, MR D.M. YATES, SC and MRS K.J. HOWARD, for the appellants.  (instructed by Minter Ellison)

MRS A.C. BENNETT, SC:   If it please the Court, I appear for the respondent with my learned friends, MR S.C.G. BURLEY and MR C. DIMITRIADIS.  (instructed by Mallesons Stephen Jaques)

GLEESON CJ:   Yes, Dr Emmerson.

MR EMMERSON:   If the Court pleases, it is convenient to start with the relevant statutory provision, which is section 100(1)(e) of the Patents Act 1952 and which we have set out in paragraph 13 of our written submissions. The 1952 Act takes the form, so far as grounds of revocation are concerned, of setting out an exhaustive list of possible grounds, including want of novelty, inutility and so on. The particular ground that we are concerned with is the ground which is generally referred to as “obviousness” and which is more precisely set out in section 100(1)(e)

That requires, in our submission, the following analysis:  one starts with the invention “so far as claimed in any claim” and then one asks whether that “was obvious and did not involve an inventive step.”  The basis of comparison to determine whether it is obvious and does not involve an inventive step, is having regard to what was known or used in Australia on or before the priority date of the claim.

KIRBY J:   What is the difference between “known or used”?  If it is used, would it not be known?

MR EMMERSON:   It probably would, your Honour.  The cases really seem to treat this as a composite phrase and as this Court held in the Minnesota Mining Case that composite phrase amounts to common general knowledge in the art.  It is important, in our submission, to bear steadily in mind that the comparison starts with the invention so far as claimed, not from somewhere else, and that what one is required to have regard to is what was known or used in Australia before the priority date, that is to say, the common general knowledge.

In our submission, stated compendiously, the word “obvious” means “obvious”.  It does not mean “capable of being reached” by some process of inquiry or by empirical research.  Further, since what was known or used in Australia on or before the priority date, means common general knowledge.  It does not allow one to make the comparison with documents which are not part of common general knowledge but might be able to be found in the course of some sort of literature search.

A fortiori, it does not include matters which are not set out in documentary form at all but which might be ascertainable as a result of empirical experiment.  Neither of those categories can fall within the description of what is “known or used”.  So it follows that if one adds to common general knowledge matters discoverable by a literature search, or, more so, matters discovered by empirical research, and take that as your starting point and ask, “Was the invention obvious by comparison with that?”, then you will get the wrong answer.  Equally, you will get the wrong answer if you read the word “obvious” in a strange sense meaning ascertainable by empirical research or other literature searches.  Once again, you will not be applying the test under the Act.

KIRBY J:   It is another case where the passive voice is being used, “known”.  It does not say known to whom, therefore you do not get, on the face of the statute at least, the pool of people and the level of their knowledge.

MR EMMERSON:   That is absolutely correct, your Honour.  However, we say that the pool of people is well settled as being people who are skilled in the art but they are supposed to be unimaginative and mere mechanical plodders.  Part of the difficulty that has arisen in this case is as a result of the tension between that concept and the people who actually do work in this art, who tend to be highly qualified with research degrees and to be, in fact, capable of original research and, indeed, that is why they are employed.

I will come in more detail to that latter point but for the moment I note that we, of course, accept what your Honour Justice Kirby puts to me that the statute itself does not set out what is the body of those people but the body of those people seems to be well settled and we do not, in these proceedings, dispute the view that it is settled and settled in the way that I have endeavoured to outline.

KIRBY J:   How did “unimaginative” and “plodders” come in on the face of the statutory language?  I know you do not contest it but it is not evident to me how that happened, especially given that we are in the realm of inventions, however, that was what I suppose we have to focus on, ultimately.

MR EMMERSON:   Yes.  Can I perhaps answer that in two parts, your Honour.  How it arises is that a long line of cases has told us that these are the people to whom it must be obvious.  As a matter of principle, one can see that the test for obviousness must be somehow applied to persons in the art, as distinct from mere lay persons, but since one is talking about the area of invention, it is no good asking whether the invention, as claimed, would have been obvious to a person who was inventive and who made a number of inventions because things might be obvious to him which would not ordinarily be obvious in the art.  Indeed, it would be rather paradoxical if one in the area of invention was to exclude from patentability things which were done inventively by a person who was capable of invention.

We have included in paragraph 14 the position under the 1990 Act. As the Court will be aware, the proceedings have been conducted on the footing that it is simply necessary to inquire whether the invention so far as claimed was obvious according to the test set out in section 100(1)(e) in the 1952 Act.

We do note, however, that very similar issues, albeit differently worded, arise under the 1990 Act.  We have set out in paragraph 14 how one gets there and we have also given a reference to paragraphs 27 to 29 of the judgment of the learned primary judge which probably sufficiently sets out these matters.

To go through the step:  the approach that the 1990 Act takes is that once again the grounds of revocation are listed exhaustively and the relevant ground, however, is expressed very broadly, namely, “that the invention is not a patentable invention’, and one gets that from section 138(3)(b).

That takes us to the definition of what is a “patentable invention” and there are various requirements for patentability of which the relevant one is that the invention must involve “an inventive step” when compared with a prior art base as it existed before the priority date of the claim, and that is set out in section 18(1)(b)(ii).

Then one asks what is meant by “inventive step” and you are told that by looking at section 7(2), that an invention, so far as claimed, will:

be taken to involve an inventive step . . . unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim –

and then there is an express addition which is not relevant in these proceedings but which we note because there are certain circumstances under the 1990 Act, although not under the 1952 Act, in which one can take into account information that was published even though it did not become part of common general knowledge in the art.

Now, I must apologise to the Court.  The form in which we set out that latter qualification at the bottom of page 4 in our outline of submissions, in fact, is the presently existing form.  The form in which it existed at the date of these proceedings was slightly different in language, although the difference is not relevant for the purposes of the present proceedings.  We have set all that out in our replacement Annexure A, setting out various statutory provisions.  That was delivered to the Court yesterday and I hope that it has become available to members of the Court.

Can I show the Court where the relevant provisions are set out.  Section 7(2), to which I have just been referring, is set out as at the relevant time at the top of page 2 in our replacement Annexure A.  The amended form is set out on page 5 of our replacement Annexure A.  The Court will note that what has, in fact, happened is that the language describing an additional document or document which can be taken into account has been changed from:

either of the kinds of information mentioned in subsection (3), each of which must be considered separately –

to the present form of words:

the information considered in subsection (3).

But that change is not something which is in issue in these proceedings or, in our submission, relevant to these proceedings.

To complete the picture of what may be added to “common general knowledge” under the provisions of the 1990 Act, one should go to section 7(3), which at the relevant time had the form which is set out on page 2 of our replacement Annexure A:

For the purposes of subsection (2), the kinds of information are:

(a)  prior art information made publicly available in a single document or through doing a single act; and

(b)  prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;

So, in certain circumstances under the present Act you can add in an extra document or more than one but there is an overriding condition, being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant, to work in the relevant art in the patent area.  So there is that expansion.  The test that is set out in the last three lines of section 7(3) could be loosely referred to as a “diligent searcher” type of test.  That, however, is not a test which is available under the 1952 Act and, indeed, it was a test which was specifically considered and rejected by this Court in Minnesota Mining.

I have mentioned the expression “common general knowledge”.  An often quoted definition of common general knowledge is that derived from the Minnesota Mining Case and which is set out in paragraph 16 of our written submissions and it worthwhile, perhaps, looking fairly closely at that.  It is set out in Minnesota Mining at page 292 in a passage about two‑thirds of the way down the page:

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.

I would note that it is described as “background knowledge and experience” so that one is concerned with something which is actually known and used and also that what is being referred to here is general knowledge.  As Sir Keith Aickin put it in Minnesota Mining, it must be treated as being used by an individual as a “general body of knowledge”.

Now, in our submission, that is quite different from individual pieces of knowledge gathered together for the purposes of a particular investigation.  That is not common general knowledge.  Common general knowledge is the general body of knowledge of persons engaged in the relevant trade.

So this takes us a bit further down the track in understanding the test for obviousness, in our submission.  You start with that body of common general knowledge which is what people skilled in the art have and use in their work and you look at the invention so far as claimed and you ask, “Is that obvious in the light of that common general knowledge?” 

The suggestion that the expression “known or used” might include more than common general knowledge was, in fact, the principal subject of the reasoning of Sir Keith Aickin in the Minnesota Mining Case which was, of course, adopted by other members of that Court.  We set out shortly in our paragraph 17 how this had happened.  In HPM v Gerard Industries Mr Justice Williams had expressed a view that “known or used” might include more than common general knowledge of a skilled worker in the relevant field at the priority date.

Sir Keith Aickin considered this and considered the statutory history at some length at pages 287 to 292 in Minnesota Mining and based on the construction of the Act and its history he reached the conclusion that common general knowledge was limited to real common general knowledge, not something – perhaps I should put it more generally.  He rejected the contention that in taking as one’s base for determining whether an invention is obvious, one should look beyond what was in truth common general knowledge to something that was outside that.  This led him to uphold that documents which had been available in Australia for public inspection before the priority date could not provide a basis for the argument that the invention claimed was obvious unless those documents were shown to be part of common general knowledge.  That latter point was taken up by this Court in Firebelt v Brambles just recently.

KIRBY J:   I noticed Mr Handley referred in his argument to Justice Williams’ decision.

MR EMMERSON:   Yes, that is correct.

KIRBY J:   Is this the point upon which Minnesota Mining reversed the primary judge in that case?  Is that the point that differs from Justice Murphy’s finding at first instance or not?

MR EMMERSON:   Yes, it is the point of difference because ‑ ‑ ‑

KIRBY J:   He followed Justice Williams and then when it got to the Full Court the Full Court preferred the contrary view.

MR EMMERSON:   I believe that is so, your Honour.  I would have to double check to make sure that that was the statutory history.

GLEESON CJ:   I think you will find it is wrong if you look at page 254.

MR EMMERSON:   I am indebted to your Honour.

GLEESON CJ:   Justice Murphy did not get to this issue.  His decision turned on this question of whether the product was inextensible, according to what appears on page 254.

MR EMMERSON:   I am grateful to your Honour.  I spoke too quickly and without thinking.

GUMMOW J:   There was a great debate about judges making experiments by themselves.

MR EMMERSON:   In fact, in that particular case all the judges did make experiments, even the ones who were simply agreeing with what Sir Keith Aickin had said.  I think at least two of them go out of their way to say they had tested the tape in question on the back of their own hands to see whether it was inextensible in ordinary use.

KIRBY J:   We will have to keep our fingers off the Internet keys to see whether an old plodder, like ourselves, finds something easily.

MR EMMERSON:   Yes, indeed.  But that test of inextensibility, as your Honour the Chief Justice very rightly, with respect, points out, arose in that case in the context of the issue of infringement rather than the issue of obviousness.  I should just perhaps continue in answer to what your Honour Justice Kirby was putting to me to say this that there had been indications that the Court was preparing itself to consider the question of what was available in testing obviousness.  Sir Keith Aickin, in particular, had mentioned it expressly in two or three earlier judgments but had concluded in each case that this was not the appropriate time for determining that matter.

Indeed, at page 287 in Minnesota Mining itself he sets out the various issues and makes it clear that now is the time to decide this particular issue.  We have set out in paragraph 19 of our submissions two things that we say follow from this analysis.  First, in testing for obviousness or lack of inventive step, the comparison to be made is that between the invention so far as claimed and common general knowledge.  It is not made between what might have been discovered in successive intermediate steps.

Now, that is important because, in our submission, you do not, when testing the question of obviousness, divide up the path from common general knowledge to the invention into a succession of steps and ask of each step, “Is that step obvious?”

You look at the invention as claimed and you look at common general knowledge and you compare the two, and you ask, “Is that step obvious?”  Accordingly, it is contrary to principle to seek to inquire on the issue of obviousness where is the inventive step in the sense of asking which of many steps is to be described as inventive.  That is not the question at all.  The question is whether “the” step is itself inventive, and it will be inventive if it is not obvious to the notion or person skilled in the art, having available common general knowledge but not matters which were not part of common general knowledge.

It may be convenient, while the Court has in front of it the Minnesota Mining Case, to take the Court to the structure of the judgments in that case.  The Chief Justice, at 259, says that he is in complete agreement with what Justice Aickin had written, and he deals specifically at 260 with what Justice Williams had said in HPM v Gerard.  That was the suggestion that one could look at matters which were beyond the scope of common general knowledge.  The Chief Justice agrees with the analysis of Justice Aickin, which was that in any event these matters were simply obiter for the purposes of HPM v Gerard.

Justices Stephen and Mason agree with Sir Keith Aickin at page 260.  Justice Mason, as indeed the Chief Justice, both tried the experiment to see whether the tape was inextensible.  Then the principal judgment in the case is that of Sir Keith Aickin.  There is a fairly long description of issues of infringement and what is the essence of the invention and so on, which need not concern us.  The learned Justice takes, for the most part, the primary dictionary meanings as being the meanings of the various terms in the specification.  However, at page 287, we start the inquiry to which I have referred about whether the dictum of Justice Williams in HPM v Gerard was correct; noting amongst other things ‑ and this is relevant for the purpose of consideration of present authorities ‑ that this does mark a point of divergence between our law and the law in England.  Indeed, that was one of the difficulties that are dealt with by Sir Keith Aickin from page 288 and following, that the provisions dealing with the issue of obviousness and their statutory context are not identical between the English Act of 1949 and the Australian Act of 1952.

KIRBY J:   That would have worried them more in those times than it would us today.

MR EMMERSON:   That is undoubtedly true, your Honour, yes.

KIRBY J:   Although I suppose in an international discipline like patent law you do strive, as far as possible, to have common doctrine.

MR EMMERSON:   Yes.

McHUGH J:   But not in this area.  Is not there a great deal of difference between various jurisdictions on the question of inventiveness, obviousness?  Do not the Netherlands and Switzerland have a more stringent test than common law jurisdictions?

MR EMMERSON:   It is fair to say, your Honour, that there is a vast divergent ‑ ‑ ‑

KIRBY J:   No doubt fuelled by economic advantage and local concerns.  This is an area of very great debate.

MR EMMERSON:   It is undoubtedly an area of great debate.  It is undoubtedly an area in which there must be some sort of balancing between protecting inventions and other considerations.  It is a matter of debate and different language is used in different countries.  The English Act, of course, is now quite different.  Not only do we have our 1990 Act which has a number of major differences from the 1952 Act, but they have their 1977 Act which diverged from the 1949 Act.

So, I would, with respect, agree with what, I think, your Honour Justice Kirby was putting to me, that English authorities are probably not a very good guide as the law now stands, but at the time when the 3M decision was handed down the Australian Act of 1952 had been based to a substantial extent on the English Act of 1939, although there had been, as the learned Justice sets out in Minnesota Mining, a number of inquiries and various decisions that had to be taken about what would be followed and what would not.  But it is still the case that rather more caution was observed in those days in departing from English authority than is now appropriate.

The passage dealing with all these issues concludes at page 292 in Minnesota Mining and his Honour concludes, about a third of the way down the page, that:

For those reasons I am satisfied that we should not regard the observations of Williams J. in the H.P.M. Case as correctly stating the law in Australia.  It is not a matter of overruling the decision because, as I have said, it was based upon a different ground.  The dicta however should not be followed.

He then goes on to give the definition of “common general knowledge” to which I have taken the Court and I should add that the specific context of it was a question that had arisen as to whether certain documents which had been published in Australia before the priority date, but which had not been shown to be part of common general knowledge, should be taken into account on the issue of obviousness.

It is useful, in our submission, to look at the passage which starts towards the bottom of page 292.  Having said that “common general knowledge” should be treated as a “general body of knowledge”, about 10 lines from the bottom of the page, his Honour goes on to say:

I do not with respect think that it is correct to describe that process as the making of a mosaic although it has often been so described, a usage which however may be misleading.  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 from known facts and known principles, as well as the application of such principles.

Now that in the context of learning in this area of the law at the time which forbade the making of a mosaic in testing the issue of novelty.  At the top of page 293, beginning at about line 4 on that page, his Honour refers to the question of “mosaic” and points out, contrary to the submission that had been before the court, that it is not a matter of taking some:

prior publications and then select from them appropriate extracts of pieces of information –

and trying to see whether they add up to a demonstration that the invention was obvious.  He says:

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.

Now, in our submission, that is very important from the point of view of the present proceedings.  You look at the invention so far as claimed and you ask whether that is obvious.  It is not to the point to inquire what a diligent searcher might have been able to find; you have to ask whether the invention was obvious having regard to common general knowledge.

McHUGH J:   What do you say concerning the passage towards the bottom of page 294 in the judgment of Sir Keith Aichin, where he says:

There may be some fields of endeavour in which those who work therein study and make themselves familiar with all patent specifications as they become available for inspection . . . becomes common general knowledge –

why is that not a fair working rule in this particular area and, indeed, does not the evidence tend to indicate that is the case?

MR EMMERSON:   No.  His Honour the trial judge considered this and rejected it.  He noted that three things were part of common general knowledge, but beyond that he said there were difficulties.  So there is no finding and, indeed, the findings, in our respectful submission, are to the contrary that you can assume that anybody who was working in this area will be familiar with all the patent literature. 

Perhaps I can just deal with this.  If one goes to page 63 of the appeal book, paragraph 105, beginning about a third of the way from the top of that page, the learned trial judge says this:

No doubt I may take it that the competent formulator would have had to hand a number of the major pharmaceutical textbooks which were referred to, would have had a good working knowledge of their contents and would have been well able to make full use of them as tools of their trade.  But what of patents?  It may well be – but there is no evidence of it – that competent formulators would be aware of a number of important patents relevant to their profession.

He says:

Dr Story’s evidence was to the effect that patents were often mines of useful and practical information.  But no witness gave evidence that at the priority date he knew, as part of his general background knowledge, anything taught by –

and there is the mention of the two patents which were in dispute as part of the argument in that part of the case.

To continue with an answer to what Your Honour Justice McHugh was putting to me, it is our submission that what Sir Keith is doing at the bottom of page 294 and the top of 295 is to say there may be circumstances in which patent literature really is part of common general knowledge but that is a matter of fact to be proved by evidence, it is not something which you assume, and it follows in particular that the mere fact that a patent or some other document has been shown to be publicly available in Australia, even if it is shown to be consulted in Australia, that does not make it part of common general knowledge.

I would just note in passing, since we are on page 294 of Minnesota Mining, that the danger of attempting to assess the issue of obviousness by dividing up the claim in suit into integers and asking whether each integer itself was obvious, is touched on by Sir Keith at this page.  He also mentions the earlier case of Palmer v Dunlop Rubber to which a reference is given where Sir John Latham, at pages 60 to 61, had made very similar observations.

The conclusion that is reached by Sir Keith Aickin as regards the prior documents is set out at page 295 in the paragraph beginning a line 9 on that page:

The respondent relied upon a number of prior specifications which had been available in Australia for public inspection before the priority date as providing a basis for the argument that the invention claimed was obvious.  For the reasons which I have set out above I do not regard such specifications as capable of sustaining that argument without evidence that they were part of common general knowledge at that time.  There was no such evidence and accordingly it is not necessary for me to examine those specifications.

So his Honour excludes them from consideration. 

His Honour does mention certain other things which were part of common general knowledge in that case.  In the last few lines of the second‑last paragraph on that page:

The evidence showed what kind of products would have been the common general knowledge in Australia as well as the nature of the problem awaiting solution.

So there were other matters which the Court was able to take into account as being part of common general knowledge but not the specific documents which had been the subject of that dispute.

McHUGH J:   Dr Emmerson, it concerns me a little as to whether or not the statements in the 3M Case are really relevant in the particular field with which we are dealing.  The notion comes out of the 19^th century cases and what you were really talking about was the skilled workman, the skilled technician, aware of the practices and techniques in his or her trade, that sort of person seems to be very different from the sort of person that are involved in this particular field.  They were, as you said, highly qualified people with research degrees who have to solve quite complex problems.  Now, should we continue to use the 3M test in a field such as this?

MR EMMERSON:   In our submission, yes, we should continue to use the 3M test in a field such as this.  It is true that the field of endeavour, with which we are concerned here, is one in which highly skilled people work, but we say that the danger is, in a way, the reverse of what your Honour was putting to me, that cases before the 3M decision, will be taken as providing some sort of paraphrase for the notion of “obvious” where that paraphrase may conceivably be of some assistance in some cases where you have mere artisans but which are simply not appropriate for a skilled team.

With a skilled team, the question, we say, must be, “Was the invention obvious to that team?” not “Could that team have solved whatever problem it was that the inventor was addressing?”

McHUGH J:   I know, but that is what worries me about it.  When you find statements like the statement of Lord Herschell in Vickers v Siddell about it must have been obvious at once.

MR EMMERSON:   Yes.

McHUGH J:   Well, that is understandable when you are talking about artisans, as you mentioned, but is it realistic to use such a test in a field such as this?  It just seems to me that the time may have come where, in this type of pattern, one has to look at the question of obviousness somewhat differently than might have been looked at in the conditions of industry prevailing in the 19^th century, even the late 19^th century.

MR EMMERSON:   We would not, of course, dispute that one has to look at these matters in the light of modern conditions and, indeed, that is an aspect of where we say the courts below have gone wrong in the present case, because they have tended to substitute the question, “Could the skilled person in the art have solved the problem?” in place of the true question which is, “Was the invention obvious to such a person?”

GLEESON CJ:   But the question you attribute to them will always be answered “yes” because the problem was solved.

MR EMMERSON:   Yes, exactly.  We say that that therefore misplaces the distinction which is drawn in section 100(1)(a) by overlooking the requirement, not just that the problem should be solved but that the problem should be obvious to the ordinary person skilled in art equipped just with common general knowledge.

GLEESON CJ:   By hypothesis the problem has been solved otherwise we would not be here.

MR EMMERSON:   Absolutely.  Yes, your Honour.

CALLINAN J:   I suppose, if you are looking at a field where people of very high expertise and intelligence are working and yet they have not come up with the solution, then that suggests a lack obviousness, unless and until some particular person has solved it.

KIRBY J:   That assumes that they have turned their mind to it.

CALLINAN J:   But people do turn their minds to obvious things.  If there is money in it, they tend to.

MR EMMERSON:   Yes.  Well, there is, and they did turn their mind to it and, in the case of my clients, a highly‑skilled team worked on the matter and they had been working very hard for more than a year before the first suggestion of something within the scope of the patent arose.

McHUGH J:   But the fact that it was a team in this case rather highlights the fictional nature of the old tests in modern conditions because ordinarily in this field the work will not be the product of a single individual but by a highly‑skilled team bouncing ideas off each other, and in this case there was said to be a brainstorming session, if I remember ‑ ‑ ‑

MR EMMERSON:   That is right.

McHUGH J:   Right.  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.

MR EMMERSON:   Your Honour, could I just take up one minor point and then deal with the major thrust of what your Honour was putting to me.  The notion of having complete recall of everything within the field is one which is sometimes drawn from the English cases because the notional skilled worker in the art, under the English test, was allowed to have more in mind than common general knowledge.  Under our test, it is not a test of complete recall of everything in the art.  Common general knowledge really means what it says, in our submission, and so these are the things that the skilled worker actually did know.

McHUGH J:   Yes, but the skilled worker is entitled to look up the literature, is he not, to look up the textbooks at least?

MR EMMERSON:   We would say no.

McHUGH J:   What?  Is that right?

MR EMMERSON:   The question is, “Is it obvious?”, not whether he is capable of working out the answer.  We would say it must, as a matter of fairness, be so because otherwise one would have the paradoxical result, in our submission, that you have a patent system which is supposed to encourage and reward inventiveness.  You imagine that in the real world a team is set up in order to investigate a particular problem.  They reach a solution to the problem which is not obvious to them or to ordinary teams in the area.  It would be paradoxical if one, therefore, moved the goalposts and said, “You still can’t have a patent because you’ve been able to solve the problem.”

McHUGH J:   I do not know.  I am a little surprised.  I have carried around in my head, obviously wrongly, the notion that the skilled worker at least could have access to the standard texts in his or her trade or profession.  That is wrong.  Is there ‑ ‑ ‑

MR EMMERSON:   Not unless they are shown to be part of common general knowledge.

KIRBY J:   Even a barrister is allowed to do that.

MR EMMERSON:   Even a barrister, with respect, occasionally carries out research.

HAYNE J:   And he often makes an invention.

McHUGH J:   Is there any Australian case on this question, as to what literature that the skilled worker can look at?

MR EMMERSON:   Yes, the Minnesota Mining Case.  We say, with respect, it covers the point precisely.

KIRBY J:   Where does Justice Aickin actually say that?  Does he actually say you cannot?  You just have to have it in your brain.  Do not worry that it got there because you have looked in the past at textbooks.  Do not worry that you have done some research in the past or that you have had your university training and you have done your PhD.

MR EMMERSON:   With respect, things that you might learn or, indeed, the things that ordinary people who work in the area might learn in the course of a university degree do become part of their common general knowledge.  For individual workers all sorts of things become part of their general knowledge.  The question then is whether that general knowledge is specific to the individual worker because of his or her particular background experience or whether, in fact, it is the common general knowledge of the people working in the art, that is to say common to all the people working in the art.

GLEESON CJ:   It used to be sometimes said of lawyers that the important thing was not what you could remember but that you knew where to look.

MR EMMERSON:   Yes.

GLEESON CJ:   How do you relate to the concept of “common general knowledge” knowing where to look as distinct from knowing at the time what you will find?

MR EMMERSON:   If you know where to look and know exactly what you are going to find when you get there, as, for example, looking up a set of mathematical tables or something of that sort, then we would have no difficulty in saying that is, of course, part of common general knowledge.  But the mere fact that one knows, broadly speaking, how to carry out a research project and you look at a whole lot of literature and you make what is called a search – and it is a search because you do not actually know what you are going to find until you have found it ‑ ‑ ‑

GLEESON CJ:   But I suppose it would be laughable to suggest that everything that is in Halsbury’s Laws of England is part of the common general knowledge of lawyers, but how do you distinguish between those parts of Halsbury that are within the common general knowledge of lawyers and those that are not?

MR EMMERSON:   You distinguish, if the issue ever arose, by evidence of what parts had really become part of the mental furniture of lawyers in general or lawyers working in a particular area.

KIRBY J:   This is a fiction.  You have to invent this fictitious person, but surely it is a fiction that moves with the times.

MR EMMERSON:   Your Honour, with respect, it is not a fictitious person and, indeed, in a sense one might see the Minnesota Mining decision as a reaction against the notion of a fictitious person who knows everything but has no imagination at all.

KIRBY J:   Well, I withdraw fiction.

MR EMMERSON:   Yes.

KIRBY J:   It is an invention.

MR EMMERSON:   No.  We are talking about real people.  I mean, if the question were to be asked of lawyers, you can identify things which, with any luck, anyone who comes out of law school knows.  You can also identify things which, with any luck ‑ ‑ ‑

KIRBY J:   Such as how you work out the duty of care in negligence?

MR EMMERSON:   Speaking for myself, your Honour, I have come out of law school but I am not sure that I would care to state precisely how you work out the duty of care in negligence.

KIRBY J:   Easier in our day, easier in those days.

MR EMMERSON:   But there is an identifiable body of knowledge and this forms the common – within which particular people or people of a particular class work.

McHUGH J:   But in the 3M case itself, what was attributed to the skilled worker or technician was knowledge of the kind of products concerning surgical tapes that was in use in Australia prior to the priority date.

MR EMMERSON:   Which, with respect, is precisely right.  You ask who is the notional skilled person working in the area.  The notional skilled person is working in the area of surgical tapes.  It should therefore come as no surprise to learn that on the evidence such people were fully familiar with the surgical tapes which were around.  There is nothing in the notion of common general knowledge that prevents one from excluding from it something which is, in fact, part of people’s general knowledge.

McHUGH J:   Yes, I know, but witnesses gave evidence in that case as to the sorts of tapes that were available and their advantages and disadvantages ‑ maybe they are disadvantages ‑ and all of that was attributed to the skilled workmen.  Why can you not attribute to the skilled workman the trade or professional equivalent of Halsbury’s Laws of England?  It is there.  Why is that not part of the common general knowledge of the particular professional trade?

MR EMMERSON:   Because the trade equivalent of Halsbury consists of a vast amount of information, large parts of which might not be part of the ordinary working mental furniture of a person skilled in the art.

KIRBY J:   Even to a Justice of the High Court there may be some little passages there that we do not regard as obvious when we read it?

MR EMMERSON:   Yes, with respect, your Honour.

GLEESON CJ:   A solicitor once briefed me to advise on whether or not a person who purchased a bottle of adulterated soft drink, sold without an opportunity of intermediate inspection, might have a cause of action against the manufacturer.  I was able to say there is a case in point.

MR EMMERSON:   Things do not have to be known to absolutely everyone in the art, it is a matter of common general knowledge, and even in Your Honour the Chief Justice’s argument, if the question had come from someone who worked in the area of product liability, then it would very surprising indeed if that question had to be asked of counsel.

McHUGH J:   In most trades and professions these days people in those trades and professions have recourse to general publication.  Even car salesmen will look up the price of various models that are second hand ‑ ‑ ‑

MR EMMERSON:   With respect, we have not the slightest difficulty about that.  They know that there are certain reference books and you go them and if you want to know the price of brand X of a motor car, that is where you find it.  They are not then undertaking a research project, they are simply carrying on in their ordinary way, not doing research at all.

McHUGH J:   I may be misunderstanding what you are saying.  Do you have any objection to the skilled technician or worker looking up standard reference books in the field?

MR EMMERSON:   It depends what reference book and for what purpose.  If you go to a reference book where you know in advance what you are going to find then, of course, I have not the slightest difficulty.  But if you have a skilled worker who says, “This is a problem.  I am not at all sure how I could solve it.  Perhaps I will look at reference X”, and he looks at reference X and does not get terribly much help and he thinks, “Perhaps I will look at reference Y” and so on, then what he is attempting to do is add to his general knowledge something which was not there beforehand and, in those circumstances, if he eventually finds what he is looking for and gets to a particular point and you ask, “Is it patentable?”, you have the twin tests. You first ask, “Is what he has got to something which is new or is it something which, in any event, was set out in the book that he has consulted”, because if it is not new it is not patentable.

But let us suppose that he reaches, by this process, something which is new, then you have to ask whether, before he carries out any research and in our particular case before he carries out any laboratory testing, at least he can see what the answer is going to be, subject to matters of fine tuning and things of that sort.  In your Honour’s example, a car salesman is given the question what is the price of a particular make, model, year of a second‑hand car.  As part of his common general knowledge he knows where to find that precise information.  It is quite different from somebody who is starting from scratch and does not have a working knowledge of that which he is seeking to find from books.

McHUGH J:   I understand that, but the problem seems to me is just this use of the term “obviousness” in this field and other similar fields in the 21^st century, because if you read it literally, the cases must be few and far between in this field where it could be used to invalidate patents.  I mean, that is your basic argument.

MR EMMERSON:   Yes, your Honour.  We say that if, as well as everything else, you take as your basis for what is obvious, not just common general knowledge, but that which a skilled worker could find in a literature search, followed by a test, followed by perhaps a further literature search and further testing and a process of that sought, and then having come to that position you ask was the invention obvious, then it is an unfair test, it is not a statutory test and, of course, it is difficult to see how any substantial number of patents could withstand such a scrutiny.

McHUGH J:   Yes.  Dr Bennett will no doubt instruct me on the matter but at the moment I have some difficulty in seeing how something could be obvious if you can run into dead ends and come out again and start on another course and carry on.  It may take some time but, nevertheless, it is still said to be obvious.

MR EMMERSON:   That, with respect, is our point.  In those circumstances, we would say it is not obvious.  The statutory word is “obvious” and that simply does not describe the process of dead ends and backwards and forth and searches and so on.

GUMMOW J:   I think we have to look at perhaps paragraph 109 of the trial judge’s judgment, which I think you accept warmly and embrace, and then we have to see whether he took a wrong turning himself in paragraph 110.

MR EMMERSON:   Yes, that is correct, your Honour.  We say that the start of the wrong turning or the foreshadowing of the wrong turning perhaps happened at page 46 in his paragraph 43.

GUMMOW J:   Paragraph 43?

MR EMMERSON:   Yes, where he says:

It may not necessarily follow, however, that documents which would have been found on search, but do not form part of the common general knowledge, are simply irrelevant.

GLEESON CJ:   You must have that page number wrong, Dr Emmerson.

HAYNE J:   I think it is page 36, is it?

MR EMMERSON:   I am indebted to your Honour Justice Hayne.  Yes, I did, indeed, have that page number wrong.  It is page 36, paragraph 43 in the learned primary judge’s reasons.

CALLINAN J:   Dr Emmerson, is your submission on this recorded at page 53 in paragraph 85, perhaps a little bit elliptically?  Your criticism of the experts relied upon the other side:

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

about line 20.

MR EMMERSON:   That is certainly part of the criticism that I made, yes.

CALLINAN J:   At some stage – and you might want to do it in writing – it would be interesting to see specifically what you criticise because, although his Honour says he will “return to the submissions after discussing the evidence”, I cannot find anywhere where there is specific reference to the particular submissions.  His Honour seems to discuss the evidence but does not, so far as I can discover, relate particular submissions to the acceptance or rejection of evidence.

MR EMMERSON:   Could I perhaps state in general terms what we say about Dr Marshall.  He was a skilled formulator.

CALLINAN J:   He only got there:

because he was prompted or “nudged” in the right direction.

That was your submission, was it not?

MR EMMERSON:   Yes, stated shortly.

CALLINAN J:   And did not get there any way, completely.

MR EMMERSON:   Yes, but we have perhaps at a more basic level a criticism of the use that was made of Dr Marshall’s evidence, and that is this.  We say the test should have been, if Dr Marshall was presented with the relevant facts which would make clear what the problem was, would the solution have been obvious to him in the sense that, without carrying out further experiments and so on, would he have suggested, perhaps amongst other things, the invention?  That did not happen.  What happened was Dr Marshall was initially briefed when his first report came in.  As the trial judge found, Dr Marshall did not suggest any integers of the claim, let alone all of them.

CALLINAN J:   He had six goes at it, did he not?

MR EMMERSON:   He had six goes, and we say he still did not get that.  Now, we say that that simply shows that the invention was not obvious to Dr Marshall.

GUMMOW J:   Do you not put your case rather unnecessarily high?  Your submission is that he should have got it without any go, but what is really probative I think is that he had six goes and did not get it.

MR EMMERSON:   Yes, we would say that for this sort of evidence to be relevant and useful for a court considering the issue of obviousness, it should be possible for a person who wants to invalidate a patent along these lines to produce evidence that experts in the area, when fairly told the nature of the problem, say, “I can see how that problem will be solved.  This is what you do.”  Now, in fact none of the respondent’s experts did that.  Dr Marshall went to six reports and still did not get precisely there, and was nudged.  His evidence, we say, cannot be of value because he produces reports.  He says, “Now here is a whole list of possibilities.”  So there is a sort of decision tree.  Then there is a homing in onto a particular part of that decision tree and homing in again and success of reports.  So it is like the old game of 20 questions.  He is not being asked properly whether the matter was obvious.  Now, equally ‑ ‑ ‑

HAYNE J:   Is that any more than a reflection of the scientific method?

MR EMMERSON:   If it is a reflection of the scientific method, we would say that the mere fact that something can be discovered, using the scientific method does not mean that that discovery is obvious.  It is often quite the other way around.  It may well be that what was here followed was some sort of reflection of the scientific method but the test ought to be:  fairly put the facts to the witness in a way preferably, I might say, that the adverse party can also be appraised of, so that we know what is the issue that is put to the witness, then we look at the answer that the witness gives and can use that to say whether the answer found by the patentee is an obvious one.

GLEESON CJ:   As I understand it, you accept that obviousness and taking or not taking an inventive step are just two sides of the one coin.

MR EMMERSON:   Yes, we do accept that, your Honour.

McHUGH J:   It is not quite though, is it?  You could get situations where there would be nothing new.

MR EMMERSON:   Well, in that case, the claim would fail for want of novelty and there would therefore be that objection, because, of course, there is a distinction between the objection that something is obvious and the objection that something is not novel, which has, of course, been considered by the courts on a number of occasions.

GLEESON CJ:   If you look at it from the point of view of not taking an inventive step, that is different from not taking a step, or perhaps not taking a series of steps.

MR EMMERSON:   Yes, indeed, because in the case of the inventor, he undoubtedly took a step – that is to say, you look at the statute, you look at what he claimed and you look at common general knowledge, and there is, so to speak, a notional step between the two.

GLEESON CJ:   But whether he was right or wrong, what Justice Lehane said in paragraph 110 distinguished between taking an inventive step and taking routine steps, which an unimaginative skilled formulator would take.

MR EMMERSON:   Yes.  Following on from the passage at page 36 of the appeal book, paragraph  43 is, in our respectful submission, the start of where the learned primary judge went wrong.  It is the start of where he was substituting a test of “Would the skilled addressee have solved the problem in certain circumstances?” for the test “Was the solution obvious to the skilled addressee?”

GLEESON CJ:   Well, is it wrong to distinguish between inventive steps and routine steps?

MR EMMERSON:   It is not helpful.  First, you have to look at the finishing point in order to determine the step.  That is to say, one should not be concerned with analysing the various things that an inventor or somebody else did, step by step, and say of each one, “Is it inventive?”  Secondly, in our submission, the word “routine” is too vague a word to be helpful in specifying the nature of the inquiry here. 

If it is taken to have its primary meaning as just being fixed and unvarying and so on, then we would have no particular difficulty about it.  Here is the start of his Honour falling into error by asking whether the skilled formulator, given a sufficient amount of dead-end retracing of steps, experiments, literature searches and so on, could have found the answer.

HAYNE J:   Do you go so far then as to say that the need to apply recognised scientific methods of testing and experimentation to achieve the solution of the problem will ordinarily deny obviousness?

MR EMMERSON:   If you cannot tell what the nature of the answer is going to be until you have carried out a program of scientific research, the answer is, yes.  But if, on the other hand, you say the question is, shall we say, “Is there arsenic in the soup?  I apply Marsh’s test and that will tell me whether there is arsenic in the soup”, then that is not something which is inventive.

HAYNE J:   But in the present context, “I wish to deliver this drug in pill form with an enteric coating.”

MR EMMERSON:   Yes.

HAYNE J:   The question is which enteric coating is best.  If, to achieve that outcome it is necessary to test and experiment to achieve the solution of a satisfactory delivery by enteric coated pill, do you say that, of itself, at least ordinarily, denies obviousness?

MR EMMERSON:   Not if it involves fine tuning.  The case that your Honour is putting to me, as I understand it, takes it that you know what is to be in the rest of the pill.  You know that you want to ‑ ‑ ‑

HAYNE J:   You know you have a drug.  You know you wish to deliver it in pill form.  You know you wish it to have enteric coating to regulate where in the body the drug is released into the system.

MR EMMERSON:   But is there also an issue of whether you might make some changes in the central part of the drug?

HAYNE J:   That is the end to which you are aiming.  Does the fact of testing and experimentation deny obviousness?

MR EMMERSON:   It can deny obviousness and it will do so unless the testing is no more than a matter of fine tuning so that if you assume that you have the various components of the pill and you are wanting to go from a pill which more or less works to something which is a bit better, then you might explore a change in enteric coating or the thickness of coating and so on.  There clearly comes a stage when that may be merely fine tuning.  But the distinction is that, on that hypothesis, you know at the outset of the particular inquiry we are talking about that you are going to have the pill, you are going to enteric coat it and so on.

GLEESON CJ:   The distinction between inventive steps and routine steps referred to by Justice Lehane was taken from Justice Aickin’s judgment in Wellcome Foundation.

MR EMMERSON:   Yes, it was.

GLEESON CJ:   What you were referring to a moment ago as fine tuning, is a narrower idea, is it not, than what Justice Aickin referred to at page 286 of Wellcome, “as taking as a matter of routine whatever steps might have led from the prior art to the invention”?  Is there some time frame within which that has to occur?

MR EMMERSON:   His Honour does not deal with time frame.

GLEESON CJ:   He talks earlier up the page about a “series of routine experiments”.

MR EMMERSON:   Yes, we would emphasise the word “series” in that context.  His Honour seems to have had in mind that you might be able to know in advance what experiments you might want to carry out.  You might want to measure density, you might want to measure acidity as well as density and a whole of series of things and you would be able to write down on a piece of paper before you started, “These are the experiments I am going to do.”  If those experiments are routine in the sense that those are the experiments you do every day when a sample comes in to be tested, then that is what Sir Keith had in mind, in our submission, when he speaks of a “series of routine experiments”.

Could I, perhaps, take the Court to Wellcome and say something about the structure of the decision in that case.

CALLINAN J:   Do you not get some support from what is said at page 287 though, the third paragraph?

If evidence of the failure of other attempts to solve a well‑known problem . . . is admissible . . . it is difficult to see why the patentee’s own lack of success in earlier attempts would not also be admissible ‑ ‑ ‑

MR EMMERSON:   Yes.

CALLINAN J:   There were a large number of attempts here before you got it right, is that not so?

MR EMMERSON:   Yes, there were indeed.  We would, with respect, draw comfort from that passage.

If one turns to the Wellcome Case, it is to be noted, we would say, that this is, of course, decided relatively shortly after Minnesota Mining.  It refers to and applies the reasoning in Minnesota Mining and we would invite the Court to draw the inference that Wellcome is in no way seeking to depart from the reasoning of Sir Keith Aickin in Minnesota Mining.  It is also important to note that although necessarily one finds different passages in the judgment being quoted at different times, that whereas in Minnesota Mining the Court quite expressly identified a particular problem, said, “Now is the time which is appropriate to solve the problem and this is the way we resolve it.”  In the case of Wellcome v VR the issue that arose before the Court arose in the context of a dispute about discovery.

So, the question was whether particular lines of inquiry could be relevant such that documents which might suggest particular lines of inquiry should be discoverable.  Indeed, his Honour after a discussion of various possibilities and earlier authorities does seem to come down to the conclusion that documents in question, or some of them at least, were discoverable because they might set up a line of inquiry.

It is also worth noting that the structure of Sir Keith Aichin’s reasoning in this case was to start off by stating the problem which arose in the context of discovery, which he does at page 269.  The question then was whether evidence of what had been done by the inventor was admissible and hence documents relating to that might be discoverable.  The argument that was put on behalf of the patentee seeking to resist discovery was a perfectly straightforward one.  He said, “It does not matter for the purpose of assessing an issue of obviousness whether the invention was obvious to the inventor or not.”  The question is to be tested objectively in the sense that you look to see whether a notional skilled person in the art would have found the invention obvious.  Therefore, so the argument went, it cannot be relevant to ask what did the inventor do and what did the inventor’s document show.

Now that background leads Sir Keith to state, at the bottom of page 270, what is the test for obviousness.  It appears in the paragraph beginning eight lines from the bottom of that page:

It is as well to bear in mind that the question of obviousness 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.

Now, in our respectful submission, that is a classic statement of what you look to on the issue of obviousness and it does not give rise to any of the difficulties which seem to have been encountered by the courts below in dealing with this case.

KIRBY J:   But the Act talks to science and invention at different stages.  Its origins lie in earlier centuries and nowadays science, in the field of nuclear physics and the field of biology and in the field of informatics, has gone beyond the scope, immediate Eureka-type exclamations, it is more complex, and therefore, if the Act is to speak with relevance to science and technology as they exist today, the ultimate question that has to be addressed is whether in that moving context what is obvious moves with that change and therefore that with the advance of the availability of information, including through the Internet and so on, that you face up to the reality of that factual substratum to which the statute speaks.

MR EMMERSON:   The way that this keeps up to date, in our submission, is that ‑ ‑ ‑

KIRBY J:   Otherwise it will not have much work to do, because science is now beyond the wit of ordinary simplicities.  It is more complicated.

MR EMMERSON:   Yes, and, of course, we have no difficulty with the proposition that in testing obviousness you are not looking to ask whether something would be obvious to the layman but you are asking whether something would be obvious to the skilled worker in the field.  But the other side of the balance, to keep the matter fair, is that you really are asking whether it would be obvious to the ordinary skilled worker of the field.  You are excluding from obviousness something which is obvious to a highly inventive worker in the field and you are keeping in mind that the question is directed to obviousness and not to the capacity to solve problems.

DR EMMERSON:  No.

GAUDRON J:   But can you tell us how you say the problem would have been formulated back at the priority date?

MR EMMERSON:   Yes.  It would have been formulated by stating that we have here a compound with the following characteristics and there is a convenient summary of them at the bottom of page 21 and the top of page 22 of the appeal book, paragraph 9, and we would add to it a more detailed description of the various instabilities of omeprazole and its low solubility in water.  Having formulated that as the problem, the question is, how do you produce a formulation for human use.  Now, in our submission ‑ ‑ ‑

GAUDRON J:   And would that have revealed that lack of potency or perhaps instability, if that is a synonym for that word in this context, when the pharmaceutical product was brought immediately into contact with the enteric coating?

MR EMMERSON:   There was not instability immediately the product was brought into enteric coating, with respect.

GAUDRON J:   No, but there was some instability at that point, was there, over time?

MR EMMERSON:   Depending on what formulation was tried, there was sometimes instability during the process of formulation, but ‑ ‑ ‑

GAUDRON J:   Formulation with an enteric coating?

MR EMMERSON:   Yes.

GAUDRON J:   Yes.  Now would that piece of information have been given to the addressee?

MR EMMERSON:   But, your Honour, it is also the fact that the most promising line of formulation, identified by Pilbrant and Cederberg in their paper, had a core containing omeprazole and it was directly enteric coated, and that was thought to be promising, the most promising.

GAUDRON J:   We are talking about the priority date, are we not?

MR EMMERSON:   Yes.

GAUDRON J:   Forget about, therefore, the article.

MR EMMERSON:   Yes.  Indeed, I hasten to say that I am not for a moment suggesting that the notional addressee has access to the article.

GAUDRON J:   No.  If you were formulating the problem on the priority date to your research team, would you tell your team that there was instability, at least on some occasions, when the compound was coated directly with an enteric coating?

MR EMMERSON:   No, you would not.  With the greatest respect, we would say that is not even a fair way of putting it ‑ ‑ ‑

GAUDRON J:   Why would you not tell your team?

MR EMMERSON:   Because we are by that stage talking about what you might learn as the result of a research program.  We are not simply defining the problem.

GAUDRON J:   Surely there is a difference, is there not, Dr Emmerson, between a research program and confirmatory testing?

MR EMMERSON:   Yes, absolutely.

GAUDRON J:   Now, what would be the difference here – well, either confirmatory or negative testing?

MR EMMERSON:   Our submission is that what one is seeking to do in applying the test laid down by the statute is not to provide the notional addressee with information which is not published and which would be obtainable only by testing.

GAUDRON J:   No, but you have to tell him the problem, have you not?

MR EMMERSON:   Exactly, but the problem is we have a chemical compound which has these various instabilities which can be set out scientifically and which has ‑ ‑ ‑

GAUDRON J:   Which of the instabilities that you have described, emanating at pages 21, 22, is the instability that relates to the contact with the ordinary enteric coating?

MR EMMERSON:   You would not know that at the start.

GAUDRON J:   That is really the nub of the case, is it not, in this case?  The nub of the case is how you formulate the problem to your notional addressee.

MR EMMERSON:   Your Honour, part of the difficulty that had to be overcome by Astra’s own research team in carrying out its research was not directed to, “How do you characterise omeprazole and its various physical and chemical properties?”, but, “How do you formulate it?”  In the course of formulating it the sort of things that you can observe are, “Does it discolour?  Is it” ‑ ‑ ‑

GAUDRON J:   Surely you can do a bit more than that.

MR EMMERSON:   The sort of example – discolouration actually formed quite a significant part of the evidence because it is a sign of decomposition.  “Does it discolour?  Do you find it discoloured when you first tried to formulate it or do you find that it discolours on storage?”

GAUDRON J:   Formulated in what?  That really is the question.

MR EMMERSON:   With respect, this is the answer that I am seeking to give.  It is up to the notional addressee to see whether the notional addressee can work out a formulation given the characteristics of omeprazole.

HAYNE J:   Do you accept that, given the stability properties of omeprazole, it is an obvious that an oral dosage form must be protected from the acid in the stomach?

MR EMMERSON:   There must be some protection but it does not follow from that that the protection must be ‑ ‑ ‑

HAYNE J:    What I am quoting from seems to be from the complete specification at line 25 on page 3 of the supplementary appeal book, where it says:

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 –

et cetera.

MR EMMERSON:   From which page?

HAYNE J:    Page 3 of the supplementary book, line 25.

MR EMMERSON:   Yes, that is not the patent in the form in which it is presently in suit.

HAYNE J:    Perhaps so, but is it a statement which you would accept?

MR EMMERSON:   Well, given the instability problem, something has to be done about the instability, but whether that something consists of keeping it dry or whether it consists of coating it or whether it consists of buffering it or whether it consists of mixing with alkali and so on, one simply does not know.  His Honour, as to the suggestion that the instability was caused by an action between the core and enteric coat, says at page 64, paragraph 107:

No one gave evidence that he had previously, or since, encountered such a problem; there was no evidence of any product manufactured or marketed, before the Priority Date, in the making of which such a problem had had to be dealt with –

So we are here in a new area but, of course, instabilities have to be dealt with, though, with respect, I would challenge, because it is another part of the argument in another part of this case, that certain statements which are made in specification drawn up abroad necessarily reflect the state of knowledge in Australia.  The specification, as amended, is set out at page 37 and following in the second Court book.

GUMMOW J:   But is it correct simply to say that the problem would be that outlined at page 73 of the book, under “Background of the Invention”?  Could not that be put in the brief?  This is the amended form at page 73.

MR EMMERSON:   Yes.  The difficulty is the “Background of the Invention” is not really an account which is directed to the particular question that we are here concerned with which arises against an objection of obviousness and the background itself mixes in thinking by the Astra team which was not public with thinking that it was.  Nevertheless, the low stability of omeprazole in water, the low solubility of water, degradation proceeding rapidly, sensitivity to acids, all of those things are amongst the complex of problems which would have to be considered.

In further answer to what your Honour Justice Gaudron was putting to me, we say that analytically there must be a clear line of demarcation in applying the statutory test for obviousness between information which is necessary simply in order to understand the nature of the task which in this case consists of knowing the properties of omeprazole and being informed of information which is not publicly available and which can be derived only by attempting an actual formulation.

GAUDRON J:   What, at page 73, was not publicly known?

MR EMMERSON:   Publicly known or part of common general knowledge?

GAUDRON J:   No, I thought we were still talking about formulating the problem for the addressee or the brief for the addressee.

MR EMMERSON:   Yes.  Formulating the brief for the addressee, yes, well ‑ ‑ ‑

GAUDRON J:   What at page 73 would you not give the addressee?

MR EMMERSON:   What one would give to the addressee is:

Omeprazole is however susceptible to degradation/transformation in acid reacting and neutral media.  However, the half‑life of omeprazole in water solutions at pH‑values less than four is shorter than ten minutes.  Also at neutral pH‑values the degradation reaction proceeds rapidly, eg at pH‑7 the half‑life of omeprazole is about 14 hours, while at higher pH‑values the stability in solution is much better –

it is staying more alkaline conditions.  One would not be given the reference to Pilbrant and Cederberg.  One would be given the statement:

The stability profile is similar in solid phase.

Because, up until then they have been concerned with the liquid:

The degradation of omeprazole is catalyzed by acidic reacting compounds –

would be given.  The next sentence is dealing with a partial way to solve the problem and so we do not include that amongst the things that is given:

The stability of omeprazole is also affected by moisture and organic solvents.

All that would be given, though one would probably expect a more compendious set of statements to be given.

GAUDRON J:   But what about line 26 on 73:

Thus an oral dosage form –

would that be given?  Is that not what you are trying to do?

MR EMMERSON:   No, that is getting to a part of the stage that the addressee is supposed to work out for himself.

HAYNE J:   Well that is a radical departure from what you have been telling us all day, Dr Emmerson.  Go to paragraph 9 of the trial judge’s judgment where you tell us that the problem is sufficiently identified and the last sentence of it is:

In order to work as a drug, it must be released rapidly when it reaches the top of the small intestine; but it must be protected from acidic gastric juice on its way through the stomach.

Do you wish to resile from the proposition that paragraph 9 is part of the problem that has been given to the addressee?

MR EMMERSON:   I do not wish to resile, with respect.  That it is part of the problem that is given to the addressee.  The addressee is to be told the nature of the properties of omeprazole.  The addressee is a skilled formulator and the addressee can work out for himself that if one of the properties that he is given is that it has a low solubility in water and various range of solubilities, then he can tie that into the position that will be reached in the stomach and the gut.  So we have no difficulty with that, but the logical drawing of the line is between the properties and what you must conclude from them.  I accept, your Honour, that it is stated compendiously, “must be protected from gastric acid juices” and so on, but once you know that you have acids stability, that is really information which the addressee naturally works out for himself.  So he says, “I see we have got problems of acid stability”, then the question is, “How does he get over them?”, and all the other problems?

GLEESON CJ:   Would you care to comment on paragraph 92 of the judgment of Mr Justice Laddie that is attached to the written submissions of the respondent?  It would seem to be close to the point we have been discussing for the last few minutes.

MR EMMERSON:   We would, broadly speaking, disagree with his Honour’s findings and we would say that those would not be appropriate findings in the light of the learned primary judge’s findings in the present case.  The notion that someone “would have found out almost immediately that an incompatibility problem existed”, there was a lot of argument as to what was the cause of certain phenomena, and still even disagreement at the hearing of our case as to whether there were incompatibility problems or leakage problems.  So we would resist the first sentence of what his Lordship says, so one does not get to the second sentence.  Then it is said:

It would have been immediately apparent to him that such a separating layer would need to dissolve or disintegrate in the intestine to avoid bioavailability problems.

That is a matter where different considerations point in different ways.  You need to have a coating which maintains its integrity because otherwise you are not going to get any bioavailability at all.  On the other hand, you need to get a coating which breaks down at the appropriate part of the gastro‑intestinal tract because if you do not have that you still do not get good bioavailability.  So there are various causes that might follow.  We would say, with respect, that his Lordship’s approach there is not consistent with the findings in the present case.  If such a suggestion were made in our case we would say, with respect, that it is simply wrong.

KIRBY J:   You took us to the passage between yourself and Justice Wilcox and you got to the point where you said you were recorded as saying “No”.

MR EMMERSON:   Yes.

KIRBY J:   I did not know whether that indicated that you were challenging the record.  This is page 13 paragraph 53 ‑ ‑ ‑

MR EMMERSON:   No, indeed I am not.

KIRBY J:   I just wondered what you meant by “recorded”.  You are happy with the record?

MR EMMERSON:   That is an extract from the record.  I am happy with the record.  The record goes from page 329 through to 331 on this topic.  That is a point towards the end of that and we insert it to make it clear that that was our position.

KIRBY J:   Could I ask you this.  It is a general question.  I realise that the thrust of your submissions relate to what you say is required by authority, specifically the authority of this Court.  You essentially say that the primary judge and the Full Court, especially the Full Court, have just not applied 3M and Wellcome.

MR EMMERSON:   Yes.

KIRBY J:   That is the linchpin of your argument.  At page 8, paragraph 29 of your submissions you finish with a passing reference to what you say is “the undoubted policy underlying the patent system”.  So that, as I understand it, your arguments are the matter is resolved by authority, but it is reinforced by considerations of policy.

MR EMMERSON:   Yes.

KIRBY J:   If one gets to a point of considering that second issue, would not policy in the world of patents, as expressed in the 1952 Act or even the new Act, in contemporary circumstances where – I have read somewhere there are 160,000 patents outstanding, many of them computer generated in the field of genomics for determination by the European Patent Office and the United States Trademarks and Patents Office – that the policy would tend to favour, in the advance of science and technology, the need for real inventiveness and, as it were, a loosening up, if anything, of the 3M test, so that in contemporary science and technology you would re‑express that test, perhaps in a slightly different way – I put it very poorly – to require really and truly inventiveness and to disqualify for any obviousness, softening the obvious, strengthening the inventiveness.  Now, I do not know whether you can deal with it now or whether you want to deal with it on a note but I am interested in the policy question.

MR EMMERSON:   Your Honour, the policy question, in our submission, does not invoke any change which makes it less easy to be granted a valid patent.

KIRBY J:   In a sense, it is bound up in the questions you were asked earlier about whether now you have move beyond the chemical literature into the availability to the propounded person of the Internet and other sources of information available today.

MR EMMERSON:   Yes.

KIRBY J:   It may not be a matter you want to deal with or can deal with briefly now, but at some stage I would appreciate some help on that.  You do mention it in passing but as far as I am concerned when you get to this Court, you have special leave and the issue is being argued, then I think we have look at the issues of legal principle and policy.

MR EMMERSON:   There are undoubtedly issues of legal principle.  Could I just put to one side, with respect, one thing that your Honour was putting to me, that I started with authority and then went on to policy.  The way we would put our argument is that we start with the words of the Act and we say that that language is sufficient to make it clear that one is looking ‑ ‑ ‑

KIRBY J:   I understand that, that that is undoubtedly correct, that this Court has repeatedly said so in a number of contexts recently.  There is a statute, you have to start with a statute and sometimes that is the end of the matter.  But there is a lot of authority that is gathered around this and therefore we go to the second stage and the question then is if there is a degree of uncertainty or ambiguity at what the law is at the end of that, as a lot of the debate we have had today indicates there is some, then the question then is what issues of principle and policy inform the choice of, as it were, fairly strict rule in 3M and what, in new circumstances, suggest that that approach should be loosened up a little?

MR EMMERSON:   Well, in order to fully answer the policy question, one would unfortunately need to travel beyond the facts that are available to this Court, but we would say that the statute itself draws a balance between encouraging the inventor and what is provided to the public, but it is a balance which largely looks at the commercial results so the inventor gets a monopoly for a period of time in working its invention, and after that period of time is over, then that invention becomes available to the public.

Now, in the present case, you ask, should it be easier or more difficult to get a patent?  The evidence is that the present invention took a very large amount of expenditure, of time and money on behalf of my clients.  Whether a subsequent analysis leads to it being attacked, is not something which one really knows of the time that that expenditure has been made, but what encourages the expenditure is to have certainty and reasonable strength in patents and, ideally one would say, patents such as the present one, which really do take a skilled team a year, or years, in order to make it.  It is something that should be rewarded and one should not look to a relaxation of 3M, which would allow in all sorts of other bits of prior art, which have been found retrospectively by someone seeking to attack a patent, because, in that respect, we would respectfully submit, that the reasoning of 3M is just as cogent today as it was when it was first written.

It is not ultimately a matter, in our submission anyway, of searching.  It is a matter of the balance being struck by the Act, but in working out the Act, we would say that given the real difficulties of making this invention, then it is right and proper that it should be rewarded.

GLEESON CJ:   Is that a convenient time, Dr Emmerson?

MR EMMERSON:   If the Court pleases.

GLEESON CJ:   We will adjourn until 10.15.

AT 4.17 PM THE MATTER WAS ADJOURNED
UNTIL THURSDAY, 30 MAY 2002