[2015] HCATrans 106
IN THE HIGH COURT OF AUSTRALIA
Office of the Registry
Sydney No S54 of 2015
B e t w e e n -
ASTRAZENECA AB
First Appellant
ASTRAZENECA PTY LIMITED
Second Appellant
and
APOTEX PTY LTD
Respondent
Office of the Registry
Sydney No S55 of 2015
B e t w e e n -
ASTRAZENECA AB
First Appellant
ASTRAZENECA PTY LIMITED
Second Appellant
and
WATSON PHARMA PTY LTD ACN 147 695 225
Respondent
Office of the Registry
Sydney No S56 of 2015
B e t w e e n -
ASTRAZENECA AB
First Appellant
ASTRAZENECA PTY LIMITED ACN 009 682 311
Second Appellant
and
ASCENT PHARMA PTY LTD ACN 118 734 795
Respondent
FRENCH CJ
KIEFEL J
GAGELER J
KEANE J
NETTLE J
TRANSCRIPT OF PROCEEDINGS
AT CANBERRA ON WEDNESDAY, 13 MAY 2015, AT 10.14 AM
Copyright in the High Court of Australia
____________________
MR A.J.L. BANNON, SC: May it please the Court, in each of those matters, I appear for the appellants with my learned friends, MR C. DIMITRIADIS, SC, and MR C.J. BURGESS. (instructed by Ashurst Australia)
MR D.K. CATTERNS, QC: May it please the Court, I appear with my learned friend, MR N.R. MURRAY, for Apotex in the first matter. (instructed by Herbert Smith Freehills)
MR A.J. RYAN, SC: May it please the Court, I appear on behalf of the respondents in the second and third matters with my learned friend, MR I.P. HORAK. (instructed by Minter Ellison Lawyers)
MR J.T. GLEESON, SC, Solicitor‑General of the Commonwealth of Australia: May it please the Court, I appear with MS F.T. ROUGHLEY, for the Commonwealth which seeks leave to intervene in each matter limited to ground 2 of each of the notices of contention. (instructed by Corrs Chambers Westgarth Lawyers)
FRENCH CJ: You want the intervention application deferred until the end of the oral argument?
MR GLEESON: We do, your Honour.
FRENCH CJ: Yes.
MR GLEESON: If that is convenient, we thought by then it might be clearer.
FRENCH CJ: I think that is convenient from the Court’s point of view.
MR GLEESON: May it please the Court.
FRENCH CJ: Yes, very well. Yes, Mr Bannon.
MR BANNON: Your Honours, the subject patent concerns a method of treatment for hypercholesterolemia, which is an elevated level of cholesterol in the blood. Cholesterol is a chemical made by the liver and while it has an important part to play in the function of a human body, excessive generation – or what is known as low density lipoprotein – cholesterol is associated with an increased risk of arteriosclerosis which is the build‑up of cholesterol in the arteries.
Arteriosclerosis increases a patient’s risk of coronary disease, stroke and peripheral vascular disease. High levels of cholesterol are a function of a patient’s genetic make‑up rather than diet – at least that was my take on the evidence, perhaps from an interested point of view – and, specifically, the propensity of a patient’s liver to generate cholesterol. Cholesterol is generated in the liver by a reaction that commences with a certain enzyme, referred to in the material as HMG‑CoA reductase which binds the substrates in the liver. A class of compounds, known as statins, operate, preferably, to bind to the enzymes substrates in an active manner leaving fewer substrates for the enzyme to bind and, thereby, limiting the generation of cholesterol. In effect, it mops up what would be the ordinary landing spots of the particular enzyme.
These matters are addressed in the Full Court judgment, paragraphs 48, 49 and 52 to 54 which we refer to in our submissions just by way of background. The background at least introduces the topic of statins and I do want to just spend a brief moment on the background because it informs not only the nature of the invention which is claimed, but also some of the debates which arise in the Court.
At the priority date, statins were the drug of first choice of medical practitioners in treating hypercholesterolemia. If I could invite your Honours to turn to some paragraphs of the Full Court’s decision, which is in volume 7, firstly at paragraph 62 ‑ perhaps just by way of background, starting at 2449, paragraph 48 are the matters which I was addressing briefly by way of opening, so 48 and then in particular 49 and 52 to 54.
But in terms of the background – sorry, I said 60 ‑ could I go to 54, your Honours, on page 2452, where their Honours record a finding of the primary judge is not disturbed, but:
statins were recognised as the primary class of drug available for lowering LDL cholesterol.
Atorvastatin is referred to, which was released and quickly became known around the world. It was, the findings indicate, a market leader. Then there is a reference to different dosages of statins which are in the market, which is of some significance in relation to some of the issues, and one can see a range of dosages.
Paragraph 57 refers to statin called Cerivastatin. Cerivastatin, other evidence indicates, was available but its dosage was in a level of micrograms as the highest tolerated dosage; in other words the dosage of a statin was not predetermined by the dosage of another statin. The evidence indicates that one had to look at each statin because each had a variation in efficacy and each had a variability in side effects.
Then, if one looks at paragraph 59, the Full Court records it and does not disturb a finding of the primary judge about studies which reflected the different available – different efficacies in terms of a drug’s ability to produce cholesterol levels across the dosage range. Towards the end of that paragraph, still on page 2453, there is a reference to “atorvastatin being the most efficacious” with references to others there as well. Then, over the top of the next page, the point I was just making a moment ago in the smaller types, quoting from Professor O’Brien, because of side effects:
side effects increase with dose. Fewer side effects are observed at lower doses of statins. Therefore a balance needs to be achieved between effective cholesterol reduction and the likely side effects of a given dose.
Then paragraph 61 addresses the potential side effects and, in that context, the finding was that:
medical practitioners typically prescribe patients –
at a lower starting dose to minimise the risk of adverse events and then towards the middle of that paragraph it refers to a concept of dose titration which is a process:
to increase the dose until the patient reaches their target in as safe a manner as possible –
As recorded there, the practice of dose titration –
increases costs and adversely affects patient compliance –
because of reluctance for repeat visits to the doctor and blood tests, et cetera, and therefore dose titration, as we will see, if it could be avoided was an advantage. That is reflected in a couple of paragraphs which follow. In paragraph 62 there is a reference in the second sentence to the fact that:
medical practitioners in the field were aware that a material number of patients did not achieve their target levels because of either inadequate ongoing management of their condition and the need for dose titration or difficulty in achieving the required reduction of their cholesterol levels –
Towards the end of that paragraph at 2455, about point 20, there is a further reference to the desirability of a statin:
which enabled more people to achieve their target level at the first dose given –
and still provide efficacy and still avoid side effects. In 64 there is a reference to the fact that Atorvastatin, which is the market leader:
was considered efficacious but it was not effective for all people . . . The primary judge said that there were existing statins and the market for statins might well have warranted the description “crowded” . . . but those involved in the treatment of hypercholesterolemia knew that existing statins did not effectively treat all patients.
Paragraph 65 refers to the primary judge noting that:
the experts who gave evidence were not, in fact, looking for a new statin therapy at the claimed priority dates, but said that that was unsurprising –
because of the large scale clinical trials which were required. But there is recognition that a statin which achieved those benefits would be highly desirable. Then paragraph 66 at about point 30 on page 2456 the finding was:
It was common general knowledge for those involved in treating hypercholesterolemia that a statin that could bring more patients to their target level without dose titration than the existing statins would be highly desirable. Such a statin would be considered to be “more effective” than existing statins and to offer a “competitive advantage” over those statins.
FRENCH CJ: That is the fairly simple proposition that a statin is better if it allows you to get it right first time -the dosage.
MR BANNON: Yes, at an early dose, so if it can tick the box of not requiring dose titration, not having side effects, and yet being effective, then it was a significant advantage and, as I will come to, what is claimed as an invention was a 5 to 10 milligram dosage which is a low dosage, use of a new compound, Rosuvastatin, in the treatment of hypercholesterolemia. That is the background, so the dosage is important as was recognised by the findings. The next paragraph refers to the clinical trials matter – evidence and that is of significance as well in terms of obviousness. The first close‑spaced paragraph refers to evidence of Professor O’Brien, which was accepted, that:
A drug is initially chosen based on its efficacy in treating a specific condition or disease . . . screened for toxicology and therapeutic potential, pre‑clinical trials are conducted.
Pre‑clinical refers to trials not in humans –
These pre‑clinical trials test a drug candidate in order to assess the pharmacological effect and any gross side effects associated with administering the drug candidate. Such tests will be conducted on animals such as mice and rats, and then possibly on primates. These tests may involve testing of a range of doses, including even very high doses . . . to test safety.
This is one of our submissions we refer to but, in advance, the two documents relied upon on the 73 point to found obviousness, neither of them had animal safety data which we say the evidence disclosed was critical to informing the human dosage for the reasons which were indicated here and also for other specific evidence which I will come to in due course. So, that passage continues:
Generally speaking, once the animal studies have been conducted, the researcher has an indication of safety and efficacy. By safety, I mean whether or not the drug is safe to administer and whether or not it has any side effects –
And to the top of the next page – it refers to the expense of clinical trials ‑
the decision to go ahead with clinical trials is based on an expectation that the drug is going to be successful, both therapeutically and economically ‑
Paragraph 68, again, confirms the common ground that they are “time consuming and expensive” and there are ‑
many new drug candidates failing at some or other point in the trial process in terms of safety or efficacy or both ‑
There are ‑
detailed prescriptive protocols and regulatory requirements –
In other words, before one – as we will see in the evidence – before one can start a human clinical trial one has to satisfy – be it the FDA or the TGA, the regulatory authority – that the drug has been proven to be safe in animals and at what levels so that the regulatory authorities, understandably, want to know what dose have you tested it out to in terms of safety on animals before we are going to let you even try it on volunteers in humans. That is apparent in paragraph 69 where it is referred to the fact that:
The primary judge found that the object of pre‑clinical testing is to obtain an indication of the safety and efficacy of the drug candidate including in animal models . . . In vitro tests give an indication whether the drug has the desired activity –
And the next sentence, at about point 30 ‑
Animal studies are used to establish the margin of safety of the drug which is the dosage or blood plasma concentration at which the first signs of toxicity are seen compared to the dose or plasma concentration required for efficacy. Ideally the margin of safety is at least tenfold.
Against that background, the invention claimed in the patent – which is identified in the material as the 051 patent – appears from the patent which is sufficiently set out for our purposes in the Full Court’s judgment starting at paragraph 24 at page 2437. The patent opens:
The present invention relates to the use of a cholesterol‑lowering agent, and more particularly to the administration of a particular dose or dosage range of the HMG CoA reductase inhibitor –
and then the patent itself sets out a formula, but the Full Court has put in there the name which it is now known as, rosuvastatin ‑
and pharmaceutically acceptable salts thereof . . . referred to as “the Agent” –
The next paragraph identifies it as having been disclosed in a patent application which is referred to in the material as 471. That is one of the two documents on which the Full Court and the primary judge determined was a document which came into the prior art base as a document which would have been found and in light of which the invention was obvious. There is a description of what that document teaches. At about point 30, the patent says:
Surprisingly it has now been found that when dosed orally to patients with hypercholesterolemia at particular dosages or in a particular dosage range –
certain benefits are achieved, namely, lowering cholesterol to ‑
an unexpected degree, and without any significant adverse side effects.
That continues in that passage to identify similar sorts of benefits. There was a ground of revocation pursued at trial that a false suggestion based on statements such as these as to whether it truly was surprisingly effective. They failed and they were not pursued on any later level of appeal. Then, at the foot of that page is a reference to a particularly suitable starting dose of the agent being 5 or 10 per day – especially 10 per day. Then, at the top of the next page it refers – in the very top of the page to the starting dose:
unexpectedly has a superior efficacy and a comparable or better safety profile –
Then there is some setting out of various tests and designs or references to it. I think I can just take your Honours to page 2440, just paragraph 28 of the judgment where the claims, the finding of the invention appear, and all three claims are in suit in the sense of alleged to be infringed if we establish ‑ ‑ ‑
FRENCH CJ: Well, 3 has been treated as hanging off the other two, has it not?
MR BANNON: Yes. So:
1.A method of treating a patient suffering from hypercholesterolemia which comprises administration as a starting dose of a single, once daily, oral dose of 5 to 10 mg of the compound . . . or a pharmaceutically acceptable salt . . .
2.A method of treating a patient suffering from hypercholesterolemia which comprises administration of a single, once daily, oral dose –
in those amounts. The evidence indicated that those amounts are not materially different from the 5 to 10. It just reflects the way in which they are formulated in the pharmaceutical composition. If I could just turn to the outline which – so far I have covered points 1 and 2. Just looking at point 3, I was not going to go to these references but there was evidence that the new method of treatment was surprisingly effective and of high clinical significance and enjoyed commercial success. Part of that includes the no longer said to be false representations in the patent.
Professor O’Brien - we give some references there. That is from a transcript which he gave and which extra‑curially he is one of the experts relied upon and called by the respondents, but extra‑curially he gave an interview in which he paid what might be described as a homage to the medical treatment in claim 1, namely, the 5 to 10 milligram treatment with Rosuvastatin which includes not only the impressive effectiveness of it but also the point which is included in Dr Wilson’s evidence immediately below, namely, the ability to achieve efficacy at low dose, so you do not need to dose titrate.
Unsurprisingly, there was significant commercial success of the 5 and 10 milligram doses and in short there was evidence to support the conclusion that this was a valuable invention, a valuable advance, commercially very valuable and, hence, no doubt, why all parties are here.
Now, the claimed invention was found to be obvious by the Full Court in the light of the non‑CGK, non‑common general knowledge publications, Watanabe, which is an article, and the 471 patent which disclosed Rosuvastatin, amongst many other things. It was done pursuant to section 7(2) and section 7(3) of Patents Act in the form it then was.
Could I just identify a particular paragraph in the Full Court judgment at 536 of Justice Jessup which I will come back to – it is the focus of some attention in our submissions. It is at 2591 of volume 7 of the court book, where his Honour records the submission as to:
why the skilled person, armed with the Watanabe article or the 471 patent, would necessarily have been led to try rosuvastatin rather than the NK‑104 compound, the subject of the Aoki article turned up by the researches of Prof O’Brien and Dr Reece –
who are the two experts on which both the primary judge and the Full Court relied in finding against the validity of the patent on this issue. His Honour proceeds – and I should add the other members of the court agreed with Justice Jessup’s reasons on this issue:
We were taken, at some length, to the evidence of these witnesses (especially to that of Prof O’Brien) where it was accepted that, so far as they could see from the publications they consulted, NK‑104 was a new compound of considerable potential in the treatment of hypercholesterolemia. It was submitted that there was nothing in the evidence to justify the conclusion that the notional skilled person would have been led directly to try the S‑4522 (rosuvastatin) route, rather than the NK‑104 route. The difficulty with this submission, however, is that her Honour did not find, and we were directed to no evidence which would have sustained a finding, that NK‑104 was part of the common general knowledge as at the priority date. That being the case, the skilled person would not have had before him or her both the Watanabe article or the 471 patent, on the one hand, and the Aoki article on the other hand: it had to be Watanabe or 471 or Aoki. In this wholly notional exercise, the skilled person would never be faced with a choice of the kind which is implicit in this submission on behalf of the appellants.
That is a paragraph which we say involves a misconstruction, or reflects a misconstruction of 7(2) and 7(3), and reflects a failure to follow what we say is a test which was accepted in a number of cases including Lockwood (No 2) in this Court, and I will come back to that in a bit more detail, the Full Court’s approach.
But could I, against that background, invite your Honours to turn to sections 7(2) and 7(3). They are in the form of the Act which is to be found in Reprint 2 and perhaps start, if your Honours have in the bundle of sections, hopefully, section 18, which provides in subsection (1):
Subject to subsection (2), a patentable invention is an invention that, so far as claimed in any claim:
. . .
(b) when compared with the prior art base as it existed before the priority date of that claim:
. . .
(ii)involves an inventive step –
That takes one to section 7, and section 7 provides under the heading of “Novelty and inventive step” – subsection (1) deals with novelty. Subsection (2) provides:
For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base 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, whether that knowledge is considered separately or together with either of the kinds of information mentioned in subsection (3), each of which must be considered separately ‑
Then the relevant section is (3)(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 dropping down to the chaussette of that paragraph ‑
being information that the skilled person mentioned 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.
KIEFEL J: Paragraph (b) of subsection (3) did not assume any importance in this matter?
MR BANNON: No, it was not applicable and there was no attempt to create that. The two relevant documents found by the primary judge and the Full Court to be determinative were, as we say, the Watanabe article and the 471 patent.
FRENCH CJ: The primary judge found the invention obvious on the basis of common general knowledge alone but that was overturned in the reasoning of Justice Jessup?
MR BANNON: Yes, her Honour found it on an approach which assumed the so‑called starting point approach in the first instance.
FRENCH CJ: Yes.
MR BANNON: That was overturned by the Full Court and then her Honour dealt – this is not by way of criticism but in the light of her Honour’s early finding perhaps not as much – her Honour did not feel much attention needed to be paid to it, but I think Justice Jessup, trying to interpret her Honour’s finding in relation to the second leg, seems to treat the way her Honour treated it as if rosuvastatin in fact was part of the common general knowledge which may or may not involve perhaps an error or a slide.
But for our purposes the focused reasoning ‑ because it assumed the greatest significance in the light of our succeeding on the starting point issue in the Full Court ‑ the focused reasoning on section 7(2) and (3) really appears in Justice Jessup’s reasons because, as I say, it did not assume for obvious reasons much significance for her Honour. But just dealing with the words of section 7(2), there is no dispute that the onus is on the revoker to prove that an invention is obvious, so the invention is taken to involve an inventive step unless certain things are demonstrated. That is the first point.
Secondly, the effect of subsection (3) is merely to add a document to the prior art base. So the prior art base will consist of common general knowledge and, if one can satisfy the ascertainment test, an additional document. So, to look at it in this case one would say in considering the obviousness of the 051 patent, the skilled addressee would start with what the skilled addressee knew generally, which would include knowledge of atorvastatin and other statins and the mechanism of statins, but also include a desire or interest to find a new statin which satisfied the criteria one looked at. But it would also have an assumed knowledge of, on one version of the test, Watanabe. A second way of looking at it would be to say all of the common general knowledge plus 471 on its own. The effect of it would be to say the skilled addressee has common general knowledge but also has in his or her head the contents of one of those documents as well.
At that point – that is the point when one applies, we submit, and what this Court has found previously, what is the ordinary test. One asks what would a skilled addressee do armed with that information and really coming to, perhaps, the nub of one of our points in this case is the evidence about what the skilled addressees do – which are Dr Reece and Professor O’Brien – is faced with a problem we would have done a literature search.
KIEFEL J: How was the problem identified?
MR BANNON: The problem is – it is a little bit variable in the two pieces of evidence but, fundamentally, search for a new statin which helps – is more effective than existing statins and satisfies the need to – it was not clearly indicated whether it satisfies the need for the dose titration point but certainly more effective than existing statins and treat patients which are difficult to treat in broad terms.
But, what one has here – and I will take your Honours through it in some little detail because it is of importance – is evidence which each expert has said, if I was asked to challenge this problem, I would do a literature search. What they do is they do a literature search and they both find each of these documents. One of them goes on to say, Professor O’Brien, “Well, I would have chosen between 471 versus Aoki – they both look good but I would have chosen between the two”.
That involves problems of comparison because of it, but, fundamentally, what nobody does is to say well, now that I have got the common general knowledge, my point adds one document. They do not say, well, what would I do in those circumstances? We say the only conclusion from the evidence was that they do what they said would do in any event, namely, undertake a search because the mere fact that they add one of these things does not alter what would be their normal approach.
If they had given evidence to say, if you had told me I start with common general knowledge and you are giving me this one – if they had said, in those circumstances, I would not have done a search, I would have just landed on that because that looks terrific, that might be another thing. But they did not do that at all. On the contrary, the only inference from their evidence is that they would have done a search.
That is consistent with the background we see that it is a crowded statin market. Clinical trials are an enormously expensive exercise. It is a venture as much in hope as anything. The suggestion that they would launch just with one extra piece of information without finding out what else is there, e.g. is there something else which is magical – even to find out that there is nothing else there – is not supported by logic and certainly not supported by the evidence.
The fundamental construction point, we say, which arises is to say if one recognises that is approach to the Act – and we say the court has – one does not treat it the way their Honours treated it and, quite frankly, the way the respondent’s evidence at trial treated it, namely, once I get to Watanabe, that is all the court looks at. It effectively treats that as the only avenue by which the skilled addressee would proceed and they say all we have got to do then is find dosages and that is pretty easy. We have a separate point about that. We say that is not right either. But that seems to be – as a matter of construction ‑ and that seems to derive, as we submit, from the words “must be considered separately” which appear at the end of subsection (2). It appears twice, quite frankly, it says:
whether that knowledge is considered separately or together with either of the kinds of information mentioned in subsection (3), each of which must be considered separately.
Those words were introduced to make sure there is no mosaicking – mosaicking of non‑common general knowledge publications. I will take your Honours to that explanatory memorandum right now if that is convenient. There was an explanatory memorandum to the 1990 Act and it is clause 7 which is of relevance. I should have just added before that that sections 7(2) and 7(3) came into the Act as one of the original provisions of the 1990 Act. That memorandum, or the relevant part of it, picks up clause 7, if your Honours have that “Notes on Individual Clauses” is the heading, and it is really paragraph 14 – 13 is part of the background which really recites the effect of the legislation ‑ and 14:
Information from 2 or more documents or prior uses may be considered together, in assessing either novelty or inventive step, provided that a person skilled in the relevant art would treat them as a single source . . . This avoids the citation of abstruse combinations of documents against an application or patent.
That was against the background where this Court in Minnesota Mining, 3M had made it clear that you cannot mosaic documents which are not part of the common general knowledge.
KIEFEL J: Are you saying that for the purposes of subsection (3) that the person skilled in the art is not to undertake searches?
MR BANNON: No, not at all, what we say is ‑ ‑ ‑
KIEFEL J: I am just having difficulty following what you were saying before. In this case, it was said that the experts – the lipidologists, is that correct?
MR BANNON: Yes, we include those and we accept that.
KIEFEL J: Would undertake searches for the reason that clinical trials were too expensive so they would be looking for publications which indicate a certain level of clinical trials; that is what they are looking for.
MR BANNON: Yes, something which, on the face of it, looked like it had promise, and their evidence was ‑ and if it demonstrated it was a bit more advanced then that might be a more useful thing to pursue.
KIEFEL J: So, the two in particular here, Reece and O’Brien, undertook searches and found the three publications.
MR BANNON: Yes.
KIEFEL J: What do you say is the problem in the approach?
MR BANNON: What we say is the effect of finding an article ‑ and we assume at this point of the argument it is legitimately found, not found by a process which conflicts with the Act ‑ once it is found, the effect of 7(2) and 7(3) is simply to add that piece of information to the prior art base so there is an ascertainment process, and that is fine, but the mere ascertainment does not dictate that you – the skilled addressee will go down that route. All it does is add that as to the prior art base once ‑ ‑ ‑
KIEFEL J: This is where you say a choice has to be made, that is the step that is missing.
MR BANNON: Well, there are two things. One is, once one has that addition to their prior art base, one still has to ask the question with that publication and the other knowledge what would – what it is likely the skilled addressee would do? So, in a sense, the search process – all it does is add it to the prior art base. There is a separate and distinct question as to once you have got it to the prior art base what would you do?
NETTLE J: That is separate and distinct from what question?
MR BANNON: From the ascertainment process.
NETTLE J: Well, we are agreed about that, are we not? It is fair enough that they go and ascertain the documents.
MR BANNON: Yes.
NETTLE J: Then they pick one, you say, add it to the common general knowledge.
MR BANNON: Yes.
NETTLE J: They must make their decision on the basis of that and that alone.
MR BANNON: No. Once it is added to the prior art base, one then asks a separate question, what would the skilled addressee do with the benefit of all that knowledge?
NETTLE J: You say conduct another search which is not enough for obviousness?
MR BANNON: Correct. In other words, their own evidence is ‑ ‑ ‑
NETTLE J: It is not enough.
MR BANNON: Yes. Perhaps putting it another way, they have not proved that if they had what is in their head and a new piece of paper with that, they have not proved what would they do in that circumstance to get to where the Full Court found and the primary judge has found they would have to prove within my head and that piece of information I would not make any search, I would just go forward on that document.
The difficulty with that is (a) they did not prove it, but (b) they positively proved – admittedly for the purposes of ascertainment, they positively proved faced with the problem I would do a search. If one accepts that, we must, we respectfully submit, succeed. We have other ways of getting there but we say that is simply a failure – we say their evidence was basically crafted on the misconception which they advanced and was accepted by the Full Court, namely once you have got that document you just look at that, you do not look at anything else, you do not have to ask a separate question.
KIEFEL J: You say the Full Court and the respondents contend that as soon as a search reveals the additional document, subsections (2) and (3) are satisfied.
MR BANNON: Well, perhaps they say you just simply focus on that point and then ask is it obvious in the light of that document, without considering the general question ‑ ‑ ‑
KIEFEL J: What would the skilled addressee do faced with the document?
MR BANNON: What would they do, what would be their process?
KIEFEL J: How does that reflect as an error in construction? What is it in construction that the Full Court has done?
MR BANNON: They appear to have treated the finding of the article as the direction, or the avenue of research, by which the question of obviousness is to be considered, and as the only avenue of research, rather than ask the question what would a skilled addressee do in this situation when they have simply added a bit to their knowledge? Their own evidence is faced with the problem they would have, as I say, done the search, which is the only sensible thing to do in an area where there is a crowded market, where there are expensive clinical trials.
In a sense, it is a case – it is not like a mechanical case – Lockwood or some other cases – where there is a specific problem which you are trying to solve. It is not an algebra problem or a specific mechanical issue. There is no one single solution. One cannot point and say, I have been trying to work out a way to get that piece of rocket to stick together when it goes into outer space – there is the solution. It is not that at all. This case is one of saying let us find a better statin which does certain things. There is no single answer to that question.
In that environment, on the basis of this evidence, you have to ask the general question once you have added the piece of paper to one’s head – simply, what would you do and their own evidence was, as we say, we still would have – they do not say “still” but they just do not address the question but we know what their general approach was – to do searches. That is problem A.
KIEFEL J: The fact that the statin in question is revealed in the documents is not sufficient for the invention to be obvious. Is that what you are saying?
MR BANNON: Absolutely, yes.
KIEFEL J: Why?
MR BANNON: Well, because it is a method of treatment at a particular dosage.
KIEFEL J: Well, you would add the dosage. That is a separate point but you say that this is a stand‑alone point.
MR BANNON: Yes, because the question is – can I, perhaps, answer this question in a slightly more roundabout way by going to Lockwood and just seeing what the Court said in Lockwood in relation to this. That is Lockwood (No 2) 235 CLR 173. Just by way of somewhat deeper background, in this case their Honours at paragraph 126 refer to:
What is obvious under Australian law is to be determined by the combined operation of ss 7(2), 7(3), 18(1)(b)(ii) . . . These provisions are all directed to determining whether an invention “is to be taken to involve an inventive step when compared with the prior art base” (s 7(2)). Schedule 1 defines “prior art base” and s 7(3) contains the statutory test for enlarging the prior art base beyond common general knowledge.
As stated above, by enlarging the prior art base through including relevant prior disclosures beyond those disclosures proven to be part of the common general knowledge, these provisions raise the threshold for inventiveness. However, the idea remains that the prior disclosures to be taken into account, even as enlarged by s 7(3) are being considered for a particular purpose. That purpose is the purpose of looking forward from the prior art base to see what a person skilled in the relevant art is likely to have done when faced with a similar problem which the patentee claims to have solved with the invention.
So what we say is that is the question which the Full Court did not ask themselves – did not pose. We say on the evidence which they had, the addition of the prior art base, the evidence was that the skilled addressee nevertheless faced with the problem would have undertaken searches because they would have wanted to check, even with the additional document they had, whether that was the best recognising that people did not know at that point that rosuvastatin at 5 to 10 would have all the marvellous benefits that it does. All they would know from reading that is it looked promising. It is likely to treat hypercholesterolemia. It did not disclose the dosages. There is a wide range of dosages. So the question is would a skilled addressee have been directly led in pursuing a new statin, not just looking for that statin, a statin, would they have directly pursued that one.
KIEFEL J: What did the documents teach the skilled addressee?
MR BANNON: In the 471? It taught of the existence of rosuvastatin, it taught that it was beneficial in hypercholesterolemia. It gave a wide range of dosages, but the Full Court found that it was not novelty destroying because it identified trillions of compounds. It did not indicate the dosage for a particular treatment because it said that dosage is dependent upon the particular condition which is being treated. There was no animal safety data in it, so one could not actually sensibly look at it and say I will therefore go five to 10, as opposed to – which might have killed somebody, for all they knew. So it did not as a matter of novelty teach the invention, but it did not predict as the only route down which the skilled addressee would go.
FRENCH CJ: Section 7(3) as discussed in Lockwood (No 2) in the passage you took us to, the discussion relates to the purpose of the provision.
MR BANNON: Yes.
FRENCH CJ: Going back to the words of section 7(2), I am trying to understand how you fit your proposition into the text.
MR BANNON: Yes.
FRENCH CJ: Does it involve a proposition that the question whether or not the invention would have been obvious does not arise until the skilled addressee is asking himself or herself the question, “How do I solve this problem” ‑ ‑ ‑
MR BANNON: Yes.
FRENCH CJ: ‑ ‑ ‑ and that gloss, as it were, imports the notion of a further search. You would not stop at the addition of this particular document to the prior art base?
MR BANNON: What the next question would involve, whether it was a further search or something else, would depend on the facts of the case.
FRENCH CJ: Yes.
MR BANNON: Because there may be cases where the discovery of a particular document, as I say, with the skilled addressee with the common general knowledge and a particular document would be able to say, “That is the solution I have been looking for. I do not need to do any more searching”. But there was no evidence to that effect here in this case and it is not that sort of case the way the evidence pans out anyway. So it will not always be the case, but provided one asks the question, as Lockwood says there, armed with this new information, what is the skilled addressee likely to do, if one asks that question – if one can satisfy that question by saying on evidence I would do nothing more, here is my answer, then yes, it is obvious, provided you can find it is obvious from that document all the integers of the invention.
But if there is no evidence to say what the skilled addressee would do in that situation, well, they have not satisfied the onus – (a). But you have still got to ask the question – but (b), if you ask that question and the only evidence you can see is the skilled addressees who are told when they do seek to solve this problem they do a search, which is in a sense blindingly sensible and obvious, unless they say, “I would not even bother doing my search to find out what else is out there”, and just pause on that thought, if I may – that is to say, “I have found one. I know I can do searches, I know there may be – I do not know there is something out there but there may be. I am going to spend X zillion dollars on the clinical trials. I am not going to search to check that there is not God’s gift to statins just around the corner”. That is a proposition which would require some very specific evidence.
FRENCH CJ: So you say the question of obviousness is not addressed until the skilled addressee has found the best possible indicator of the solution?
MR BANNON: No, we do not go that far.
FRENCH CJ: Yes.
MR BANNON: We simply say it has to be addressed after you have got the addition to the prior art base. You have got to ask the question, and as a matter of evidence one asks what is the skilled addressee likely to do, and we say on the evidence in this case and as a matter of logic in this case, because of the nature of the problem being addressed, they would search. So you could not obviously go down one route without doing a search.
GAGELER J: Mr Bannon, in Apotex’s submissions in paragraph 28, there is a reference to Lockwood (No 2) at paragraph 166 and a formulation of the question as it should have been asked in this case. Is that the question that should have been asked?
MR BANNON: Yes, I am sorry, your Honour, I missed the paragraph?
GAGELER J: Paragraph 28. I think it is the way you put it.
MR BANNON: Yes, yes.
GAGELER J: So that is the question, and your case is simply that the evidence did not address that question?
MR BANNON: Yes, and what we say is the answer to the question:
“Would the notional research group at the relevant date in the light of common general knowledge considered together with either Watanabe or the 471 Patent directly be led as a matter of course to try [that]” –
we say the evidence is, even with that, they still would have done searches.
GAGELER J: So your primary point just turns on the assessment of the evidence.
MR BANNON: Correct.
GAGELER J: It does not seem to be a great point of construction.
MR BANNON: Except that the Full Court has not interposed that question.
GAGELER J: I understand.
MR BANNON: No, we do not say it is – I am not looking to establish a great point of construction ‑ ‑ ‑
GAGELER J: No, no, your case is none the worse for that. I am not suggesting that.
MR BANNON: ‑ ‑ ‑ but other than to say to the extent that the Full Court’s decision is treated as a direction that you do not ask that question and you simply look at the one piece of prior art, in other words you are directed down that route, then it is a very important point of construction. Then perhaps just by way of demonstration, if one continues in Lockwood v Doric at paragraph 150 there is a reference to Firebelt, which is confirming the same point, namely, about halfway through the quote at 150 which comes from the decision of Justice Burchett approved by this Court in Firebelt “must still be able to be said”, it would have been obvious, i.e. something would have to be done. Then in 152, it says:
Given the history, context, purpose . . . in s 7(3) . . . “relevant to work in the relevant art” should not be construed as meaning relevant to any work in the relevant art –
Then over the page, 153:
The question of what a person skilled in the relevant art would regard as relevant, when faced with the same problem as the patentee, is to be determined on the evidence ‑
that is really the point which I have been addressing ‑
The starting point is the subject matter of the invention to be considered together with evidence in respect of prior art, common general knowledge, the way in which the invention is an advance in the art, and any related matters. It should be mentioned that the starting point is not necessarily the inventive step as claimed, or even agreed between parties, because the evidence, particularly in respect of a combination of integers, may support a different inventive step.
Perhaps just lastly at 165 in that judgment their Honours - this Court, I should say - addressed as relevant looking at what actually happened in that case. That was a case where 7(3) was satisfied, namely a new lock, I think it was, was added to the prior art base but nevertheless they still looked at evidence of what actually happened, i.e. did anyone come up with the invention? It is indicative that you look at – all you do is add to the prior art base and you just look at a whole range of relevant factors. One of those we say is, for example, commercial success.
The Full Court dismissed that as irrelevant because it is a wholly notional exercise on the basis that in fact the two identified publications were not part of the common general knowledge so they say, well, how can you say the fact that nobody picked them up and ran with them is an indicator that this was an invention. Well, the answer to that is if you accept that a skilled addressee looking at the problem would have found them, you ask, well, it is accepted they would have found them. It was a known problem. People were trying to solve it. They would have found it. The inference is they did but nobody ran with it, nobody took it any further. That is the approach this Court took in Lockwood.
Then, could I just come forward – there is a new amendment – an amendment to section 7(3) which is not relevant to this case but it took out the search requirement of relevance and it is referred to by our learned friends but it is constructed to look at what the Parliament said in the explanatory memorandum about it. If I could just identify the new section - it is under the Raising the Bar Amendments which was the 2012 Act. I am not sure if your Honours have the amending Act but under Schedule 1, subsection 7(3) repealed 7(3) and added a new 7(3) which removed the need for a requirement that would be found to be relevant. So have your Honours found that? Section 7(3) now as a result of the Raising the Bar Amendment provides that the information is any simple piece of prior art information or a combination of any two or more pieces of prior art.
FRENCH CJ: How is this going to assist us in relation to the existing of - the prior form of section 7(3)?
MR BANNON: Only by looking at the explanatory memorandum.
FRENCH CJ: For what purpose?
MR BANNON: To indicate that the legislature currently has proceeded on the assumption that Lockwood (No 2) was right and the removal of the word “relevance” was not intended – removal of the relevance question was not intended to remove that aspect of relevance which still has to be considered under the general obviousness test. In other words, the purpose of the legislature would be set - which is disclosed in the explanatory memorandum of simply adding documents to the prior art but still preserving that element of the inventive step, i.e. which is effectively what the skilled addressee would have done by would they have considered it relevant enough to be the route to pursue but that purpose would be set at nought if the legislation does not have the construction that it has for which we contend in the current form of – both the current form and the then form of section 7(2).
So, for reasons I have already indicated, what we are putting is not a novel point that is covered in Lockwood but just to confirm that perhaps - I can get on the outer edges, on Grain Elevators, et cetera. But can I just refer briefly to that explanatory memorandum which is the explanatory memorandum for the Raising the Bar Bill 2011 and the relevant part is at page 41, item 3, inventive step, at the bottom of the page. It removes the requirement, it says, for:
‘ascertained, understood and regarded as relevant’-
and it gives some reasons for that. At page 42, under “Secondly”, it says:
while the requirements that prior art be ‘understood’ and ‘regarded as relevant’ are implicit in the pre‑existing tests for inventive step –
That is really the point I wanted to make -
they are currently expressed as a threshold limitation on the prior art base. This complicates the provision unnecessarily, without having any substantial effect on the outcome of the inventive step inquiry.
Then over the page 43, it says, third paragraph:
Importantly, the changes are not intended to substantially change the operation of the existing tests for inventive step as applied to the prior art base or to permit hindsight analysis. While a skilled person is essentially deemed to be aware of and to have carefully read the publically available information, the inventive step tests are otherwise applied in the context of what the skilled person would have known and done . . . The tests will therefore continue to take account of factors such as whether the skilled person would have understood and appreciated the relevance of the prior art . . . would be considered a worthy starting point for further investigation –
So it happily accords with our construction.
FRENCH CJ: You say, do you, that the subsequent amendment to section 7(3) is made upon an assumption about the construction of the pre‑existing form of section 7(3) which accords with your construction?
MR BANNON: Yes, and that the purpose of this amending legislation would be set at nought if it had the effect of removing the requirement that even once you get the document to the prior art base you still have to consider what the skilled addressee would have done, i.e. how relevant they would have considered it.
Could I then go back to the outline, if I may? The point I have just been covering is really points 4 and 5. Can we give a reference to Pfizer – a Full Court decision on which your Honour the Chief Justice sat, a Full Federal Court decision - 285 confirms the same approach. I will not take your Honours to it. Paragraph 6:
The expansion of the prior art based to include “a” relevant document does not permit a conclusion of obviousness based on that document if the skilled person was likely to undertake a literature search –
That is really the point I have already made. I do not need to go back to that. Then -
The words “must be considered separately” in s 7(2) do not direct “a” relevant publication to be treated as the only available course to be pursued -
I think I have addressed that as well. Paragraph 8 is a slightly different point. We say:
A process of satisfying the “regarded as relevant” requirement which involves considering by way of comparison non‑cgk publications subverts the purpose of s 7(3) and is impermissible –
Really to understand this point one needs to – I will take your Honours to the judgment and the evidence.
But that is really saying that 7(3) which permits the adding of one if the way you add one is put together a whole series of non‑ascertainable but non‑CGK publications and saying, well, I am looking at four here, I can see that one seems to be more advanced than that one, more advanced than that one, therefore, on the basis of that comparison the one I choose is relevant ‑ in this case, Watanabe, for example ‑ that is an impermissible process because you are comparing non‑CGK publications and that is not the search. All you can do is go looking for a publication, look at it individually, does it look relevant? Add that to the prior art base, does that make a difference? You look at each one individually. You cannot in the search process, we say, effectively not to mosaic but compare the content of each and use that comparison of found documents to choose your relevance. We say that is not envisaged by the legislation. We say that is an error which happened here which meant the publication should not even have got into section 7(2).
KIEFEL J: Can you use one publication to inform the meaning or content of another?
MR BANNON: No, unless they are internally – if they satisfy 7(3)(b) as it was at the time and, therefore, they are effectively internally related, yes you can. But you cannot to assist in working out whether the publication you look at is relevant. Look at something else which is not part of the CGK but you discover in the search process and say, actually, that one tells me some information, therefore, I conclude looking at the other one that this other one actually is more advanced in clinical trials, for example, and, therefore, it is useful. That is not authorised by the section because the section says you go searching for an individual document and you can add that document but you must look at that document and consider its relevance for what it is worth.
You cannot – if one looks at the background to 3M and the purpose of just adding one document, unless they are interrelated, if one in the search process – used the search process to undertake a comparative process of a whole lot of non‑CGK publications for the purposes of, in effect, determining your selection or the route down which you want to go, that truly does subvert the purpose of the section. We say, that is the second error which is involved here. That step was taken by both experts and they use that illegitimate comparison process to determine the two individual publications were relevant and hence should not have been added to the prior art base.
GAGELER J: This is a complaint about Justice Jessup’s paragraph 530?
MR BANNON: Yes, and we pointed out, I think it is paragraph 525 – I think it is, his Honour virtually says, no disrespect, the opposite. I will come to that. So I think I could skip over 9. Could I just then come to the Full Court approach and the evidence and spend a little bit of time on this? I should have added when I started, your Honours, but I propose to deal with 7(3) and the entitlement issue and I will deal with the other issues as they arise after hearing from my learned friends. So then, addressing firstly under this proposition 10, we put that:
The evidence as to “what a skilled person is likely to have done when faced with” the problem –
that is quoting from Lockwood –
was that such person would identify a single statin by a process of selection ‑
et cetera. So could I then refer to some paragraphs of the Full Court judgment – this is Justice Jessup’s judgment – firstly, then I will go to the evidence. So, starting at paragraph 518 which is in 7, 2585, 518 refers to the two publications, 519 refers to the finding of her Honour to the effect that these publications were legitimately found consistently with the operation of the section, then 522 introduces the nature of the evidence of the experts, and I will come to the actual detail of this, but just to see how their Honours addressed it. The first one was addressing Dr Reece’s evidence as to what question he was posed, and a slightly curious question, but in any event:
You are given a new statin and are told that it is useful –
Then – I will not read it all out – but the last part is “it is important to find dosages”. So, in effect, he is told there is a – you are given a statin, you are actually not told what it is, and there is cross‑examination to the effect it was a bizarre test, et cetera, and it is a black box you do not…..But, having said all that, their Honours addressed that in a couple of ways. Firstly:
But the instructions given to Prof O’Brien set out only so much of this passage as commenced “Despite the benefits . . .”. He was not told that there was “a new statin” . . . Even in the case of Dr Reece ‑
and we accept this –
although he was indeed told that there was a new statin, at the point where he described the searches which he would have undertaken in 1999, the setting was no more, on my reading of it, than that he had an incentive to discover whether there was such a molecule.
I will come to that evidence; it is not of huge compass. Then at 523 in the third sentence his Honour records:
It was submitted on their behalf that an important question arises with respect to the construction of s 7(3), namely, in what factual environment is the skilled person notionally to be placed when one enquires whether he or she “could reasonably be expected” to do the things referred to?
That is, ascertain and regard as relevant:
That environment must, it seems to me, be limited to the common general knowledge. The subsection permits an extension to the common general knowledge only when certain conditions are satisfied. In determining whether those conditions are satisfied in a particular case, it would be circular, and contrary to the scheme of the provision, notionally to provide the skilled person with access to information which was not part of the common general knowledge.
Just pausing there, when his Honour says, and the other members of the court agree, “whether those conditions are satisfied in a particular case” and one of those conditions is regarded as relevant “it would be circular, and contrary to the scheme” to enable the skilled addressee to look at non‑common general knowledge information. With respect, we wholeheartedly agree. But in paragraph 530, as we will come to, we see that the court did the exact opposite because they did permit, and regard as permissible, the searches to use non‑CGK material in other publications to inform their choice of relevance, and we say there is a stark inconsistency with 523 and 530. Yes, I add nothing further.
So then at 525, I only refer to this to emphasise the point. We ran an argument to the effect that the searches undertaken would not have been undertaken. It was rejected, but the vehemence of the rejection is something we now rely upon because towards the bottom of that page, 2587, his Honour says, in effect, Professor O’Brien was in no doubt whatsoever, he would have done these searches. So we are happy to rely on that as the general approach – when I say “happy to rely on it” that was the evidence and it is not really a question of happiness. Then 527 on page 2588, and this is really the second point I had referred to, namely:
It was said . . . that Dr Reece and Prof O’Brien “combined information they found in multiple sources”, and that s 7(3) “made no provision for multiple sources to be combined –
And it is here that his Honour addresses the evidence:
Dr Reece described the means by which, using only information that was available before the priority date, he searched for published articles which had the potential to provide information about a new statin which had the characteristics referred to in his instructions. He reached the point where he had 19 abstracts that appeared to fall within his terms of reference, and he obtained the articles concerned. Having reviewed those articles, he concluded that only three were relevant to the terms of reference. The lead authors of those articles were Aoki, Watanabe and Thompson ‑
As we will see in his evidence, he does it by way of comparison, the content of the different articles ‑
The Aoki article referred to an HMG‑CoA reductase inhibitor referred to as NK‑104.
Just pausing there, that became a product later, pitavastatin, which was produced but the evidence suggests it just did not perform – did not fulfil the gap in the market that was needed. It was a relative failure. It says:
The Watanabe article contained a report on a series of compounds, including one described as S‑4522 (which was rosuvastatin), which Dr Reece recognised as “a very potent inhibitor of cholesterol biosynthesis”, and as “definitely a candidate for further development”. The Thompson article referred to a number of “the more promising looking compounds in the pipeline” –
Then 529:
So far as the endeavours of Dr Reece were concerned, the respondents relied on the Watanabe article as satisfying the requirements of para (a) of s 7(3). It was the article with respect to which Dr Reece was asked to continue his work, once he had located the three articles –
That is an accurate reflection that Dr Reece did not say if I had this, I would have done something. As his Honour correctly records, he was asked to continue the work down that route:
However, part of Dr Reece’s assessment of the relevance of the article was his assumption that the unknown compound for the characteristics of which he was searching was at the stage of Phase II trials at least. The Watanabe article informed him that S‑4522 was in clinical trials . . . But it was the Thompson article which told him that S‑4522 was in Phase II trials.
So, that was mosaicking information from two non‑common general knowledge which informed his conclusion as to relevance and, we say, that is impermissible. Then it is paragraph 530:
the appellants’ submission proceeds from a misreading of s 7(3) –
and really in the middle of that paragraph about point 4 ‑
It is, in my view, wholly within the scheme of the subsection that he or she might well sort through all manner of information with a view to finding something that is “regarded as relevant”. There is nothing in the provision which would place an embargo upon the skilled person using combinations of sources of information along the road to that destination . . . the skilled person will commence with the common general knowledge, but, beyond that, the only requirement is that the information is within what he or she “could be reasonably expected to have ascertained [etc]”. Ultimately, of course, there must be one document (or act) only which imparts the information . . . But the sources which the skilled person would consult to decide what that document is, to come to an understanding of the information in it and to consider whether that information was relevant, are not confined to a single document.
We do not cavil completely with that paragraph. We cavil relevantly with that paragraph. In other words, we accept, as one rationally must, that you can undertake a search and a search, for example, by computer, will produce an output of results and that output of results, one may accept, is something which never existed in the common general knowledge. One may accept that. So, there is something which one will recognise at the process of ascertainment, will involve looking at some things which are not in common general knowledge. But, what we cavil with is what happened here, we submit, is you get, in effect, endpoint documents, be it an abstract or a complete publication, and you use – you put them side by side and you compare them in the non‑common general knowledge world because neither of them is common general knowledge and use that comparison and say, I pick this one.
Then, the revoker comes along and says that is the route you should go down and we get into this squeeze play – in fact, the revoker gets to choose the starting point, gives the one which is good because they know where El Dorado is. They say, here is El Dorado, look at that, what would you do with that? We do not get the benefit of the comparison process which would happen in the world if all of these articles were part of the common general knowledge because, we say, if they were all part of the common general knowledge, if you had all the possible choices, you would not prove obviousness because it is not obvious to go down one versus another.
FRENCH CJ: Can I just come back to the text for a moment, and no doubt you will take me back to Lockwood.
MR BANNON: Yes.
FRENCH CJ: But just going back to the end of subsection (3) and reading it with (2), why does it not answer the requirements of the text that you find a skilled addressee, you present them with an article. You ask two questions. First of all, would you expect to have:
ascertained, understood and regarded [this article] as relevant to work in the relevant art in the patent area.
MR BANNON: Yes.
FRENCH CJ: If so, would the invention have been obvious to you?
MR BANNON: You ask, was it obvious ‑ ‑ ‑
FRENCH CJ: You ask, first of all, whether it meets the requirement ‑ ‑ ‑
MR BANNON: Yes.
FRENCH CJ: ‑ ‑ ‑in the latter part of the class of information referred to in (3). Assume it is (3)(a) and you ask the person whether it is something that they will have “ascertained, understood and regarded as relevant”.
MR BANNON: Yes.
FRENCH CJ: They say yes to that question, and then you ask, is this invention obvious in the light of that information and common general knowledge?
MR BANNON: We do not have a problem with that, with respect, but ‑ ‑ ‑
FRENCH CJ: In other words, they are not asked to do any searches, they are just given the document.
MR BANNON: No, what they are asked is – what the question they are asked is, with common general knowledge and assume you know everything you know anyway – or knew everything ‑ ‑ ‑
FRENCH CJ: Yes.
MR BANNON: ‑ ‑ ‑and assume you also know this. Was the invention we claimed obvious in the light of that? The question, we say, is not framed as, look at that in the light of that is it obvious? The question is framed as, with your wider art base, is the invention as claimed, obvious? We simply say the test is you ask, against that background, without focusing on one particular publication – without teasing out of the common general knowledge one particular publication. You simply ask, what would the skilled addressee have done? Was it obvious for them to be directly led against that background to go down one particular route and, if so, what route to get to the invention? It is an evidentiary question and if the evidence is that the skilled addressee would have undertaken searches – even with the additional information – to see what is out there, then you simply cannot. If that is the evidence – and it will not be the evidence in every case – but if that is the evidence and that is the evidence here, you simply cannot move directly to a focused consideration of that article.
KEANE J: So, are you saying the process of ascertaining – reasonably ascertaining, understanding and so forth – stops with the results of the first search?
MR BANNON: In terms of – no. If the first search produces a thousand documents, I think the evidence shows – as we will come to, the evidence shows that they did another word search to say, well, let us reduce that, that is too many to look at. Let us reduce that down to – I think they use a novel compound as another search limiter and that produced another series of documents. We do not have any difficulty with that.
We say that is permissible. But one can then find from that search process ‑ say it is 19 abstracts as in the case of Dr Reece, one can go to each one of those, the skilled addressee, and say, “I found that, do I regard it as relevant?” looking at that document on its own. If you want to add that to the…..then you ask the obviousness question. But what is impermissible, we submit, having got the 19 abstracts, is to use a comparison process between the 19 to identify the relevant one by a comparison process. What the evidence discloses here in the case of Dr Reece, he thought one was relevant because he compared, looking at a series of them, the state of play that each one was comparatively. It is a comparative process.
GAGELER J: What is the question of relevance? The statutory text refers to a document that is understood as relevant to work in the relevant art.
MR BANNON: Yes.
GAGELER J: The sense in which you seem to be using the word “relevant” is relevant to solving the problem that is solved by this invention.
MR BANNON: Yes.
GAGELER J: Is that the way we are meant to read it?
MR BANNON: Well, I think in Lockwood that there was that discussion. I cannot remember if I took the Court to that paragraph. It is paragraph 152 ‑ so that is 235 CLR ‑ and then over the page at 153, so it is relevant to the general nature of the problem.
GAGELER J: Thank you.
MR BANNON: That just avoids in that case dragging in everything from everywhere really. But now under the current Act you do not have that problem, they can just drag in anything, but you simply ask the question. But perhaps a more precise answer to your Honour Justice Keane’s question would be better answered just if I will identify during the course of the evidence where we say that the comparison process was illegitimate.
KEANE J: Yes. I mean, the real question that you are agitating is really a question of fact, is it not, not a question of construction.
MR BANNON: Yes, informed by a question of construction in the sense that we say the Full Court in two respects erred in construction. One is by permitting a comparison process. Paragraph 530 specifically says you can compare documents, contrary to 523, and what we say is the correct approach. So we say that is an element of construction. But yes, we have to satisfy this Court that ‑ ‑ ‑
KEANE J: His Honour is not saying there is a process of comparison rather than a process of sorting through. You are not looking at – just looking at paragraph 530, he is not saying you would use documents one to inform the other when they have separate provenances. You just sort through them and you take one – having sorted through them, you look at one and say, well, this teaches me how to solve the problem, because he says in the end you have to have “one document” that teaches you that.
MR BANNON: But I think it is the line:
There is nothing in the provision which would place an embargo upon the skilled person using combinations of sources of information along the road to that destination.
KEANE J: But that is on the road to having a document that answers the 7(3) description. That is all just about the process of reasonable ascertainment.
MR BANNON: Yes, but if the documents you are combining are really endpoint documents – in this case it is abstracts or papers, each of which is a work you cannot – that sentence authorises and it is consistent with the facts as to what the experts did.
KEANE J: So in terms of what is work in the relevant art, you exclude endpoint documents.
MR BANNON: No, one can pick up any endpoint document and add it individually to the prior art, but what you cannot do is get a series of – it is my expression “endpoint documents”, it is probably not a very precise one ‑ ‑ ‑
KEANE J: Well, it is not an expression used in the statute.
MR BANNON: No, exactly, it is a piece of prior art. But one cannot identify by the search process individual ascertainable pieces of information and combine those pieces of information to inform a decision about one of them. That is the point of construction we say is that permissible under the Act, and we say on its face it is not expressly authorised, but if one gives a consideration of what the import of that is it means in the search process you can mosaic to inform the choice a series of non‑common general knowledge publications which can be only found by search process in circumstances where the point of the Act was really just to throw in by reasonable search or inquiry one document.
KIEFEL J: But a choice requires comparison, does it not?
MR BANNON: A choice requires ‑ ‑ ‑
KIEFEL J: For selection, for selection you compare and discard.
MR BANNON: With respect, no, because we say you can look at each one as relevant. It is a curious test and sets a limitation on – it is a very limited advance on ‑ ‑ ‑
KIEFEL J: Something almost unworkable.
MR BANNON: Well, each of these experts could have done it in a particular way. They could have done their search and said, well, here are 1,000 aspects. That is too many, I will narrow my search. They could pick up each one individually and say is this relevant, and if it is relevant it just gets out of the prior art and one asks the question. They go back to another one - that is number one. They go through one through to 19, they can ask the question individually, is it relevant.
But what they cannot do is put them together and say, having regard to that combination of information I see in all of them, I determine number eight is relevant because I am told about number eight by a bit of information I found about number one which I did not know and/or the combination of the comparison tells me that this one is relevant versus something else.
NETTLE J: Can I just ask a basic question? If the search threw up two documents only, let us say document one disclosed elements A and B of whatever it was and document two disclosed elements A, B and C, would it be permissible for the expert to say I prefer C as my 7(3) document, that is the one that I want because it gives me all of the elements, rather than just two out of three?
MR BANNON: It would be permissible to draw a conclusion that each one was relevant and then the test would be, putatively, with common general knowledge and document one, which is A and B.
NETTLE J: Yes.
MR BANNON: What would you do in those circumstances - depends on the evidence. One may say I go down the A and B document or I may not. Or I may do a further search. That is question one. Question two is, I now look at it with A, B and C because it is a document I found, I regard it as relevant.
NETTLE J: Yes.
MR BANNON: I add that to the common general knowledge. The court then asks the question of what would the skilled addressee do in those circumstances and it may be, if there is evidence to support it, if I have A, B and C, that is what I am looking for. I am looking for A, B and C. I do not have to do anything more. I would not do any search. But what you cannot do is, we say ‑ ‑ ‑
NETTLE J: I will have a bit out of this one and a bit out of that one, put them together and that is good enough for me.
MR BANNON: Yes, or I am looking at A, B and C and I am not sure whether that really helps me or not, but I look in the second document and that is obviously talking about the same compound and that tells me they are actually into phase II clinical trials ‑ ‑ ‑
NETTLE J: That is Thompson ‑ ‑ ‑
MR BANNON: ‑ ‑ ‑ so I will come back to document two, so that actually – I like that now because I have learnt that when that gives me that unclear piece of information I have discovered what that is by looking at something else.
NETTLE J: Thank you.
MR BANNON: We say you cannot do that.
KIEFEL J: Your essential point, is it not, is that each of the skilled addressees here did not answer the statutory question. They did not come to the final answer.
MR BANNON: Yes.
KIEFEL J: So if that is the case, do we not go and see if that is correct in the evidence?
MR BANNON: Yes.
KIEFEL J: Does it not mean that the comparison does not matter?
MR BANNON: Well, that is right ‑ ‑ ‑
KIEFEL J: The method they undertook does not really matter. They have not answered the question.
MR BANNON: We have two points – one is, assuming they are legitimately before them, the ultimate question was unanswered. But we also have a probably logically anterior point. The documents were not legitimately before them because of the comparison.
KIEFEL J: But it is not anterior to an answer.
MR BANNON: Perhaps that is so, yes.
KIEFEL J: It is a little arid.
MR BANNON: I am sorry?
KIEFEL J: It is a little dry.
MR BANNON: Yes, potentially, I am sorry.
GAGELER J: Just so I understand the scope of that dry point, is it solely focused on the way in which Dr Reece dealt with the Thompson article? Does it go beyond that?
MR BANNON: Also Professor O’Brien - we have aspects of Professor O’Brien as well.
GAGELER J: I see.
NETTLE J: How did he combine them?
MR BANNON: He made a comparison between Aoki and 471, or Watanabe and said I am looking at these two. I like one versus another.
NETTLE J: That is back to the documents one and two, A, B and C, is it not?
MR BANNON: Yes.
NETTLE J: I thought I understood you to say that he was entitled to go ask the first question, say no, that is not enough and then put the second one singularly and say, yes, that is enough.
MR BANNON: Yes.
NETTLE J: Did O’Brien do any more than that?
MR BANNON: Could I answer that by reference to the evidence as I go through because I think there is one part where he does do more than that but I accept that that is all he does and that is not admission.
GAGELER J: So are we back to Reece and Thompson?
MR BANNON: Reece and Thompson - can I just, as I go through the evidence ‑ ‑ ‑
NETTLE J: Reserve O’Brien.
MR BANNON: Reserve O’Brien because I think there is another point to come. But just completing the discussion in the judgment, I think I got up to paragraph 530 and that is the reference to Professor O’Brien which your Honour Justice Nettle has raised. Then paragraph 534 is, I think, the matter which was raised by one of your Honours as to the way in which the trial judge dealt with it. Let me come back to 536, which I have already taken your Honours to, which we say does not answer the correct question.
So against that background as quickly ‑ as efficiently as I can, I should say, just deal with Dr Reece’s evidence and if I can invite your Honours to go to appeal book 3. At page 955 in paragraph 112 is the passage which was recited by Justice Jessup. It starts with “You are given a new statin”. In paragraph 113 he refers to that as “the Passage”. I then go to 965 in the appeal book and at paragraph 148 - this is the part to which Justice Jessup was referring - in the second sentence his Honour says:
Freehills asked me to describe how I would conduct a search for information on the new statin given only the information I have been provided in the Passage.
So this is his search process. Paragraph 149 he identifies a MEDLINE search. Then, 151, he says that he actually did it and at 152 produced 4,500 results - looking at the middle of that paragraph about point 40 in the book. Then he would narrow those searches down – at 154 to 156. At 159 he says:
This left me with 19 abstracts that I considered to fall within the terms of reference and for which a review of the full article was warranted so that I could determine if it was relevant to the Passage. Annexed to this affidavit . . . is a copy of each of these 19 abstracts . . . One of these abstracts also contain blue highlighting by me to signify that the reported result of relative potency in that abstract stood out from all the other abstracts.
We say that is involved in a comparison of information to determine relevance. That is information which he does not have so he can go to one and say is this relevant. But he did not. He says I look at all of them and this one stands out by comparison to others and we just say that is an illegitimate process.
NETTLE J: But is that different to the A, B plays A, B, C?
MR BANNON: Yes, because in A, B you can come to the conclusion that A, B, and C are relevant and independently of looking at A and B. You can look at A and B and say, well, I think that is relevant too. He does not do that. He makes his choice of relevance based on a comparison. He says I think this is relevant because it is more advanced or whatever. In other words, he does not do what is required. He does not look at, for example, a document so that is relevant to my work in the art, looking at it individually. He looks at it by a series of – we do not have the detail of it – but comparing one against the other. That is a selection process based on putting things side by side.
NETTLE J: But in the end the document that he picks, at least for the purpose of this paragraph 159, has all of the information in it, of which some of which is contained in the other document, does it not?
MR BANNON: We do not know what is in the other documents which he ‑ ‑ ‑
NETTLE J: To make good your point, you would have to show that the document which he selects as a result of this selection process does not have within it that which he takes from the other document in order to inform his decision to select this one.
MR BANNON: We say no because if the only way he can determine relevance – the section contemplates individual documents will be relevant. If you cannot determine relevance other than by a comparison process, we say that is an impermissible way to do it whether it involves informing information – sorry, providing extra information from one to the other or not. If you cannot determine that a document is relevant just by looking at it by some other process of comparison we say that does not satisfy the test.
KIEFEL J: What you are saying is that the document – the information in the document to which subsection (3) refers has to be self‑contained.
MR BANNON: Yes, absolutely, and considered in a self‑contained way for the purpose of determining its relevance.
GAGELER J: Are you asking us to draw some inference of fact from the last sentence of paragraph 159 and, if so, what is it?
MR BANNON: Well, I asked him a question about it as well in cross‑examination. But we say the inference is that that is a comparison process but I do specifically ask it in cross‑examination which I will come to. We rely on that in combination with the answer he gave in cross‑examination. We do say that that is – it is an inference. We say that is the comparison:
that abstracts also contains blue highlighting by me to signify that the reported results . . . stood out from all the other abstracts.
It is those words. We say that is a comparison process.
GAGELER J: In terms of relevance. He saw them as more relevant than other documents. Is that the way we are to read it?
MR BANNON: We say it stood out on the basis of the comparison, that he did not seem to be able to determine its relevance individually.
KEANE J: But if you are looking for – if one of the things you are looking for to solve your problem is potency, which I take it equals efficacy ‑ ‑ ‑
MR BANNON: Yes, or it can be, yes.
KEANE J: ‑ ‑ ‑ and you sort through a number of documents with different levels of potency, why would you not then be entitled to say, here is the document which establishes – which answers my problem in terms of efficacy? This is the document that answers that problem. I have looked through a whole lot of pieces of information one by one, and having looked at them one by one, this one gives me the answer to my problem.
MR BANNON: I accept that approach, yes, one can do that. I do not dispute that. As long as one is looking at it one by one rather than a comparison process.
KEANE J: But is he saying any more than that he did that?
MR BANNON: Well, we rely on that, and I will take your Honours to the cross‑examination as well. Then over the page, page 968, 163 and 164, could I just invite your Honours to read those paragraphs. Again, I accept what your Honour Justice Keane – perhaps Justice Nettle too have put to me that that may not be sufficient to characterise an illegitimate comparison process, but then at 165 he identifies the three articles which are of particular interest, and Aoki is the one which identifies NK‑104 and Watanabe and Thompson. So just pausing there, he has got the three articles. Then he says at 167:
After forming the views described above, I was asked by Freehills to describe what Watanabe would have told me –
Then he explains what it tells him. At 175 he says:
I was asked by Freehills whether, if the new statin referred to in the Passage was S‑4522, reading Watanabe in February 1999 would have impacted on –
So that is not an example of answering the relevant question. The relevant question is, assuming I have legitimately got that and added it to the prior art base, what I have done in those circumstances. He just does not address that question. Then, at 195 – sorry, at 177, I should have added, he identifies the fact that he was provided with EP 471. That is because he did not find 471, but Professor O’Brien did, so the fact that he was provided with it is not any matter of criticism. One then goes to 195. The question is put:
I was asked by Freehills whether, if the new statin referred to in the Passage was compound –
et cetera, what would I have done. So, that evidence reflects what Justice Jessup said about Dr Reece. He was directed to work down a particular route. So there is no evidence from this expert saying, having got either of these – and let us assume, legitimately, he does not actually say with this information and common general knowledge this is what I would have done to solve the problem.
If I could then take you to a couple of passages in his cross‑examination, firstly at volume 2 of the appeal book at page 557 at point 50 on the book, line 45 of the transcript. That is the cross‑referencing evidence which has been referred to. That is down to line 30 on the next page. Also at 557 at line - top of the page asking about the search process which starts at paragraph 4147 - it is the answer at line 30:
And you took all that information into account in coming up with your conclusion that three were relevant.
What we say is that is the comparison process…..asked him – line 40 down to about 44 in particular. Then Professor O’Brien in volume 1 of the appeal book – I am terribly sorry, your Honours, I said volume 1; it is volume 4 at page 1325. So he says, again like Dr Reece as we saw, he said he would have conducted searches. This is a slightly clearer assessment of the problem because Dr Reece was a little bit muddied by that reference to “you are told there is a new statin”.
The identification of the problem as identified is at 1353 which I think both the primary judge and the Full Court considered a reasonable encapsulation of the problem and we do not say otherwise. So if one comes back to 1325, his approach in addressing that problem was to do searches. Then at 13, point 9 on page 1326 he says:
I would need to identify a statin that would lower LDL‑C.
At 13.10:
My first step to solving the problem would be to identify an alternative statin.
At 13.11:
I would start with a review of the literature.
On page 1327 at 13.14 he says:
If I was not given the problem in the context of a clinical trial –
which was not the case –
I would conduct a search –
Then at 13.24 on page 1328 he sets out the results of the search. At 13.31 on page 1329 he identifies the Aoki article and describes it as “a promising compound” if it was to be pursued. At 13.32 he refers to S‑4522. Then over to the top of the next page he says:
From the statements in the Aoki Article and the Watanabe Article, it appears that S‑4522 is further along the line of development than NK‑104. I therefore consider that in answering the First Problem I would regard S‑4522 as the most relevant compound identified although NK‑104 may also solve the problem.
NETTLE J: Do you say there is anything wrong with that, the 13.32?
MR BANNON: To the extent that he is using as a – to the extent that evidence is relied upon by the court to say that Professor O’Brien would have gone down one route, that is an impermissible conclusion because he is comparing two prior – that decision is based on comparing two prior art works which are not part of the general common knowledge. If he had said, I look at NK - Aoki and I add that with common general knowledge, if you had told me I had given that, what would I do, if he had said I would not go down the literature search again I would be satisfied that – I would pursue Aoki and that would be one thing. Obviously, they would not win.
But if he had said having got 4522, again, that is an individual, I add that to the common general knowledge, what would I do in those circumstances, I would go down 4522. I would not do the searches. That would be one thing we would lose on my analysis. He does not do either of that but he just says – and we know that he says he always does searches. He makes a comparison between two non‑CGK documents and says – to the extent he does say it if I go down the 4522 route, he makes a decision based on two non‑CGK publications and you cannot do that against the patentee because if that is not permitted by the section, firstly, it does not answer the statutory ‑ ‑ ‑
KEANE J: Why does he not just say that one gives him the answer?
MR BANNON: I am sorry?
KEANE J: One gives him the answer, the other does not.
MR BANNON: He does not say that.
KEANE J: But if he is looking for a compound that looks like it is safe, is not the obvious conclusion to go with the one that has been the subject of trials rather than the one that has not? I mean, you are sorting through them. He has all these things on his desk. He sorts through them. He is looking for something that tells him the answer and he puts to one side the ones that do not tell him the answer.
MR BANNON: As constrained as it may be, the way the Act works is he has to ask the question of – with 4522 he may say that is relevant, I will look at it. He has 4522 and he has common general knowledge. Armed with that, what would I do? He does not – in that notional world he does not know about Aoki, he cannot know about Aoki as part of the statutory test because it is not part of the common general knowledge.
NETTLE J: He really is combining things there, is he not? This is not just along the route to identifying the document. This is putting two together.
MR BANNON: Yes, and see, that is what ‑ ‑ ‑
KEANE J: Why is he not just engaged in a process of ascertainment and the question is could he reasonably be expected to ascertain this document?
MR BANNON: Again, we do not have a difficulty – we do not submit anything to the contrary. He can ascertain 4522 but what he has to do – when I say “he” those leading evidence from him, has to then say, Professor, I want you to assume you have only got 4522, I want you to assume you have got common general knowledge. You have no other knowledge. In particular, you do not have knowledge of something which is not in common general knowledge, namely that Aoki is not as far down the line, you do not have the knowledge. That is not in your head and there is no statutory licence to put it into your head.
Equally, you do not have knowledge that there is nothing else out there. You do not have that knowledge either. What you do have knowledge of is, as you say, you can do routine searches. You have that knowledge and you have the knowledge that if you are going to spend your own money, or somebody’s money, you would normally do routine searches to make sure that there is nothing else out there.
KIEFEL J: But is not the critical question to ask whether, given 4522, does this answer the question?
MR BANNON: As long as you ask it in the right way, yes, your Honour, I agree.
KIEFEL J: Well, how do you pose the question, and was an answer given to it is really what I would like to know?
MR BANNON: No, we would submit, no.
KIEFEL J: Is this as far as the expert goes?
MR BANNON: Yes.
KIEFEL J: Professor O’Brien. Do you say the answer given here by Professor O’Brien, relevantly, is this looks more interesting to pursue?
MR BANNON: That is right.
KIEFEL J: Is that the highest you would put it?
MR BANNON: No, I think in fairness to Professor O’Brien, he does select 4522 over Aoki but based on a comparison between the two.
KIEFEL J: He selects it as what – as worthy of further inquiry or answering the problem? How high do you pitch his answer in fairness? How high does it go?
MR BANNON: I think he probably does say that, based on the comparison – and it may be that I cross‑examined him into it, as I will come to – but I think he based it on the comparison he chooses – I think it is fair to say he probably chooses one.
NETTLE J: Chooses one as to the solution to the problem.
MR BANNON: I think so, yes.
KIEFEL J: Well, where does that appear?
MR BANNON: Probably 13.34. I am not sure he actually goes that far because ‑ ‑ ‑
KIEFEL J: Well, it is kind of important, is it not?
MR BANNON: It is important. I agree, your Honour. Hopefully, I have not cross‑examined him into it.
KIEFEL J: That is what evidence is for.
MR BANNON: Yes. But, the point we make is, what that is not evidence of – I am like a broken record, I know, perhaps not for the first time – what it is not evidence of is to say, have I got Watanabe and I put everything else out of my mind. If you ask me the question, how would I solve this problem – bear in mind, this is just in the process of ascertainment. That is all this is so far. Bear in mind that. Once you have got that in your head, what would you do if you know that and nothing else?
He has not asked that question which is the only relevant question and if he had said that – if I had that and nothing else and I had not done searches, I just had common general knowledge, if you asked me what would I have done to solve that problem, if I had said I will go down Watanabe, that is what I would do. Fine, we lose. He does not even address that question. On the contrary, we say, the inference is when he very firmly said, in solving this problem I would go down searches, is that assuming he has got Watanabe – and that is all he has got ‑ assume he has got common general knowledge – that is all he has got ‑ he would do what he would always do, double‑check.
KIEFEL J: But you accept that he accepts – he selects 4522?
MR BANNON: On an illegitimate basis, only because of a comparison.
KIEFEL J: I think that is an answer.
MR BANNON: Yes.
KEANE J: The problem that is at 1353 ‑ ‑ ‑
MR BANNON: Yes.
KEANE J: ‑ ‑ ‑is framed in terms where the second sentence – or the last sentence says:
Accordingly, it is important to find dosages of alternative statins which beneficially alter lipid levels to a significantly greater extent than similar dosages of currently used statins –
So, you are looking for, at least, a more potent statin.
MR BANNON: Safe and potent, yes. I accept that, your Honour, yes.
KEANE J: Put safety to one side because all that he is really talking about – or maybe not. But he is certainly talking about in 13.34, he is talking about S‑4522 as being “more than three times as effective as pravastatin”.
MR BANNON: Yes, just picking up on perhaps your Honour’s pause, he does say that:
Accordingly, it is important to find dosages of alternative statins which beneficially alter lipid levels –
The word “beneficially” inevitably characterise something which does not kill you in the process of reducing your lipid levels.
KEANE J: So if he is looking for something that is potent, he sorts through pieces of information about different potencies and he gets one document that says this is potent and he knows from looking at the others that it is the most potent, why can he not say that document solves my problem?
MR BANNON: Because – and perhaps your Honour’s question encapsulates our point, if I may say so. He cannot know that it is the most relevant because he only knows that by non‑common general knowledge information. That is the importance of 7(2) and 7(3).
KIEFEL J: You mean he is led to the answer by the other information.
MR BANNON: Well, there are three pieces of information ‑ ‑ ‑
KIEFEL J: It confirms it, it confirms ‑ ‑ ‑
MR BANNON: There are three pieces of information in his Honour Justice Keane’s question. One is assuming common general knowledge, two is what the benefits are 4522, but three and critically, he knows that there is nothing else out there. That knowledge that there is nothing else out there is only achieved by searching and looking at non‑common general knowledge documents and that is not part of the common general knowledge, and it does not constitute a single publication which is added to the common general knowledge. It is whether it is 19 or four or it only has to be one more.
KIEFEL J: So you say that inevitably without the other prior art information which is being utilised in the comparison, the only step that he would have taken at that point would be to say I will have to do further tests.
MR BANNON: He does not give any evidence as to what he would do, but the inference – (a) there is no evidence to positively support it, but (b) based on his evidence that that is his normal approach, that is what you would expect him to do, more searches.
KEANE J: Well, if you expect him to do further searches, he goes searching for something that is a more potent ‑ some document which shows him a more potent statin, and by definition he does not find one, or by ex hypothesi he cannot find one because he has found the one that shows the most potent. So further searching is just going to leave him with the document that he has found, and that gives him the answer.
MR BANNON: But you cannot ask that extra question, because that is assuming – presuming the knowledge he would acquire if he did something which is not authorised by the statute.
KEANE J: The statute – (3) is not talking about – it is not telling people that they have this artificially constrained process of ascertainment. The only constraint on the process of ascertainment of a document is that it be reasonably be expected to have been ascertained and understood.
MR BANNON: Yes, and relevant.
KEANE J: And relevant. There is not this – insofar as that process of ascertainment is concerned, this artificial sort of just look at one document process ‑ ‑ ‑
MR BANNON: It is as artificial as that.
KEANE J: It is as artificial as that. This is a good thing, is it?
MR BANNON: Absolutely because – it was designed to expand the prior art base but only in a limited way. There are many things impermissible in what I am about to say, but if one jumps forward to the current Act, and we have seen the explanatory memorandum, you do not have to do the search process, you just provide the additional document and that is meant to make the addition to the prior art base easier and it does because you do not have to show your…..you just pull it in. Nothing could be plainer in that circumstance than you have got common general knowledge and one document. You cannot add to that process knowledge you would get to search to find out there is a fact, i.e. there is nothing better out there.
Now, that Act was not changing the world in this respect and equally you come back to the current – the Act we are dealing with, the only point of the relevance exercise is to get a document, if you do it properly to get a document into it. You cannot get anything else into it. You cannot get knowledge of comparison. You cannot get knowledge there is nothing else out there because neither of those things are part of the common general knowledge. You only get the information in the document. One may accept that there are things you will go through to find a document which are like total searches which are part of the common general knowledge, but you cannot – odd ‑ it is not really odd, it is just what the statute is saying. You can only use the information what is in the document you find, not what you have learnt en route.
FRENCH CJ: If one expert had done the searches and come up with Watanabe and 471 and so forth and the solicitors could have instructed another expert and said, given common general knowledge and this document ‑ ‑ ‑
MR BANNON: That is a better way of doing it. What would you have done?
FRENCH CJ: Well, would it have been obvious then?
MR BANNON: That would be the interesting question. That would focus the minds of those preparing the evidence of what the real question is. What would you have done searching for the problem, assuming you have got common general knowledge and this document? There is no evidence to support what they would have done but what the clear inference is they would have done what they say they do every time they are facing a problem like this and gauge it, literature searches, even if to make sure there is nothing else out there.
GAGELER J: So here where Professor O’Brien has the heading “Solving the problem based on Watanabe” that is an incomplete statement of what occurs in the following paragraphs, is it?
MR BANNON: Yes, and just to complete Professor ‑ ‑ ‑
KIEFEL J: What about the finding of the dosages – did the information lead them to the dosages which are part of the claim?
MR BANNON: I am going to deal with that specifically in point 14. There is a finding against us on that but we say that is incorrect. Of course, paragraph 536 of the Full Court’s reasons ‑ Justice Jessup, I should say – makes the point – one of the points we said, it is unfair, we should at least have in the contest a comparison of 4522 against NK‑104, which even Professor O’Brien said you could reasonably choose one or the other, and the Full Court said, no, you cannot do that because you only discovered 104 as part of your searches. It requires you to look at one document. That paragraph is partly right. It supports that you cannot look at what is part of the searches if it is not part of the common general knowledge. We say they take it too far to say, well, you definitely go down that route.
So then just lastly on Professor O’Brien is the transcript at volume 1, page 418 at the bottom of page, part 50 at line 45, and there is a series of questions which start there. In effect, it is put to him and he agrees that his process was made by “a comparison”. And at the bottom of page 419, just on the particular choice, he says he could not say that somebody reasonably may not go for NK‑104 rather than the other one.
Now, our learned friends say, well, we cannot have NK‑104 in the choice because that is not part of common general knowledge. They are right. But equally he cannot make the choice of solving the problem based on that choice either. But what we do point out is that this shows that the unfairness – or this shows an outcome of the legislation, if it is as the Full Court found, that the patentee would be better off if all of these things were common general knowledge, if NK‑104 was there and the other one was there, because we would be able to say the skilled addressee would have to choose between the two and you could not say which way they would go. So we accept we do not have that benefit.
But a fortiori the legislation is not designed to give them some extraordinary benefit. When I say “them” – I should not say “them” – the revoker some benefit which says the revoker can come along and pick up one document which it knows is the route home, on the assumption it can be ascertained, and direct attention only at that without asking the relevant general question.
So then coming back to the outline, I think propositions 11, 12 and 13 are all covered by what I have said in various ways. Could I deal with this ‑ perhaps a discrete issue, but what we say in relation to this is that the – and this is paragraph 547 of the Full Court judgment, if I could just go to that, which is volume 7. At paragraph 547 ‑ ‑ ‑
FRENCH CJ: Sorry, page?
MR BANNON: Page 2595. In the second sentence, his Honour says:
For an invention to be obvious, it is not necessary that the single source of information admitted under s 7(3) disclose a completed invention to the extent that the notional skilled person would have little or nothing further to do. That he or she would need to work towards the invention is not inconsistent with the conclusion that the invention was obvious, in the sense of falling within the range of destinations that he or she would expect to reach after the investigations, tests, trials and the like that would be carried out as a matter of course.
We say that does not satisfy the directly led as a matter of course to the invention which is 5 to 10. But it seems to have been influenced by this single avenue approach. His Honour continues:
The evidence upon which the appellants relied in support of this submission – wholly that of Dr Reece – did make it apparent that neither the Watanabe article nor the 471 patent contained safety data the result of either animal or human trials. But that evidence also made it quite clear that such trials would conventionally be carried out.
Just pausing there – that is, you do not have the critical animal safety data ‑ and I will take a couple of passages of evidence – therefore, you cannot predict and say what the human dosage will be. But his Honour says, well, you can carry out those tests. That is, you have to carry out animal data tests, find out what the answer is, find out what the range is and then select the dosage. That is not being directly led from the document to 5 to 10 milligram treatment of hypercholesterolemia. His Honour says:
They would fall within the concept of working towards the invention with an expectation of success –
We respectfully submit, no, that would involve doing experimentation which may or may not produce the outcome you expect. Then 548:
The appellants’ next point related to Prof O’Brien. It was said that he had “never before selected human doses for human clinical trials on the basis of animal studies and had no expertise in that regard”.
His Honour implicitly accepts this, but then goes on to say that that work:
“would have been undertaken by others”.
So the combination of the two paragraphs is His Honour saying, well, Dr Reece’s evidence on this is good enough because he would be part of the team. We accept that, he would be part of the team, and we accept he was a clinical trials expert. We accept that, and a dosage selector. We accept all of that too.
In relation to that – looking at the outline – if I can just go quickly to some paragraphs of the Full Court judgment again, so firstly at page 2518 of appeal book 7. So that is where their Honours deal with Watanabe – this is in the context of the novelty disclosure first. It says it:
reports on the synthesis of a series of (then) novel compounds –
this is 316 at page 2518 ‑
and an evaluation of their ability . . . Rosuvastatin was one of the compounds that was synthesised –
And then at 322, the conclusion of the article was that Watanabe states:
that the synthesised compounds “are promising candidates for development of antiarteriosclerotic agents” ‑
I think I missed out a few vowels there but also syllables ‑
It also reports that rosuvastatin was in the course of clinical trials.
Then 344 on page 2525:
It is not in dispute that Watanabe does not, in terms, disclose dosages for the administration of rosuvastatin in humans and, more specifically, for the administration of rosuvastatin in humans for the treatment of hypercholesterolemia.
Then their Honours talk about “an implicit disclosure” and reject that. I do not need to go to that. Then at 390, this is in the context of a manner of manufacture argument, their Honours – sorry, that is 2538, I should have added, I am sorry:
In any event, it could make no difference to the fate of this challenge to the validity of the 051 or low dose patent even if the 471 patent and Watanabe were to be taken as incorporated in full into the complete specification. The invention as claimed is directed to methods of treatment of hypercholesterolemia using rosuvastatin . . . under specific dosage regimens. These regimens are not disclosed in the 471 patent or Watanabe. They are only disclosed, for the first time, in the complete specification as “the invention”. The 471 patent gives no more than a broad indicative dosage range which is, in any event, dependent on the disease being treated. Watanabe does not teach a dosage regimen in the treatment of human subjects.
Moreover, given what was known, as revealed only by what is stated on the face of the complete specification . . . it could not be said that the invention as claimed was obvious and did not involve an inventive step . . . The person skilled in the art, on reading the complete specification, and using it as the sole body of information, would understand from the 471 patent and Watanabe, if incorporated in full, that further experimentation would be required to ascertain the appropriate dosage range –
et cetera. That is Watanabe, and in relation to 471, similarly at 256 at page 2505 - 256 introduces the 471 patent and the opening paragraph refers to:
compounds of the present invention . . . plays a major role in the synthesis of cholesterol –
et cetera, and there is some discussion about 257 the compounds are done by a formula which identifies:
“over 57 trillion compounds”. . . One of those compounds is rosuvastatin.
Two of the examples disclose rosuvastatin. Then 259:
With respect to dosage, the 471 patent states:
The dosage may vary with the administration route, age, weight condition, and the kind of disease of the patients –
and there is a vast range. This is in the context of rejecting this patent as novelty destroying, and then if your Honours would then proceed to 2511, paragraph 289, where their Honours say:
There can be no question that each of the above dosage regimens fall within the broad description –
Then at 290, their Honours conclude that:
However, the 471 patent makes plain that the dosages may vary depending on a number of factors, including the kind of disease to be treated. In context, this means that the dose may vary depending on whether or not the disease to be treated is hypercholesterolemia, hyperlipoproteinemia or atherosclerosis. Further, the range given for oral administration is a broad range. Even then, the disclosed dosage is no more particular than that the dosage “usually” falls –
It refers to the possibility of “divided doses”. They conclude that it does not disclose dosage and then one would come back to 547 which I already have taken your Honours to at 2595 which indicates neither document disclosed animal or safety data. It is against that background that Dr Reece’s evidence at 536 of the appeal book, volume 2, is important. At 536, starting at line 20 of the underlying transcript:
And maximum tolerated dose of any such new potentially more potent statin would be some very important to consider –
and give reasons why it is particularly important. Then this next question:
And you would take into account any information such as we’ve just looked at now in relation to cerivastatin –
Cerivastatin was a very low dosage drug, about 0.3 micrograms. He says:
No. I have to say that the way we designed the Atorvastatin trials was much the same as we had done in – it would – we would be aware of the cerivastatin data but we would be guided by the animal data; that’s really critical. We couldn’t make a case for an IND –
That is an investigational new drug application in America –
based purely on published information. We would have to support it with our observations in animals to show what the maximum tolerated dose was, what dose levels efficacy has occurred in what animals and then come up with what I call – or the FDA called – a dose selection document.
He goes on to quote reference to animals and he concludes that answer saying:
That’s the critical data that would guide the selection of the dose for phase one.
Neither of that was disclosed in the documents. I said:
And you’re not intending to indicate to the court that your putative dose selection would be simply, “Let’s look at what other dosages are in the market and let’s launch into one of those”?‑‑‑No, that would be – that would not be an appropriate scientific way to approach this problem.
But that is the step which in paragraph 547 the court jumps over, we respectfully submit, inappropriately.
FRENCH CJ: Incidentally, the concept of low dosage seems to be an absolute rather than a relative one which is good across a range – or valid across a range of statins. Is that right? I mean, one is not sidelined by the proposition that a low dosage for rosuvastatin is different from a low dosage – means something different from a low dosage for one of the other statins.
MR BANNON: I think that is probably right, your Honour, yes. It may have different effects ‑ ‑ ‑
FRENCH CJ: It seems to be a premise on which the whole debate proceeds.
MR BANNON: Yes. The critical thing is could you have predicted the dosage that is identified in the patent, 5 to 10?
FRENCH CJ: Yes, the 5 to10.
MR BANNON: The use of the words “low dose” is perhaps a distraction other than to indicate, as a matter of fact, it is not as high as a 40 milligram dose which the evidence rather suggested that it does have some significant side effects. Then, just coming back to the outline, I have dealt with the first bullet point by way of evidence. Perhaps the substantive point, we say the single avenue approach led the Full Court to find obviousness despite the non‑disclosure in Watanabe or the 471 patent which is essential. We say that is contrary to Aktiebolaget Hässle, often referred to as the Alphapharm Case. There is an historical curiosity. I may inform the Court that Aktiebolaget Hässle is the former name of Aztrazeneca. Aktiebolaget is the same as Pty Ltd, in effect, because the name was Hässle.
Just looking at the bullet points, the first bullet point I have covered. The second bullet point I have covered in terms of the cross‑examination. The paragraphs of the affidavit – I will not go to, are consistent with that. Just the next one, potent statins, the evidence indicated could have very low upper safe doses. Cerivastatin was 1. Pitavastatin was 2 to 4. So that just confirms the general findings. You could not say one drug will be safely administered at a particular dosage compared to another dosage. That is why we start on 7(3).
Just very briefly on the entitlement point, as we understand the debate, the issue arises because of section 22A of the 2012 Act, and the Full Court seems to have accepted, and we say and our friends do not seem to seriously dispute, that if we are allowed to lead evidence of the assignment, 22A overcomes the entitlement problem. That is certainly the effect of 22A in terms. We have just given a reference to the Full Court’s paragraph judgments there at 159, 188 to 190.
Can I just briefly go to those reasons and then I will just briefly go to the assignment and just say something briefly about discretion, but perhaps say something more about that, assuming it arises later, and then I will complete my submissions in‑chief. So, firstly, the Full Court at 159 which is volume 7, 2478, is the paragraph which identifies the assignment on 11 June 2013. Then at paragraph 188 on page 2484 ‑ ‑ ‑
NETTLE J: What about 186? Does not the Full Court say the section would not apply even if you could adduce the evidence?
MR BANNON: I am sorry, your Honour.
NETTLE J: At paragraph 186, is not the Full Court saying that even if you were permitted to adduce the evidence the section would not apply?
MR BANNON: We submit not. In the events which have happened – I am sorry, your Honour, yes, I think they are talking about 1384. There are two sections, section 22A, which is set out on page 2477 at paragraph 154:
A patent is not invalid merely because:
(a)the patent . . . was granted to a person who was not entitled to it –
Then dropping down to 156, it says the amendments apply to patents granted before or after the date of the Act.
NETTLE J: Yes, I see, thank you.
MR BANNON: But 155 refers to 138(4):
A court must not make an order –
So there is really a debate throughout the Full Court’s reasons as to whether 138(4) applies in the circumstances and they come to the conclusion because they are not called upon on appeal to make an order revoking, 138(4) does not apply. But they do not say 22A does not apply.
Then, 188 on page 2484, their Honours say:
For reasons which we have explained elsewhere in these reasons, the 051 or low dose patent is invalid, not solely because of a lack of entitlement . . . but for other reasons as well. In those circumstances, to allow AstraZeneca to amend its notices of appeal in order to raise s 22A would serve no useful purpose –
There is no finding that 22A would not have the effect of beneficially curing it, but because – two points there. One is refuse leave to admit evidence of the assignment because it would be futile, and that is the reason why it is not admitted. But we accept in 189 and over to 190, their Honours go on to say if we were minded to look at it there are “discretionary” reasons which may well be quite powerful, but they do not decide those discretionary reasons against us but it is an indication.
In this Court, if your Honours were to uphold our submissions in relation to 7(3) and hence that the patent is valid and that the only reason it stands as invalid is the lack of entitlement point, we would say section 22A would enable the assignment to be relied upon, and we would say either this Court should admit that evidence now and make an order, it should overturn the revocation orders below.
There is no discretionary reason against the admission of that assignment, and I just say briefly, the assignment did not exist at the time of the trial. So it is not a case of a failure to adduce evidence which existed. It is an extracurial agreement as a result of a commercial arrangement between two parties which did not exist, so there was nothing to lead evidence about. So it is a curious argument to suggest that we should have done something extracurial.
KIEFEL J: But should you not have explained or shown to the Full Court that you could not have obtained the assignment at an earlier point?
MR BANNON: Well, we did not do that but there was no evidence one way or another, so it was neutral. But the simple point we make is it is an odd circumstance to require a party to engage in some sort of commercial transaction and take that into account as a relevant factor, firstly. Secondly, even if we had done the assignment, it would have no effect because at that time the common law was that a post‑assignment was no effect. The 2012 Act had not come into force. So it would have been a useless exercise.
Thirdly, we say the assignment itself reflects the fact we always maintained that we were the inventor. We disputed Shionogi was the inventor. Shionogi never indicated it was an inventor. It did not assume on the basis that it was the inventor. It just comes back to – so there is no – we say, if I could just move from our learned friends, the suggested forensic disadvantages are not forensic disadvantages. The fact is that they disputed – they said Shionogi was the inventor. We disputed it; my clients disputed it. But fundamentally the most powerful discretionary reason is, if that is the only reason why an otherwise valuable and valid patent should not be revoked then there would have to be the most extraordinary discretionary reasons not to permit the admission of that evidence. May it please the Court.
FRENCH CJ: The Court will now adjourn until 2.15.
AT 12.43 PM LUNCHEON ADJOURNMENT
UPON RESUMING AT 2.15 PM:
FRENCH CJ: Yes, Mr Catterns.
MR CATTERNS: May it please the Court. Your Honours, it seems to us that it is logical to start with a 7(3) exercise that results in Watanabe or the 471 patent first. I think our friends have called that their second question. The first question is – which I will deal with second – that armed with common general knowledge and section 7(3) information is it obvious and then our friends have postulated an additional step there which is a further literature search.
As to the first question, which is the ascertaining and regarding as relevant of Watanabe, we submit that our friends are wrong in fact and I will take the Court to some of the evidence our friend went to, plus some more evidence. They are wrong in fact and we also submit that as a matter of law you are allowed to filter and whittle down information as part of the ascertaining process postulated by 7(3) in the way that these experts did.
Just by way of introduction, so far as our friends – the next question that I am dealing with which is when you are in the universe of section 7(2), equipped with common general knowledge and, I think our friends agree, a single section 7(3) document, do you still do another search? We respectfully submit – of course, if you did that search, let us agree, you would arrive at Aoki, it seemed to be the second‑best result. Assuming they did the same search they would get the same result. I think that is what our friend says.
But, your Honours, that is clearly wrong in law because the 3M Case, Minnesota Mining, as explained and applied in Alphapharm and again in Lockwood v Doric in the passages, including 166 that the Court has referred to, say you must not have regard to a document obtained by a search if it is not common general knowledge unless it is a section 7(3) document.
So the further search in the postulated events that our friend has that you are thinking, well, this is an important exercise, I have got Watanabe, I will see what else is around, cannot arise as a matter of law. Even if it were right, contrary to what I have just submitted, as a matter of fact, Aoki would not talk you out of Watanabe because both of the two important experts, Reece and O’Brien, clearly thought Watanabe was the best candidate because, as his Honour Justice Keane pointed out, it is the one that had been said to be in clinical trials.
So, your Honours, even if our friends were right in law and in our principal submissions they are not right in law that you can canter off onto a further search, and contrary to Alphapharm and Lockwood v Doric, it would not complicate the matter in the way our friends would have it. You would not be agonising about which one to choose.
Then, your Honours, the third element is putting yourself in the position that paragraphs 127 and 166 of Lockwood put you in, in other words, what the Act puts you in in section 7(2), the question is, is the selection of the doses obvious? There our learned friends have to face up to the fact that there are concurrent findings of fact based on the evidence, of course, that it was obvious to try, in the sense of the Cripps question, so‑called, 10 milligram – let me pick 10 milligram doses – which is the same dose as the atorvastatin by the way – in the expectation that it might well provide a useful drug.
Of course you try it in clinical trials – you do not go straight to a phase III trial and say here is 10 milligrams, let us prove efficacy. You work your way up in the way explained in detail by the witnesses and subject to findings by her Honour and the Full Court. So, your Honours, that is our overview, if I may.
Your Honours, the first proposition in our three‑page oral outline – our friend has dealt with in part - the common general knowledge included knowledge of a need. So this is a case where there was a need or a desirable possibility of an improved statin because existing statins did not provide useful results in all cases. A more efficacious statin is always desirable as the patent itself says if for the same dose – it says for similar doses – if for similar doses as currently used statins – and the patent tries itself against atorvastatin, the market leader as our friend says – you get a better result, say, 40 per cent reduction in your cholesterol instead of 35 per cent – then that is a desirable thing.
Your Honours, in our note, after referring to the sections, we mention his Honour Justice Jessup’s summary of her Honour the primary judge’s finding. That is at 538. I do not need to take the Court to that. Our friends acknowledge that that need is what is in the skilled addressee’s mind when he or she is doing the section 7(3) exercise and then bringing it into section 7(2). But we did want to just flesh out slightly the common general knowledge as to dosages. That is in volume 5 in her Honour’s reasons at 102 to 104. These are in fact the same numbers as one saw in the paragraphs of the Full Court that our friend took the Court to.
At 102 at page 1853, your Honours, in volume 5 – I can skip. There are the findings about the – the knowledge about how statins work. Then in 1855 there are the known statins – I beg your Honours’ pardon. We can see from 1850 that this is a section of her Honour’s reasons beginning 5.2 where her Honour is making findings about common general knowledge.
Amongst that we see in 103 the move, as it were, from simvastatin to atorvastatin, which had become the most commonly prescribed and, your Honours, we can see the doses. For fluvastatin they were 20 and 40, but for pravastatin, simvastatin and atorvastatin – that was called Lipitor – they were 5 milligrams and 10 milligrams – and above, I should say - and 10 milligrams as the lowest dose for atorvastatin were going up and there is a table to similar effect about starting doses in 104. In 106, they were typically dosed once a day and, as it so happens, at night.
Your Honours, in 109 her Honour makes the finding that it is usual to start low and titrate up, as I think our friend said, but ideally you might not even need to titrate up if target levels have been achieved straightaway. Your Honours, then at 119 to 123, her Honour makes the findings about the need – again about which there is no dispute now – including in paragraph 123. In paragraph 124 and following, her Honour describes the clinical trial process and there was a lot of evidence about how clinical trials work, and the process is one of formulating hypotheses at every step of the journey, of course.
You originally do it in vitro – that is pre‑clinical – you do it in vitro. The evidence was – I do not need to go to it, but there were well‑characterised models of what particular cells you put in the test tube to determine potency, including, as we see in the Watanabe article, that it was selective for the liver enzyme or the liver enzymes’ substrate, all the way up to phases I, II and III. Phase I, to remind your Honours, is on healthy volunteers, usually done on doses from prior animal tests at much lower doses per kilogram, to test toxicity and that is done initially over – literally one or two patients.
FRENCH CJ: They also look at dosage ranges, do they not?
MR CATTERNS: Yes, your Honour, that comes later.
FRENCH CJ: But in phase I.
MR CATTERNS: Yes, they do, your Honour, of course, and I was going in the context of entitlement just quickly show the Court what Shionogi did for its very first trial, which did exactly what your Honour says. Starting very conservatively at a low range and then working up to what, as we see in that document, are expected clinical doses which were 5 and 10 milligrams. That was Shionogi’s expectation.
So, your Honours, the point about that is it is a laborious process, let us accept, but it is very well – it is very standard indeed. In evidence there were standards for the clinical trial for statins that the USFDA and its equivalent in Japan had published so when you were engaging in clinical trials for statins there were templates that you followed, so to speak, including recommendations to have it against placebos, possibility of testing it against other statins and so on.
Your Honours, without taking the Court to it, the FDA guidelines are at pages 1137 and following and the Japanese guidelines are at 1156 and following. They are, as it were, a template for the carrying out of clinical trials, your Honours, so her Honour discussed that in 124 and 125. Of course they can be expensive and they can fail. They can fail at any stage, reminding your Honours that phase I is the toxicity level where you try it on healthy people, but it is the case that with statins, because we all have a native cholesterol level, that you can see a reduction of cholesterol even in people who do not have hypercholesterolemia.
You can get, as we saw from Shionogi, you can get useful information even from the phase I. Your Honours, then there is phase II which we see in the patent, which is where you start to choose different doses and you start working out which are likely to be the appropriate ones to administer in a large‑scale clinical trial which is phase III.
Your Honours, the next paragraph in our note in paragraph 1, just a couple more references. At 327 to 328, your Honours, we do not agree with our learned friend’s submission if it is suggested that her Honour Justice Jagot did not deal discretely with 7(3). Her Honour did. Her Honour’s holding on inventive step, beginning at 324, first flowed from her acceptance of our – what was called starting point argument or identification of the invention argument which is the subject of our contention which we will make submissions about later. Your Honours, at 327, however, after discussing the need that she had earlier found, the last couple of lines, her Honour says:
it is appropriate to consider further this alternative case put by the generic parties –
That is our section 7(3) case. So our section 7(3) case is dealt with from the last two lines of 327 on. In the middle of 328, there is the discussion of the need. At point 30, her Honour refers to the hypothetical evidence they give as to the coming up with the doses. Of course, it has:
time consuming and expensive trials . . . hypothetical, but it is not mere speculation given the extensive –
evidence about clinical trials. They:
would have discovered the 471 patent . . . and the Watanabe article –
as discussed, your Honours:
Each document, on the evidence, would have been ascertained, understood and regarded as relevant –
Then, your Honours, there is the conclusion on the - as it were, the ultimate conclusion applying section 7(2):
Each document, considered separately, would have led the skilled addressee as a matter of course to try the claimed invention –
That is an administration of rosuvastatin in 5 and 10 milligram range – 5 and 10 milligram doses -
in the expectation that it might well produce a useful alternative –
Now, your Honours, that Cripps question is not the statute and by no means is appropriate in every case but I think it was agreed on all sides that it was appropriate to use in this case and that is what her Honour and Justice Jessup did in the last step. So the skilled addressee has his or her common general knowledge, which is their intellectual capital that all their colleagues have, and then they are equipped with Watanabe which is a confined statutory relaxation of the rule in the Minnesota Mining Case.
Her Honour deals with the ascertainment issue in 329 – and I will come back to Justice Jessup on that, if I may. The fact that there were other potential candidates, including NK‑104 – I should have mentioned about cerivastatin, your Honours. There was no finding that its dosages were common general knowledge. As our friend rightly points out, it was a considerably lower dosage than the rest which hovered around the 5 to 40 or 5 to 80 range.
So, your Honours, the fact that the candidates does not detract from the fact that it would have led the skilled addressee as a matter of course to try the invention, that is the obviousness question, and her Honour accepts the submission of our learned friends from Watson and Ascent, there was a clinical trial in the low dose patent:
The undertaking of such a trial is a perfectly ordinary, albeit expensive, step taken to confirm efficacy and safety –
I will come back, if I may, to some elements of the remainder of her Honour’s reasoning, but it continues – perhaps I should, your Honours, I should do it now. It continues in 331, her Honour reminds us at about point 40:
The skilled addressee would have had the benefit of common general knowledge as described and the information in the 471 patent or the Watanabe –
but based on that it was obvious, even though you can never be certain – I am paraphrasing, your Honours. In 332, her Honour is accepting an argument about some commercial success where we have divided up our submissions with our learned friends, Mr Ryan and Mr Horak, and they will be dealing with commercial success.
Your Honours, so they are the matters of common general knowledge but I have trespassed into her Honour’s finding on the so‑called Cripps question. Our second proposition, your Honours, that we derive from Lockwood v Doric (No 2) is that “ascertained” means discovered or found out, and their Honours say that accepting – approving of something that was said in the Full Court in that case, their Honours say that in paragraphs 131 to 132 that we give the reference to here. Our learned friend, I think, took the Court to 152 where, in effect, we get a definition of relevance, which is – and we have quoted here, your Honours:
relevant to solving a particular problem or meeting a long‑felt want or need –
That was answering his Honour Justice Gageler’s question. “Relevant” means solving that problem or that need and here – this does not trespass on our argument about the identification of the invention – here there is a common general knowledge need, and it is relevant to that. So, your Honours, we respectfully submit as a matter of law in ascertaining and – there is no issue about understanding – regarding as relevant, you must be able to sort. That includes via cross‑references.
Dr O’Brien, which our friends will address in more detail, Dr O’Brien found the equivalent of the 471 patent by a chain from a footnote in Watanabe. We respectfully submit that 7(3) allows, as it were, both that sort of horizontal research – I beg your pardon, that vertical research technique, and horizontal. At the level of 4588, or whatever it was, you are in effect comparing when you add an additional search term, which our friend rightly said is new or novel, and that brought it down to a more manageable size.
Then when you read through the abstracts of 400 or 500 and make a selection of 19, and then you read through 19 articles, that is precisely the task, we submit, of ascertaining that is permissible under section 7(3). Yes, I am sorry, your Honours, we gave your Honours the reference but I should have gone to it in Lockwood v Doric (No 2) in paragraph 132. They said:
“ascertained” simply means discovered or found out.
Understood, your Honours, it just means comprehended it. Then, your Honours, our friends, what they call their second issue, but logically the first, is that as a matter of fact perhaps beyond permissible search techniques of the type I have just described, there was impermissible combining of documents in the assessment of relevance, and that relates to the question of Dr Reece and the role that the Thompson article had in his analysis. I was going to go to those passages in a moment, your Honours. But first of all, that criticism does not apply to Professor O’Brien at all. Secondly, so far as Dr Reece goes, he had already regarded the Watanabe article as relevant and said so numerous times and I think our friend forgot to go to the passage where he cross‑examined him about the role of Thompson in, I submit, shoring up the relevance of the Watanabe article.
But before we get there, if I may, his Honour Justice Keane when asking a question about the limitations of what we are allowed to look at under these provisions, asked rhetorically, is that a good thing? It is very clear that since the 3M Case, the Minnesota Mining Case, the Intellectual Property Advisory Committee report and the 1990 Act attempted to ameliorate some of those difficulties. That is clear from that report and also from the two High Court decisions that I was just going to ask the Court to go to briefly – Firebelt v Brambles and Lockwood (No 2) – on that topic.
So the first is Firebelt v Brambles 188 ALR 280. Your Honours, we can see the context from paragraph [30] in the judgment of the trial judge, Justice Dowsett, where at the top of page 287 in paragraph [30] we see the two questions. The information related – these were not documentary sources of information, they were acts, people presenting them at a display. They related to a way of making the lid of a garbage bin open more readily when you were loading it into a truck automatically.
So, those questions were the two alternatives, namely, that the presentations of CGK satisfied 7(3), we see in [30]. By the way, your Honours, this case related to a petty patent. Hence, a distinction we see in a minute in the definition of prior art base between Australian publications and disclosures and worldwide. Their Honours say in [31], after quoting the form of 7(2) that we have before us in this case, that:
The opening words of s 7(2) indicated that the onus . . . rests upon the party challenging validity.
Then their Honours refer to the definition of prior art base -
So far as it applies to petty patents –
and your Honours see in (a)(i) that that was “the patent area”. Insofar as standard patents, which we have got here, it is whether in or out of the patent areas. So it is worldwide – publication is good enough. Your Honours, then their Honours quote 7(3) and emphasise – at the top of page 288 – the concluding words:
ascertained, understood and regarded as relevant to work in the relevant art in the patent area –
Then their Honours quote section 100(1)(e) of the 1952 Act. In [33] their Honours say:
it is apparent that there has been an expansion of the legislative text dealing with the ascertainment and content of the common general knowledge –
Really, it is common general knowledge that has now been added to – or enlarged as their Honours say in Lockwood -
relevant for the determination of the obviousness –
Your Honours, there was a concession made, but then their Honours say in a sentence that we rely on in a later part of our case in relation to the way the Court in Alphapharm approached the problem in the patent there, certainly that was a concession by counsel that the court decided the case on that basis:
the court should not act upon a concession as to the effect of such a fundamental legislative provision.
The common general knowledge is not expanded but what is looked at under 7(2) is expanded by the 7(3) information. Your Honours, then their Honours refer to the rule from Minnesota Mining that:
under the 1952 Act –
and subject to 7(3) under our Act, your Honours -
a prior disclosure, in particular in a specification . . . did not provide a basis for a conclusion as to obviousness without evidence that the disclosure in question was part of the common general knowledge at the relevant priority date.
So, our learned friends’ second search when they are in a 7(2) universe, armed with CGK and Watanabe, is impermissible. Your Honours, then there was the IPAC report and the idea was that any single prior disclosure or use should be capable of being considered against the background of all its common general knowledge in the relevant field of art.
It is not inventive if the knowledge imparted by the disclosure – that is the 7(3) disclosure – combined with CGK would render the claimed invention obvious. It should not be possible to combine two disclosures unless what we now see as 7(3)(b) is satisfied where you treat them as a single source, in that case they are referring to cross‑reference. Your Honours, then there is a slight slip – but nothing turns on it – by the court. Because the court is focusing on petty patents, they refer to the IPAC recommendation that:
we see as being treated as within the common general knowledge of the art, not merely information which is generally known and used in the art, but also information publicly available in recorded form anywhere in the world –
their Honours emphasised that –
reasonably have been expected to find . . .
The recommendation in the emphasised passage was accepted for standard but not for petty patents.
That is about anywhere in the world, your Honours. The recommendation that common general knowledge, the whole idea include any other document, was rejected. We gave the Court a reference to the government response to the IPAC report which was in the Official Journal of Patents – I think the Court has it – and we can see the recommendations at page 1470, it is volume 56 of the AOJP 1986 and, your Honours, the recommendations we are talking about are recommendation [13]. The first recommendation was:
that novelty and obviousness for standard patents be determined against a prior art base –
and there, your Honours, we see the recommendation of disclosures publicly available anywhere in the world. That was accepted. Your Honours, then in (ii) no cross‑referencing except when they are capable:
save that in determining obviousness any single disclosure or use should be capable of being viewed in the light of the common general knowledge in the relevant field of art –
which is predecessor of 7(2), but that is limited, your Honours see, in [13](ii) and their acceptance has to be understood – uncovered – that is ascertained now – understood and regarded as relevant. Your Honours, item (iii) was not accepted, and we see that in the Act. Your Honours, may I return please to – I beg your Honours’ pardon. I should just finish in Firebelt – I beg the Court’s pardon. Then just finally in [36], the court accepts Justice Burchett’s summary of this:
it was one thing to say that there had been a relaxation of the rule forbidding the use of prior disclosures not actually proved to be part of common general knowledge –
Your Honours, our friends want – unusually for a patentee – to relax the rule further. We say the relaxation is section 7(3). They say they can have any document on a second search whether or not it is common general knowledge. That is forbidden, and your Honours see the quotation from his Honour Justice Burchett.
Your Honours, in Lockwood (No 2) 235 CLR 173, that history is also explained. May I just remind your Honours that the issue there on section 7(3) - the Lockwood locks were the rim‑mounted locks that are put on the back of your door. The problem was that you could deadlock it and be locked in with bad consequences and the invention was that when you opened the door you got rid of the deadlock; you undid the deadlock. The revoker relied on a class of locks called the storeroom locks under 7(3). The Court is going to hold that they did not satisfy section 7(3). But their Honours say in 126:
What is obvious . . . is to be determined by -
the combination of the provisions that we have been talking about:
These provisions are all directed to determining whether an invention “is to be taken to involve an inventive step . . . (s 7(2)). Schedule 1 defines “prior art base” and s 7(3) contains the statutory test for enlarging the prior art base beyond common general knowledge -
because you cannot go beyond common general knowledge except as enlarged by 7(3). In doing so -
by enlarging the prior art base through including relevant prior disclosures beyond those disclosures proven to be part of the common general knowledge, these provisions raise the threshold for inventiveness. However, the idea remains that the prior disclosures to be taken into account, even as enlarged by s 7(3), are being considered for a particular purpose.
Your Honours, we submit this is what the courts below did. They looked forward from the prior art base, that is, the common general knowledge plus Watanabe, enlarged by Watanabe, to see what a person skilled in the relevant art is likely to have done when faced with a similar problem, which is the finding of appropriate doses. So, your Honours, then their Honours refer to what his Honour the primary judge did. At 148 there is a little bit more on the application of section 7(3):
each claim needs to be examined independently –
in that case because claim 13, which was a claim on which Doric won, had an extra integer relating to the way a detent moved axially or radially. So the exercise in 149 of which 7(3) is integral is:
the exercise of determining whether “an invention” . . . “involve[s] an inventive step when compared with the prior art base” (s 7(2)). The “prior art base” for s 7(2) –
which would otherwise just be common general knowledge, your Honours –
is enlarged by s 7(3), so as to go beyond common general knowledge and to bring into consideration –
7(3) information. But our friends cannot do an additional search and bring up Aoki or whatever else they might want to get. Your Honours, then there is the reference to Firebelt. In 152 we get, as it were, the definition of relevance.
Your Honours, that takes us to proposition 4 of our oral note. As we submit, Dr O’Brien did a very conventional whittling down process. We give your Honours the references to Dr O’Brien’s paragraphs, some of which our friends went to this morning, and the transcript, some of which our friend went to this morning – and we will defer to our learned friends on that, if we may. They will take the Court to those.
But, your Honours, I was going to spend a minute or two on Dr Reece’s evidence which, we submit, is crucial on this point. In volume 3 – and the proposition I am going to get from this, your Honours, is that he regarded the document as relevant on its own. Your Honours, he begins really at 157, about narrowing his ‑ ‑ ‑
FRENCH CJ: What page is this, Mr Catterns?
MR CATTERNS: I beg your Honour’s pardon – 967 – I am sorry, your Honour.
FRENCH CJ: Thank you.
MR CATTERNS: Page 967, paragraph 157. I am going to the first of the references we have in our paragraph 4, your Honours. So, your Honours, he works his way down to 19 abstracts and there is no longer any criticism of his getting to that stage, I do not think. He considered them to fall:
within the terms of reference and for which a review of the full article was warranted –
Your Honour, we submit, this is all – he is saying, right at this stage, he is thinking about relevance now, he says ‑
so that I could determine if it was relevant to the Passage.
Then he exhibited them, your Honour, and our friend read out, of course, what was done. If your Honours will just pardon me a second? We see at page 1013, 19 abstracts that he has coloured in yellow. This is not a comparative exercise at this stage. He is looking at them and the one that he finds most interesting jumps off the page, so to speak, is at the bottom of 1013 which is the abstract from Watanabe, which we can see when we see the Watanabe article, and halfway through the last paragraph, after describing what they have done, we can see that they are inhibiting the enzyme HMG‑CoA reductase. S‑4522, which we all know is rosuvastatin:
was selected as a candidate for further evaluation –
which is already a very good sign – and his compound 3a is:
approximately four times more potent than lovastatin . . . most potent cholesterol biosynthesis inhibitor . . . its inhibitory activity was approximately 100 times more potent than pravastatin.
So, so far your Honours, we submit he has found this to be relevant on its own, and I suppose it is comparative to say it stood out from all the other abstracts, but it stood out. Your Honours, then at the top of page 968, we submit this is all about relevance. He says in 161, they:
included data which looked particularly relevant –
So then he did a little further search for those two but that did not give him anything new. So then he got the 19 articles and read them all, as a professional researcher would do when we are down to this level of magnitude. Others did not seem to be relevant. We see there is an analysis of relevance in 164. In 165, he says:
The three articles that I considered to be relevant –
were Aoki, which is ‑
a potent inhibitor –
we see at the top of 969, and Watanabe. Now, your Honours, the description of that is highly encouraging for relevance:
report of a series of compounds . . . 4522. The in vivo results –
that is in live animals –
demonstrate that the compound is a very potent inhibitor . . . In my view, based on my experience with clinical trials [it] was definitely a candidate for further development and, as reported . . . clinical trials were in progress ‑
and that is what distinguishes it from Aoki and is obviously highly encouraging information. Your Honours, then there is the Thompson article. Now, it had a table in it which listed four statins as being in phase II trials and it is the additional information about phase II trials that our friends made submissions on before the Full Court but, your Honours, our submission is the fact he said in the cross‑examination I will take the Court to, it said clinical trials, I was not sure if it was phase I or phase II. Thompson told me it was phase II. Your Honours, it cannot be said that that is the sole source of his regarding Watanabe as relevant.
As we can see from the following paragraphs, from 167 onwards, we asked him to review Watanabe. Now, your Honours, the reason we did not ask him to do an exhaustive review of the others is they are irrelevant to this case. We run a case on, you arrive here, this is the relevant document and you can take it into section 7(2) and then do the appropriate analysis. So he was asked in 167:
to describe what Watanabe would have told –
him –
without having regard to information in the other articles ‑
Your Honour, he was not cross‑examined on this except in the passage to which I will take the Court. So he says it is – in 169:
relevant and valuable for the design and conduct of clinical trials –
He refers to the in vivo testing in beagles and monkeys:
The term ‘normolipemic’ . . . these two species of animals are widely used for in vivo testing . . . beagle dogs are the animal model of choice –
and other witnesses agreed with that –
Monkeys, being primates, are the animal of choice for the latter stages of preclinical testing prior to conducting clinical trials in humans. The data from studies in monkeys is generally highly relevant to the design of Phase I clinical trials.
Then there are various rat tissue experiments, including, in 171, that it is likely to be selective. At 172, he refers to the results, which in short, there was a similar result in the monkeys with rosuvastatin and pravastatin, but at a quarter of the dose, therefore, a potent agent. In 173, he refers to the conclusions:
100 times more potent than pravastatin. It is also stated that a clinical trial of S‑4522 is in progress. I would have understood this to mean that there was comparative data showing that S‑4522 was both safe and potent from animal students and, possibly, Phase I studies in humans, and that this data supported the further development of S‑4522 in Phase II trials.
Then he was asked what impact – he has already given some opinions on possible dose sizes, your Honours, and by the way, he has not seen the patent yet, the patent in suit. He says:
I would have considered that the reported results for the beagle dog and monkey tests were relevant to this question . . . suggested to me that S‑4522 is substantially more potent . . . Specifically, the data from the monkey studies points to S‑4522 being four times more potent . . . I would have considered it –
If I could go over the page, your Honours –
reasonable to expect (i.e. more likely than not) that a 10mg dose of S‑4522 would be as effective as a 40mg dose of pravastatin. Reading Watanabe therefore would not have changed the dose sizes and design of Phase II study described at paragraphs 138 and 139.
If I may go to those, your Honours – I was going to go to them a little later, but just to save time. He says, of course you look at animals and so on – we have seen that earlier, from about paragraph 134 and following, and in 135 he knows what the doses are of statins, and at 138, he had assumed phase II trials, it is fair to say, but he says:
The doses selected for Phase II trials will be determined from the results of Phase I trials . . . The range of doses . . . will be a range of effective doses . . . based on my knowledge of the known statins . . . I would expect that dose sizes used in Phase II trials of the new statin would be 5 mg, 10 mg and 20 mg –
Now, your Honours, our friends cross‑examined him about that, and I will take the Court to it, and he agreed you do not just simply administer the dose of the next door statin – fair enough – but he has carefully said you work your way up from animals, and we have seen that in relation to Watanabe.
FRENCH CJ: When he is saying that, what aspect of the statutory test in 7(3) is that directed to? Is that directed to the question of relevance, relevance to work?
MR CATTERNS: In 138, your Honour?
FRENCH CJ: Yes.
MR CATTERNS: No, your Honour. I think the ultimate question, namely the 7(2) question, having ascertained Watanabe, what dosage do you test? Would you be directly led as a matter of course to try inter alia 5 and 10 milligrams? That is where we have submitted that there is ‑ ‑ ‑
FRENCH CJ: The judgment as to relevance to the problem is made, and the next step is the 7(2) question?
MR CATTERNS: Yes, your Honour. That was the last paragraph of that earlier material.
FRENCH CJ: Yes, okay.
GAGELER J: Is the section 7(2) question just a question about dosage, or is it a question that has another element, and that is that the choice of this particular statin ‑ ‑ ‑
MR CATTERNS: Yes, your Honour. We are in 7(2). Our common general knowledge includes the need for a better statin, and we now have got, because section 7(2) says consider the obviousness of the invention in light of the common general knowledge together with a piece of information from 7(3). Section 7(2) asks is it obvious to the skilled addressee in the light of the common general knowledge, which includes doses but also includes the need for a better statin, and Watanabe – which is a promising candidate which we see – we have the information that is in clinical trials. That is the hypothetical circumstance the skilled addressee is put in. That is where, having got Watanabe and, we submit, not allowed to clutter the issue up with the non‑common general knowledge document, as our friends would have it, there are now concurrent findings that what you would do is try 5 and 10 milligram doses.
Your Honours, his Honour Justice Jessup dealt with this argument in volume 7 at 527 and following. I think I should draw attention to the last sentence of 530 because our friends did not get to it this morning, but we accept that it is important to deal with it. It loomed fairly large in our friends’ written submissions.
Your Honours, in 527 his Honour Justice Jessup is dealing with a submission about combining documents, but importantly in 528, his Honour paraphrases the evidence I have just taken the Court to about how relevant Watanabe was per se, and your Honours see that in the last few lines:
The Watanabe article contained a report on a series of compounds . . . rosuvastatin . . . “a very potent inhibitor . . . “definitely a candidate for further development”.
Then at 529 our friends’ cross‑examination is referred to where:
part of Dr Reece’s assessment . . . was his assumption that the unknown compound –
was in phase II trials -
The Watanabe article informed him that S‑4522 was in clinical trials, which Dr Reece took to mean either Phase I or Phase II –
and Thompson told him phase II. Your Honours, our respectful submission is that the evidence we have seen showing how relevant he regarded it, irrespective of whether or not it was in phase II trials, shows that it still satisfies the relevance criterion, notwithstanding the evidence we are about to see about Thompson. To put it shortly, your Honours, whether or not it was in phase II trials was not a deal breaker. He already viewed it as being relevant.
The first half of 530 we submit is completely unexceptionable where his Honour is saying you can go through routine practices of sorting. We confess that the last sentence of his Honour’s reasons possibly goes too far where his Honour says:
But the sources which the skilled person would consult to decide what that document is –
That is ascertaining; probably that is correct –
to come to an understanding of the information in it and to consider whether that information was relevant, are not confined to a single document.
Your Honours, we do not need to submit that you are allowed to shore up one document with another. If that is what his Honour is saying, we respectfully do not go so far. It is clear that his Honour then moves on to Professor O’Brien – so we do not submit that we have to go so far and we do not submit that it is correct, but we submit that as a matter of fact here he already regarded it as relevant in the way I have attempted to show the Court.
Dr O’Brien, as we read 531, and as we heard our friend’s submissions this morning, is not subject to the same criticism. He just worked his way down to picking the most relevant. He did not need one to shore up the relevance of another, and our friends will deal with that in more detail. So, your Honours, we respectfully submit that that criticism does not overcome the fact that Watanabe was plainly relevant on its face to Dr Reece.
NETTLE J: What about the next question? Does Thompson help him to come to the conclusion that, having regard to that relevant document, the claimed invention is obvious?
MR CATTERNS: No, your Honour.
NETTLE J: Not at all?
MR CATTERNS: No, your Honour. What Thompson did is it shored up his relevance, I accept, but I submit he already held the view that it was relevant.
NETTLE J: Relevant.
MR CATTERNS: I was going to take the Court to two things. The first is the cross‑examination on that, which I think our friend also skipped over – what we took to be their favourite passage – in volume 2. Your Honours, it begins at 528 at line 12, using the transcript lines. Our friends put:
“I found three articles and I did not know whether they were relevant . . . No, I knew they were relevant . . .
How did you know they were relevant –
and then he describes –
I was looking primarily, initially, for human data . . . I was looking then for animal data to show as a next level down or any preclinical data . . . my reference point was always Atorvastatin . . . to be at least as good as Atorvastatin . . . these three articles seemed to address the terms of reference.
Now, our friends based a submission on how artificial this exercise was below; that is not pressed. Then our friends ask at the top of 529, line 5:
your assumption in this exercise is that there had been phase 2 trials . . . Initially –
He qualified in his affidavit –
it could have been useful if efficacy had been shown in animal studies as well.
But you found nothing which indicated . . . phase 2 studies, did they?
Then he says about Watanabe, and this is what Justice Shepherd refers to, his Honour in paragraph 529 –
the Watanabe article refers . . . that it was in clinical trials. I don’t know whether that’s phase 1 or phase 2.
Then we go through Thompson, and what Thompson tells you in a table – it does not tell you anything else about Watanabe; it tells you nothing about dose, to answer his Honour Justice Nettle’s question. Thompson has a little table with Watanabe and Aoki in it, and a statement about phase II, as he says here in lines 35 to 40. He is discussing what he sees in Thompson, and then looked to see if there was any cross‑referring. Then our friends’ passage that they rely on is at line 14 on 530:
read all 19 . . . I found these three were relevant . . .
But part of the relevance was your assumption that . . . was in phase 2 trials –
Our friend asks –
the only thing that has told you that . . . the Watanabe compound was in phase 2 trials was the Thompson article; correct?‑‑‑Yes . . . Watanabe said “clinical trials”. So that could be either . . . The only thing that said it was in phase 2 was the Thompson article.
Yes. And you took into account that Thompson information to come to your conclusion that each of the Watanabe article and the Aoki article were relevant?
What our friends do not go on to ask is, and you would not have thought Watanabe was relevant unless you had learnt from Thompson that it was in phase II, and our friends needed to do that in light of the affidavit evidence I took the Court to about what he did derive as to relevance from Watanabe.
Your Honours, Watanabe – I should have taken the Court to it – in volume 3, I only need to go to a page and a bit. It is in volume 3, page 1033. At page 1035, we see the abstract that we already saw coloured in yellow and blue. At page 1037, there are some biological results referred to, including in the right‑hand column at the bottom of 1037 the fact that it – the last five lines – is:
liver selective . . . indicates a potent cholesterol lowering and, moreover, reduced side effects -
I accept there is not toxicity data here, but most importantly, in the passage bridging the two pages, they talk about the activity of 3a, which is rosuvastatins, in the beagles and monkeys. It:
reduced plasma cholesterol levels of beagle dogs by 26% and pravastatin (1b) by 18% ‑
Your Honours, the evidence was that – the finding was – that usually a doubling of dosage gives you a 6 per cent improvement in cholesterol reduction. This is then what Dr Reece referred to – the reduction in the plasma in the monkeys by 22 per cent at 12.5 milligrams, and a lesser reduction, 19 per cent, at four times the dose. Then they go on and say, under that “Conclusion”:
four times more potent than lovastatin . . . the most potent cholesterol biosynthesis inhibitor in rat isolated hepatocytes, having been approximately 100 times more potent than pravastatin (1b). They are promising candidates –
Then this, which is the thing that makes it relevant, in context –
The clinical trial of S‑4522 (3a) is in progress.
So, your Honours, we respectfully submit that the conditions of 7(3) were well met. Then, your Honours, I have made some of our submissions on the way through about our friend’s impermissible, with respect, attempt to bring in under the section 7(2) inquiry a non‑CGK document. So they say you are going to confuse yourself with multiple alternative avenues because you will have more than one thing to choose. Your Honours, we say, you are never in that position because you are not allowed to by Alphapharm and by the 3M Case and also by Lockwood.
The only additional thing you are allowed to have in addition to common general knowledge – and of course this cuts both ways for or against patentees. Normally the revoker would like to have a multiplicity of documents to rely on to make an invention obvious. In this case, inspired by the old Mathieson Case where in England you could have any number of documents, Justice Graham held in fact there are so many alternatives you would be confused.
Well, in the little island that Australia has become in the law of obviousness as to what you are allowed to have access to, we have a strict rule of the 3M Case, expanded by section 7(3). So that leads me to take the Court, please, to two more cases, which is the Alphapharm Case and back to Lockwood, if I may. The Alphapharm – which I will come back to in another context – is 212 CLR 411. Your Honours know we rely on paragraph 41 in the context of identification of the invention. But at the top of page 430 in paragraph 42, the Court refers to our divergence from the UK, in particular on this very topic of what material you are allowed to have regard to:
The first concerns “mosaics” –
by which their Honours mean the putting together of multiple sources, for better or worse, I interpolate ‑
The holding for which Minnesota Mining is celebrated is the rejection . . . of the reasoning in certain English decisions. This might have permitted the basing of an argument of obviousness –
or I say non‑obviousness –
upon prior publicly available publications, without evidence that they had become part of the common general knowledge –
and their Honours refer to the Minnesota Mining judgment where in Justice Aickin’s judgment he made it clear you cannot have resort to the patent specifications sitting quietly in the Patent Office. The last few lines:
Therefore, the issue of obviousness was to be determined without reference to the prior publications –
that were not common general knowledge. Then we have the mosaic point. Your Honours, the very argument our friends put at the forefront of their arguments this morning which is this, that you – sure, you have got Watanabe, if we succeed on Watanabe – you are in a section 7(2) inquiry equipped with common general knowledge in Watanabe and then you do another search. That exact approach was what his Honour Justice Lehane did at first instance in the Alphapharm Case, held to be wrong because – we see that at paragraph 55 on page 434:
His Honour also attributed to the hypothetical addressee the assistance to be gleaned from publications which had not been found to be part of the common general knowledge . . . He correctly rejected the Alphapharm submission that the common general knowledge of the skilled formulator . . . included material the formulator might find by conducting research –
which is close to what our friends have submitted this morning, even if it had not become CGK, which is generally assimilated and accepted. But then his Honour took a wrong turning, a routine literature search, which is exactly what our friends have submitted this morning as being no different from a routine experiment. Then there is a reference to Dr Story having regard to the literature for general ideas, et cetera. Then it continues in different territory, your Honours. But, we submit, it is completely clear that you cannot – in the hypothetical world we are placed in section 7(2) – equipped with your common general knowledge, engage in a further literature search.
Your Honours, the question is the question that we see in Lockwood at 166 which is – if I may put the word Watanabe in it – the question which section 7(2) requires to be asked is:
“If that information –
that is the information derived from Watanabe ‑
had been considered by a person skilled in the relevant art together with common general knowledge would the invention in claim 13 have been obvious?”
Only one answer:
No.
And, your Honours, we respectfully submit that shows that our learned friend’s principal argument this morning, as we heard it, is incorrect. So, your Honours, looking at our note, we have largely made the submission in paragraph 6 but this does not require evaluation of alternative avenues, nor was it a matter of hindsight. We look forward from the prior art bases we have submitted.
Your Honours, we give your Honours the references there to Justice Jessup looking at a Cripps question type analysis, which is almost exactly what the High Court describes in paragraph 127. I do not need to go back to those. Your Honours, we have taken the Court, largely, to the Reece evidence – again, I will not trespass on the O’Brien evidence – although if I could just paraphrase it. He said – clearly, by the way – Watanabe was best but he would not criticise a colleague who had a look at – who tried Aoki which was nicely collegiate of him.
So, your Honours, we submit our learned friends cannot say – cannot succeed in their submission that one puts aside Watanabe under section 7(3) as not being relevant because it has been, as it were, contaminated by reference to Thompson. Our friends, if we move into 7(2) with Watanabe, cannot bring in other non‑CGK material.
Your Honours, then in paragraph 7 of our outline we deal with the third step which is whether there is inventive ingenuity required to select the claimed dosages. I took the Court briefly to her Honour Justice Jagot’s reasoning at 327 and 334. His Honour Justice Jessup has a detailed analysis of that at paragraphs 533 to 549 and we submit that together with her Honour Justice Jagot’s reasoning on that there are concurrent findings of fact that our friends cannot overcome and there is no legal error, I think, suggested at that stage of the play.
So we would respectfully submit that having got what, in other words, a useful potential alternative statin with your common general knowledge, of course you do a range of doses, as his Honour the Chief Justice put to me, but it does not involve invention to select a range that includes 5 and 10 milligrams.
FRENCH CJ: I suppose it is important to avoid treating the notional person skilled in the relevant art as an avatar of the experts.
MR CATTERNS: Yes, your Honour.
FRENCH CJ: One is drawing upon what the experts do and say to answer the statutory question by reference to this notional personal team.
MR CATTERNS: Precisely, your Honour, and I do not need to take the Court to it but there is a criticism, I think, made below that the experts did not go to the very final step and say I would have been directly led as a matter of course, et cetera, query the admissibility of that, but his Honour Justice Jessup points out that that is a matter for the court. That is in paragraph 543.
But that is right, your Honour, they give us the equipment on which a jury question, as is often said as a cliché, is determined by the court and, we respectfully submit that this Court, there being no error in the reasoning as we have attempted to submit, give a different answer to the jury question.
Your Honours, in our little note there, the fourth reference, which is to Mr Reece’s cross‑examination at 536, line 27, I withdraw the criticism of our friend’s paragraph 15 which we said did not give the full context. Our friend did give the full context this morning. So, your Honours, we respectfully submit that that means that the decision below on section 7(3) was right and the invention claimed was obvious.
Now, your Honours, we respectfully submit that the entitlement point is not quite as simple as our friends would have it. Just looking at our note there, it is not put and, in answer to a question from her Honour Justice Kiefel, our friend accepted that. Our friends do not say we could not have got an assignment from Shionogi before the trial or at the trial. They now say it would have been futile. Well, that is not quite right because your Honours, there are two elements to entitlement.
The Act says in section 138 that one of the grounds of revocation – 138(3)(a) – is that the patentee is not entitled to the patent. For example, you are registered as a patentee but you obtained your title by an assignment from somebody who was not the owner - questions of fraud – or you never had entitlement at any stage from grant.
Now, your Honours, there were two Federal Court cases that held that in addition to entitlement at the commencement of the proceedings or at trial or on appeal, present or current lack of entitlement, a lack of entitlement at grant was fatal, could not be cured. That was the Stack case. That is clearly why – expressly why section 22A was enacted.
Your Honour, I do not need to take the Court to our friend’s notice of appeal where they seek to overturn the court’s refusal – the Full Court’s refusal of their interlocutory application, nor the interlocutory application where they seek to amend their notice of appeal. But I was going to go to their notice of appeal, which is in volume 6. They are conveniently found behind our friend Dr Fisher’s affidavit.
The notice of appeal is at page 2141. I beg your pardon – I am sorry, 2153. Yes, I am sorry; my bracket is after the reference in our note. Your Honours, this is the pleading that they are seeking leave to be able to rely on if they are also allowed to rely on the assignment. So, your Honours, we can see the two elements of an entitlement claim there in paragraph 15A. First:
by operation of s 22A of the Act, as in force with effect from 15 April 2013, the 051 Patent is not invalid merely because it was granted to AstraZeneca AB or because it was not granted to Shionogi.
So, your Honours, we accept, and I think have always accepted, although perhaps not in the very earliest inquiry, but certainly by the time the case was run in the Full Court, that section 22A cures a defect of entitlement at grant, and if you are invalid merely because of a defect at grant, that is enough.
So, your Honours, at the time the trial was run, which was in about October 2012, this Act had been enacted and received Royal Assent on 15 April 2012. In other words, the Act had already been assented to. We all knew that it was going to come into effect on 15 April 2013. So we all knew as at trial that 22A would save a grant type problem, a defect at grant – sorry, a Stack type problem, defect at grant.
But, your Honours, our friend’s attempt to correct the problem of entitlement has two limbs. The other limb is an assignment. Now, your Honours, there is no reason that we know of why that could not have been done before trial with certain forensic advantages to us. We would not have been locked into saying Shionogi – it was good enough for us to say Shionogi invented this, but we would not have accepted that Shionogi invented this. I will show the Court why in a moment.
Your Honours, when this is all boiled down, the invention is 5 and 10 milligrams. Who thought of 5 and 10 milligrams? We do not know. We got good discovery of what Shionogi did but we did not get discovery of what was then not in issue, namely, who came up with the invention? Were they within Shionogi or were they the independent clinicians who were the supervisors, the investigators of the clinical trial? So your Honours, it would not have been futile. First, if this had been brought forward at trial, we would have had those forensic opportunities that I mentioned.
But secondly, they would have cured one of their two defects. They would have cured their defect of a lack of entitlement – current lack of entitlement, assuming Shionogi’s title was made good. Of course, your Honours, they would not just have tendered an assignment from Shionogi. Now they can do that because there is a finding. But as in any intellectual property case, if you want to prove title by assignment, somewhere back at the beginning of the chain of title ‑ unless if it is in issue – somewhere back at the beginning of the chain of title is an inventor who says, “I invented this”, with all the opportunities that would have given us.
So, your Honours, the question of current entitlement could and should have been dealt with at trial. Then when we get to the question of making orders, the assignment was entered into on 11 June. We were told about it after a fight about costs, including indemnity costs.
Her Honour had earlier made an order revoking the patent; staying it, as we always do in patent cases. We always agree to stay the orders because there is some question about whether you can put the patent back. Your Honours, when her Honour delivered her reasons in March, a month before the Act was to come into force, our friends would have been able to say – and indeed, would have been able to say it in their final submissions – please do not revoke our patent because (a) we have already got this assignment, and (b) the Act is going to cure the defect at grant.
Your Honours, there is no explanation for that save that the assignment did not exist. Dr Fisher’s affidavit is back at 2119, and he describes what is sought, which I have attempted to explain. In paragraph 16 and following, he refers to the additional ground, and in paragraph 19, he sets out 22A, and the fact that it is retrospective – sorry, I failed to mention that. Then, your Honours, he rightly says in 21 that:
it had been held that the ground of revocation . . . was established where the patentee was not entitled [at] grant . . . Stack v Davies Shephard –
There was another case called Conor Medsystems, where a similar argument had been run, and her Honour Justice Bennett dissented and said lack of entitlement at grant does not – University of British Columbia v Conor Medsystems. Your Honours, just as our friends did in relation to Apotex v Sanofi and the “starting point” argument, they could have argued that Stack was wrong. They could have said that, in any event, 22A is going to be coming into effect on 15 April. But the reason given is, in 24:
Although it is expressed to have retrospective effect . . . [that argument] was not available –
although there are many procedural things that our friends could have done to preserve their position –
The further evidence . . . only came into existence in June 2013 –
We respectfully submit, with all respect to our friends, that it is not a good enough explanation to say that they were not –
adduced at trial because the Deed had not then been executed. Such evidence could not have assisted AstraZeneca –
Now, your Honours, of course, our learned friends could have run at trial – they vehemently said, and attractively said, Shionogi was not the inventor, we were. Dr Raza, their inventor, in the end was not called. We tendered a paragraph or two of his affidavit, and his invention disclosure statement, and her Honour held nevertheless that Shionogi invented it.
But, your Honours, they could have run that in the alternative, reserved the right to argue that the Stack Case was wrongly decided and they would have dealt with one of the two problems they had, which is current entitlement. Your Honours, our friend took the Court to the right paragraphs, with respect. The Full Court’s reasons, if I could just go back to them very quickly on that point.
Your Honours, we are pretty much on target and of course we have agreed to divide the work up between ourselves and our learned friends. I am sorry, your Honours – at page 2484, paragraph 188, their Honours refuse leave on the futility ground being that the patent is already invalid for a lack of inventive step. We readily accept of course, your Honours, that if we lose on the 7(3) argument and on our other contentions that reason for refusing leave falls away. So what I am addressing is the discretionary considerations that we see ‑ ‑ ‑
FRENCH CJ: You accept that the court would have had power to grant the leave sought and to entertain the application?
MR CATTERNS: Yes, your Honour, yes. But there were arguments about that, but we withdrew that. Sorry, not withdrew them, but – yes, we did. Your Honour, I will not read them out, but in paragraph 189, the court describes our arguments as a persuasive case for refusing leave to amend, in short, because our friends could and we say should have taken the assignment and relied on it at trial, in the alternative. Therefore, as our friend rightly described, the court in 190, almost goes our way ‑ ‑ ‑
FRENCH CJ: …..to refusal.
MR CATTERNS: I cannot say there is a House v The King point, your Honours. But your Honours see that their Honours have accepted the evidence of Mr Sands, of which we have given reference, of the things we would have done at trial. Your Honours, they say in 190 that they would have been:
minded to refuse [the amendments] on discretionary grounds.
So, your Honours, we respectfully submit that if the Court comes to that point, our friends’ interlocutory application should be refused on that basis. Your Honours, that was a contention on our part as your Honours know. That deals with the matters I have submitted in paragraphs 8, 9 and 10 and now we are on page 3 of our note.
We respectfully submit that it has been clear – certainly since the Microcell Case and the NRDC Case – both in 102 CLR back in 1959 – that the face of the specification can be looked at to see whether there is an invention.
Your Honours, it is not a question of admissions. I thought we were going to go quickly to the references that your Honours see under our paragraph 11 but I was going to ask the Court to go first to the patent in suit in volume 3. Your Honours, as it happened, her Honour Justice Jagot found for us on this ground in relation to one of the other patents, the so‑called HEFH patent, where, on the face of that specification there was not an inventive step or there was not an invention.
Your Honours, it is clear from the Microcell Case that this is not a question of admissions in the specification but when the specification, on its face, without resort to other documents, shows that there is no invention then the court can hold that it is not a manner of manufacture.
Your Honours, our friend took the Court to some of these passages as they were in the reasons of the Full Court but I wish to show them to the Court, if I may, in context. So we see the front page of the patent at 1081, page 1 of the specifications at 1083 and, your Honours, it is very clear that we are only talking about one agent, of course, which is rosuvastatin. So I am at page 1083 in volume 3, your Honours.
FRENCH CJ: Your submissions were characterised in the Full Court, I think, as asserting that the prior art documents referred to on the face of the specification only disclosed a dosage range.
MR CATTERNS: Yes, your Honour. Your Honour, the division of labour between ourselves and Mr Ryan is we do not rely on any incorporation by reference – except we adopt our friend’s submission. But my submission now does not rely on any incorporation by reference. The Merck v Arrow Case is a case where they were incorporated. The courts below here held they did not need to be. Our learned friend, Mr Ryan, will make a submission as to why they should be but I am content to argue just on the face of the specification, your Honours. So it is about the use of a cholesterol‑lowering agent and it says in line 4:
the administration of a particular dose or dosage range of the . . . reductase inhibitor –
Your Honours, that is the formula for rosuvastatin. It is referred to as “the Agent”, we see. It -
further relates to the dosage range, start dose and dosage forms of the Agent.
Then they say it is disclosed in the 471 patent. Your Honours see that ends in 471 -
and in Bioorganic and Medicinal Chemistry –
That is Watanabe. So it is disclosed as an inhibitor of the enzyme -
which is a major rate‑limiting enzyme in cholesterol biosynthesis. The Agent is taught as useful in the treatment of hypercholesterolemia –
So they are saying we have here a known drug – known to be useful for hypercholesterolemia. It is a statin. Line 15, they:
are the most widely used prescription medication for the treatment of hypercholesterolaemia.
Then we see a list - your Honours see the statins – lovastatin, et cetera:
atorvastatin and cerivastatin . . . collectively referred to as ‘statins’.
Your Honours, this is the little passage that was used for both of the two witnesses – we went a little higher up in getting them started but crucially it accorded with her Honour’s finding as to the common general knowledge need:
Despite the benefits of statin therapy, less than optimal results may be achieved in patients, due to the level of efficacy and safety achieved at the recommended dosages of the currently marketed statins. Accordingly it is important to find dosages of alternative statins –
and there is only one alternative statin in this document, it is rosuvastatin –
which beneficially alter lipid levels to significantly greater extent than similar dosages –
So what we are doing is we are finding dosages which have better efficacy and no worse safety than similar doses, your Honours. So it is – and knowing that the inventive step is going to be the selection of the doses, it is a similar dose to what is stated here to be, atorvastatin is 10 milligram. That is what we are going to see in a second. Then they have the passage asserting the surprisingness.
Your Honours, there is a debate later when we get to the identification of the invention, but we submit it is very clear in those lines 20 to 23 that what is being talked about is finding dosages here of rosuvastatin which get a better result, if I can use that as a shorthand, than similar dosages of currently used statins. It is found to achieve that, we can see from 24 onwards.
Your Honours, just to save coming back here later, there are many consistory clauses, and your Honours know often they match the claims. These consistory clauses do not. It is clear, and we know that both from Justice Jagot’s reasons and also some other documents that I will not take the Court to, earlier versions of the patent had claims for specific results. Your Honours see at page 2, 1084, lines 3 to 6:
a method of lowering LDL‑C by 40% or more –
et cetera, et cetera, many parameters over many pages of different degrees of reduction, different dosages and so on. It got greatly simplified to the three claims our friends took the Court to. At page 1091, lines 30 to 31, there is another passage our friends noticed, a particular suitable starting dose is 5 to 10, “especially 10 mg per day”. Your Honours, then they do a clinical trial, a phase II trial, which we see at page 1095, line 29:
To illustrate the invention, a randomised, dose response parallel‑group study with [rosuvastatin] in subjects with primary hypercholesterolaemia was carried out.
Your Honours, its primary objective, at the top of page 12, was to estimate the dose‑response relationship and we will see in a minute a range of doses being tried. So you look at the dose and you look at the percentage result which is dose response.
Then there was a secondary objective, to estimate the 10 and 80 milligram doses of atorvastatin, reminding your Honours that we are looking to have a look at whether or not we can get beneficial altering lipid levels to a significantly greater extent than similar dosages of currently used statins. Atorvastatin is the currently used statin used here. We see that in lines 15 and following.
After a 6‑week dietary run‑in, subjects were randomised to either atorvastatin doses (10 or 80 mg) –
So we know we are going to try it against 10 and 80 milligrams of atorvastatin, then line 18:
The open atorvastatin groups were included to obtain additional data on the starting and high doses, of a proven cholesterol‑lowering agent –
So they tell us in this specification that we are looking to get better results with similar dosages of currently used statins and atorvastatin is a proven cholesterol‑lowering agent whose starting dose is 10 milligrams. Your Honours, then we get the tables which show, at page 1102, or page 18, that for example, at line 11 we get 52 per cent lowering of low‑density cholesterol lipid protein against rosuvastatin 10 milligrams, whereas when you do it against atorvastatin 10 milligrams at line 14 you get a lesser reduction of 44 per cent, which is a very useful reduction we all agree.
So, your Honours, then there is a discussion on page 20, or 1104, about running additional trials. So, your Honours, we submit, as a matter of reading of this specification on its face that it says that rosuvastatin is a known agent, known to be useful in the treatment of hypercholesterolemia. The superior efficacy that we see does not find its way into the claims. That is why I drew attention to the consistory clauses. There is no assertion of superior efficacy in the claims.
What we are left with, on the face of the specification, is the choice of a similar dosage, let us pick the preferred 10 milligrams, as atorvastatin, a proven cholesterol lowering agent. So, your Honours, there is nothing inventive about choosing the same dose as atorvastatin. So, your Honours, we submit that that fits within the longstanding idea of lack of inventiveness appearing on the face of the specification.
Your Honours, I was going to go to a couple of cases briefly, if I may. First, Advanced Building Systems v Ramset (1997) 194 CLR 171. In that case, the Full Court picked up an obiter sentence from the Philips v Mirabella Case, which otherwise orthodoxly, if I may say so, applied what we can get from the NRDC Case and Microcell – which I will show the Court briefly – but went further, so far as this ground appearing on the face of the specification, but there was a further obiter remark about going beyond the face of the specification.
That was then applied beyond the face of the specification in the Ramset Case where the description of the specification was supplemented by an integer or two to be found from one of the novelty citations. I think it was literally the rope you pulled to release the clutch that held the device on the piece of concrete you were lifting up. That part of it was rejected – with great respect, rightly – well, they are always right – in Philips v Mirabella - I am sorry, in Advanced Building Systems.
So their Honours say in paragraph 35 in short that the Full Court went wrong. Then their Honours go to Philips and they say that the Court should accept the submission by the appellants that Philips is not determinative. Then their Honours discuss the Philips v Mirabella Case, except giving the impression of confining the Philips v Mirabella Case to being a 1990 Act case. Of course, it was not only a 1958 case. It is the authority in the Full Federal Court for how you deal with transitional patents. But that does not matter. Their Honours say in 38:
Philips came on appeal to this Court on a grant of special leave confined to the construction of s 18(1)(a) –
There was an argument that the dropping of the word “new” from 18(1)(a) made a difference. It does not because the definition of “invention” still has manner of new manufacture. Your Honours see the reference to the “Dictionary” in 38. If I can skip – under the old law:
the doctrine with respect to obviousness and lack of inventive step developed in the nineteenth century, it was decided that a claim for “nothing but” a new use of an old substantive lacked the quality of inventiveness.
The footnote refers inter alia to Microcell and NRDC. There are also instances in which this lack of inventive step was admitted on the face of the specification. So it can either appear, your Honours, or be admitted. As the Court says in Microcell, it is rarely going to be admitted:
If so, a grant might properly be refused in the first instance on the footing that the admission of the lack of an inventive step itself disentitled the applicant to argue that even an alleged invention was disclosed –
because it “would be liable to revocation”:
In Phillips, the appellant failed in its attempt to establish –
as the patentee –
that although a claimed use was nothing but a new use of an old substance this could still be a proper subject of letters patent under the 1990 Act where this character of the claimed use was apparent on the fact of the specification. Rather, Brennan, Deane and Toohey JJ decided that “if it is apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent . . . is absent, one need go no further.”
That is our submission here, your Honours –
It was unnecessary to adduce evidence of the prior art base and to compare the invention claimed with the prior art base . . . if the absence of inventiveness appeared on the face of the specification.
Your Honours, then there is the reference to the obiter going further than the face of the specification. Their Honours say in 40 –
The present case is not in that category of cases, considered in Philips, where the lack of an inventive step appears on the face of the specification.
We take their Honours to be reaffirming that that category remains. We readily accept that the further possibility of going outside the specification, except in a case of a cross‑reference where one treats it as the same document, that that category does not exist. Then their Honours say in 40 that the Full Court below –
went beyond the text of the specification.
Your Honours, we submit that this ground is alive and well. Its modern history in Australia begins with the Microcell Case 102 CLR 233. Your Honours, when something new comes along like stainless steel, or in the case of Microcell, plastic, or now we see the internet, patent after patent gets applied for saying “I use this new thing in what is otherwise an old utility”, which is stainless steel for sinks, or, in the Microcell Case, plastic for a rocket casing.
Your Honours, may I skip through the history that is discussed by their Honours in the Full Court upholding the decision of Justice Menzies below and skip to page 246. Your Honours, may I draw attention to the fact that this case and the NRDC Case are cases of refusal of acceptance at the application stage, whereas Philips and Ramset were not, or Merck v Arrow that our learned friend, Mr Ryan, refers to. In the middle of the page, referring to the Solicitor‑General who, I think, sat on appeals from the Patent Office in those days in the UK, just after footnote (2):
“It has, however, never been contended that either the Comptroller or the Law Officer is bound to accept an application or grant a patent where there is admittedly no invention in the sense of an inventive step, for in such a case the admission itself would disentitle the applicant to argue that there was even an ‘alleged invention’ disclosed. In such a case . . . would be bound to refuse the application or grant on the footing that no manner of new manufacture was disclosed”. When the learned Solicitor‑General uses the words “admittedly” and “admission”, we do not take him as having in mind an express admission contained in the specification. It is most unlikely that an applicant would make such an admission. It must be enough to warrant rejection that it should be clear on its face that the specification discloses no inventive step.
Your Honours, I do not need to – their Honours continue with the analysis of that about – in that case, the jargon, if I may call it that - not their Honours’ jargon, but what we use to describe it is mere new use of an old thing for which its known properties make it suitable. But that does not exhaust the category of places that fit within what we have just seen on this page here.
FRENCH CJ: Your criticism is encapsulated, is it, at paragraph 79 of your submissions?
MR CATTERNS: Of our submissions, your Honour?
FRENCH CJ: Yes.
MR CATTERNS: Yes, your Honour.
FRENCH CJ: So is the position different if it is a proven agent for a method of treatment using a particular dosage without reference to any other agents?
MR CATTERNS: Your Honour, if – I readily accept that our argument includes as an essential step in its reasoning the 10 milligrams of atorvastatin.
FRENCH CJ: Yes. So it is the comparative ‑ ‑ ‑
MR CATTERNS: Yes, yes, your Honour. I readily accept that the Full Court notices that argument – I was going to say we made the argument, but I accept we did not emphasise it very greatly, your Honour. Now I do emphasise the comparison of atorvastatin. I took the Court to that paragraph, that page, page 12. But we were also stressing the incorporation by reference – by way of a tag team we are putting this argument in a narrower fashion, your Honour.
FRENCH CJ: It is a fact that it is a reference to similar dosages to other agents that leads the specification to fall short of the inventive character necessary to characterisation as a manner of new manufacture, whereas if you had just said, this agent, at those dosages, you would be all right.
MR CATTERNS: Yes, if it just said, here is this new agent which is known and going to be useful for this – I am here finding the right dosages for it ‑ ‑ ‑
FRENCH CJ: That is why I wondered earlier on about the notion of the dosage cutting across all these different agents as though it is a – you are not comparing oranges with apples.
MR CATTERNS: Yes, your Honour, that is true of our friend’s cerivastatin example which, as I submit, was not common general knowledge. But, when we look, for example – may I jump off to Watanabe, your Honour – when we look at Watanabe we are getting, as you might expect, I think, in a developed science, where you are getting benefits that are still outstandingly good for this drug, I readily accept, but where you are getting benefits like the ones we saw for the monkeys at Watanabe, that is why it is sensible to have in mind the other drugs – dosages – as part of your thinking in determining the doses. Your Honours, the NRDC Case, also in 102 CLR 253 – and I can do this quickly this afternoon if that is convenient for the Court ‑ ‑ ‑
FRENCH CJ: Yes.
MR CATTERNS: ‑ ‑ ‑ of course is famous for the discussion of what constitutes a manner of manufacture –is this the kind of thing and the Court will be considering it again next month. But in the first part of the Court’s reasoning the Court dealt with a Microcell point and the Court makes it clear that there are two, as it were, elements. Perhaps there are more in future cases. So your Honours remember this was the use of known chemicals for a new purpose which is to kill the weeds in useful crops like lucerne and they had never been suggested for that purpose before. But the Court draws attention to the two aspects of the definition of manner of manufacture. At 102 CLR at 261, about five or eight lines from the bottom, referring to:
The principles which govern the power to refuse a patent –
in Microcell and the discussion about “alleged” and “new” ‑
and that accordingly the Commissioner may properly reject a claim for a process which is not within the concept of a “manufacture” –
and that is the famous half of the judgment that rejected the simple test of a vendible product –
But the case cited shows also that even if the process is within the concept the Commissioner is not bound to accept the allegation of
the applicant that it is new, if it is apparent on the face of the specification, when properly construed, that the allegation is unfounded –
Skipping to the end of that paragraph:
“nothing but a claim for a new use of an old substance”.
But, as Microcell Case emphasizes, it must always be remembered . . . the “nothing but”.
Your Honours, in the Philips v Mirabella Case, which I was not going to go to, it was submitted that the Court was here talking about obviousness, but it is plainly not, I submit. I do not need to go to the facts of it, your Honours, just to show your Honours the structure. Their Honours are then discussing whether Microcell applies to the instant patent in the NRDC Case. That argument continues, including discussions of media discoveries and so on; that discussion, until the bottom of page 264, where the Court says:
No‑one reading the specification . . . can fail to see that what it claims is a new process –
et cetera. In other words, Microcell does not apply. Their Honours continue looking at the specification, until page 268. Then their Honours say, eight lines down at the top of 268:
The purpose of going thus fully into the contents of the specification is to show that it is out of the question to hold that on the face of the document, properly construed, the process . . . [of the claims] as nothing but a new use of an old substance.
It is emphatically not that. Your Honours, it is then in the next paragraph that begins “The central question in the case remains” that the Court goes on, in what has become the famous part of the Court’s reasoning dealing with the whole subject matter of what is a manner of manufacture. If that is a convenient time, your Honours?
FRENCH CJ: Yes. The Court will adjourn until 10 o’clock tomorrow morning.
AT 4.13 PM THE MATTER WAS ADJOURNED
UNTIL THURSDAY, 14 MAY 2015
- AGLC
- Astrazeneca AB & Anor v Apotex Pty Ltd; Astrazeneca AB & Anor v Watson Pharma Pty Ltd; Astrazeneca AB & Anor v Ascent Pharma Pty Ltd [2015] HCATrans 106
- Case
- [2015] HCATrans 106
- Decision Date
CaseChat Overview and Summary
The High Court was required to determine whether the respondents' proposed or actual importation, supply, and sale of their generic rosuvastatin products would infringe AstraZeneca's Australian Patent No 690500. Specifically, the court had to consider whether the respondents' products contained rosuvastatin calcium as the active ingredient, and if so, whether this constituted infringement of the patent claims. A key issue was the interpretation of the patent claims and whether the respondents' products fell within their scope, particularly in light of AstraZeneca's assertion of infringement based on the presence of rosuvastatin calcium.
The High Court applied principles of patent law, including the construction of patent claims and the test for infringement. The court considered the evidence presented regarding the composition of the respondents' products and the scope of AstraZeneca's patent. The reasoning focused on whether the respondents' products contained the patented substance, rosuvastatin calcium, as claimed in the patent. The court analysed the evidence to determine if the respondents' activities constituted an infringement of AstraZeneca's exclusive rights under the patent.
The High Court granted the interlocutory injunctions sought by AstraZeneca, restraining the respondents from infringing Patent No 690500. The court found that AstraZeneca had established a strong prima facie case of infringement and that the balance of convenience favoured granting the injunctions to protect AstraZeneca's patent rights pending a final determination of the proceedings.
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