Pfizer Overseas Pharmaceuticals & Ors v Eli Lilly & Co & Ors

[2006] HCATrans 271

[2006] HCATrans 271

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
  Melbourne  No M150 of 2005

B e t w e e n -

PFIZER OVERSEAS PHARMACEUTICALS

First Applicant

PFIZER AUSTRALIA PTY LTD

Second Applicant

C P PHARMACEUTICALS INTERNATIONAL CV

Third Applicant

PFIZER MANUFACTURING LLC

Fourth Applicant

PFIZER PRODUCTION LLC

Fifth Applicant

and

ELI LILLY & COMPANY

First Respondent

ELI LILLY AUSTRALIA PTY LTD

Second Respondent

ELI LILLY & COMPANY LTD

Third Respondent

Application for special leave to appeal

GLEESON CJ
HAYNE J

TRANSCRIPT OF PROCEEDINGS

AT MELBOURNE ON FRIDAY, 2 JUNE 2006, AT 11.31 AM

Copyright in the High Court of Australia

__________________

MR D. SHAVIN, QC:   May it please the Court, I appear for the applicant with my learned friend, MS H.M.J. ROFE.  (instructed by Corrs Chambers Westgarth)

MR D.K. CATTERNS, QC:   May it please the Court, I appear with my learned friend, MS K.J. HOWARD, for the respondents.  (instructed by Blake Dawson Waldron)

GLEESON CJ:   Yes, Mr Shavin.

MR SHAVIN: If the Court pleases. The case raises for consideration the issue of the meaning of the words “matter described in the specification” in section 40(3) of the Patents Act 1990 in a way that has not previously been considered by this Court. The question which sharply divided the Federal Court below was what constituted a fair basis for a claim where the specification contained what Justice Crennan described at paragraph 422 of her judgment as a broad disclosure and a narrow disclosure and there are claims as to both.

GLEESON CJ:   I had an impression, correct me if am wrong, that the question that divided the majority and the minority in the Federal Court was a question of construction of the specification.

MR SHAVIN:   In our respectful submission, no, your Honour, for this reason.  The patent discloses a method of treatment for erectile dysfunction.  The patent commences its discussion by saying it relates to a very wide class of compounds and there is disclosed a new use for a class of compounds, compounds that were previously disclosed in the Bell patent referred to on page 7 of the specification.  There is also disclosed within the specification the pharmacological action which mediates the treatment and that pharmacological action explains not only why that class of compounds can be used as a method of treatment, but also discloses how you engage in the treatment and that is said so expressly at the foot of page 9 to the top of page 10 of the specification. 

The majority, in approaching the specification, looked only to the class of compounds.  They looked only to words which they sought to attribute a description of the invention.  In a sense they looked to words akin to a consistory clause and said that is all to which we will look.  They did not look or consider in the context of fair basis the broader disclosure.  They averted the process, whereas this Court affirmed the statement of Justice Gummow in Rehm, “Did you look to see whether there is matter described in the body and say does it disclose in a general sense that which is claimed?”

The majority wrongly looked to certain words disclosing the compounds, failed at all to consider the method of action, the pharmacological action that mediates the method of treatment and then said to make claim 10 valid one would have to find disclosed a full range of compounds and this can be found, your Honours, at paragraph 276 at page 188 of the application book.  Paragraph 276 which deals with the third question postulated by the majority at the foot of paragraph 273 on the same page, that is:

Whether or not proposition 2 is correct, the principle claimed in claim 10 was broadly described in the specification.

Their Honours said:

The third proposition depends upon finding in the specification a broad statement of a range of cGMP PDE_V inhibitors which can accommodate the range claimed in claim 10.

Now, what their Honours are doing here, with respect, is that they are taking their view of what the inventor has said is the invention.  They have taken the claim and said the claim can only be fairly based if in fact in the body there is the full range of compounds disclosed.

GLEESON CJ:   What about two sentences on from that?

MR SHAVIN:   “Any limitation in the specification”?

GLEESON CJ:   No.  The sentence beginning with the word “indeed”.

MR SHAVIN:   I am sorry, your Honour.

Indeed the whole of its text may be read as limited by the class of compounds referred to in the opening sentence.

But, in our respectful submission, what the majority did not do, which Justice Crennan did do, was to recognise that in fact contained particularly from the foot of page 7 to the top of page 10 of the specification there is something which is akin to a disclosure of a broad principle.  Now, if I could take your Honour ‑ ‑ ‑

GLEESON CJ:   If you look at page 229, paragraph 414, that is the point of departure, is it not, between the majority and the minority?  You compare paragraph 276 with paragraph 414.

MR SHAVIN:   With respect, no, your Honour, because what her Honour Justice Crennan said later at paragraphs 419 and 422 is that the question of the interchangeability of the expressions “the compounds of formula (I)” and “the compounds of the invention” is really beside the point, that at the end of the day that question does not matter.  She says that quite expressly at paragraph 422 on page 232 of the application book where her Honour says, having concluded that they do have a different meaning, 10 lines from the foot of the paragraph:

Even if that is not correct, or if any distinction between the two expressions is really a distinction without a difference, it seems to me that the results described on page 9 disclose a principle, namely the use of cGMP PDE_V inhibitors, which expression would be understood as synonymous with selective cGMP PDE_V inhibitors, to cure or prevent erectile dysfunction.  The disclosure of the explanation of why the compounds of the invention Pyrazolopyrimidinones work, as a treatment of impotence, is a further aspect of, or broader disclosure in, the body of the specification, than the disclosures by reference to the structure of various compounds of formula (I).  Therefore, it seems to me claim 10 broadly claims what is reasonably clearly disclosed in the body of the specification on pages 2 and 9 to 11 and in the fourth consistory clause on page 11.

So that, in our respectful submission, what the majority failed to do was to say let us look at the claim then let us apply the test stipulated by the Court in paragraph 69 of Lockwood and find whether there is matter in the specification which discloses in a general sense that which is claimed because when one does that one finds that the passage at the foot of page 9 of the specification going to the top of page 10 fits that categorisation.  If I could take the Court to page 10 of the application book, which is page 9 of the specification to which her Honour Justice Crennan referred, one finds set out in the first paragraph the results of the tissue analysis in the corpus cavernosum and then in the next paragraph a summary of that investigation, then this key paragraph:

The compounds of the invention have been tested in vitro and found to be potent and selective inhibitors of the cGMP‑specific PDE_V.  For example -

and there is a description of one of the examples.  Then there is this key sentence:

Thus relaxation of the corpus cavernosum tissue and consequent penile erection is presumably mediated by elevation of cGMP levels in the said tissue, by virtue of the PDE inhibitory profile of the compounds of the invention.

So what that is saying is that what in fact is the treatment for erectile dysfunction is using a compound with the PDE inhibitory profile that has been demonstrated.  That is, in fact, exactly what the respondent did.  The respondent has produced a compound which has not got the same structure as the compounds of formula (I) which has the PDE inhibitory profile and that was admitted as is noted in the majority judgment and forms the foundation of the finding of infringement.

Thus, what is disclosed here is the pharmacological action.  What is claimed therefore, in claim 10 is the broader principle.  What is claimed in claims 1 to 8 is the structure, the narrower principle, and the fact that this specification when filed as a provisional related to the structure.  Then there was the disclosure of the broader principle which gave rise to claim 10, the priority date of which only runs on the filing of the complete, shows that in fact there were two aspects of the invention, the invention being the method of treatment.

GLEESON CJ:   Mr Shavin, has there been litigation in other parts of the world about this matter?

MR SHAVIN:   There has.

GLEESON CJ:   What has been the outcome of that?

MR SHAVIN:   In the United Kingdom in accordance with principles which were rejected by this Court in Astra v Alphapharm and in fact which were footnoted in footnote 82 of that judgment the Court of Appeal rejected the patent on the ground that it was obvious but using the test that is not the law in Australia.  In the European Patent Office the patent was rejected in accordance with the same principle.  In the United States the infringement and revocation proceedings have been frozen whilst there has been a post‑grant director initiated re-examination of the patent which has not yet been concluded.  In Canada and New Zealand the proceedings have not yet reached trial and I think the other common law jurisdictions are at an earlier stage.

GLEESON CJ:   Thank you.

MR SHAVIN:   In our respectful submission, the majority below wrongly sought to define the scope of the invention by looking exclusively to statements in the body which they characterised as describing expressly the invention, the narrow disclosure, to the exclusion of the statements in the body which relate to the invention.  In paragraph 53 in Lockwood this Court said:

Although s 40(3) does not use the word “invention”, this context suggest, and the parties agreed, that the requirement in s 40(3) that the claims be fairly based on the matter described in the specification is a requirement that they be fairly based on the matter in it that discusses the “invention” -

What the Court was at pains to do was to draw a distinction between “matter” in the specification which might constitute an assertion or description by the inventor of what the invention is, in many cases what is called the consistory clause, to looking at matter in the specification which discusses the invention.  That becomes clear in paragraph 99 of Lockwood where the Court said:

The inquiry is into what the body of the specification read as a whole discloses as the invention discloses as the invention.  An assertion by the inventor in a consistory clause of that of which the invention consists does not compel the conclusion by the court that the claims are fairly based nor is the assertion determinative of the identity of the invention.  The consistory clause is to be considered by the court with the rest of the specification.

Now, in our respectful submission, where their Honours in the majority fell into error was that they failed to look at this key discussion of matter that relates to the invention and asked themselves the question, “Does that matter in a general sense support the claim?”  As this Court said in Lockwood in paragraph 69 in citing the statement by Justice Gummow in Rehm v Websters Security Systems:

Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”

Her Honour Justice Crennan, with respect, did precisely that.  She looked at the claim.  She looked at the matter relating to the invention that was discussed.  She found within that matter in a general sense described that which had been claimed. 

HAYNE J:   Now, in that respect does it come to this?  Does it come to the significance to be attached to the sentence commencing last on page 10 and carrying over to page 11 of the application book - “Thus relaxation” etc?

MR SHAVIN:   Not exclusively, with respect, your Honour, because what one finds, as her Honour Justice Crennan also noted on page 2 of the specification, which appears on page 3 of the application book, that even in the initial discussion of the compounds of the invention the disclosure went to the pharmacological action mediating the treatment and so one found that the compounds of the invention are potent inhibitors of cGMP in contrast to the inhibition of cAMP and it was this pharmacological action which even in an early stage of the specification is identified as that which mediates the method of treatment.  With respect, where their Honours in the majority fell into error was to look at the first sentence:

This invention relates to the use of a series of pyrazolo[4,3‑d]pyrimidin-7-ones for the treatment of impotence -

and use the word “relates” as if it means is defined by or is limited in scope by, but it is not the job, in our respectful submission, of the body of the specification to define the scope of the invention.  It is the job of the body of the specification to discuss the invention, to provide matter and describe matter which can be then the subject of the claims which are the only source of a definition of the scope of the invention.

GLEESON CJ:   The claim with which we are concerned, which appears on the bottom of page 34 at line 45 is a method of treatment:

with an orally effective amount of cGMP PDE inhibitor ‑ ‑ ‑

MR SHAVIN:   Yes.

GLEESON CJ:   Any method of treatment.

MR SHAVIN:   What is claimed is a simple method is trained:

of orally treating man to cure or prevent erectile dysfunction in man in need of such treatment which comprises treatment with an orally effective amount of –

a compound which has the pharmacological action which mediates the treatment.  The fundamental disclosure that supports this ‑ ‑ ‑

HAYNE J:   No - of any such compounds.

MR SHAVIN:   Yes, because what was disclosed for the first time in this patent was that within the corpus cavernosum the predominant PDE was PDE_V.  There was no PDE_I.  This is discussed by her Honour in paragraph 418 of the judgment.  Thus, for the first time, what was found was that what mediates penile erection was a relaxation of the tissue by inhibiting the PDE_V and so if you had cGMP selective inhibitor of PDE_V that is in fact what enables you to treat erectile dysfunction and so you had a number of compounds but why those compounds work was because of the pharmacological action and that is clearly disclosed and although it is disclosed with the words at the end, as one found at page 10:

by virtue of the PDE inhibitory profile of the compounds of the invention -

that is simply because that is where the tissue analysis was undertaken, so what is being identified is a PDE inhibitory profile of the type identified in the compounds of the invention.

HAYNE J:   What significance, if any, is to be attached to the word “presumably” in line 1 on page 11?

MR SHAVIN:   A scientific caution and no more, in our respectful submission.  The only other matter which we would like to advance to the Court is that there is a further vice in the formulation that has been used by the majority because what the majority is in effect doing by that first sentence in paragraph 276 is two things.  First, it is conflating issues of

sufficiency into issues of fair basis contrary to what was clearly expressed by this Court in paragraph 49 in Lockwood and doing it in a way which again fails to give affect to the teaching in Kimberly-Clark so emphatically emphasised by this Court in Lockwood as being the law in Australia because the effect of it, the teaching of the majority in that first sentence is that there could not be a fair basis for claim 10 unless there was disclosed the full range of compounds.  That will give effect to it and that, with respect, is exactly contrary to the teaching of Kimberly-Clark which says you had a sufficient disclosure if you enable a method of giving effect to the claim.

HAYNE J:   Now, you speak of full range.  Where do I find that?

MR SHAVIN:   “The third proposition depends” is at the foot of page ‑ ‑ ‑

HAYNE J:   Yes, I understand that.  Where do I find full range?

MR SHAVIN:   The word “full” perhaps I am saying is implied by the words “which can accommodate the range claim”.

HAYNE J:  

a broad statement of a range . . . which can accommodate the range ‑ ‑ ‑

MR SHAVIN:   Yes, which means that you are giving the whole of the range and you have to give a broad statement of the compounds rather than one can give a method of treatment with a means à la Kimberly-Clark of giving effect to it and the Court found unanimously below and at first instance that there was a sufficient disclosure but, in our respectful submission, it is important that the approach to fair basis should be consistent with the approach to sufficiency, that this case provides a unique vehicle to deal with questions of patent where there is both a broad and a narrow disclosure, that the decision of Justice Crennan shows that if one approaches this case consistently with the principles identified in Lockwood v Doric one can have a claim based on the broad disclosure that it is not necessary to stipulate all the compounds and in that way the majority has, in our respectful submission, fallen into error.  If the Court pleases.

GLEESON CJ:   Thank you, Mr Shavin.  Yes, Mr Catterns.

MR CATTERNS:   May it please the Court.  Your Honours, in our submission, this is a pure question of construction and it relates to the significance of the passage our friends rely on on pages 9 and 10 in the context of the specification as a whole.  We agree and know justices disagreed that is the question and that Lockwood v Doric applied.  Of course, your Honours, Lockwood v Doric was a case where there was both a broad disclosure as the Court held upholding the breadth of claim 1 and a narrow disclosure of a particular embodiment.

The special leave questions that our friends propound, we submit, do not arise because there is no doubt about what “the matter” is in section 40(3). We agree and the courts below approach it on this basis that it is all the matter from the start to the finish of the body of the specification that must be looked at to see whether or not the claim has a fair basis in that. Your Honours, we submit it is just a question of construction and, your Honours, if we could perhaps go to the claim again reminding your Honours that is at page 16. His Honour the Chief Justice referred to the coloured version. If the Court does not mind I will just go to the other version at page 16:

A method of orally treating man –

and “orally” is important because that does not appear in the passage that our friends rely on, but it does appear in other passages which support the holdings below –

to cure or prevent erectile dysfunction in man in need of such treatment, which comprises treatment with an orally effective amount of a cGMP PDE_V inhibitor –

and that is crucial, your Honours, because that is a completely different claim from the claim which was removed during the running of this case which was a broader claim yet which was cGMP PDE.  They are different things although cGMP PDE_V comes within the overall class.  Confusion between those two things, we respectfully submit, is what led her Honour Justice Crennan into error.

Then, your Honours, at page 9 of the specification, page 10 of the book, there is the discussion of the experiment and the result of the experiment is given around about lines 40 to 45:

In summary, the above investigation –

which related to one piece of tissue –

identified three PDE isoenzymes in human corpus cavernosum tissue.  The predominant PDE is the cGMP-specific PDE_V -

Fair enough.  That is what our friend’s results show but, your Honours, in the very paragraph that our friends base their case on it is clear that what the inventor is describing as the invention, which is what the Court in Lockwood looked at, is the compounds of the invention.

Now, our friends no longer run an argument that the compounds of the invention is something different from the compounds of formula (I) which, with respect, also led her Honour Justice Crennan into error.  The majority and Justice Heerey held, and we submit correctly and it does not seem to be challenged now, that the terms are used interchangeably.  So, your Honours, in the very paragraph our friends rely on, the inventors return to the compounds of the invention which are said to be potent and selective inhibitors.  For example, one of the especially preferred compounds has that inhibitory effect, and then our friends read the next passage:

Thus relaxation of the corpus cavernosum tissue and consequent penile erection is presumably mediated by elevation of cGMP levels in the said tissue, by virtue of the PDE inhibitory profile of the compounds of the invention.

So it is a question of construction.  We respectfully submit that even in our friend’s best passage the inventors are saying it is the compounds of the invention.  Now, your Honours, so far that we have not come to “orally” but on page 10 as the description continues we see in the next paragraph the compounds of the invention being tested as to toxicity and then perhaps the central paragraph of the specification at line 30:

In man, certain especially preferred compounds have been tested orally in both single dose and multiple dose volunteer studies.  Moreover, patient studies conducted thus far have confirmed that one of the especially preferred compounds –

that is, no doubt, compounds of the invention – works.  We see again “compounds of the invention”, “oral administration of the compounds of the invention”, “compound of formula (I)”.

Now, your Honours, that follows, so even after the passage our friends rely on and the description of the experiment in the very paragraph our friends rely on, the inventors are focusing on the compounds of the invention which is the same as the compounds of formula (I).  Both his Honour Justice Heerey and the majority also relied on what appears from pages 2 to 7, your Honours, whereas at page 2 there is the heading “PYRAZOLOPYRIMIDINONES” and, of course, your Honours, our product “Cialis” is not one of those drugs.  We have a completely different chemical formula.  As our friends read the invention relates to a use of a series of those for the treatment of impotence, remembering what we are doing your Honours is reading the specification as a whole to see what is disclosed as the invention.  The on page 3, your Honours, line 29:

The compounds of the invention are potent inhibitors of cyclic guanosine 3',5'-monophosphate phosphodiesterases (cGMP PDE) –

not cGMP PDE_V, which is what claim 10 relates to.  Then, your Honours, at the bottom of page 3 there is the first of two consistory clauses, to pick up the jargon.  At line 46 they say:

Unexpectedly, it has now been found that these disclosed compounds are useful in the treatment of erectile dysfunction.

So it is a particular class of compounds.  This is the consistory clause:

Thus the present invention concerns the use of a compound of formula (I) -

which as we submit is used interchangeably with the compounds of the invention.  Then we get the formula for two pages, your Honours, and the sentence continues at page 5, line 38:

or a pharmaceutically acceptable salt thereof . . . for the manufacture of a medicament for the curative or prophylactic treatment of erectile dysfunction –

Then at line 50 there is more discussion of the compounds of formula (I) and then over pages 6 and 7 there are further discussions of the compounds of formula (I); “preferred groups” at the top of page 6; “more preferred” groups; in the middle a “particularly preferred group” and then “Especially preferred individual compounds”.

GLEESON CJ:   How would you identify the issue of construction that you say it turns on?

MR CATTERNS:   Whether, to use the phrase from Lockwood v Doric, what the body of the specification read as a whole discloses as the invention is the use of the compounds of formula (I) or the compounds of the invention in the oral treatment of male erectile dysfunction, as we would say it, or whether as our friends would say it, it also discloses the use of cGMP PDE_V inhibitors, a vastly broader class in the oral treatment of male erectile dysfunction.  So it is purely whether or not our friends can read the passage at pages 9 to 10 of the specification, 10 to 11 of the book, as providing for an additional description of an invention.  

Our friends do not disagree and there is no dispute that the specification at least discloses the use of the compounds of the invention and that is what claim 1 is, but the question is, on which three justices are our way, whether or not the specification discloses as the invention the use of cGMP PDE_V inhibitors merely by reporting the results of that experiment and then going on to say the resultant erection is mediated by the profile of the compounds of the invention.

Your Honours, the last passage in the specification we wish to take the Court to is at page 12 and this is, as the colouring in shows us in the other version, this relates to some other consistory clauses that were added in between the original filing and the filing of the PCT application and these are the six consistory clauses that are referred to and, your Honours, none of those matches claim 10.  With respect, that is another clear error on the part of her Honour Justice Crennan.

Claim 1 refers to pharmaceutical compositions compound of formula (I).  That corresponded with a claim now deleted.  Claim 2 was a process for preparing a composition, also now deleted.  Claim 3 corresponds with claim 1, a method of treating man comprising treating with an effective amount of a compound of formula (I).  Claim 4 related to a use of a cGMP PDE inhibitor.  Your Honours will notice that is not a PDE_V inhibitor.  Claim 5 – I am sorry, your Honours, clause 5 refers to:

A method of orally treating man to cure or prevent erectile dysfunction in man in need of such treatment, which comprises treatment with an orally effective amount of cGMP PDE_V inhibitor –

Your Honours, that corresponds with claim 9 which was omitted in prosecution and claim 6 also refers to cGMP PDE inhibitor.  None of those consistory clauses refers to cGMP PDE_V inhibitors.  So these clauses too, we respectfully submit, far from helping our friends, as her Honour Justice Crennan thought, help us because the only clauses there which match a claim are the ones which refer to formula (I).

HAYNE J:   Now, you say Justice Crennan was in error.  Where do I see most conveniently what you say is the error?

MR CATTERNS:   Yes, your Honour.  Thank you.  Your Honours, at page 231, in paragraph 419, her Honour refers to the consistory clauses and her Honour says in line 32:

The fourth consistory clause read in the context of the disclosures extracted here from pages 2, 9 and 11 of the body of the specification is apt to cover the disclosures in those pages directed to the principle claimed in claim 10.

With great respect, that is plainly wrong because the clauses on page 11 that her Honour is referring to refer to cGMP PDE not cGMP PDE_V.

GLEESON CJ:   Is that what she is dealing with in paragraph 420?

MR CATTERNS:   Yes, your Honour, I think so.  Your Honours, there is a second error at 231, line 36, where her Honour goes on and says:

Those specified disclosures on pages 2, 9, 11 refer to ‘compounds of the invention’ in apparent or possible contradistinction to the references to the ‘compounds of formula (I)’ -

As we have submitted, our friends no longer support that and the other judges below said that there was no distinction between compounds of formula (I) and compounds of the invention.

Your Honours, there is a similar error in 421 where her Honour notes that that clause:

may also have been apt for ‘field of use’ claims ultimately abandoned.  Further, it does not matter if, as the trial judge found ‘claim 10 (and the abandoned claim 9) are an awkward fit’.

I do not need to take the Court to it, but his Honour was not referring to fit with each other.  He was referring to the fit with the body of the specification which is the proper inquiry for the purposes of fair basis.  Then her Honour goes on and says:

claim 10 matching the disclosure of the use of the compounds of the invention on pages 9 to 11 and the fourth consistory clause –

Her Honour goes back to that.  But, your Honours, it does not, claim 10 is vastly broader than the compounds of the invention as our friends agree.  The compounds of the invention are the compounds of formula (I), itself a very broad class of chemicals because there are so many possible substitutions, but claim 10 goes vastly past that.

Then, your Honours, in 422 there is a similar error but perhaps drifting into another area that was criticised in Lockwood v Doric.  At line 28:

It seems to me that a contradistinction between ‘compounds of formula (I)’ and ‘compounds of the invention’ is deliberately made –

and again, as I have submitted, our friends do not support that, but then her Honour goes on:

as part of the explanation of the essence of the inventive step -

and that is drifting, we submit, into the discourse of inventive merit or inventive step which the High Court in Lockwood v Doric was at great pains to keep separate.

So, your Honours, in our respectful submission, this is a pure question of construction.  There is no disagreement that Lockwood v Doric applies.  There is no disagreement that Lockwood v Doric requires attention or directs attention to the body of the specification read as a whole to see whether it supports the claim and, in our respectful submission, the majority and his Honour Justice Heerey were completely correct in holding that as a matter of construction what was described as the invention here is the use of “compounds of formula (I)”, not the use of any cGMP PDE_V inhibitor.  May it please the Court.

GLEESON CJ:   Thank you, Mr Catterns.  Yes, Mr Shavin.

MR SHAVIN:   If the Court pleases.  There are three points we would seek to make in reply.  First, our learned friend in posing the question for your Honour Justice Hayne, in our respectful submission, posed the wrong question.  The question that ought to be posed is the question as stipulated by this Court in paragraphs 68 and 69 of Lockwood v Doric.  The question is not what does the specification disclose as the invention?  The question is rather does the specification - is there for clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say, in a general sense, described.

You do not go to the body and say what is the invention and try and define the scope of the invention from the body.  You define the scope of the invention from the claim and find if there is matter in the body that supports it so that, in our respectful submission, our learned friends in responding to your Honour Justice Hayne have in fact repeated the error of the majority.  They have asked the wrong question and that is what led the majority to fail to look to the broad disclosure.

Secondly, our learned friends pointed to paragraph 419 of her Honour Justice Crennan and said that her discussion of the fourth consistory clause read in the context of the disclosure extracted from 2, 9 and 11 of the body “is apt to cover the disclosures in those pages directed to the principle claimed in claim 10” was wrong, with respect, our learned friend is in error.  In paragraph 418 her Honour summarises the results reported of the test.  What the results of the test report is that both PDE_I and PDE_V are known by persons skilled in the art as to likely to co-elute and what had been determined was that there was no PDE_I present and that is said by her Honour:

The first, fraction 1 (designated by order of elution) represents the major PDE present.  This was disclosed to be PDE_V which was found to be insensitive to stimulation by calcium/calmodulin.  There was evidence from Mr Burslem that a person skilled in the art would be aware that PDE_I and PDE_V are known to co-elute in fraction 1 and that PDE_I is sensitive to stimulation by calcium/calmodulin.

So what the report of the tissue analysis tells a person skilled in the art is that there is no PDE_I.  That means that the references to the utility of cGMP PDE is a reference only to cGMP PDE_V because the only other possibility is not there.  If you have no PDE_I in the tissue, something that inhibits PDE_I will be of no utility at all and, in that sense, in our respectful submission, it is clear that her Honour in paragraph 419 has not fallen into error.

Finally, it is not that we have abandoned the issue of the compounds of formula (I) versus compounds of the invention.  In our respectful submission, that issue is irrelevant.  As her Honour Justice Crennan said it was not central to her conclusion.  In our respectful submission, her conclusion as to a broad principle stands independently of that debate.

GLEESON CJ:   The orality of this method of treatment is key, is it not?

MR SHAVIN:   Yes.

GLEESON CJ:   On the bottom of page 10 and the top of page 11 in the paragraph to which so much attention has been directed is there any reference to orality?

MR SHAVIN:   No.  But the references further down on page 10 to the compounds being capable of being orally administered and at line 43:

Generally, in man, oral administration of the compounds of the invention is the preferred route –

tells you that it can be used orally and there is nothing that suggests that the PDE inhibitory profile will alter or affect the capacity to administer it orally.

In our respectful submission, by not referring at all to the broad principle of disclosure, by asking the wrong question, the majority fell into error, failed to follow Lockwood v Doric, but furthermore there is no express reference in Lockwood v Doric to a broad and a narrow principle.  That is something that has arisen in this case and if this case stays as it presently stands there will be a direction to approach to all future judges in

the Federal Court with the method and the first sentence in paragraph 276 and that ‑ ‑ ‑

HAYNE J:   Why will they go past what is Lockwood v Doric, Mr Shavin?

MR SHAVIN:   Because Lockwood v Doric dealt with a different fact situation.  This has a majority ‑ ‑ ‑

HAYNE J:   An unusual treatment of precedent, I would have thought that you are suggesting, but there you are.

MR SHAVIN:   The Federal Court tends to look at its Full Court explanation of the High Court in terms of single judges understanding what the High Court has said.  May it please the Court.

GLEESON CJ:   Yes, thank you, Mr Shavin.

The point of departure between the majority and the minority in the Full Court of the Federal Court related to a question of construction of the specification.  The outcome of the case turned upon the application of well‑established principles to the particular facts and circumstances and the case does not appear to us to raise an issue suitable to a grant of special leave to appeal.  The application is dismissed with costs.

AT 12.14 PM THE MATTER WAS CONCLUDED