Wyeth & Anor v Sigma Pharmaceuticals (Australia) Pty Limited; Wyeth & Anor v Alphapharm Pty Limited; Wyeth & Anor v Generic Health Pty Ltd [2012] HCATrans 116 (11 May 2012)

Last Updated: 16 May 2012

[2012] HCATrans 116

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S393 of 2011

B e t w e e n -

WYETH

First Applicant

WYETH AUSTRALIA PTY LTD (ACN 000 296 211)

Second Applicant

and

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LIMITED ACN (004 118 594)

Respondent

Office of the Registry
Sydney No S394 of 2011

B e t w e e n -

WYETH

First Applicant

WYETH AUSTRALIA PTY LTD (ACN 000 296 211)

Second Applicant

and

ALPHAPHARM PTY LIMITED ACN (002 359 739)

Respondent

Office of the Registry
Sydney No S395 of 2011

B e t w e e n -

WYETH

First Applicant

WYETH AUSTRALIA PTY LTD (ACN 000 296 211)

Second Applicant

and

GENERIC HEALTH PTY LTD ACN (110 617 859)

Respondent

Applications for special leave to appeal

GUMMOW J
HAYNE J

TRANSCRIPT OF PROCEEDINGS

AT SYDNEY ON FRIDAY, 11 MAY 2012, AT 10.50 AM

Copyright in the High Court of Australia

MR A.J.L. BANNON, SC: If the Court pleases, I appear with my learned friend, MR C. DIMITRIADIS, for the applicant in each of the applications. (instructed by Jones Day)

MR D. SHAVIN, QC: If the Court pleases, I appear with my learned friend, MS H.M.J. ROFE, for the respondent in matter S393. (instructed by Griffith Hack Lawyers)

MR S.C.G. BURLEY, SC: If it please the Court, I appear with my learned friend, MR P.W. FLYNN, for the respondent in matter S394. (instructed by King & Wood Mallesons)

MR A.D.B. FOX: If the Court pleases, I appear for the respondent in matter S395. (instructed by Middletons Lawyers)

GUMMOW J: Yes, Mr Bannon.

MR BANNON: Your Honours, in our submission, the Full Court decision poses a new conceptual hurdle for a patentee who seeks protection for an invention consisting of a method claim which, in terms, is not limited to the use of a specific product. The hurdle amounts to this. The patentee discloses that the inventor cannot perform the method claim across the whole breadth of the claim, it is not fairly based and that the method to be fairly based must be limited to the extent to which the inventor can perform that method claim. We submit that that conceptual hurdle which they pose infects both questions which we say arise and are worthy of consideration by this Court.

It is sufficient to understand the argument or to develop the argument to look at two claims in the patent in suit initially, which appear either in the trial judge’s reasons at page 26 of the application book or in the separate bundle, if your Honours have that. It is claims 1 and 27.

GUMMOW J: Sorry, which page?

MR BANNON: It is claim 1. Page 26 of the application book and claim 1 is set out there at about line 20:

A method for providing a therapeutic blood plasma concentration of venlafaxine over a 24 hour period which comprises administering orally to a patient in need of venlafaxine a single daily dosing formulation of venlafaxine hydrochloride that provides a peak blood plasma level of venlafaxine in from about 4 to 8 hours –

There is a subsidiary point about whether or not it is fairly based in relation to depression that does not really raise a major issue. Claim 4 picks up depression. The only other claim to be referred to is claim 27, which is over the next page, which includes “an encapsulated formulation”. Both the trial judge and the Full Court found - - -

GUMMOW J: What is the practical significance of this? The practical significance is a priority date problem, is it not?

MR BANNON: It is internal fair base and priority. We need to get over both problems.

GUMMOW J: Otherwise there would be a lack of novelty, et cetera.

MR BANNON: That is so. So far we have succeeded – when I say so far, at the trial level we have succeeded in resisting all grounds of invalidity, including a lack of inventive step. The Full Court decided all grounds of invalidity in our favour other than the fair basis and priority date issue, which are related, and the inventive step issue - - -

GUMMOW J: You are agitating Mr Shavin.

MR BANNON: That would be par for the course. But they have not decided inventive step, so there is an outstanding issue in relation to inventive step. But the effect, we say, of the findings to date is that what those claims disclose is an invention in the sense that it is novel, a new matter of manufacture, it is useful, sufficiently described and clearly defined and not the product of any false suggestion.

GUMMOW J: We are looking at claim 1?

MR BANNON: Yes.

GUMMOW J: That is a method claim of administration orally, et cetera.

MR BANNON: Yes. It is not limited to any particular formulation of venlafaxine provided it otherwise satisfies the requirements in that claim, and there is no dispute about the absence of limitation, at least on the findings to date. As I say, the Full Court has not overturned or has not decided the inventive step question because of their view in relation to priority date. As I say, to put it shortly, claims 1 and, relevantly, 27 define an invention which is desired to be used by competitors, and three of them are lined up here on my client’s right.

The claim, in terms, does not preclude any of those claims, the manufacture of any particular formulation of venlafaxine hydrochloride, nor does it claim a monopoly in any manufacture of any such formulation. That is just another way of saying it is not a formulation claim. In terms of inventive step, again so far based on the trial judge’s findings, the claim does not amount to a mere desideratum. That would be an issue on no new matter of manufacture, argued at trial, not pursued on appeal. Equally, it could not be said to be a mere goal or a wish list, because again that would be the grounds of no new matter of manufacture, again found in our favour, not overturned on appeal.

There is utility in the profile. The trial judge identified, if I could just take your Honours to what her Honour said at page 75 of the application book in paragraph 206. Her Honour recorded our submission or our observation:

Wyeth observed that the expert evidence supported this conclusion. According to Professor Charman “any formulation using or incorporating hydrogel tablet technology that achieves the plasma profile would be useful in the Method of the Patent”.

Then over the page, paragraph 208, her Honour says, leaving out the first sentence:

The patent discloses a method for the treatment of a patient in need of venlafaxine by administering orally a single daily dosing formulation of venlafaxine hydrochloride that provides a peak blood plasma concentration . . . Once this characterisation of the invention is accepted, the applicants’ lack of fair basis contention in respect of hydrogel tablet technology fails.

We respectfully submit her Honour was correct in that summation because what the inventor or the patentee is effectively saying is, “If you perform my method using any formulation, you infringe”. The mere fact that the inventor was unable, and discloses that fact, to say, “I cannot perform my new method”, using a particular formulation, does not mean that she, in this case, had not invented a new method and, indeed, the findings of inventive step confirm that.

GUMMOW J: Can we just look at Generic’s written submissions at page 474, which perhaps encapsulate matters, paragraph 4, special leave question 1. Answer depends on the terms of the particular specification, no matter of general principle. Special leave question 2 turns on this point about the regulations, which does not really seem to come to much in terms of a grant of special leave. So, what is the answer to their point? Namely, the principles of fair basis are pretty well settled by now. How they turn out in their application will always be enmeshed in the particular text compared with another text.

MR BANNON: Because the way in which their Honours describe the reason why the specification does not support the claim is based on a misunderstanding of the nature of method claim. That appears by reference to page 296, firstly, in Justice Bennett’s reasons.

GUMMOW J: Whereabouts?

MR BANNON: Paragraph 94, and this is dealing with the patent as granted:

The specification of the Amended Patent repeatedly states that the invention is a method and also states that the formulation is for use in the method of the invention. Although there remain references to the solution to the problem of preparation of an ER formulation being the ‘formulations of this invention’, for the purposes of internal fair basis, it can be said that there is fair basis for claims to a method, generally as set out.

In other words, that is a recognition that the specification as granted does support a claim which is to the use of a method which is not limited to any specific formulation, at least not to the one which is identified in the preferred embodiment. Then her Honour continues –

However, the specification still contains the statement that ‘attempts to produce single daily dosing, [ER] or tablets by hydrogel technology proved to be fruitless’ and that the success of an ER formulation, which was at least part of the inventive step and of the invention, was in the context that an ER dosage form of venlafaxine hydrochloride was ‘impossible to achieve with hydrogel tablet technology’.

It follows that claims 1 to 17 . . . which encompass a formulation of venlafaxine hydrochloride which includes a formulation achieved using hydrogel tablet technology, travel beyond –

We submit that erects something which has not been addressed, set out by any previous court, namely, if you claim a method which is found to be inventive, an invention across any – without limitation to the product being used, that is amounted to saying the mere fact that you state that I cannot be the inventor/performer in one way, that means you are somehow or other not fairly based for the invention. It is a confusion of what is a method and a product claim. That is the issue and that is an issue of principle which arises. The same matter appears in Justice Nicholas’ decision at page 320 in paragraph 171. His Honour says:

I agree with Wyeth that claims 1 to 17 of the Amended Patent cover methods of treatment that involve the administration of formulations containing venlafaxine hydrochloride produced through the use of hydrogel tablet technology.

In other words, they are not limited –

I do not think it is possible to read those claims down so to exclude from their scope methods of treatment that utilise such formulations. This is significant because, in my view, the specification contains what is tantamount to a disclaimer of hydrogel tablet technology.

The language of disclaimer is not known in patent law other than it is used in the context of some statements of principle saying what is not claimed is effectively disclaimed. The language of disclaimer in a body in the context of the fair basis, we respectfully submit, is not known and, effectively, again it amounts to a misunderstanding that once you have a method which is found to be inventive and new, the mere fact that the inventor says, “I cannot perform it a particular way”, does not mean that they have disclaimed the method across all forms. It is effectively saying, “I am not claiming a formulation which consists of hydrogel technology. I am not saying I have invented that. I am claiming the method. If it turns out you can perform that method in a way which includes hydrogel technology, well, good luck to you, but that is within my method”. The invention lies in the method. To similar effect is Justice Yates at page 338.

GUMMOW J: Page 338?

MR BANNON: At 338, at the very top of the page. Again, his Honour uses the language of, second line:

Rather, it is matter that was effectively disclaimed in that part of the specification as being part of the invention.

If we claimed all formulations as products which covered hydrogel technology, yes, there might some substance in this point, their Honours raise, but because we claim a method, it cannot logically follow that this is an extra hurdle which a patentee has to jump over. It is a conceptual matter. It would be the same, for example, your Honour, as if the opponents of the patent proved that at the date of grant of the patent – let it be assumed we have not said those words in their specification – had proved as a matter of fact the inventor did not know how to perform the invention across the full range of the method, if they proved that as a fact, would that make any difference? Answer, no, because the sufficiency law does not require you be able to perform it across the width of the claim.

So therefore the mere fact that the inventor makes that acknowledgement, we say, as a matter of principle, and it is an important principle which can infect a considerable number of patents, the mere fact that the inventor makes the statement that they cannot perform it across the full breadth of the invention cannot logically mean that it is not fairly based. That is the issue which arises on internal fair basis.

The external fair basis, the same issue effectively arises because that process of reasoning infects their Honours’ consideration when they look at the priority document because the priority document, we say, and the trial judge found, discloses two inventions. One is a particular formulation, which was one may accept the tool which the inventor used to discover additionally the method. Their Honours read that and say, in effect, well, where they disclaim again hydrogel technology, that must mean, in effect, that the claims in the priority document which are unlimited to the formulation – that is claims 9 and 10 – should be read down, but it is infected by this proposition that as a conceptual matter, you are not fairly based if you tell the world you cannot perform the full range of the method claim.

Once one gets over that conceptual problem and realises that that involves error, we respectfully submit the issues which arise in considering the external priority fall our way because, when one looks at those earlier claims in the priority document, which have been referred to in our submissions, they are plainly not limited to any particular formulation. A consequence of a finding that at the priority date the skill worker would not have thought of and no one had disclosed a method unlimited in that form which was useful, in a sense, informs a consideration of the priority document.

It was effectively what the Full Court has said, accepting for present purposes that our method is inventive and novel and accepting that claims 9 and 10 of the priority document – leaving aside the one reference to encapsulation – are necessarily unlimited on their terms, a skill worker – and that is the ultimate test – who, it may be accepted, appreciates that an unlimited method claim is an invention and something they had not thought of and is useful, would read that and fail to appreciate, or would think, in effect, that the drafter of that priority document had not appreciated that themselves, because that is the size of it, that one accepts that this is an invention in its unlimited form and a skill worker must appreciate that they read that document, see unlimited words in claims 9 and 10 that effectively add a limitation to that. Why? Because, effectively, they must think that the inventor has not appreciated what they appreciate, namely, that there are two inventions.

Once one appreciates one gets over that conceptual hurdle which I have identified, one comes back to this proposition. Is there any defence in patent law in a conclusion that an inventor may have invented a specific product by use of which that enables that inventor to go on and appreciate that there is, in fact, an inventive method independent of the formulation which also provides a benefit in the form of use of invention as consideration for a monopoly in that method. For those reasons, we submit special leave ought be granted.

GUMMOW J: Now, is there any agreement between the three counsel as to who goes first?

MR SHAVIN: If the Court pleases, it was proposed that I would go first on external fair basis. My learned friend, Mr Burley, would then follow on internal fair basis. My learned friend, Mr Fox, would follow if there was anything additional to add.

GUMMOW J: What do you say about this point, with reference to page 296 at paragraph 94, page 320 at paragraph 171 and page 338 at paragraph 247, that they disclose on the part of Justice Bennett some confusion of understanding of the distinction between method and product claims and Justice Nicholas and Justice Yates have made it worse by their treatment of the term “disclaimer”?

MR SHAVIN: We say, your Honour, first that you do not get to internal fair basis because of the external fair basis issue. My learned friend, Mr Burley, was proposing to deal with the internal fair basis issues. Each of these questions that your Honours raise with me relate exclusively to internal fair basis. When you look at the external fair basis, it is not at all infected by these questions because the - - -

GUMMOW J: Mr Bannon says it is, at the end - - -

MR SHAVIN: Could I deal with that, your Honour, because my learned friend presupposes a state as to the priority document which is not accepted by any of the judges in the Full Court and is not supported by a plain reading of the specification. It is plain, when one reads the whole of the specification in the priority document, that what is identified as the problem to be overcome and the solution is a particular formulation of the invention of venlafaxine hydrochloride and the use aspect of that invention is the use of those formulations. So that the invention disclosed in a conventional analysis under Lockwood (No 1) at paragraphs 98 to 100 is that you identify what is the underlying invention disclosed.

The Full Court individually, but each reaching the same conclusion, found that when you look at the priority document as a whole, what is disclosed is a formulation and its use, but what is not disclosed is any new method of principle unrelated to the formulations of the invention. One can see that in the priority document both from its title, from the brief description, from the detailed description and from the example. All of them go to this proposition. One finds, for example – I think the Court requested and was provided yesterday with a copy of the priority document, otherwise sufficient extracts can be found in the reasons of Justice Nicholas, but it might be easier to look at the document itself if it is available to the Court?

GUMMOW J: This is the US patent application?

MR SHAVIN: It is, if your Honour pleases.

GUMMOW J: No 60/014006?

MR SHAVIN: That is correct, if your Honour pleases.

GUMMOW J: Yes, we have that.

MR SHAVIN: Yes. The Court will appreciate that that was the priority document claimed by the grandparent. There was a divisional from the grandparent in 2000, there was a further divisional in 2003 and there were very substantial amendments made in December 2006 with some minor amendments made in January 2007 that result in the amended patent.

If I could very quickly walk the Court through the specific specification, and this leads, of course, to the first reason why special leave ought not be granted. This is a matter about the construction of a particular specification. It is not a matter about general principle in terms of external fair basis. What the court below did was a conventional application of the clear statement of this Court in Lockwood (No 1) in paragraphs 98 to 100.

In the priority document, the Court will see the heading is “Extended Release Formulation” and in the first sentence, what one finds is that extended release formulations are known because there is a description as to how they are conventionally produced. Then one finds that the conventional production of them is by the use of hydrogel technology, but it does not work with venlafaxine hydrochloride. So that when one looks at the brief description of the invention, we find in the first paragraph at page 2, line 12:

In accordance with this invention, there is provided an extended release (ER), encapsulated formulation containing venlafaxine hydrochloride as the active drug component –

In the next paragraph:

Through administration of the venlafaxine formulation of this invention, there is provided a method –

Then one there finds a description of the method, but the method has as its essential integer or element the administration of the venlafaxine formulation of the invention. If I could pause at this point, one can find here the error which we say, with respect, the learned trial judge fell into, because at paragraph 165 of her Honour’s reasons appearing at page 64 of the application book, her Honour says:

The US priority document discloses two inventions. The first is an encapsulated formulation. The second is a method for obtaining a certain drug to plasma relationship over time yielding a “tighter plasma therapeutic range control” than multiple daily dosing, eliminating the sharp peaks –

If I could take the Court back to the priority document, one can find that on page 2 in the second paragraph, starting at line 16. You have:

a method for obtaining a flattened drug plasma concentration to time profile, thereby affording a tighter plasma therapeutic range control than can be obtained with multiple daily dosing. In other words, this invention provides a method for eliminating the sharp peaks –

But what her Honour omitted to include in her identification of the invention was the opening phrase:

Through administration of the venlafaxine formulation of this invention.

It is there that her Honour fell into error, and each of the judges in the court below, in our respectful submission, correctly identified that you do not have two independent inventions, rather, you have the one invention for a formulation and its use. We can see, as we proceed, if one goes to the next paragraph, it starts:

The use of the one-a-day venlafaxine hydrochloride formulations of this invention reduces by adaptation –

Then if one goes to the “Detailed Description of the Invention”, we can see a detailed description of a formulation in the first paragraph, and at lines 17 and 18:

the polymorphic forms such as Form I or Form II may be used in the formulations of the present invention.

In the next paragraph:

The extended release formulations of this invention are comprised –

and one there finds a detailed description of the formulation together with some equivalents which might be used. On page 4 this continues. There are some various substitutions that are identified in the first two paragraphs, and then at line 11:

It was completely unexpected that an extended release formulation containing venlafaxine hydrochloride could be obtained because the hydrochloride of venlafaxine proved to be extremely water soluble. Numerous attempts –

So there is a detailed discussion of the attempts. Then finally at line 26 we find that:

Addition of hydroxypropylmethylcellulose 2208 to the venlafaxine hydrochloride-microcrystalline cellulose mix made production of spheroids practical.

The following examples are presented to illustrate applicant’s solution to the problem of preparation of the extended release drug containing formulations of this invention.

So what we have is a very detailed discussion of the fact that we know there are extended release drugs. We want to find one here. We had trouble with the formulation. We have a description of the invention, which is the formulation and its use. Then when one gets to the examples, the examples are headed “Venlafaxine Hydrochloride Extended Release Capsules” and through them one has a description of the capsules with three different coating levels. One has an examination at the foot of page 5 of its dissolution and that continues into pages 6 and 7, and then what one finds at page 8 under Table 2, that:

Table 2 shows that the plasma levels of two 75 mg/capsule venlafaxine hydrochloride ER capsules and one 150 mg/capsule venlafaxine hydrochloride ER capsule provide very similar blood levels. The data also show that the plasma level after 24 hours for either extended release regimen is very similar to that provided by two immediate release 75 mg tablets of venlafaxine hydrochloride administered at 12 hour intervals.

So what is this directed to? This is directed to establishing that the formulation of the invention works as an extended release. There is nothing that can be found in the body of this specification which demonstrates that there are two separate unrelated inventions, one a formulation and the other a method of treatment unconfined to the formulation.

The Court will recall that in Lockwood, at paragraph 98 – and could I trouble the Court to look at that to refresh the Court’s memory. It is to be found in the bundle of authorities at tab 5. This Court in Lockwood at 98 used as an example that demonstrated the principle that was being articulated a consideration of the decision of this Court in Olin. At the top of page 310, the Court said:

The process had two key elements – the use of compressive deformation (as opposed to tensile deformation) and the carrying out of the process at particular low temperatures. Some of the claims were limited by reference to both elements. Some, claims 10-13, were not, since they did not refer to compressive deformation. Jacobs J therefore held that those claims were not fairly based on the two key elements disclosed in the specification, and his decision on this point was upheld on appeal. That conclusion did not depend, however, on the fact that the specification set out “aspects of the invention in much the same language as that of the subsequent claims”. It depended on the body of the specification being construed as a whole to reach the conclusion that the invention had the two elements of compressive deformation at low temperatures, and the passages omitting compressive deformation as being loose or stray in nature –

So we say here that to the extent that there is a method disclosed in the priority document, it has two key elements. It has the element of the preparation of the formulations of venlafaxine hydrochloride of the invention and their use. That does not mean that one can look at any passages, or even claims 9 and 10, to which our friends have referred in their outline and say, there we can find some language which looks wider. That will provide a basis fairly, a proper fair basis for a wide claim. That was made very clear by this Court in paragraph 99 of Lockwood where the Court said:

as the Patentee submitted, the correct position is that a claim based on what has been cast in the form of a consistory clause is not fairly based if other parts of the matter in the specification show that the invention is narrower than that consistory clause. The inquiry is into what the body of the specification read as a whole 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.

Where our friend’s submissions fail is that they identify the invention as being in two parts, one a general method, the second the formulation. With respect, that is simply not tenable having regard to the terms of the priority document. For that reason, the decision of each of the judges of the court below that there was no ability of the claims of the amended patent to claim priority back to the priority document through section 114, regulation 3.14 or, alternatively, regulation 3.12, because there is not matter disclosed in the priority document that will support the scope of the monopoly claimed.

Thus it is, in our respectful submission, there is no matter of principle raised. This case is a conventional application of the principles articulated by this Court in Lockwood. It is an articulation which depends and depends exclusively on a construction of the priority document and neither of those matters are matters which would justify, in our respectful submission, the grant of special leave. If the Court pleases.

GUMMOW J: Yes, Mr Burley. Do you want to say anything about internal fair basing?

MR BURLEY: Yes, your Honours. To address first the question that your Honour Justice Gummow posed in relation to those passages my learned friend, Mr Bannon, referred to, the starting proposition that my learned friend proposed that there is a new conceptual hurdle that has been erected by the Full Court as a result of what he characterises as a misconception of the difference between a method claim and a product claim. Of course, my learned friend took your Honours to the claims at page 26 of the application book. Each of those claims includes as an integer a single daily dosing formulation. It is via such formulation that there is any conveyance of the method so achieved.

The approach taken by each of the judges was to examine what the disclosure of the invention was insofar as it concerned that formulation and the disclosure was very much confined to the proposition that through overcoming hurdles with conventional hydrogel tablet technology, the patentee managed to create a formulation using spheroid core and other technology which enabled her to achieve a particular method. The combination of integers which involves the method with the formulation is one which their Honours were considering in the context of the disclosure and so my learned friend’s reference did not take your Honours to paragraph 49 of Justice Bennett’s reasoning at 286 of the application book where her Honour turned to the amended patent to understand the invention there described:

I am assisted by the way in which the patentee describes:

• the invention;
  
• what is said about the problem faced by the patentee; and
  
• the advance over matters previously known.
  

Her Honour there recognises in paragraph 50 –

The invention of the Amended Patent is said to be a method. What was in the forefront of the description of the invention in the Priority Document, that is, a formulation for treating depression and the elimination of the side effects of nausea and emesis, is now relegated to the role of further embodiments.

Then at paragraph 54 after citing parts of the specification, 55 dealing with the background, her Honour observes that there is:

an explanation of the conventional preparation of sustained or ER forms. It is stated that it is conventional to prepare encapsulated drug formulations which provide extended or sustained release properties where the production of tablets is, as here, not feasible. One way is to form spheroids using standard techniques, which may be coated to retard dissolution. Gelatin capsules are filled with . . . The Amended Patent discusses the unwanted side effects with two or three doses a day . . . It is in this context that the Amended Patent turns to a brief description of the invention, saying that what is provided is an ER formulation which provides, in a single dose, a therapeutic blood serum level over a 24 hour period. It is this invention that is said ‘to provide a method for eliminating’ the uneven blood plasma drug levels of multiple dosing. Again, as in the Priority Document and the Original Patent, the Amended Patent states that ‘in accordance with the use aspects of the invention’ a method is provided –

and so on.

GUMMOW J: Now, what do you get out of that?

MR BURLEY: Your Honour, her Honour was plainly addressing the fact that it is a method claim but in the context of the description of there being issues as to how one achieves the formulation. If your Honours look at the top of page 285 of the application book, her Honour quotes the amended patent, where it says:

It was completely unexpected that a single daily dosing formulation containing venlafaxine hydrochloride for use in the methods of the invention could be obtained because the hydrochloride of venlafaxine proved to be extremely water soluble. Numerous attempts to produce single daily dosing, [ER] or tables by hydrogel technology proved to be fruitless –

A further statement in the specification, which appears at page 10 is that:

Thus, the desired dissolution rate of a sustained release dosage form of venlafaxine hydrochloride, impossible to achieve with hydrogel tablet technology, has been achieved with the film-coated spheroid compositions of this invention.

That is a statement by the patentee as to what problems were overcome in the context of arriving at the particular method. So when your Honours turn to paragraph 94 of her Honour Justice Bennett’s reasoning, your Honours see that her Honour is having regard to the specification and the repeated statements that:

the invention is a method and also states that the formulation is for use in the method of the invention. Although there remain references to the solution to the problem of preparation of an ER formulation being the ‘formulations of this invention’, for the purposes of internal fair basis, it can be said that there is fair basis for claims to a method, generally as set out. However, the specification still contains the statement that ‘attempts to produce single daily dosing, [ER] or tablets by hydrogel technology proved to be fruitless’ –

Your Honours, the task that Justice Bennett adverted to was precisely that which this Court in Lockwood v Doric prescribed, which is to have regard to what the patentee discloses as being the invention in having regard to whether or not the claims are fairly based. His Honour Justice Yates similarly adverted to the necessity to understand the disclosure of the specification and at application book 337 at paragraph 336, starting at paragraph 242, Justice Yates says:

First, despite its deletions, additions and other amendments, the specification of the Amended Patent still incorporates, in the way that I have described above, the unambiguous statements that, so far as Wyeth is concerned, the search for an ER formulation produced by hydrogel tablet technology is “fruitless” and “impossible to achieve”. Once again, these statements cannot be ignored, although Wyeth sought to do so by appealing to evidence from

Professor Charman and Dr Marshall to the effect that the relevant - - -

GUMMOW J: We do not need to hear you any more, Mr Burley, on this. Yes, Mr Bannon.

MR BANNON: On internal fair basis, your Honours, nothing which has been submitted overcomes the agreement by all three judges of the Full Court that the specification supports a method claim which is not limited to an embodiment. That is the paragraph of Justice Bennett’s reasons I took your Honours to earlier. The other judges agreed in that. The consistory clause which attracts the words of claim 1 is completely consistent with that. Hence, internal basis does reduce, we respectfully submit, to the proposition which I put earlier, some form of effective disclaimer from a method counterclaim which we respectfully submit is a matter of patent law that makes no sense once you appreciate the difference between a method and a product claim.

Secondly, in relation to external fair basis, could I briefly take your Honours back to the US document. This document is, within the lexicon of the regulations, a basic application. There is no requirement, unlike a provisional, that the basic application describe the invention. The basic specification must fully describe the invention, a provisional must describe the invention, a basic application has no similar requirement. The document does not stand as a specification or a provisional as such. If one looks at the title on the third page of the document, it is actually described as a provisional application, presumably which would have some significance under US law, but for our purposes it represents a piece of paper which can contain matter.

Secondly, if one goes to page 11 of that document, there is a heading “What is claimed is:” and one of the matters which is claimed is what appears in 9 and 10, which, any reading of it, makes it clear that there is no limitation to a particular formulation other than the use of the word “encapsulate” which we pick up in claim 27 at worst, but it represents matter. So claims 9 and 10 are not to be read as part of a specification which requires full description. They are to be read as part of a basic application or a la a provisional of providing matter.

In response to the proposition of my learned friend, Mr Shavin, that the reasons of the judges below were not infected by what I say is the fundamental misconception or hurdle erected in dealing with the priority document, can I refer your Honours to three references, firstly in relation to Justice Bennett's reasons at 278 of the application book. In the second last sentence of paragraph 26 – this is dealing with the priority document:

There was no suggestion in the specification or in the claims of the Priority Document that the patentee overcame the problem with the use of hydrogel tablet technology.

The next paragraph:

the Priority Document does not describe an invention or inventive step that includes hydrogel tablet technology . . . The description of the invention in the specification and the description of how to achieve it are the consideration for and basis of the claimed monopoly.

Well, that is not the right language to talk about a basic application. Then to paragraph 31:

It simply cannot be said that, properly construed, claims 9 and 10 of the Priority Document encompass a hydrogel tablet formulation.

That is infected, we respectfully submit, by the same proposition which infects internal basing. Similarly, Justice Nicholas’ reasons at page 318, paragraph 162, again focuses on the statement in the priority document in relation to the inability to achieve success using hydrogel technology. Lastly, Justice Yates, page 333, paragraph 220, again confirms that his Honour’s consideration of the priority document was influenced by the same hurdle, which we say was improperly and unnecessarily erected by the Full Court. May it please the Court.

GUMMOW J: Thank you.

We are not satisfied that any question of principle respecting fair basing is presented by these applications. Nor are the other grounds relied upon sufficient to attract a grant of special leave. Special leave is refused with costs.

AT 11.35 AM THE MATTERS WERE CONCLUDED