Delay
189 The cornerstone of the respondents' and Eremad's submissions on the question of delay is that Australian law in relation to the requirement for internal fair basis under s 40(3) of the Act is sufficiently analogous to the prohibition on added subject-matter under the EPC (as it arose in the various oppositions and revocation actions which I have summarised above) and also sufficiently analogous to the objections raised by the USPTO in relation to the prosecution of the US application, that Bayer Pharma was on notice as early as 2003 that it should amend the Australian patent. They submitted that, in light of these overseas events, Bayer Pharma should have been prompted to consider amending the dissolution test claims of the Australian patent (as it now seeks to do) and that, by not moving significantly earlier than it has, Bayer Pharma has been guilty of excessive (and therefore unreasonable) delay.
190 It is of course clear from Dr Broesamle's evidence that, after the grant of the Australian patent until the time that infringement proceedings against the respondents were actively under consideration in January 2012, Bayer Pharma gave no consideration to whether the Australian patent should be amended. This is not a case, therefore, where the patentee has deliberately delayed in seeking amendments after having determined that they should be made.
191 The respondents' and Eremad's submissions focussed, firstly, on the prosecution of the US patent application, commencing with the introduction of claims 45, 47 and 49 by the amendments filed on 10 March 2003. As I have recounted, these claims were dissolution test claims which contained a dissolution test in more confined terms than the dissolution test in claims 7 and 9. I have accepted Mr Sopp's explanation for introducing claims 45, 47 and 49 in a narrower form, namely that it was prudent as a matter of practice (which, in context, must mean United States patent practice) to include claims where the USP Paddle Method was recited with as much detail as possible based on the disclosure on page 4 and in Example 2 of the US specification. This is not to accept, however, that claims 7 and 9, in their then wider form, were impermissibly wide under United States law. Nevertheless, as events transpired, claims 7 and 9 (together with claims 45, 47 and 49) came to be further amended in December 2003 in response to the Office Action issued on 4 June 2003. The respondents and Eremad saw this as a matter of particular significance. They submitted that this revealed to Bayer Pharma the need to bring the dissolution test claims into line with the terms of the dissolution test stated in the body of the US patent specification, and thus constituted an exemplar for the position in Australia.
192 In considering this submission it is important to bear in mind why these particular amendments were made to the US application. They were made to meet a particular objection raised under the second paragraph of 35 U.S.C. s 112, which states:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
193 As the evidence makes clear, the specific objection raised by the examiner in this regard was essentially a clarity objection, not an objection that was akin to a fair basis objection under s 40(3) of the Act. The evidence shows that this is precisely how MWZB interpreted the objection and dealt with it on behalf of Bayer Pharma. By making these amendments, I am satisfied that Bayer Pharma was only seeking to overcome a particular clarity requirement of US patent law as interpreted and applied by the USPTO in the instant case.
194 Should the making of these amendments have prompted Bayer Pharma to review the scope of the claims in its then pending Australian patent application? In my view the answer to that question is plainly "no". I am not persuaded on the evidence that the making of those particular amendments in those particular circumstances had any real relevance at the time to other jurisdictions and, in particular, to Australia. Indeed, at about the same time, on 1 December 2003, an examination report issued with respect to the Australian patent application. As I have noted, objections were raised under s 40(3) of the Act, but these related to other matters. No objection was raised that claim 9 (then the only dissolution test claim) did not include one or more of the three features. There is no reason why Bayer Pharma should have translated into the Australian sphere its experience with the USPTO in the context of addressing the requirements of United States patent law when the Australian examining authority apparently saw no similar clarity problem with claim 9 under Australian law. It is also to be remembered that the present claims 3, 11, 27 and 32 of the Australian patent were introduced on 30 November 2004 during prosecution of the application. On examination, no objection was raised to the form of these claims at that time or, indeed, at any other time until the filing of the respondents' cross-claim in the principal proceeding. Of course, Bayer Pharma has sought its amendments pre-emptively and not in response to that cross-claim.
195 It follows that I am not persuaded by Mr Schieber's evidence that the issues addressed in respect of the US application should have led to some further consideration of the content of the specification and "the congruity" between the specification and the claims in corresponding applications outside the United States. It seems to me that this evidence speaks more as a counsel of perfection - perhaps the product of analysis by hindsight of the now known facts of the present case - rather than as a statement of the real-world position facing Bayer Pharma and its advisers at the time.
196 In its submissions, Eremad sought to make much of the fact that, during the course of discussions between Bayer Pharma, P&V and MWZB in relation to the Office Action that issued on 4 June 2003, Bayer Pharma did not want to, or at least preferred not to, limit the dissolution test in the claims of the US application to a tablet containing 3 mg of drospirenone. In my view no criticism can be levelled at Bayer Pharma for simply wishing to keep its claims in as broad a form as legally possible. In any event, it is to be remembered in this regard that, ultimately, Dr Broesamle instructed MWZB to use the most appropriate wording for the claims under United States patent practice. Mr Sopp's evidence, which I accept, was that the likely explanation for the choice of the final wording of the dissolution test claims proposed by MWZB was that the examiner's objections were more likely to be overcome by amending the relevant claims to define the USP Paddle Method as specifically as possible. This approach is understandable and plainly includes an element of expediency directed specifically to overcoming a particular objection to ensure the successful prosecution of the US application.
197 Eremad also sought to rely on the fact that, in the course of considering the draft response prepared by MWZB to the Office Action, P&V had commented (on 12 August 2003) that a statement in the specification about micronizing drospirenone to provide rapid dissolution "is only correct" if the dissolution test in the specification is "simultaneously mentioned". This comment, however, was not directed to the permissible width of the claims. I am not prepared to read it as an acknowledgement of some awareness by P&V, let alone some concession by Bayer Pharma, that the invention could only properly and permissibly be defined by strict adherence to the terms of the dissolution test stated in the body of the specification. Indeed, as I have recorded above, as late as 3 December 2003, P&V were contending for a claim that provided for any oral dosage form of drospirenone in which at least 70% of the drospirenone dissolves within 30 minutes during dissolution testing: see [73] above. I am satisfied, therefore, that this comment was made by P&V as a "minor comment" (their words at the time) that was directed, and intended to be directed, only to the text of MWZB's draft response to the USPTO. It is apparent that P&V considered the draft, in that form, to be an incomplete statement about the dissolution of micronized drospirenone in vitro unless the dissolution test was also mentioned.
198 With respect to the Official Report issued by the APO on 1 December 2003, Eremad drew attention to the fact that P&V's instructions to DCC on 19 November 2004 also included a reference to the dissolution test stated on page 4 of the Australian specification. This was done in the context of P&V quoting part of their response to the EPO in the course of prosecuting the European patent applications. In that response, P&V were arguing for the allowance of more than one independent claim to cover the different physical forms in which the invention might be present. In that quotation, P&V stated:
… Moreover, since the small particle size may be expressed by its functionality so as to achieve a rapid dissolution, we are of the steadfast opinion that the essential feature of providing drospirenone in a small particle size may be expressed in terms of "at least 70% of said drospirenone is dissolved from said composition within 30 minutes, as determined by USP XXIII Paddle Method 2 using water at 37°C as the dissolution media and 50 rpm as the stirring rate".
199 This is a critical part of the quotation, which was not referred to by Eremad. It was the foundation for Bayer Pharma's submission to the EPO that the inventive feature of the invention could be defined in alternative ways, including by reference to the dissolution test stated in the above quoted terms, which does not include any reference to the three features.
200 When responding to the Official Report on 30 November 2004, and providing the revised claim set containing claims 3, 11, 27 and 32 in their present form, DCC referred to the dissolution test on page 4 of the Australian specification, but went on to say:
Thus, as should be understood, the small particle size of drospirenone may be defined in terms of the surface area of drospirenone. Furthermore, it may be expressed in terms of the means to achieve a smaller particle size (ie. to dissolve drospirenone in a suitable solvent and spray it onto the surface of [an] inert carrier). Moreover, since the small particle size may be expressed by its functionality so as to achieve a rapid dissolution, [Bayer Pharma] submits that the essential feature of providing drospirenone in a small particle size may be expressed in terms of "at least 70% of said drospirenone is dissolved from said composition within 30 minutes, as determined by USP XXIII Paddle Method 2 using water at 37°C as the dissolution media and 50 rpm as the stirring rate".
Hence, [Bayer Pharma] respectfully contends that the inventive feature of the particle size of the present invention may be defined in alternative manners, such as the drospirenone having a surface area of more than 10,000 cm²/g, the drospirenone in micronized form, the drospirenone sprayed from a solution onto an inert carrier or the drospirenone being dissolved from a composition corresponding to at least 70% within 30 minutes as determined by USP XXIII Paddle Method 2 using water at 37°C as the dissolution media and 50 rpm as the stirring rate.
In summary, [Bayer Pharma] submits that independently defining the invention in terms of the surface area of the drospirenone, micronized form of drospirenone or functionally in terms of the in vitro dissolution of drospirenone, are appropriate definitions for the dosage forms of drospirenone according to the present invention.
201 Once again, on further examination, no objection was raised to the form of the amended claims then lodged.
202 The gravamen of Eremad's submission is that Bayer Pharma prosecuted the Australian patent application only on the basis of the statement of the dissolution test on page 4 of the Australian specification. This is not correct. As the quotation above shows, the statement of the dissolution test on which Bayer Pharma prosecuted its Australian patent application was, specifically, the test now stated in claims 3, 11, 27 and 32 in their present form, not some arguably narrower form.
203 After dealing with the prosecution of the US application, the respondents and Eremad advanced submissions that were based on the much later developments that had taken place in relation to the prosecution of the PCT applications in Europe.
204 Eremad pointed to the fact that Bayer Pharma had submitted amendments to the European Dissolution Divisional in September 2008 to bring the description in the body of the specification into conformity with the claims (which did not contain the three features). In this connection it submitted that, as a result of this development, Bayer Pharma was on notice that there was a "disconformity" between, on the one hand, dissolution test claims that omitted the three features and, on the other, the statement of the dissolution test in the specification as originally filed in respect of that application, which did incorporate the three features.
205 In my view no real significance can be placed on that particular development so far as other patent applications are concerned. It can only be said that, at the time, Bayer Pharma was responding positively and appropriately to a specific request of the EPO to amend the body of the specification in relation to a specific patent application, and nothing more. No question was raised, at that time, about claim definition or claim width that should have prompted Bayer Pharma to consider, more generally, the scope of the claims in patents it had then applied for in other jurisdictions.
206 More importantly, the respondents and Eremad pointed to the fact that, by October 2009, Bayer Pharma was on notice of the added subject-matter objections that had been raised separately and differently by Teva and Leon Farma in the oppositions to EP '301. They pointed to the fact that, by May 2010, Bayer Pharma had proposed amendments to introduce some or all of the three features to the dissolution test claims of EP '301 in order to address the objections that had been made.
207 It is undoubtedly correct that, by May 2010, Bayer Pharma had formed the view that the added subject-matter objections raised by Teva and Leon Farma could be addressed by the amendments it then proposed. It does not follow, of course, that Bayer Pharma held the view that, in the absence of the three features, the dissolution test claims extended beyond the disclosures of the specification of the European Parent Application as filed. That was the very matter that was in contention before the EPO and determined by the Opposition Division in December 2011. Bayer Pharma's written submissions in that opposition show that it was urging on the EPO that a literal comparison was insufficient and that the added subject-matter objections should be dealt with as a matter of substance.
208 The respondents and Eremad also pointed to the judgment given in Gedeon Richter in March 2011 and the EPO's Preliminary Opinion issued in May 2011. The respondents submitted that, by that time, Bayer Pharma was on notice of two decisions from important bodies in different jurisdictions to the effect that the dissolution test claims needed to conform with the disclosure on page 4 of the specification. They submitted that Bayer Pharma should have then assessed whether similar problems existed in other jurisdictions and whether the claims conformed with the specifications in the way required by the laws in those jurisdictions. They submitted that, although there may be differences in the way that patent laws in different countries deal with the issue of "support" or "fair basis" for claims in the specification, the laws of Europe, the United Kingdom and Australia all include a common concept or principle which should have at least prompted Bayer Pharma to consider the possibility that amendments to the Australian patent might be necessary.
209 A similar submission was advanced by Eremad. In the context of the United Kingdom revocation proceeding, Eremad submitted that Gedeon Richter's added subject-matter objection rested on the proposition that, by reason of the deletion of the three features, the statement of the dissolution test in the specification of the UK patent was broader than the test stated in its parent (which included those features). It submitted that, similarly, the present amendment application is brought to overcome the risk that, by reason of the omission of the three features in the dissolution test claims, those claims are broader than the statement of the dissolution test on page 4 of the specification (which includes the three features).
210 These submissions must be treated with some caution. Expressed in that form, they do not give appropriate recognition to what are undoubtedly two different legal requirements - one dealing with added subject-matter as applied in EPC jurisdictions, and the other dealing with internal fair basis as understood and applied under Australian law. As I have endeavoured to explain above when dealing with Mr Shieber's evidence on this issue, this distinction is a matter of some significance and should not be ignored in considering the objections advanced in the present case.
211 It can certainly be said that, from October 2009, Bayer Pharma was on notice that there was an added subject-matter problem with respect to EP '301 and its equivalents in EPC jurisdictions. I would accept that Bayer Pharma's knowledge of that problem should have required it to consider, from that time, the possibility that amendments to those equivalents might be necessary. Indeed, throughout 2010 and 2011 Bayer Pharma proposed a number of amendments to patent applications in a number of jurisdictions, most notably (but not exclusively) EPC jurisdictions, including some in which, apparently, no opposition had been raised on added subject-matter grounds. I am not persuaded, however, that the existence of that problem, which was essentially a "European issue", was one that should have required Bayer Pharma to consider the possibility that patents in jurisdictions operating under quite different legal requirements, in relation to the drafting of specifications and their claims, might also require amendment. This is particularly so in the Australian context where Bayer Pharma had in fact successfully dealt with particular objections under s 40(3) of the Act that had been made by the appropriate examining authority during the examination phase.
212 In coming to this view, I do not leave out of consideration Dr Broesamle's evidence that, when Bayer Pharma came to consider the commencement of the principal proceeding, it conducted an internal review of the Australian patent, which included considering the invalidity arguments that had been raised against corresponding patents in the United Kingdom, the United States and before the EPO. It also included considering, in a preliminary manner, the amendments that Bayer Pharma had voluntarily proposed or which had been required to the claims of corresponding patents in other jurisdictions. Bayer Pharma obviously considered these matters to have some relevance to its review of the Australian patent. There is, however, in my mind a clear distinction between, on the one hand, circumstances which, objectively, should have catalysed a particular course of conduct (here, reviewing the claims of the Australian patent), and, on the other, appreciating, when independently engaging in that conduct, that those circumstances might assist in making decisions. The present case is of the latter kind.
213 In any event, even if the added subject-matter problem with respect to EP '301 and its equivalents in EPC jurisdictions should have catalysed a review of the scope of the dissolution test claims of the Australian patent, a patentee in the position of Bayer Pharma would at least have been entitled, in those circumstances, to the benefit of some authoritative decision on the added subject-matter objection before proceeding to amend. Both the respondents' and Eremad's submissions appear to acknowledge this possibility. The earliest such decision was given in Gedeon Richter in March 2011, which was followed by the decision of the Opposition Division of the EPO in May 2011. I am not persuaded that the period of time that elapsed from the giving of those decisions until Bayer Pharma gave notice in the principal proceeding of its intention to amend (February 2012) is one that represents delay of a kind that would disentitle Bayer Pharma to a favourable exercise of the discretion under s 105 of the Act, in the absence of other circumstances that would be disentitling.
214 For the avoidance of doubt, I would add that I do not consider the added subject-matter problem with respect to EP '301 and its equivalents to have any greater significance in relation to the Australian patent simply because of the earlier objection raised by the USPTO in the Office Action issued on 4 June 2003. The objection raised by the USPTO on that occasion was a fundamentally different one, as I have already explained.