Apotex Pty Ltd v Les Laboratories Servier (No 2) [2009] FCA 1019.

Synopsis

When an amendment to a patent application or granted patent is requested before the Patent Office, the Office must allow the amendment provided that it meets the relevant requirements under the Patents Act. However, if the same amendment is requested before a Court, the Court may choose to exercise its discretion and refuse the amendment even though it is considered otherwise allowable. In this case, Les Laboratories Servier (the patentee) found itself on the wrong side of the Court's discretion where otherwise allowable claim amendments were refused on the basis of undue delay and lack of full and frank disclosure surrounding the amendments.

FACTS OF THE CASE

Perindopril is a pharmaceutical compound used in the treatment of hypertension. Les Laboratories Servier (“Servier“) filed on 6 July, 2001 Australian Patent Application No. 2001276418 directed toward, amongst other things, a new α-crystalline form of a perindopril salt and a process for its synthesis. On 28 July, 2005 the application was advertised to allow three months for opposition purposes.

Due to opposition proceedings brought by Lupin Limited, which were subsequently withdrawn, the application had still not proceeded to grant in March, 2007. In the meantime, Apotex Pty Ltd (“Apotex“) had launched a generic form of perindopril in 2006 for importation and sale in Australia.

On 9 March, 2007, Apotex filed with the Office a belated Notice of Opposition to the acceptance of the application, together with an application for an extension of time within which to file the Notice. The extension of time application was ultimately refused on appeal to the Administrative Appeals Tribunal on 19 March, 2008.

Meanwhile, on 2 March, 2007 Servier filed a request with the Office to amend the claims of the application. Leave to amend the application was advertised on 16 August, 2007. Apotex filed an opposition to Servier's amendments which was dismissed by the Office on 11 April, 2008. Apotex subsequently appealed that decision on 22 April, 2008, but on the same day Servier withdrew their request to amend and sought immediate sealing of the application. The patent was sealed as Australian Patent No. 2001276418 (the “AC Patent“) on 1 May, 2008 without incorporation of the amendments.

Apotex filed for revocation of the AC Patent on 1 May, 2008. Servier subsequently filed a notice of motion to amend the AC Patent before the Court on 26 May, 2008. The Case study 5 Proposed Claim Amendments Allowable but Nevertheless Refused by the Court Apotex Pty Ltd v Les Laboratories Servier (No 2) [2009] FCA 1019. amendments were in the same terms as those previously presented and allowed by the Office, but abandoned by Servier.

Apotex opposed Servier's attempt to amend the AC Patent, and this gave rise to the proceedings that are the subject of this decision.

THE DECISION

The proposed amendments

The 18 claims of the AC patent as granted are directed toward an α-crystalline form of perindopril tert-butylamine salt (claim 1), a process for preparing the salt (claim 2), a pharmaceutical composition comprising the salt (claim 8), a method of treating a cardiovascular disease using the salt (claim 13), and use of the salt in the manufacture of medicaments for treatment of cardiovascular diseases (claim 14). Claim 7, which is dependant on any one of process claims 2 to 6, defines the salt as being obtained in the form of “individual needles“.

The amendments proposed by Servier in essence sought to introduce claims limited by the feature of the perindopril being in the form of a specific crystal habit, namely, in the form of “individual needles“. The amendments were presented as new claims 19 to 39 that did not depend from the existing 18 claims. Accordingly, Servier proposed to maintain the claims as granted and introduce a new set of claims that were limited by way of reference to the crystal habit feature.

Servier sought to amend the AC Patent before the Court pursuant to section 105 of the Act. section 105 states that “…the Court may, on the application of the patentee, by order direct the amendment of the patent…“, and that the “…Court is not to direct an amendment that is not allowable under section 102.“. The word “may“ in section 105 provides for the discretionary power to refuse an amendment that is otherwise allowable under section 102. This is in contrast with the legislation that governs amendments made before the Patent Office which provides no such discretionary power to refuse an otherwise allowable amendment.

Apotex challenged Servier’s application to amend the AC Patent on two broad fronts: namely that the amendments are not allowable under section 102 of the Act, and even if they are allowable under section 102 the Court should refuse to exercise its discretion under section 105 of the Act to direct the amendments.

In relation to the first front, Apotex more specifically asserted that: there is no real and reasonably clear disclosure of individual needles as part of “the invention“; the newly added claims are not fairly based; the specification does not disclose any or best method of producing the “individual needles“; and that the term “individual needles“ is unclear and not capable of defining the scope of the invention.

As would be expected, Servier rebutted all of Apotex’s submissions. In doing so, Servier pointed to the feature of individual needles being disclosed in the body of the specification as filed and accepted and in existing claim

7. Although conceding that at its broadest, the invention is for the α–crystalline form of perindopril, Servier also argued that they were not precluded from pursuing a more narrow form of the invention.

Her Honour (Bennett J), with guidance primarily from the decision of Lockwood Security Products Pty limited v Doric products Pty Limited [2004] HCA 58; (2004) 217 CLR 274, swiftly dealt with all grounds raised by Apotex and concluded that the amendments proposed were allowable.

Consideration of the Courts discretionary powers under section 105

Prior to laying out the relevant facts in the case, her Honour referred to a number of authorities that were of assistance as guidelines, and highlighted a number of points as relevant to the exercise of the Court's discretion, including:

  • whether there has been a full and frank disclosure of all relevant matters;
  • whether the patentee has sought to obtain an unfair advantage from the unamended patent;
  • whether there has been any unreasonable delay in seeking amendment; and
  • whether any circumstances arise that would lead the court to refuse the amendment.

In deciding on matters of discretion under section 105, her Honour also pointed out that the “…Court is concerned with the conduct of the patentee and not with the merit of the invention…“.

Apotex sought to convince the Court to exercise its discretion and refuse the application to amend primarily on the grounds that Servier failed state the real reason why it requested the amendments, and that Servier's approach to the application with respect to evidence and discovery was unsatisfactory.

Of particular relevance to these grounds were two affidavits relating to Servier's application to amend filed by Servier's solicitor. In relation to the affidavits, her Honour again pointed out that “the obligation of good faith requires a patentee to disclose correct reasons for the amendments which it seeks“.

The first affidavit by Servier's solicitor stated little more than that following a review of the AC patent he formed the view that the specification contained subject matter relating to the crystal habit and filterability of the crystals that could be the basis of additional claims.

The second affidavit by Servier's solicitor reiterated points made in the first, but also stated at [4] that “It is, and has at all relevant times been, my understanding that the purpose of including narrower or dependant claims is to reduce invalidity risk“. In response to a request by Apotex's solicitors, Servier's solicitors qualified paragraph [4] by stating that the reference to invalidity risk is “general and does not relate in particular to the Alpha Crystalline Patent“.

While the second affidavit put forward further reasons for Servier's proposed amendments, Apotex argued that it still did not constitute full and frank disclosure by Servier on the issue.

On that basis, Apotex served a notice to produce on Servier. Servier's initial reaction to this was that discovery was not necessary. Apotex brought the matter before the Court and following the Court's orders of 9 July, 2008 they sought several categories of documents from Servier. However, Servier refused to produce documents in a number of those categories and produced documents in the remaining categories in a piecemeal manner.

Apotex again brought the matter before the Court, and her Honour ordered that Servier serve on Apotex communications or records of communications between relevant parties relating to the reasons for seeking the amendments. The documents were produced and Apotex tendered them before the Court. Apotex argued that the tendered documents, and not the evidence given by its solicitor, disclosed Servier's real reasons for making the amendment application. In particular, Apotex pointed to correspondence in 2007 between Servier and its solicitors in which the solicitors state that the “amendments to the AC Patent were designed to overcome potential validity issues raised by the UK proceedings.“

On consideration of all the facts, her Honour held that the amendments were allowable under section 102 of the Act, but under the circumstances considered that discretion under section 105 should be exercised to refuse the amendments.

In reaching this conclusion, her Honour stated that she did not accept Servier's suggestion that the disclosure of its reasons for proposing the amendments was part of an “iterative process“. The first affidavit by Servier's solicitor simply made no mention of the true reasons for proposing the amendments that were uncovered by the proceedings. Her Honour went on to point out that “…Servier failed voluntarily to disclose all relevant matters until they were exposed by Apotex.“.

Her Honour also made reference to Servier's intention to maintain the granted claims and yet still advance the amended narrower claim set with the premise that these claims reflect the invention. In that regard, her Honour stated disapprovingly that “Servier intends knowingly to take advantage of the wider claims which do not reflect the invention described in the AC Patent, while at the same time seeking amendment better to defend the validity of the AC Patent and prove infringement by Apotex“. This statement was presented in a context of Servier being well aware at the time of proposing the amendments of the validity concerns of the corresponding UK patent (which had similar claims to those of the AC Patent) and yet it maintained before the Court that such matters formed no part of its reasons to pursue the amendments.

On the matter of undue delay, her Honour noted that Servier had ample time to amend the AC Patent or the application to pursue additional claimable subject matter. In fact, as previously mentioned, amendments similar to those presented before the Court were made and abandoned by Servier just prior to the grant of the AC Patent in March 2007. Servier did not adequately explain to the Court why it abandoned the application amendments. Notably, at the time of abandoning the amendments Servier was aware of the validity concerns of the corresponding UK patent. Her Honour was of the opinion that Servier had delayed in seeking the amendments.

Servier’s application to amend the AC patent was therefore refused on the basis that they delayed in seeking the amendments, and that they failed to provide timely full and frank disclosure as to the reasons for proposing the amendment.

Servier has now sought leave to appeal this decision. In the event that the amendments are ultimately refused, Servier will have to defend the AC Patent in the revocation proceedings sought by Apotex on the basis of the unamended claims, corresponding closely to those which were successfully revoked in the corresponding UK patent proceedings.

COMMENTARY

Unlike the Patent Office, the Courts have a discretionary power to refuse an otherwise allowable amendment.Therefore, where possible, an applicant or patentee contemplating amending a specification should seek to do so before the Patent Office.

Where a patentee is aware that amendments should be made to their patent, it is recommended they make them without undue delay. Undue delay is not a relevant factor before the Office, however, if the patentee is unexpectedly engaged in litigation of its patent, those amendments will need to be requested before the Court, where any delay will be taken into account in the exercise of the Court's discretion. Furthermore, in seeking to request amendments to a patent before the Court, the patentee should make a timely and full and frank disclosure of the reasons as to why it is seeking to amend the patent.