30 November 2010

Servier Denied Patent Amendment on Appeal

Les Laboratoires Servier v Apotex Pty Limited [2010] FCAFC 131 (11 November 2010)

Amendment – application to amend under section 105 of the Patents Act 1990 – whether primary judge erred in exercising discretion to refuse application – whether requested amendment allowable under section 102 of the Patents Act 1990

This decision is the result of an appeal by Les Laboratoires Servier ('Servier') from a decision of Justice Bennett, issued on 11 September 2009 (Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2009] FCA 1019), in which Her Honour exercised the discretion afforded by s105 of the Patents Act 1990 to deny Servier's amendment request, even though she concluded that the amendments would otherwise have been allowable under s102.

The three appeal court judges, Justices Emmett, Kenny and Stone, were in agreement that the appeal should be dismissed, although they were split on their reasons. 

Justice Emmett concluded that the primary judge should have deferred a decision on the exercise of discretion until the validity of the existing claims had been explored, but that the requested amendment was not allowable under s102.  Justices Kenny and Stone found, to the contrary, that Justice Bennett did not err in exercising the court's discretion to refuse the amendment, and therefore that it was unnecessary for them to consider the further question of allowability under s102.


We briefly reviewed the first instance decision in an earlier article discussing the Australian amendment provisions by reference to four recent examples (A Tale of Four Amendment Requests, 10 August 2010).  After commencing proceedings against Apotex for infringement of Australian patent no. 2001276418, Servier sought to add narrower claims to its patent, initially asserting that the primary reason for doing so was because one of its Australian attorneys had formed a view that the specification included matter that could form the basis of additional claims.

Apotex objected that the amendments were not allowable under s102, because the proposed new claims were not fairly based on the description in the specification as originally filed.  Apotex further submitted that the court should exercise the discretion to refuse the amendment request due, in short, to Servier's delay in seeking to amend claims that it had reason to believe may be invalid, and its failure to provide a full and frank disclosure to the court of its reasons for seeking amendment.

The court denied Servier's request in exercise of the discretion under s105, despite finding the amendments to be otherwise allowable.

Servier appealed.


The original claims related to a product, being a particular crystalline form of a compound defined by Formula (I) set out in the specification, and characterised by its powder X-ray diffraction diagram, as well as a process for preparation of the product, and a pharmaceutical composition comprising the product as active ingredient.

Servier's amendments request sought to add claims directed to the product, process and pharmaceutical compound substantially as claimed in the original claims, but with the additional limitation that the crystals take the form of 'individual needles'.

Support for the new claims was said by Servier to reside in the description of the process, in which it is stated:

The perindopril tert-butylamine salt that is thereby obtained is in the form of individual needles about 0.2 mm long. That homogeneous distribution has the advantage of allowing especially rapid and efficient filtration and drying, as well as allowing the preparation of pharmaceutical formulations having a uniform and reproducible composition, which is especially advantageous when those formulations are intended for oral administration.
Justice Bennett, at first instance, agreed that this passage provided basis for the new claims, whereas Justice Emmett on appeal did not. Justices Kenny and Stone found it unnecessary to reconsider the issue.
As noted above, the appeal court was unanimous in dismissing Servier's appeal, but split on the reasons for doing so.
Justice Emmett dismissed the appeal on the ground that the amendments were not allowable under s102.  We confess to finding the reasoning a little difficult to follow, but as we understand it the judge considered the 'individual needles' not to be a feature of the 'product invention' disclosed in the specification, but rather an advantage of the 'process invention' (at [22]).  The passage describing the advantages of the process should not be 'read back into the description of the product invention' (at [25]).  Thus the additional claims are not fairly based on the matter contained in the body of the specification, and are not allowable under s102.
With regard to the discretion under s105, Justice Emmett again reached a different conclusion to that of the primary judge.  Where Justice Bennett had found it appropriate to deny the amendment request, Justice Emmett considered that it was premature to to reach a final conclusion on the issue.  He considered that since Servier maintained that the original claims were valid (despite an adverse finding in relation to corresponding claims in a UK court), 'it cannot be said, at this stage, that Servier has sought to maintain claims of a patent that it knows or ought to know are invalid' (at [69]).  His preference would therefore have been to defer a decision until the validity of the original claims had been decided (at [70]).
Justices Kenny and Stone, on the other hand, agreed with Justice Bennett, finding that her exercise of discretion to refuse the amendment request was appropriately based on 'considerations related to Servier’s delay and failure to disclose its reasons for seeking amendment' (at [102]).  They therefore declined to consider the question of allowability under s102.
This appears to be a case in which Servier made its own bed in which to lie.  There is certainly something  a little on the nose about its decision to amend the patent by the addition of a complete set of narrower claims.  If Servier truly believes that the original claims are valid, why is the amendment necessary at all?  If it is simply because there is material in the specification that could form the basis for additional, narrower, claims (as Servier initially contended), why could these not be added as claims depending from the original independent claims?
One is tempted to conclude that Servier wishes to hedge its bets, or to have its cake and eat it too.  Assuming this to be an unacceptable attempt to gain unfair advantage from the patent, the different approaches taken by Justice Emmett on the one hand, and Justices Kenny and Stone on the other, may not be so different.
Justice Emmett considered that the additional claims were directed to an invention that was different from that originally disclosed, and that they were therefore not fairly based on the description.  However, he was not willing to conclude, on the evidence, that Servier's conduct had been sufficiently egregious to warrant denial of an amendment (had it otherwise been allowable), in the absence of some further consideration of the validity of the original claims.
Justice Kenny and Stone, on the other hand, were perfectly content to reach the conclusion that Servier's conduct was such that it was perfectly open to the primary judge to deny the amendment request.
The end result is the same, either way.  We therefore cannot help feeling that Servier was undone by its conduct in this case, and the only difference amongst the four judges is in their opinions on the most suitable grounds for putting the punishment into effect!


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