In a brief decision, the Federal Court of Appeal dismissed Idenix’s appeal of a Federal Court decision which found that a patent owned by Idenix and purporting to claim anti-HCV compounds was invalid for: (i) failing to sufficiently disclose a synthetic method by which the claimed compounds could be made; and (ii) for lack of sound prediction of utility. The Federal Court of Appeal held that Idenix had not identified any errors in the Federal Courts decision with respect to insufficient disclosure that warranted intervention. Given those findings, the Federal Court of Appeal did not address the other issues raised in detail.

Norton Rose Fulbright Canada LLP represented Gilead Sciences, Inc., Gilead Sciences Canada, Inc. and Gilead Pharmasset LLC (Gilead) in the Federal Court and Federal Court of Appeal.

Case:  Idenix Pharmaceutical Inc. v Gilead Pharmasset LLC, 2017 FCA 161 (Court File No. A-483-15), affirming 2015 FC 1156

Nature of case:  Appeal from action for patent invalidity with cross claim for patent infringement and invalidity.

Successful party:  Gilead Sciences, Inc., Gilead Sciences Canada, Inc., and Gilead Pharmasset LLC

Date of decision:   July 24, 2017

 

Summary

Gilead initiated the underlying invalidity action based on a belief that the manufacture, use or sale in Canada of sofosbuvir (marketed in Canada as SOVALDI®) would be impugned by Idenix as an infringement of the patent. Idenix counterclaimed, and indeed claimed that Gilead’s sale of sofosbuvir in Canada constituted infringement of its patent. Idenix also sought to invalidate a Gilead owned patent on the basis that it was not novel in light of the Idenix patent.

The Federal Court allowed Gilead’s claim, finding that each claim of the Idenix patent was invalid for: (i) failing to sufficiently disclose how to synthesize the compounds at issue; and (ii) for lack of sound prediction of utility. The Court also dismissed Idenix’s counterclaim, finding that the Idenix patent did not enable (and therefore did not anticipate) the Gilead patent.

Idenix appeal

Idenix argued on appeal that the Federal Court made multiple errors in reaching its conclusions on insufficiency and lack of sound prediction. The Federal Court of Appeal dismissed Idenix’s appeal finding no error warranting the Court’s intervention.

The Court of Appeal rejected Idenix’s argument that the Federal Court applied an incorrect test for insufficient disclosure. Rather, the Court of Appeal found that, read in context, the Federal Court correctly considered how the skilled person would have understood the patent when it concluded that the Idenix patent, together with the common general knowledge, did not sufficiently disclose how to synthesize the compounds at issue.

Idenix had argued that the synthetic method was sufficiently disclosed by virtue of certain aspects of the method being included in schemes directed to other compounds in the patent and in other prior art. The Court of Appeal rejected Idenix’s argument and agreed with the Federal Court that “the fact that, in hindsight, individual steps in a chemical synthesis have some precedent in the literature does not mean that the overall sequence of steps for making a new compound was easy to determine.” The Court of Appeal analogized the lack of an appropriate synthetic method in the patent to the situation considered by the Supreme Court of Canada in Teva Canada Ltd. v Pfizer Canada Inc., 2012 SCC 60 and found that rather than leading the skilled person step by step through the synthesis of the claimed compounds, the specification necessitated the working out of a problem. The Court of Appeal held that in the absence of any teaching in the Idenix patent, the problem left to be worked out by the person of ordinary skill was “a burden beyond that borne by” the Patent Act as interpreted by the jurisprudence.

The Court of Appeal also rejected a number of other grounds of appeal argued by Idenix finding that either no error was made, or that even if an error was made, any error did not impact the Federal Court’s core finding that the patent failed to sufficiently disclose a method for making the compounds claimed.

Given the Court’s finding on sufficiency, it was not necessary for the Court to consider Idenix’s arguments with respect to sound prediction or anticipation of the Gilead patent in detail.

 

Links:

Idenix Pharmaceuticals, Inc. v Gilead Pharmasset LLC, 2017 FCA 161