APOTEX APPEAL


requirement for sound prediction measured against this high promise. Te judge also found the patent claims obvious. Sanofi appealed.


Te Federal Court of Appeal (FCA) reversed the decision, finding the patent valid. It said that when properly interpreted,


utility requirement and was not obvious, as the properties of the separated enantiomers could not be predicted before testing.


On utility, the sticking point, in this case as in many others, was what the promise of the patent was, if any.


Te FCA noted that courts should not strive to find ways to defeat otherwise valid patents. Rather, it said, “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction”.


Te FCA determined that any promised utility must be explicit. Te trial judge had erred by finding an “explicit promise” for use in humans, based on inferences from the patent disclosure. Te ‘777 patent described a compound having advantages (including the absence of disadvantages) over the


compounds of another patent and those advantages were disclosed in the patent specification.


Because the trial judge had found that the patent met the those


advantages were demonstrated at the time of the patent application, the patent was not invalid for lack of utility.


On to Apotex’s appeal


Apotex obtained leave from the Supreme Court to appeal against the FCA decision. Six organisations—Fédération


internationale


des conseils en propriété intellectuelle, Canada’s Research-Based Pharmaceutical Companies, Centre for IP Policy,


International Association


for the Protection of IP, BIOTECanada and the Canadian Generic Pharmaceutical Association— were granted intervener status to assist the Supreme Court in understanding the broader implications of the “utility” requirement to life science companies and the public in Canada.


On November 3, 2014, the day before the highly anticipated hearing in the Supreme Court, Apotex filed a notice of discontinuance “on a without costs basis on consent”. Tis means that Sanofi agreed that Apotex did not have to


reimburse it for any costs incurred by Apotex’s appeal—relatively insignificant in the context of the litigation as a whole.


Te practical effect of Apotex’s discontinuance is that its appeal will not be decided and the Supreme Court no longer has an opportunity, in this case, to give guidance and clarification on the existing utility requirements for patentability in Canada.


However, the discontinuance also means that the FCA’s decision finding the ‘777 patent valid and infringed is now the final word in the Apotex v Sanofi dispute over Plavix. Tis is not a minor matter given the substantial volume of Apotex’s import and formulation of clopidogrel bisulfate for export, including to the US.


While Apotex’s discontinuance is sure to be good news for Sanofi, the bringing of the Canadian law on utility more in line with that of other jurisdictions will have to wait for another day, and another case. 


Gunars Gaikis is a partner at Smart & Biggar/ Fetherstonhaugh. He can be contacted at: ggaikis@smart-biggar.ca


www.lifesciencesipreview.com


Life Sciences Intellectual Property Review


Volume 2, Issue 1


29


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