Apotex Inc., et al. v. Sanofi-Aventis, et al.

(Federal) (Civil) (By Leave)

(Sealing order)




Case summaries are prepared by the Office of the Registrar of the Supreme Court of Canada (Law Branch). Please note that summaries are not provided to the Judges of the Court. They are placed on the Court file and website for information purposes only.

Intellectual property – Patents – Medicines – Patent for medicine held to be valid and infringed by generic manufacturer – How the utility promised by a patent is to be identified and ascertained – How an appellate court is to review factual findings of trial judge as to how skilled addressee would understand the promised utility – How limitations periods are to be applied in respect of activity that only involves conduct, including import and export, in one province.

Plavix is a drug useful in inhibiting platelet aggregation activity in the blood which was developed, patented, and marketed by the respondents (collectively, “Sanofi”). The ‘777 Patent for Plavix is considered to be a selection patent that claims a subset of compounds which are already within the scope of the prior genus ‘875 Patent. The active ingredient in Plavix is clopidogrel bisulphate, the dextro-rotatory isomer of the racemate, having beneficial properties over both the racemate and the levo-rotatory isomer. Apotex Inc. (“Apotex”) attempted to market its own version of clopidogrel bisulfate. It applied for a Notice of Compliance from the Minister of Health, alleging that its version of clopidogrel did not infringe Sanofi’s patent. Apotex also alleged that the ‘777 Patent for Plavix was invalid on several grounds. Sanofi successfully obtained an order prohibiting the Minister from issuing the Notice of Compliance to Apotex. This order was upheld on appeal and again at the Supreme Court of Canada. Apotex then commenced an impeachment action in the Federal Court seeking a declaration that the ‘777 Patent was invalid on several grounds including lack of utility. Sanofi commenced its own action, alleging that Apotex had infringed its patent by importing clopidogrel into Canada and then exporting it from Canada for sale in other countries including the United States. The two actions were consolidated.

Lower Court Rulings

December 12, 2011
Federal Court

2011 FC 1486, T-644-09. T-933-09
Apotex’s impeachment action of ‘777 Patent based on lack of utility and obviousness allowed; Sanofi’s infringement action dismissed
July 24, 2013
Federal Court of Appeal

2013 FCA 186, A-7-12
Sanofi’s appeal allowed; Sanofi’s action for infringement allowed; Apotex’s impeachment action dismissed