Plavix is a very successful anti-coagulant drug which was developed, patented, and marketed by the appellant, Sanofi-Aventis (Sanofi). Apotex Inc. (Apotex), a well known manufacturer and distributor of generic drugs, attempted to create and market its own version of the active ingredient in Plavix, clopidogrel bisulfate (clopidogrel). It applied for a Notice of Compliance from the Minister of Health, alleging that its version of clopidogrel did not infringe Sanofi’s patent which, it alleged, was invalid in any event for a number of reasons, including obviousness. Sanofi responded by applying to the Federal Court for an order prohibiting the Minister from issuing the Notice of Compliance to Apotex. That application was successful so that Sanofi continued to enjoy a monopoly with respect to the manufacture and sale of Plavix: Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2005 FC 390, [2005] F.C.J. No. 482 (QL). Appeals to the Federal Court of Appeal, Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2006 FCA 421, [2006] F.C.J. No. 1945 (QL), and to the Supreme Court of Canada, Apotex Inc. v. Sanofi-Synthelabo Canada inc., 2008 SCC 61, [2008] 3 S.C.R. 265 (Plavix), were unsuccessful.
Apotex then commenced an action in the Federal Court seeking a declaration that Sanofi’s patent, Canadian Patent No. 1,336,777 (the ‘777 Patent) was invalid. Sanofi replied by commencing its own action, alleging that Apotex had infringed its patent by importing clopidogrel into Canada from Mexico and then exporting it from Canada for sale in other countries including the United States. The two actions were consolidated and were heard by Boivin J. (the Trial Judge or simply, the Judge). Following a 26 day trial, the latter found that the ‘777 Patent was invalid for lack of utility on the basis that the promise of the patent had neither been demonstrated nor soundly predicted. In addition, the Trial Judge found that the invention described in the patent was obvious. Though the Trial Judge also found that Apotex had infringed the ‘777 Patent, that finding was overtaken by his conclusion that the patent was invalid. The Trial Judge’s decision is reported as Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486, [2011] F.C.J. No. 1813 (QL), (Reasons).
This is an appeal of that decision. It raises a variety of issues including the promise of the patent, obviousness, and the limitation period applicable to certain acts of patent infringement.
THE APPEAL COURT DECISION -Conclusion:
Appeal court would set aside the judgment of the Federal Court and, rendering the judgment which it should have rendered, It would allow Sanofi-Aventis’ action for infringement of the Canadian Patent No.1,366,777 and declare that Apotex has infringed claims 1, 3, 6, 7, 8, 9, 10, and 11 of that patent. It would dismiss Apotex’s action seeking a declaration that Canadian Patent No.1,366,777 is invalid. I would return the matter to the Federal Court to deal with the issue of remedies and award Sanofi its costs, to be assessed, both in this court and in the Federal Court.
For complete judgment click on the below link:
http://decisions.fca-caf.gc.ca/en/2013/2013fca186/2013fca186.html
Apotex then commenced an action in the Federal Court seeking a declaration that Sanofi’s patent, Canadian Patent No. 1,336,777 (the ‘777 Patent) was invalid. Sanofi replied by commencing its own action, alleging that Apotex had infringed its patent by importing clopidogrel into Canada from Mexico and then exporting it from Canada for sale in other countries including the United States. The two actions were consolidated and were heard by Boivin J. (the Trial Judge or simply, the Judge). Following a 26 day trial, the latter found that the ‘777 Patent was invalid for lack of utility on the basis that the promise of the patent had neither been demonstrated nor soundly predicted. In addition, the Trial Judge found that the invention described in the patent was obvious. Though the Trial Judge also found that Apotex had infringed the ‘777 Patent, that finding was overtaken by his conclusion that the patent was invalid. The Trial Judge’s decision is reported as Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486, [2011] F.C.J. No. 1813 (QL), (Reasons).
This is an appeal of that decision. It raises a variety of issues including the promise of the patent, obviousness, and the limitation period applicable to certain acts of patent infringement.
THE APPEAL COURT DECISION -Conclusion:
Appeal court would set aside the judgment of the Federal Court and, rendering the judgment which it should have rendered, It would allow Sanofi-Aventis’ action for infringement of the Canadian Patent No.1,366,777 and declare that Apotex has infringed claims 1, 3, 6, 7, 8, 9, 10, and 11 of that patent. It would dismiss Apotex’s action seeking a declaration that Canadian Patent No.1,366,777 is invalid. I would return the matter to the Federal Court to deal with the issue of remedies and award Sanofi its costs, to be assessed, both in this court and in the Federal Court.
For complete judgment click on the below link:
http://decisions.fca-caf.gc.ca/en/2013/2013fca186/2013fca186.html