CaseApotex Inc., et al. v. Sanofi-Aventis, et al. (SCC file no. 35562)
Drug: Clopidogrel (PLAVIX®)
Nature of case: Patent Impeachment / Infringement Action
Successful party: Apotex Inc.
Date of decision: January 30, 2014

Summary

On January 30, 2014, the Supreme Court of Canada (“SCC”) granted Apotex Inc., et al. (“Apotex”) leave to appeal the July 24, 2013 Federal Court of Appeal order declaring Canadian Patent No. 1,336,777 (“‘777 Patent”) to be valid and infringed (“FCA Decision”). The SCC previously granted leave and dismissed Apotex’s appeal of a prohibition order with respect to the same patent under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOCRegulations”).  The present appeal arises from a subsequent challenge to the validity of the ‘777 Patent pursuant to section 60 of the Patent Act.

The SCC will be reviewing the FCA Decision that overturned the Trial Judge’s findings of invalidity based on obviousness and lack of utility.  Notably, the FCA Decision contains a significant analysis of the so-called “promise” doctrine – a component of the utility test in Canada that has been contested in a number of high profile drug patent cases and in a recent NAFTA challenge.  The decision to grant leave may signal that Canada’s highest court is ready to weigh in on this important legal issue.  

The Prior ‘777 Patent Proceedings

In a prior proceeding under section 6 of the PM(NOC) Regulations, Sanofi obtained a prohibition order preventing Apotex from obtaining approval for its generic clopidogrel product until after the expiry of the ‘777 Patent.  Appeals by Apotex to the FCA and the SCC were dismissed.  A detailed summary of the SCC’s decision in the section 6 proceeding was reported in a previous Pharma in Brief.

Following the dismissal of its appeal in the PM(NOC) proceeding, supra, Apotex brought an action in the Federal Court to impeach the ‘777 Patent pursuant to section 60 of the Patent Act.  Sanofi responded by suing Apotex for patent infringement.  By decision dated December 6, 2011, the Federal Court (per Boivin J.) found that Apotex infringed the ‘777 Patent, but declared the Patent to be invalid for lack of sound prediction because the inventors allegedly failed to disclose the factual basis and line of reasoning in the specification.  A detailed summary of the Federal Court’s decision in the impeachment/infringement action was reported in a previous Pharma in Brief.

On July 24, 2013, the FCA allowed Sanofi’s appeal and declared the ‘777 Patent to be valid.  (Apotex did not appeal Boivin J.’s finding of infringement).  The FCA Decision held that the Trial Judge erred by inferring a promise of utility in the ‘777 Patent in the absence of clear and unambiguous language.  The FCA also reinforced the “obvious to try” analysis from the SCC’s earlier consideration of the ’777 Patent, and determined that the Trial Judge erred in finding that the claimed invention was obvious to try.  The FCA held that the separation of a racemate of a known compound cannot be “obvious to try” if the properties of the enantiomers were unknown.  A detailed summary of the FCA Decision, now the subject of Apotex’s successful leave application to the SCC, was reported in a previous Pharma in Brief.  

The appeal will likely be heard in the Fall of 2014.

Link to decision:

http://www.scc-csc.gc.ca/case-dossier/info/dock-regi-eng.aspx?cas=35562