Case: Apotex 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
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
Regulations"). 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.
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