The Supreme Court of Canada announced today that it has granted
leave to appeal to Apotex Inc. from the Federal Court of Appeal
(FCA) in the patent case Sanofi-Aventis v. Apotex Inc.
here), in which the FCA allowed Sanofi's action for
infringement and dismissed Apotex's action for impeachment
here). At the heart of the dispute is the determination of the
validity of the Canadian Patent No. 1,366,777 (the '777 Patent)
in light of the controversial notion of the promise of the patent.
The '777 Patent relates to clopidogrel bisulfate, a drug useful
in inhibiting platelet aggregation and sold in Canada under the
brand name Plavix.
In order to launch a generic version of Plavix in Canada, Apotex
applied for a Notice of Compliance, claiming that its version of
clopidogrel did not infringe Sanofi's patent as well as
challenging the validity of the '777 Patent on several grounds
including utility. Sanofi obtained an order prohibiting the
issuance of the Notice of Compliance and the order was upheld on
appeal and at the Supreme Court (2008 SCC 61).
Subsequently, Apotex 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
countered with an infringement action alleging that Apotex had
infringed the '777 Patent by importing clopidogrel into Canada
and then exporting it from Canada. The two actions were
consolidated and the Federal Court found the '777 Patent
invalid based on lack of utility and obviousness, while dismissing
Sanofi's infringement action (2011 FC 1486). The trial judge ruled that the
promise of the patent was neither demonstrated nor soundly
predicted as of the filing date of the patent
The FCA subsequently reversed the trial judge's decision,
dismissed Apotex's impeachment action and allowed Sanofi's
action for infringement. The FCA ruled that the promise of the
patent is the standard against which the utility of the invention
described in the patent is measured. Referring to what was set out
in the Olanzapine case, the FCA said that where the inventor does
not make an explicit promise of a specific result, the test for
utility is a "mere scintilla" of utility. However, where
the inventor makes an explicit promise of a specific result,
utility will be assessed by reference to the terms of the explicit
promise. The FCA held that the Federal Court erred in reading into
the '777 Patent a promise for use in humans on the basis of
inferences, in the absence of language at least as clear and
unambiguous as that used to establish the advantages of the
selection over the compounds of the genus patent.
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The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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