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ARTICLE · 07 MAY 2015

Speculation Insufficient To Establish Indirect Patent Infringement In Canada

McCarthy Tétrault
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The relevance of expert evidence in establishing indirect infringement of a pharmaceutical in Canada has been questioned.

CanadaIntellectual Property
Bart Nowak
Bart Nowak
David Tait
David Tait
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The relevance of expert evidence in establishing indirect infringement of a pharmaceutical in Canada has been questioned. It is unclear what "facts" a product monograph is to contain that will amount to "instructions" to infringe a patent or how a party is to prove that such "facts" amount to "instructions" or how those "instructions" would be understood. What is clear is that "speculation" will not suffice.

On March 26, 2015, the Federal Court released its decision in Bayer Inc. v. Pharmaceutical Partners of Canada Inc., 2015 FC 388, granting PPC's motion to strike portions of an application brought by Bayer under the PM(NOC) Regulations. PPC is seeking regulatory approval for a generic version of Bayer's antibiotic AVELOX® (moxifloxacin hydrochloride intravenous solution for injection). In this proceeding under the PM(NOC) Regulations, Bayer asserts Canadian Patent No. 2,378,424 (the '424 Patent), which claims a formulation of moxifloxacin hydrochloride and sodium

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