Decision

Janssen Inc. v. Apotex Inc., 2022 FC 996 (Macitentan*)

Justice Pallotta - 2022-07-06

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The plaintiffs, bring this patent infringement action against Apotex pursuant to subsection 6(1) of the PMNOC Regulations ... The plaintiffs allege that if Apotex sells APO-MACITENTAN, it will infringe claims 1-5, 10-20, and 21-31 of Actelion’s Canadian Patent No. 2,659,770 titled “Therapeutic Compositions Comprising a Specific Endothelin Receptor Antagonist and a PDE5 Inhibitor” ... Apotex concedes that the Asserted Claims are valid. ... Apotex alleges that it will not infringe any Asserted Claims directly because it will not perform all of the essential elements of the claims, and it will not infringe any Asserted Claims indirectly because the “Indications and Clinical Use” section of the APO-MACITENTAN PM states that [redacted] and the PM does not suggest that physicians or patients should use APO-MACITENTAN in combination with a PDE5-I. For the reasons below, the plaintiffs have not established that Apotex will directly infringe any of the Asserted Claims. The plaintiffs have established that Apotex will induce infringement of claims 1-5 and 21-31.

Decision relates to:

 

Canadian Intellectual Property