Janssen Inc. v. Sandoz Canada Inc., 2022 FC 715 (Macitentan*)
Justice Pallotta - 2022-05-31
Read full decision. Automatically generated summary:
The plaintiffs, Janssen and Actelion, bring this patent action against Sandoz pursuant to subsection 6(1) of the PMNOC Regulations ... The 770 Patent relates to macitentan in combination with a PDE5-I to treat diseases wherein vasoconstriction is involved, including PAH. Claim 21 is an independent claim of the 770 Patent that claims the use of macitentan in combination with a PDE5-I to treat a disease wherein vasoconstriction is involved. ... For the purposes of this proceeding only, Sandoz concedes it would infringe the Asserted Claims if it is authorized to market macitentan tablets in Canada. ... Sandoz asserts that each Asserted Claim is invalid for one or more of the following reasons: (i) the subject matter of the claim was obvious in view of what was already publicly known; (ii) the inventor had not demonstrated or soundly predicted the utility of the claimed invention; (iii) the claim is overly broad, claiming more than what the inventor actually made or disclosed; and (iv) the 770 Patent specification does not correctly and fully describe how macitentan in combination with a PDE5-I would be used to treat various diseases of vasoconstriction, failing to meet the sufficiency requirements of paragraphs 27(3)(a) and (b) of the Patent Act. ... I find that, even if the skilled person were focused on WO 557, it disclosed a large number of compounds with ERA activity. Without hindsight, there is no justification for the skilled person to take the steps that Sandoz alleges would have led the skilled person to identify macitentan among a group of compounds selected for testing from WO 557. ... Sandoz has not established that any of the Asserted Claims is invalid. Accordingly, in view of Sandoz’s concession on infringement, the plaintiffs are entitled to a declaration that Sandoz would infringe the Asserted Claims by making, constructing, using, or selling its macitentan tablets in Canada.
Decision relates to:
- T-549-20 - JANSSEN INC. ET AL. v. SANDOZ CANADA INC.
- A-128-22(2023 FCA 221) - which is an appeal from this decision