Amgen Inc. v. Pfizer Canada ULC, 2020 FC 522 (Filgrastim*)
Justice Southcott - 2020-04-16
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This decision relates to an action by the Plaintiffs, Amgen Inc. and Amgen Canada Inc. [collectively, Amgen], against Pfizer Canada ULC [Pfizer], and a related counterclaim by Pfizer. Amgen brings this action pursuant to section 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [Regulations], after being served with a Notice of Allegation by Pfizer pursuant to section 5(3) of the Regulations. ... Pfizer has filed with the Minister of Health a New Drug Submission [NDS] for the issuance of a Notice of Compliance [NOC] for its filgrastim biosimilar NIVESTYM. Pfizer’s NDS refers to NEUPOGEN as a reference biologic drug for the purposes of regulatory approval. ... For the reasons explained in detail below, I find that the claims of the 537 Patent asserted by Amgen are obvious and therefore invalid. I do not find the 537 Patent as a whole invalid due to misrepresentation or insufficiency. I also find that, if the claims asserted by Amgen had been valid, Pfizer would not have been protected by the defence of prior use.
Decision relates to:
- T-741-18 - AMGEN INC. ET AL v. PFIZER CANADA INC.