First Trial Judgment Under New PMNOC Regulations Declares Claims To Biologic Drug Invalid
The Federal Court has released its first trial judgment in an action brought under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FC 522, the Court dismissed Amgen's action and declared certain claims in Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to Pfizer's filgrastim biosimilar.
Under the new Regulations, which came into force in September 2017, a full action determines the question of whether the marketing of a generic or biosimilar drug would infringe any...
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