Amgen : 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 valid claims of any patents listed against the innovator's drug. Under the previous Regulations, this question was determined by a summary application process that did not finally determine the questions of infringement and validity. Actions under the new Regulations proceed at a rapid pace, with the Court's expectation being that a two-week trial will be completed within 21 months of the action being started.  These expectations were met in this case.

The action was also notable because the 537 Patent issued in 2007 from an application filed in 1986. As such, the validity issues were decided under the Patent Act as it read immediately before October 1, 1989.

Pfizer was represented by Norton Rose Fulbright Canada LLP.

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