Pfizer’s Nivestym is an FDA approved recombinant human granulocyte colony-stimulating factor. It is a biosimilar to Amgen’s Neupogen, a drug which reduces the risk of neutropenia in patients undergoing chemotherapy.
Amgen has a Patent on the Canadian Patent Register for Neupogen. Earlier this year Pfizer filed for a new drug submission (NDS) and provided a Notice of Compliance (NOC) to Amgen, with the aim of marketing Nivestym in Canada. Amgen have asserted their 537 Patent for Neupogen to prevent this.
Pfizer sought to dismiss this action by claiming it is redundant due to a previous ruling regarding another companies attempt to market a biosimilar to Neupogen. In this ruling the Federal Court dismissed Amgen’s application under the old Patented Medicines (Notice of Compliance) (PMNOC) Regulations for an order prohibiting the issuance of a NOC for Grastofil owned by Apotex, finding that Apotex’s allegation of invalidity of the Patent was justified.
The Federal Court of Canada has refused the motion from Pfizer that it is an abuse of the Court’s process for Amgen to use the PMNOC Regulations again on that same patent. This was because the Court in the Apotex application had not conclusively determined the validity of the patent, plus the PMNOC Regulations have been amended since the first ruling and decisions made prior to the update are not binding on actions for patent infringement.
The Federal Court of Canada therefore concludes that Amgen’s 537 Patent for Neupogen is currently still valid and subsisting.
The Federal Court’s decision is available here