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On your mark, get set, go! Biosimilar litigation takes off in Canada

On May 18, 2012, Amgen Canada Inc. and Amgen Inc. (“Amgen”) commenced a proceeding (Court File No. T-989-12) under the Patented Medicines (Notice of Compliance) Regulations against Teva Pharmaceutical Industries Ltd. and Teva Canada Innovation (“Teva”) seeking an Order preventing the Minister of Health from issuing a Notice of Compliance for Teva’s proposed filgrastim pre-filled syringes (in strengths of 300 µg / 0.5 ml and 480 µg / 0.8 ml) prior to the expiry of Canadian Patent No 1,341,537.

The ‘537 Patent was filed in August 1986, issued in July of 2007, and is set to expire on July 31, 2024.  It is the only patent listed on the Patent Register against Amgen’s filgrastim product (NEUPOGEN).

According to the Notice of Application, Teva filed a New Drug Submission for its filgrastim product and has alleged:

  • The ‘537 patent is not entitled to claim priority from a U.S. application filed on August 23, 1985
  • Only claim 43 is relevant
  • Non-infringement of claims 12, 16-24, 26, 27, 29-42 and 48-82
  • Invalidity of certain claims based on:
    • double patenting
    • anticipation
    • obviousness
    • missed conflicts
    • lack of utility and lack  of sound prediction
    • invalid selection
    • material misrepresentation pursuant to section 53 of the Patent Act

This is not the first time that Amgen and Teva have been involved in a patent dispute over filgrastim.  In the U.S., Teva brought a declaratory judgment action in the Eastern District of Pennsylvania seeking declarations that each of the claims of U.S. Patent Nos. 5,580,755 and 5,582,823 (which expire in early December 2013) were invalid and that Teva does not infringe any valid claim of the ‘755 and ‘823 patents. This litigation has settled, with Teva admitting that the ‘755 and ‘823 patents were valid, enforceable and infringed.  The Court’s injunction extends to November 10, 2013, after which Teva may sell its filgrastim product in the U.S.

Amgen’s press release announcing the U.S. settlement maybe found here.