Healthcare & Life Sciences, Smart & Biggar updates


Contributed by Smart & Biggar
Amendments to USMCA remove 10-year data protection requirement for biologics
  • Canada
  • 15 January 2020

The United States, Mexico and Canada recently signed amendments to the US-Mexico-Canada Agreement (USMCA). The original USMCA was signed on 30 November 2018. The recent amendments have removed a provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical products, including biologics.

Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva
  • Canada
  • 18 December 2019

In 2018 the Federal Court granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva's bortezomib product. According to Justice Locke, Teva would not have infringed Patents 2,203,936 and 2,435,146 because their relevant claims were invalid for obviousness. The Federal Court of Appeal has now upheld the finding of obviousness, dismissing Millennium Pharmaceuticals' and Janssen's appeal.

PMPRB releases draft guidelines operationalising amended Patented Medicines Regulations
  • Canada
  • 11 December 2019

The Patented Medicines Prices Review Board recently released new draft guidelines for consultation and a backgrounder. The new guidelines aim to operationalise the amended Patented Medicines Regulations, which come into force on 1 July 2020, and provide a number of circumstances in which categories or price ceilings may be reassessed.

Federal Court issues two interlocutory decisions in Section 8 pregabalin case
  • Canada
  • 27 November 2019

The Federal Court recently issued two decisions relating to Pharmascience's claim for Section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its pregabalin product (Pfizer's Lyrica). In the first, the court granted motion for summary trial on the relevance of Pfizer's ex turpi causa defence; in the second, it overturned the prothonotary's order, which had denied Pfizer leave to amend a pleading.

Amgen not precluded from litigating same patent under amended PMNOC regulations
  • Canada
  • 20 November 2019

The Federal Court of Appeal recently dismissed Pfizer's appeal of its failed motion to dismiss Amgen's action regarding an infringing patent under Section 6 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Pfizer argued that Amgen's action ought to be dismissed as an abuse of process on the basis that Amgen had unsuccessfully litigated the same patent under the pre-amended PMNOC Regulations.

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