The Federal Court recently issued its decision on an application for judicial review of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements). The court ruled that Section 3(4), which would expand price calculation requirements in Section 4(4) of the Patented Medicines Regulations to encompass information beyond the first point of sale, was invalid. This article looks more closely into the court's decision and its implications.
The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.
The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).
In view of the ongoing COVID-19 pandemic, the Canadian Intellectual Property Office (CIPO) has further extended patent, trademark and industrial design deadlines fixed under the relevant legislation. Deadlines up to 29 May 2020 have now been extended until 1 June 2020. The CIPO may decide to extend deadlines further, depending on how circumstances evolve.
In view of the ongoing COVID-19 pandemic, the Canadian Intellectual Property Office (CIPO) has further extended patent, trademark and industrial design deadlines fixed under the relevant legislation. Deadlines up to 15 May 2020 are now extended until 19 May 2020 (18 May 2020 being Victoria Day, when the CIPO is closed to the public).