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2020 Highlights In Canadian Life Sciences IP And Regulatory Law - Food, Drugs, Healthcare, Life Sciences

In response to the pandemic, we saw quick action and flexibility from: the Canadian Intellectual Property Office (CIPO) - deadlines from March 16 to August 28 were extended until August 31. On December 14, the Trademarks Office began accepting requests for expedited examination of trademark applications associated with medical goods or services related to COVID-19; the Federal Courts - Federal Court (FC) deadlines were suspended until June 29 or July 13, depending on the province, and a number of hearings and patent trials were conducted by Zoom.  Federal Court of Appeal (FCA) deadlines continue to be suspended for some appeals, but are being lifted for selected

2020 Highlights in Canadian Life Sciences IP and Regulatory Law | Smart & Biggar

1. COVID-19: CIPO, Federal Courts, Health Canada In response to the pandemic, we saw quick action and flexibility from: the Canadian Intellectual Property Office (CIPO) – deadlines from March 16 to August 28 were extended until August 31. On December 14, the Trademarks Office began accepting requests for expedited examination of trademark applications associated with medical goods or services related to COVID-19; the Federal Courts – Federal Court (FC) deadlines were suspended until June 29 or July 13, depending on the province, and a number of hearings and patent trials were conducted by Zoom. Federal Court of Appeal (FCA) deadlines continue to be suspended for some appeals, but are being lifted for selected files on a weekly basis. The FC held that the 45-day time limit for commencing a s. 6(1) action under the

FCA provides guidance on standard for leave to appeal interlocutory PMNOC decisions | Smart & Biggar

Summary On December 3, 2020, the Federal Court of Appeal released its first decision providing guidance on the standard for obtaining leave to appeal interlocutory decisions under section 6.11(1) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations): Apotex v Allergan; . The threshold for obtaining leave requires:  A fairly arguable case taking into account the standard of review; and That the issue raised is capable of having a direct impact on the overall success or failure of the case. Analysis Prior to 2017, litigants could appeal interlocutory decisions under the Regulations – decisions typically made by Prothonotaries – first to a Federal Court judge, and then to the Federal Court of Appeal, both as of right. However, following the coming into force of the 2017 amendments to the Regulations, new section 6.11(1) permitted interlocutory appeals to go directly to the Federal Court of Appeal, with leave of that Court.

Strict 45-day time limit for starting PMNOC action was suspended by COVID-19 Federal legislation | Smart & Biggar

The Patented Medicines (Notice of Compliance) Regulations ( PMNOC Regulations) require that any section 6(1) action be brought within 45 days after the day on which the first person is served with a notice of allegation (NOA). The Federal Court has permitted such an action relating to dolutegravir (ViiV’s TIVICAY) to continue even though it was not commenced within this 45-day time limit: ViiV v Sandoz, 2020 FC 1040. Sandoz had brought a motion for summary judgment or, in the alternative, to strike the action, arguing that ViiV was statute-barred from commencing the action. The action was not commenced within 45 days of service of the NOA because of COVID-19 related issues. The Court held that the 45-day time limit for starting the action was suspended under the

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