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 Time Limits and Other Periods Act (COVID-19) from March 13, 2020 to July 30, 2020. Accordingly, Sandoz's motion was dismissed.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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