Healthcare & Life Sciences, Smart & Biggar updates


Contributed by Smart & Biggar
Federal Court finds silodosin formulation patent valid but not infringed
  • Canada
  • 24 February 2021

The Federal Court recently issued a decision in a patent infringement action pursuant to Section 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin. Although the court found that the patent was not invalid on the basis of obviousness, it also found that the patent had not been infringed.

Innovators challenge final PMPRB Guidelines in new Federal Court application
  • Canada
  • 09 December 2020

Innovative Medicines Canada and numerous research-based pharmaceutical companies recently commenced an application for judicial review of the final Patented Medicine Prices Review Board Guidelines. The guidelines aim to operationalise amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021.

Few significant changes made in final PMPRB guidelines
  • Canada
  • 25 November 2020

The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.

Federal Court orders minister of health to issue NOC to Fresenius Kabi for biosimilar
  • Canada
  • 25 November 2020

Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register in respect of HUMIRA.

Health Canada issues interim order respecting drug shortages relating to COVID-19
  • Canada
  • 11 November 2020

The minister of health recently approved the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, which introduces new tools to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated by the COVID-19 pandemic. This article examines some of the interim order's main features.

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