Healthcare & Life Sciences updates

Canada

Contributed by Smart & Biggar
Amended Patented Medicines Regulations will come into force on 1 January 2021
  • Canada
  • 03 June 2020

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.

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious
  • Canada
  • 20 May 2020

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).

OCT benefits cap and private label product restrictions abolished
  • Canada
  • 01 April 2020

Most of the final amendments to regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act came into effect on or before 1 January 2020, following public consultations. One notable change compared with the proposed amendments is the removal of the financial cap on ordinary commercial term benefits. Further, private label products will no longer be prohibited from being designated as a listed drug product or interchangeable.

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness
  • Canada
  • 25 March 2020

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases
  • Canada
  • 18 March 2020

The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the takeaway messages from the ODPRN report.


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