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.
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.
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.
In 2019 the Federal Court of Appeal dismissed Millennium Pharmaceuticals' and Janssen's appeal of a decision granting Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Millenium Pharmaceuticals and Janssen have now applied to the Supreme Court of Canada for leave to appeal.
The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.