The Pharma in Brief team is looking back at 2025’s most notable legal and regulatory developments in the Canadian pharmaceutical space and highlighting hot topics for 2026. To those who don’t make it to the end of the article, we’ll
Health Canada has proposed a substantial change to the regulation of biosimilar drugs in Canada that may result in earlier applications for marketing authorization and earlier litigation under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Specifically
The Federal Court (FC) has upheld the validity of a patent concerning a biologic drug used to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, in an infringement action under section 6 of
2024 saw no shortage of headlines in the Canadian pharma space. Here we look back on the year’s most notable legal and regulatory developments and look forward to areas to watch in 2025.
In
The Federal Court (FC) has provided fresh guidance on applying the test for challenging patent-listing eligibility in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Granting the delisting motion before it, the
On November 28, 2024, the Federal Court updated its guidelines for proceedings under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) and other complex proceedings. While the changes are not extensive, they create some new obligations and
On September 19, 2024, the Supreme Court of Canada granted an application for leave to appeal in a case concerning the scope of patentable subject-matter in Canadian law, focusing on an area known as “methods of medical treatment” (MMT
The Federal Court (FC) has upheld the validity of a patent concerning treatment of idiopathic pulmonary fibrosis (IPF) and granted injunctive relief against the generic in an infringement action under section 6 of the Patented Medicines
The Federal Court of Appeal (FCA) has held that in order to determine whether a patent claims an unpatentable method of medical treatment (MMT), it is necessary to determine whether the use of the invention requires
The Federal Court of Appeal (FCA) has held that the sale of a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is