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 Patented Medicine Prices Review Board (PMPRB or Board) has released a draft of its new price review Guidelines (the Draft Guidelines) for consultation. The Draft Guidelines outline a proposed new price-review process for Board Staff, with
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
Canada’s emerging national systems of pharmacare and public funding for drugs for rare diseases (DRDs) had key developments last week. On December 4, the Minister of Health (Minister) asked Canada’s Drug Agency-L’Agence des médicaments du Canada
The Federal Court recently refused to order a defendant to produce samples of cell culture because there was no “reasonable possibility” that testing the samples would yield evidence of patent infringement. In pharmaceutical patent cases, testing samples of a defendant’s
The Federal Court of Appeal (FCA) has confirmed that the Patented Medicine Prices Review Board (PMPRB or Board) does not have jurisdiction over the prices of unpatented medicines. In doing so, the FCA overturned decisions of
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 November 14, 2024, the Government of Canada announced the establishment of a Committee of Experts as the next step in its implementation of a national pharmacare program. The Committee is tasked with providing the Government with practical advice on
On October 10, 2024, Canada’s federal government passed legislation that will introduce pharmacare, a program of national universal drug coverage. The federal government must now take steps to implement the first phase of pharmacare, including reaching agreements with the provinces
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