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 underlying patent infringement litigation concerns Canadian Patent No. 2,655,335 (335 Patent), which teaches dosing regimens…
On September 12, 2024, the Governments of Canada and of the Province of British Columbia (BC) announced partnering to provide universal access to contraception, diabetes medication, and hormone replacement therapy. The Canada-BC Memorandum of Understanding is the first federal-provincial step taken to advance the goals of the impending Pharmacare Act.
Background
As we reported…
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 (Notice of Compliance) Regulations (the Regulations). In reaching its conclusion, the FC dismissed arguments including double-patenting and failure to…
On July 23, 2024, the Governments of Canada and British Columbia (BC) announced the execution of a National Strategy for Drugs for Rare Diseases (DRD) Agreement. This is the first DRD agreement reached since the federal government announced its rare disease strategy in early 2023.
Background
As we reported, in March 2023, Canada’s…
The Patented Medicine Prices Review Board (PMPRB) has released a new Discussion Guide for consultation on new price review Guidelines. The Discussion Guide outlines a proposed new price review process and requests stakeholder feedback on several specific topics, including the manner in which excessive-price factors such as the international price comparison (IPC) test will be…
Canada’s Drug and Health Technology Agency (CADTH) has announced that, as of May 1, 2024, its new operating name will be Canada’s Drug Agency / l’Agence des médicaments du Canada (CDA-AMC). The official launch will occur later this year, and CADTH will be updating its materials and expanding its operations accordingly.
Background
The CDA-AMC’s creation…
Canada’s federal 2024 budget has set aside $1.5 billion over five years to launch pharmacare, which will introduce national universal drug coverage to Canada.
Background
As we reported, on February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the first phase of…
The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines.
Phase 2: Discussion Guide
The next phase of the PMPRB’s consultation will begin in summer 2024 with the release of a Discussion Guide. As we reported, the first phase of the consultation…
The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug and Health Technology Agency (CADTH). The pCPA has published principles and conditions for the pTAP as well as information on its…
On February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the “foundational principles” for the first phase of a national universal drug coverage plan in Canada. The legislation includes a commitment to first launch diabetes medication and contraceptives coverage for Canadians through a universal,…
