In the first half of 2026, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories
Table of contents
- PM(NOC) Regulations: New process guidance for summary proceedings
- SCC “methods of medical treatment” appeal decision remains under reserve; to be released July 17
- Health Canada updates: Proposed Reliance Order, Pharmaceutical and Life Sciences Sector Task Force, medical devices updates, revised biosimilars guidance document on submission requirements
- PMPRB: New Chairperson, Practice Directions consultation
- CDA releases updated Procedures for Reimbursement Reviews & new data on Health Technology Assessment timelines
- Federal Court denies class action certification in generic drug price fixing case
- Regulatory and IP considerations for veterinary drugs in Canada
1. PM(NOC) Regulations: New process guidance for summary proceedings
In June, the Federal Court released an amended version of the Case and Trial Management Guidelines for Complex Proceedings, Proceedings under the PM(NOC) Regulations, and Appeals under Subsection 56(1) of the Trademarks Act, which introduces new guidance for summary proceedings in IP cases.
The Federal Court did not hear any trials in PM(NOC) matters or issue any PM(NOC) decisions on the merits in the first half of 2026.
2. SCC “methods of medical treatment” appeal decision remains under reserve; to be released July 17
In October 2025, the Supreme Court of Canada (SCC) heard Pharmascience’s appeal relating to the scope of patentable subject-matter as it relates to “methods of medical treatment”; the decision remains under reserve and will be released on July 17.
3. Health Canada updates: Proposed Reliance Order, Pharmaceutical and Life Sciences Sector Task Force, medical devices updates, revised biosimilars guidance document on submission requirements
In December 2025, a proposed Ministerial Reliance Order was released for consultation. The Order would allow Health Canada to review certain parts of a drug submission for new drugs by relying on decisions and/or documents made by foreign trusted regulators. Additional information for stakeholders was subsequently released. The proposed Reliance Order contemplates a list incorporated by reference (IbR List) that would set out the classes of drugs and foreign regulatory authorities (FRAs) that fall within the scope of the Reliance Order. In May, Health Canada issued a notice requesting feedback on the proposed phased implementation process for developing and updating the IbR list. The final Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs came into force on July 15, 2026 (our article will follow in our July issue).
In March, the federal Minister of Health announced the creation of the Pharmaceutical and Life Sciences Sector Task Force, a joint initiative led by Health Canada and Innovation, Science and Economic Development Canada. The Task Force will explore solutions to enhance competitiveness and long-term growth to support access to pharmaceutical products in Canada, and will seek to reduce unnecessary regulatory burden by modernizing regulatory frameworks.
We provided several updates relating to medical devices including: the Medical Devices Directorate quarterly performance reports for Q2/Q3 2025/2026 and Health Canada’s notice of mandatory use of the Regulatory Enrolment Process and Common Electronic Submission Gateway as of April 1, 2026.
In May, Health Canada released its final Guidance on information and submission requirements for biosimilar biologic drugs which removed the requirement that biosimilar submissions include comparative clinical efficacy trials in most cases.
4. PMPRB: New Chairperson, Practice Directions consultation
In January, Anie Perrault was announced as the new Chairperson of the Patented Medicine Prices Review Board (PMPRB) until August 9, 2028.
From March through May, the PMPRB consulted on seven proposed Practice Directions aimed at providing clarity on procedural matters related to hearings it conducts to determine whether the price of a medicine is excessive and whether a rights holder has failed to file required information.
PMPRB’s 2026 publications include:
(i) the January NEWSletter which included its 2026-2030 Strategic Plan;
(ii) the May NEWSletter which includes updates on the new Guidelines in force as of January 1, 2026: all New Medicines (with a first date of sale on or after July 1, 2022) underwent an Initial Review within the 60‑day service standard, and some In-Depth reviews have started. The reviews of Existing Medicines (those first sold before July 1, 2022) will undergo their first review under the new framework in January 2028; and
(iii) the 2026 edition of the Meds Pipeline Monitor.
5. CDA releases updated Procedures for Reimbursement Reviews & new data on Health Technology Assessment timelines
In April, Canada’s Drug Agency (CDA) (i) published updated Procedures for Reimbursement Reviews, which include a streamlined review process; they will be effective for August 2026 submissions and expert committee meetings in January 2027; and (ii) released new data on Health Technology Assessment timelines for 2024.
6. Federal Court denies class action certification in generic drug price fixing case
In February, the Federal Court dismissed a request to certify a proposed class proceeding against a large number of generic drug companies, including as the statement of claim did not disclose reasonable causes of action against the defendants. The plaintiff had alleged that the defendants conspired to allocate the generic drug market and fix prices at the maximum public formulary price in Canada.
7. Regulatory and IP considerations for veterinary drugs in Canada
In April, we provided an overview of the regulatory regime and associated intellectual property rights for veterinary drug products, together with an update on recent issues.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.