In the first half of 2025, 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
- Alexion awarded injunction against Amgen in SOLIRIS PMNOC action
- SCC to revisit “method of medical treatment” patent claims
- Federal Court again rules on patent listing timing
- Finalized PMPRB Guidelines released
- Regulatory: Risk management plan guidance, proposed regulatory amendments to address therapeutic product shortages, guide to precision regulating authorities
- Market access: Funding agreements for drugs for rare diseases, Pharmacare agreements for contraceptives and diabetes medications, CDA’s strategic plan
- Biosimilars draft guidance document on submission requirements, biosimilars update
1. Alexion awarded injunction against Amgen in SOLIRIS PMNOC action
Only one s. 6(1) Patented Medicines (Notice of Compliance) Regulations (PMNOC) decision issued in the first half of 2025. In April, the Federal Court granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its eculizumab product, BEKEMV (a biosimilar of SOLIRIS) in Canada until the expiration of Alexion’s 810 Patent. The trial judge held that a document incorporated by reference can be considered in the test for anticipation, depending on whether the prior reference provides clear direction so that the skilled person arrives inevitably to the claimed invention. The trial judge concluded that Amgen did not meet its burden of establishing anticipation or obviousness. Amgen has appealed.
2. SCC to revisit “method of medical treatment” patent claims
In a hearing tentatively scheduled for October 2025, the Supreme Court of Canada (SCC) will consider the scope of patentable subject-matter as it relates to “methods of medical treatment” in an appeal brought by Pharmascience challenging the validity of Janssen’s patent relating to INVEGA SUSTENNA (paliperidone palmitate).
3. Federal Court again rules on patent listing timing
The Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list a patent on the Patent Register against EYLEA (aflibercept) eight days after it was submitted to Health Canada; Bayer’s appeal was heard on June 24; the Court reserved. The decision followed a 2024 decision also finding that the Minister’s decision was not unreasonable to list a patent on the Register when it is determined to be eligible, not when it is submitted. The timing issue is important: in both cases, a generic company/biosimilar manufacturer (second person) filed their regulatory submission in the intervening period and a second person is not required to address a patent added to the Patent Register on or after the filing date of its submission.
4. Finalized PMPRB Guidelines released
On June 30, 2025, following lengthy consultations, the Patented Medicine Prices Review Board (PMPRB) published its new Guidelines for PMPRB Staff, which will come into force on January 1, 2026. Consistent with the Draft Guidelines, there will be a two-step pricing review process, with an initial review or annual review based on whether the price is higher than the highest international price in the PMPRB11 countries.
5. Regulatory: Risk management plan guidance, proposed regulatory amendments to address therapeutic product shortages, guide to the precision regulating authorities
In November 2024, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered, some of which are in force. Amendments requiring risk management plans for certain human drugs will come into force on April 1, 2027; Health Canada’s associated guidance document reflecting many of these policy elements comes into effect on July 1, 2025, with further changes expected in fall 2026.
In December 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages, which include updating the scope and framework for exceptional importation and sale of select drugs for which a shortage could present a serious risk of injury to human health.
In March 2025, Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow in situations where it may be appropriate for the Minister of Health to make an order pursuant to the new ministerial authorities granted by the Bill C-69 (Budget Implementation Act) amendments to the Food and Drugs Act. The new authorities could be applied, for example, to maintain product availability if there is a shortage.
6. Market access: Funding agreements for drugs for rare diseases, Pharmacare agreements for contraceptives and diabetes medications, CDA’s strategic plan
As of March 2025, the Government of Canada finalized agreements with all provinces and territories to provide funding for drugs for rare diseases that a province or territory elects to make available from the common list of drugs.
Flowing from the Pharmacare Act, to date, the Government of Canada has finalized agreements with Manitoba, British Columbia, Prince Edward Island and the Yukon to provide universal, single-payer, first-dollar access to a range of contraceptives and diabetes medications. Also pursuant to the Pharmacare Act, in June, Canada’s Drug Agency (CDA) opened a public consultation on a proposed list of essential prescription drugs and related products to inform the potential development of a national formulary; submissions are due by July 18.
In April 2025, CDA released its new five-year strategic plan and a position statement on the Use of AI in the Generation and Reporting of Evidence. In March, CDA published a Watch List highlighting AI technologies in health care.
7. Biosimilars draft guidance document on submission requirements, biosimilars update
On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. The most notable proposed revision to the current guidance is the removal of the requirement that the biosimilar submission include comparative clinical efficacy trials in most cases.
Our June 2025 biosimilars update provides a further update on biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). There are now 68 biosimilars approved in Canada of 21 innovator reference products. In addition to the SOLIRIS trial (#1 above), the Federal Court held a trial relating to aflibercept (Bayer’s EYLEA and Amgen’s biosimilar ABP938) in May/June; a decision is currently under reserve.
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.