In 2025, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2025 are below.
Table of contents
- PM(NOC) Regulations update; Alexion awarded injunction against Amgen in SOLIRIS action
- SCC hears “method of medical treatment” appeal, decision under reserve
- Federal Court of Appeal confirms second person not required to address patent submitted before biosimilar filing but listed after
- Finalized PMPRB Guidelines released, in force January 1, 2026
- Regulatory: Guide to precision regulating authorities, report on red tape reduction, clinical trial modernization consultation, medical device updates
- Market access: Funding agreements, CDA’s publications, accelerating patient access, Ontario to regulate preferred provider networks
- Biosimilars draft guidance document on submission requirements, biosimilars update
- Patent term adjustment now available in Canada
1. PM(NOC) Regulations update; Alexion awarded injunction against Amgen in SOLIRIS action
In September, we provided our eighth annual update following the significant September 2017 amendments to the PM(NOC) Regulations. This past year marked the lowest number of s. 6(1) actions started under the amended PM(NOC) Regulations.
Only one decision on the merits issued in 2025: in April, the Federal Court granted Alexion a declaration of infringement and an injunction against Amgen regarding its eculizumab product, BEKEMV (a biosimilar of SOLIRIS). Amgen discontinued its appeal.
As also reported in our anniversary update, to date, there have been no amended section 8 decisions on the merits. There are currently no pending section 8 actions, as Pharmascience’s section 8 claim relating to fampridine was discontinued in December.
Health Canada released its statistical report covering the fiscal year ending March 31, 2025 for the PM(NOC) Regulations including eligibility for patent listing, eligibility for data protection, certificates of supplementary protection, and related court activity.
2. SCC hears “method of medical treatment” appeal, decision under reserve
On October 9, 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 case involves Janssen’s patent relating to INVEGA SUSTENNA (paliperidone palmitate) with claims which include the features of a paliperidone palmitate formulation dosing regimen for treatment of schizophrenia. The webcast of the oral arguments is available on the SCC's website. As expected, the SCC reserved its decision.
3. Federal Court of Appeal confirms second person not required to address patent submitted before biosimilar filing but listed after
In August, the Federal Court of Appeal (FCA) determined that 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 such that a biosimilar sponsor that filed its regulatory submission in the intervening period was not required to address the patent was reasonable, upholding the Federal Court’s decision.
4. Finalized PMPRB Guidelines released, in force January 1, 2026
The Patented Medicine Prices Review Board (PMPRB) published its new Guidelines for PMPRB Staff on June 30, 2025, which came into force on January 1, 2026. There is now 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. The PMPRB held information sessions in November.
PMPRB’s 2025 reports included its CompassRx report (10th edition) covering the 2022/23 fiscal year, analyzing factors driving prescription drug expenditures in Canadian public drug plans and its 2024 Annual Report.
5. Regulatory: Guide to precision regulating authorities, report on red tape reduction, clinical trial modernization consultation, medical device updates
In March, 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.
In July, Health Canada and the Public Health Agency of Canada issued a Report on Red Tape Reduction, which identifies many ongoing and future initiatives, including a plan to advance an Order to expand Health Canada’s reliance on authorizations by comparable foreign regulatory authorities to satisfy regulatory requirements for certain classes of products. The proposed Order, published in December for consultation, would also increase data, information and work-sharing with international regulatory partners. In December, Health Canada and the US Food and Drug Administration announced a Request for Information Sharing program falling under the generic drug cluster, which will enhance the exchange of regulatory information to facilitate the drug review processes for generic drugs.
In December, Health Canada launched a consultation on modernizing the framework for clinical trials, including publishing draft proposed Clinical Trials Regulations and associated draft Guidance; the new Clinical Trials Regulations would replace the Food and Drug Regulations Division 5 “Drugs for Clinical Trials Involving Human Subjects.”
Also in December, Health Canada launched a consultation on two draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy. The draft guidance documents relate to the agile licensing amendments to the Food and Drug Regulations for authorities coming into force on April 1, 2027.
We provided various medical devices updates including: the new Health Canada guidance for determining medical device application type, the Medical Devices Directorate performance reports, Health Canada’s proposed Phase II amendments to the Medical Devices Regulations relating to medical device establishment licensing, and new Health Canada guidance for managing applications for medical device licences, which will take effect on February 2, 2026.
6. Market access: Funding agreements, CDA’s publications, accelerating patient access, Ontario to regulate preferred provider networks
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 makes 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. 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.
CDA released a number of publications in 2025. In April, 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. In September, CDA launched its new strategy to improve the appropriate prescribing and use of prescription medications in Canada. In December, CDA published (i) data on Canada’s drug system as part of the Data Systems and Analytics program, including Health Canada regulatory submissions and approvals and CDA HTA submissions and approvals from 2020-2024, and (ii) a new resource, Drug Access in Canada: Understanding the System.
In October, the Ontario government and the pan-Canadian Pharmaceutical Alliance (pCPA) announced separate initiatives aimed at accelerating patient access to breakthrough cancer treatments approved through the Project Orbis pathway. Project Orbis is a joint collaborative review program to facilitate faster patient access to high-impact cancer therapies.
The pCPA solicited feedback regarding its plan to formalize and expand its Targeted Negotiation Process (TNP), a further pCPA expedited negotiation pathway, but in the context of non-complex drug negotiations.
In November, Ontario legislative amendments to regulate preferred provider networks received Royal Assent.
7. Biosimilars draft guidance document on submission requirements, biosimilars update
Health Canada’s consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which accepted submissions until September 2025 remains open. The most notable proposed revision is removal of the requirement that the biosimilar submission includes comparative clinical efficacy trials in most cases. In October 2025, the US Food and Drug Administration also announced new draft guidance, focused on streamlining requirements for therapeutic protein products.
Our June 2025 biosimilars update provided an update on biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Since our update, Health Canada has approved an additional nine biosimilars, including Polpharm Biologics’ TYRUKO, a biosimilar of Biogen’s TYSABRI (natalizumab). There are now 77 biosimilars approved in Canada of 22 innovator reference products.
In November, the FCA upheld the FC’s decision enjoining Biogen and Samsung Bioepis from using the trademark BYOOVIZ for their ranibizumab biosimilar of Novartis’ LUCENTIS, holding that it was confusing with Novartis’ BEOVU trademark used in association with brolucizumab; all three drugs are used to treat age-related macular degeneration. The FC’s decision was stayed pending the appeal; the FCA granted a further stay pending a possible SCC leave application. In early November, Samsung Bioepis changed the name of BYOOVIZ to MELVIZO.
8. Patent term adjustment now available in Canada
Canada’s Patent Term Adjustment system to account for unreasonable delays by the Canadian Intellectual Property Office in issuing a patent is now available if certain requirements are met, including the patent must have issued on or after December 2, 2025 from an application filed on or after December 1, 2020. See our practical guide.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation 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.