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Canadian Patent Law in Review 2025: Notable Decisions and Updates

12/18/2025

 – Kassandra Shortt, Eleanor Wilson, Katherine (Katie) Graham

Intellectual Property

As the year 2025 comes to an end, we have reviewed some of the key decisions and updates in patent law from this past year and provided our thoughts on what we might expect in 2026.

SCC Reserved its Decision in Method of Medical Treatment Appeal

On October 9, 2025, the Supreme Court of Canada (SCC) heard oral arguments on an appeal relating to the patentability of methods of medical treatment: Pharmascience Inc. v. Janssen Inc. (SCC docket no. 41209). The Supreme Court reserved its decision.

The Federal Court of Appeal (FCA) previously found claims of Canadian Patent No. 2,655,335, relating to a dosage regimen for treating schizophrenia with Janssen’s INVEGA SUSTENNA, to be valid claims and not a so-called “method of medical treatment” (2024 FCA 23). The Supreme Court granted Pharmascience leave to appeal this aspect of the decision.

Before the Supreme Court, Pharmascience argued that methods of medical treatment are not patentable in Canada and that the Supreme Court should adopt a new test that would find a claim unpatentable if it included a “therapeutic” or “medical” essential element that relates to “how and when” a drug or treatment is to be administered by a medical practitioner. In response, Janssen argued that there is no longer a basis in the Patent Act for excluding methods of medical treatment and, alternatively, if there is an exclusion it should be limited to activities of physicians that are “non-economic” and should not extend to commercial offerings such as drugs, medical devices and their uses. At the hearing, Pharmascience also argued for an alternative test of determining whether the patent occupies an area of skill and judgment, a factually suffused inquiry that would result in some but not all dosage regimens being unpatentable subject matter.

Cassels lawyers Andrew Skodyn, Sean Jackson, and Eleanor Wilson represented the Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI), an international organization of intellectual property attorneys, as an intervenor on the appeal. FICPI’s submissions encouraged the Supreme Court to consider the international context for this issue and harmonize Canada’s patent law with that of peer jurisdictions. That approach would eliminate the special category of methods of medical treatment patents in Canadian law and have them evaluated like all other patents. Andrew Skodyn made oral submissions to the Supreme Court on behalf of FICPI.

The SCC’s decision is expected to be released sometime in 2026 and will be noteworthy for those with an interest in pharmaceutical and healthcare innovations.

Patent Appeal Board States Artificial Intelligence Cannot be an Inventor in Canada

In June 2025, the Patent Appeal Board (the Board) issued the first decision in Canada on the question of whether an artificial intelligence (AI) system can be the inventor on a patent application, stating that “inventor” under the Patent Act is limited to natural persons: Thaler, Stephen L. (Re), 2025 CACP 8.

The Thaler decision concerned a patent application, Canadian Patent Application No. 3,137,161, filed by Stephen Thaler, which named an AI system known as DABUS as the sole inventor. The patent examiner rejected the application on the basis that Canadian patent law requires inventors to be natural persons, following which the application was referred to the Board for review. The Board issued a preliminary opinion in November 2024, agreeing with the examiner’s assessment. Following an oral hearing, the Board released its final decision in June 2025. In its decision, the Board provided a detailed analysis, with a focus of the meaning of the term “inventor” under the Patent Act and the Patent Rules. The Board agreed with the patent examiner and concluded that “inventor” is limited to natural persons and does not include AI.

This decision is one of several that have arisen out of patent applications filed around the world by Mr. Thaler listing DABUS as the sole inventor. Most jurisdictions that have grappled with the same issue, including the United States, United Kingdom, European Union, and Australia, have likewise rejected the Thaler/DABUS patent applications on the basis that AI cannot be an inventor.

Mr. Thaler has filed an appeal (T-4928-25) of the Board’s decision to the Federal Court (FC).

Federal Court of Appeal “Frack” Tracks on Claim Construction and Double Patenting: NCS Multistage Inc. v. Kobold Corporation, 2025 FCA 187

In this decision arising out of the oil and gas industry, the FCA overturned the trial decision in part and provided some interesting guidance on principles of claim construction, double patenting and procedural fairness in the context of costs awards.

On claim construction, the FCA found the trial judge erred in law by construing independent claim 12 not to include subject matter that was included within the scope one of its dependent claims, claim 13. The FCA explained that the principle of claim differentiation requires that an independent claim be broader and include the subject matter of the narrower claims that depend on it, and further, that dependent claim limitations should not restrict the scope of independent claims.

Given the finding on claim construction, the FCA remitted the issue of obviousness double patenting for re-determination by the trial judge using the FCA’s construction of the claims. In commenting on double patenting, the FCA noted that the obviousness double patenting analysis requires identifying the inventive concept of each claim being compared and determining whether they are patentably distinct and is not limited to simply identifying overlap.

For a more detailed summary, see our previous Cassels Comment on this decision, authored by Andrew Skodyn, Eleanor Wilson, and Katherine (Katie) Graham.

Federal Court Awards Injunction Against Biosimilar and Considers Anticipation by Incorporation by Reference: Alexion Pharmaceuticals, Inc. v. Amgen Canada Inc., 2025 FC 754

In this May 2025 decision, the FC upheld the validity of Canadian Patent No. 2,645,810 (the 810 Patent) for Alexion’s intravenously administered biologic drug, SOLIRIS (eculizumab), which is used to treat patients with paroxysmal nocturnal hemoglobinuria. The FC granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Canada until the expiration of the 810 Patent.

Amgen had admitted infringement of the 810 Patent and relied on invalidity defences of anticipation and obviousness, both of which were dismissed.

Anticipation. Despite the test for anticipation requiring all of the essential claim elements to be disclosed in a “prior, single publication” (Free World Trust, 2000 SCC 66 at para 26), a key issue was whether a prior US patent application (US972) that incorporated another prior art document (US245) by reference could anticipate the 810 Patent. The trial judge clarified that incorporation by reference can be considered a single disclosure in the test for anticipation if the primary document (US972) explicitly and precisely directs the skilled person to specific teachings in the secondary document (US245). However, on the facts of this case, the argument of incorporation by reference was not successful. US972 did not clearly instruct the skilled person to use US245 to reconstruct eculizumab and instead would require the skilled person to selectively assemble bits of information from US972 and US245 to reverse engineer the full sequence. As a result, the FC dismissed Amgen’s anticipation argument.

Obviousness. The obviousness analysis focused on whether the skilled person would have bridged the gap between the prior art and the claimed invention without inventive ingenuity, particularly regarding the identification of eculizumab’s specific heavy and light chain sequences (claim 1) and its formulation into a pharmaceutical composition so that it can be delivered to a patient and provide the intended therapeutic effect (claim 2). Although Amgen argued that a skilled person could have combined prior art to arrive at the claimed sequences, the FC found no clear direction in the prior art to do so without hindsight. Notably, while Alexion had deposited a sequence with the Chemical Abstract Service intending public disclosure, the sequence contained significant errors and did not constitute actual disclosure. As such, claims 1 and 2 of the 810 Patent were found to not be obvious, as the prior art did not reveal both sequences or suggest their link to therapeutic success, and the skilled person could not have arrived at the invention using routine skill and general knowledge alone.

In November 2025, Amgen discontinued its appeal (A-207-25) of the decision to the FCA.

The New Due Care Roadmap: How to Avoid Deemed Expiry or Abandonment of Your Patent and Design Rights

This year brought several decisions from the FC and FCA that increase clarity on the due care standard for reinstating patents and patent applications that were deemed expired from unpaid fees, including:

  1. Taillefer v. Canada (Attorney General), 2025 FCA 28 (Taillefer);
  2. Matco Tools Corporation v. Canada (Attorney General), 2025 FC 118 (Matco FC);
  3. Poseidon, LLC v. Canada (Commissioner of Patents), 2025 FC 225 (Poseidon); and
  4. Matco Tools Corporation v Canada (Attorney General), 2025 FCA 156 (Matco FCA).

We previously reported on the first three decisions in February in a Cassels Comment authored by Andrew Skodyn, Kassandra Shortt, and Brittany Bottan. Following this Cassels Comment, in September, the FCA set aside the multi-step inquiry for due care outlined in the Matco FC decision.

In the Matco FCA decision, the FCA restored a decision refusing to reinstate Canadian Patent Application No. 3,086,194 (the 194 Application), which had been deemed abandoned under paragraph 73(1)(c) of the Patent Act. The abandonment occurred after Matco failed to pay its third annual maintenance fee due to a data migration error that excluded the 194 Application from an annuity service’s database. Although the Canadian patent agent received a Commissioner’s Notice (Notice) and forwarded it to Matco’s US counsel, the Notice was not passed on to Matco due to standing instructions not to act on maintenance fees. The FC had previously ruled that the Commissioner’s decision was unreasonable, expanding the “due care” standard to include the entire chain of events leading to the abandonment. However, the FCA restored the narrower interpretation, focusing only on actions taken after the Commissioner’s Notice was issued.

The FCA confirmed that the due care standard under paragraph 73(3)(b) of the Patent Act applies not only to the applicant, but also to their Canadian patent agents, US counsel, and annuity service. It held that the relevant timeframe for assessing due care is the period following the issuance of the Commissioner’s Notice — not earlier administrative errors. The FCA found that either Matco’s US counsel failed to exercise due care by not forwarding the Notice to Matco, or Matco’s Canadian agent failed to exercise due care by forwarding the Notice to someone who could not be expected to forward it to Matco. Importantly, standing instructions not to act on maintenance fees did not absolve the responsibility to forward critical correspondence.

This decision reinforces the importance of robust communication protocols among all parties involved in patent maintenance and confirms that reinstatement requires demonstrating due care specifically in response to the Commissioner’s Notice.

Matco did not seek leave to appeal to the Supreme Court of Canada.

Federal Court Finds Liability for Common Design Infringement for the First Time: Adeia Guides Inc. v. Videotron Ltd., 2025 FC 1725

In this decision, the FC found — for the first time in Canada — liability for patent infringement under the doctrine of common design. The FC held Videotron to be liable for infringement of two patents (Canadian Patent Nos. 2,967,187 [187 Patent] and 2,775,674 [674 Patent]) on the basis of common design. The patents related to interactive media and digital entertainment technologies owned by Adeia Guides.

Videotron contracted with two US-based companies, Comcast and Brightcove, who helped Videotron develop its “Resume Viewing” feature — a feature that allows users to resume viewing a TV program at the specific point where they left off — for two of its technologies, Helix TV and VRAI, respectively. Adeia alleged that through each relationship Videotron had engaged in infringement by common design and asserted that Videotron could not excuse liability through its “orchestration of infringement” by subcontracting aspects of its system architecture to third parties.

With respect to Comcast, the FC held that Videotron infringed both the 187 Patent and 671 Patent through its contractual agreement with Comcast. The specific common design was to launch Videotron’s Helix TV with the “Resume Viewing” function through sub-contracting part of their patent infringement to Comcast. The FC emphasized that a party cannot avoid infringement by subcontracting portions of an infringing system or by being one of several parties contributing to the overall harm. Notably, the fact that Comcast was not a party to the litigation did not bar the finding of common design, as both parties do not need to be named defendants to find infringement by common design.

With respect to Brightcove, there was insufficient evidence of the contractual relationship with Videotron to support a finding of infringement by common design of the “Resume Viewing” function for Videotron’s VRAI.

Videotron has filed an appeal (A-393-25, A-394-25, A-395-25) of the decision to the FCA.

Patented Drug Pricing: The PMPRB Released New Price Review Guidelines

On June 30, 2025, the Patented Medicine Prices Review Board (PMPRB) published its new Guidelines for PMPRB Staff (Guidelines), effective January 1, 2026, introducing a two-step process by which PMPRB staff will monitor, review, and make recommendations on patented drug prices. These changes follow years of regulatory proposals, legal challenges, and stakeholder consultations. Under the new Guidelines, pharmaceutical companies are permitted to set their own list prices for patented medicines and are not subject to pre-set pricing by the PMPRB. The PMPRB can review the listed prices at any time and, after a hearing is conducted, can decide whether the price is excessive.

For more information on the new Guidelines, see our Cassels Comment, authored by A. Chandimal Nicholas, Kassandra Shortt, Dakota Bundy, and Joshua Grant.

Patent Infringement and Agricultural Biotechnology: Litigating with Urgency: Mosiuk v BASF Canada Inc., 2025 SKCA 90

In Mosiuk v. BASF Canada Inc., 2025 SKCA 90, the Saskatchewan Court of Appeal upheld an interlocutory injunction and preservation order authorizing BASF to enter the defendants’ property, take leaf samples from the allegedly infringing canola crop, and conduct destructive testing on the leaves to assess infringement of its canola seed patent. While interlocutory injunctions are uncommon in patent cases, the nature of the patent in question, involving a living crop with a specific lifecycle, necessitated special relief to allow testing during a narrow window of time. This case highlights the unique testing considerations that can arise in agricultural biotechnology cases and provides a roadmap for patent holders to pursue interlocutory relief to conduct testing. For a more detailed summary, see our Cassels Comment authored by Kassandra Shortt, Mark Davis, and Emma Baliat.

Federal Court of Appeal Confirms Patent Listing Timing, “Frozen Register” Rule Prevails: Bayer Inc. v. Amgen Canada Inc., 2025 FCA 142

In Bayer Inc. v. Amgen Canada Inc., 2025 FCA 142, the FCA upheld the decisions of the Minister of Health and the FC (2025 FC 107) to list Canadian Patent No. 2,970,315 (the 315 Patent) on the Patent Register eight days after it was submitted to Health Canada.

Bayer submitted a patent list in relation to the 315 Patent and drug submissions for its aflibercept product EYLEA on August 22, 2023. Amgen filed its New Drug Submission (NDS) for a biosimilar aflibercept product on August 24, 2023, before the 315 Patent was officially listed on the Patent Register. The Minister treated Amgen’s filing date as August 24, 2023 and concluded that Amgen was not required to address the 315 Patent in its NDS, since it was not yet on the Patent Register. The FC dismissed Bayer’s appeal of the decision, holding that the Minister’s decision was not unreasonable.

On appeal to the FCA, Bayer argued that the Minister’s interpretation of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) was both unreasonable and incorrect because, among other reasons, the PMNOC Regulations do not contemplate any passage of time between the filing of a submission and the actual addition to the Patent Register, and therefore the addition should be considered to have occurred on the day of the submission, regardless of when eligibility was confirmed. Bayer employed the metaphor of an unfair “race” between the innovator (the first person) to add its patent to the Patent Register and the biosimilar (the second person) to file its NDS before the first person’s patent is listed on the Patent Register.

The FCA rejected Bayer’s arguments and held that the Minister’s interpretation of the PMNOC Regulations was reasonable. In doing so, the FCA highlighted the “frozen register” principle in subsection 5(4) of the PMNOC Regulations, which explicitly excludes from the requirements for the second person any patents that are added to the Patent Register on or after the date of filing of its NDS.

Ontario Court of Appeal Denies Damages to Generic Drug Manufacturer for Delayed Market Entry: Apotex Inc. v. Eli Lilly and Company, 2025 ONCA 176

In Apotex Inc. v. Eli Lilly and Company, 2025 ONCA 176, the Ontario Court of Appeal (ONCA) upheld a decision of the Ontario Superior Court of Justice (2023 ONSC 1968) denying Apotex’s claim for damages for delayed market entry under section 8 of the PMNOC Regulations.

In 2010, the Federal Court (2010 FC 1065) dismissed Eli Lilly’s prohibition application against Apotex under the pre-amendment version of the PMNOC Regulations as moot after Eli Lilly’s patent was invalidated in a separate Patent Act impeachment action involving Teva (then Novopharm). As a result, Apotex brought a section 8 claim for damages against Eli Lilly to compensate for delay in bringing its generic version of Eli Lilly’s atomoxetine product STRATTERA to market. The trial judge for the section 8 claim held that as a matter of statutory interpretation, section 8 did not apply as it only entitles a generic to damages when the prohibition application is dismissed on the merits and not for mootness. The trial judge also concluded that even if section 8 did apply, Apotex failed to prove that Eli Lilly was liable for damages.

The ONCA upheld the trial judge’s finding on the second issue and declined to consider the first issue. The ONCA found that while Apotex could have entered the market when it received its NOC in the hypothetical world, it would not have done so due to the risk of liability for infringing Eli Lilly’s patent if it had gone to market. This was further evidenced by Apotex’s risk-averse behavior in the real world, including its hesitation to market its atomoxetine product even after obtaining its NOC and invalidation of the patent, due to concerns that the patent would be reinstated on appeal. Indeed, Apotex indicated in its ANDS that it was prepared to wait for Eli Lilly’s patent to expire, until it learned of Teva’s impeachment action. The ONCA upheld the trial judge’s conclusion that, even in the hypothetical world, Apotex still would have delayed entry, meaning no damages were owed.

Apotex did not seek leave to appeal the decision of the ONCA.

Stay Tuned for More in 2026

In 2026 we anticipate important updates around patentable subject matter, with the SCC likely releasing its decision on the patentability of methods of medical treatment. We may also see CIPO issuing amendments to the Manual of Patent Office Practice (MOPOP) to reflect evolving jurisprudence on patentable subject-matter for computer-implemented inventions (see our previous Cassels Comment on the proposed amendments). Additionally, the question of inventorship for AI-generated inventions will continue to make its way through the courts with the FC being next in line to consider the question in respect of the DABUS/Thaler patent. Finally, keep an eye out for an anticipated FCA decision on the appeal and cross-appeal of ProSlide v WhiteWater, 2024 FC 1439, which will address issues relating to the territorial aspect of infringement in patent law, overbreadth, and sound prediction of utility (see our previous Cassels Comment on the trial decision).

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This publication is a general summary of the law. It does not replace legal advice tailored to your specific circumstances.

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