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The Canadian life science sector saw several significant developments in 2025. This article highlights key decisions, guidance, and regulatory changes that impacted the patent landscape.
1. Supreme Court of Canada hears arguments on validity of "methods of medical treatment"
On October 9, 2025, the Supreme Court of Canada heard arguments in Pharmascience Inc. v Janssen Inc., et al. (Supreme Court File No. 41209). A decision by the Supreme Court is expected in 2026.
At first instance before the Federal Court, Janssen's "335 Patent" was found to be valid and infringed. Pharmascience appealed on the sole issue that the claims of the 335 Patent at issue were invalid as claiming no patentable "method of medical treatment."
The Federal Court of Appeal dismissed the appeal and concluded that the inquiry into whether a claim is proper subject matter depends on whether or not the invention requires the exercise of skill and judgment of a physician. The FCA rephrased the distinction as one of how to use the invention vs whether or not to use the invention.
See our overview of the arguments raised before the SCC here, and our in-depth review of the FCA decision here.
2. Alexion v Amgen, 2025 FC 754: Alexion's eculizumab patent withstands anticipation and obviousness attacks
In 2025, there was only one decision on the merits for a pharmaceutical patent action under the Patent Medicines (Notice of Compliance) Regulations.
Alexion's Canadian Patent No. 2,645,810 (the "810 Patent") is directed to a specific antibody that binds complement protein C5, pharmaceutical compositions containing that antibody, and their use in treating paroxysmal nocturnal hemoglobinuria ("PNH"), which causes the premature cell death and lysis of red blood cells. The 810 Patent is listed on the Patent Register in association with the medicine eculizumab (the API in SOLIRIS®).
Anticipation and obviousness of claims 1 and 2 of the 810 Patent were the only two issues needing to be addressed by the Court. The claims at issue read:
1. An antibody that binds C5 comprising a heavy chain consisting of SEQ ID NO:2 and a light chain consisting of SEQ ID NO:4.
2. A pharmaceutical composition comprising the antibody of claim 1 and a carrier.
Eculizumab is the specific antibody claimed by claim 1.
Two points of claim construction should be noted with respect to biologics:
- Claim 1, "binds C5": the Court found that "binds C5" incorporates specificity such that the antibody binds to C5 and does not substantially impair the functions associated with other complement components (specifically referring to complement component C3b).1
- Claim 2, "pharmaceutical composition" and "carrier": the Court found that "pharmaceutical composition," in the context of antibodies, meant that the composition is intended for therapeutic use and that "a carrier" would allow the antibody to be administered as a solution."2
Amgen's anticipation arguments raised whether a document incorporated by reference into another could constitute a single disclosure under subsection 27(1) of the Patent Act.
The Court stated that while two such documents could constitute a single disclosure, the incorporated document must provide clear and direct information that completes the primary document's disclosure. The Court found that the primary document, US975, and the incorporated document, US245, did not amount to a single disclosure because US245 extended beyond the teachings of US975.3
US975 disclosed an amino acid sequence that was the same as the light chain of eculizumab and an amino acid sequence that only differed from the heavy chain of eculizumab at the CDR3 region. Amgen argued that the skilled person would, because of the incorporation by reference, look to US245. US245 did not disclose any full-length humanized antibodies, only fragments, but did disclose an amino acid sequence that was the same as the CDR3 sequence found in eculizumab.
The Court rejected Amgen's arguments, finding that its proposal was an impermissible mosaic of information from US975 and US245 for the purpose of an anticipation analysis. The Court found that the skilled person would have to choose specific pieces of information and assemble them with information from US975, rather than being directed by US975 to use specific information from US245.
Even if Amgen's use of the prior art was accepted, the Court found that US973 was not an anticipating disclosure because it would not necessarily lead to the preparation of eculizumab, nor would the person skilled in the art inevitably conclude that eculizumab was the originating 5G1.1 antibody framework for Example 4 of US973.4
The Court found that Amgen failed to present clear and convincing evidence that the 810 Patent was obvious. Notably, Amgen attempted to mosaic several pairs of prior art documents to suggest the invention was obvious. However, the Court found no direction in these references that would lead a skilled person to combine them.5
3. PMPRB Guidelines finalized
In 2025, the Patented Medicines Price Review Board finalized its new guidelines, which came into effect on January 1, 2026. These guidelines are non-binding but reflect how the PMPRB intends to conduct its review. The guidelines contemplate a two-step review process.
In the first step, an initial and annual review of a patented medicine's pricing will be conducted. Where a patented medicine's Canadian list price exceeds the Highest International Price among the 11 comparator countries under the regulations, the medicine will become subject to the second step, which is an in-depth review. The initial review process is estimated to take 60 days.
The in-depth review involves a scientific review, to established comparators to perform a Therapeutic Class Comparison (TCC) analysis and a price review. The PMPRB will weigh and balance the TCC analysis and how the patented medicine's price compares to the 11 comparator countries. A recommendation is then made to the Chairperson to either close the review or to issue a Notice of Hearing. The in-depth review process is estimated to take 12 to 28 months.
4. Health Canada provides updated draft guidance document for biosimilar submissions
Health Canada released a draft revision to its guidance document for submission requirements for biosimilar biologic drugs.
A key shift in the updated draft is the proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through phase III clinical trials.
See our in-depth article here.
5. Federal Court of Appeal sets high bar for due care in prosecution
In Taillefer v. Canada (Attorney General), 2025 FCA 28 and Canada (Attorney General) v. Matco Tools Corporation, 2025 FCA 156, the Federal Court of Appeal maintained the high bar for the due care requirement to reinstate a patent after a failure to pay maintenance fees. In both decisions, the Federal Court of Appeal upheld the Commissioner's determination that the patentee had failed to take due care in ensuring the maintenance fee was paid and declined to reinstate the patents at issue.
Both patentees and agents should take note of these decisions as the Federal Court of Appeal has confirmed that both parties have obligations to take due care to ensure maintenance fees are paid on time.
Under the Patent Act, a failure to pay the annual maintenance fee will result in the patent being deemed expired.[6] A patentee can reinstate the patent only if it makes a request and meets the requirements of section 46(5) of the Patent Act. Section 46(5)(b), which requires that "the Commissioner determines that the failure occurred in spite of the due care required by the circumstances having been taken and informs the patentee of this determination."7
The FCA has stated "that this due care standard can only be met if the applicant has taken all measures which a reasonably prudent applicant would have taken in light of the facts and circumstances of each particular case."8
In Taillefer,the maintenance fee deadline because the patent agent's, emails went to the patentee's junk email folder. The Federal Court of Appeal upheld the Commissioner's determination that due care was not taken in the circumstances, agreeing that both patentee and agent should have had alternative communication and monitoring in place to ensure fees were paid on time.9
In Matco Tools, the patentee switched maintenance fee payment service providers from its US counsel and instructed its US counsel to take no further action with respect to maintenance fees. However, the patent at issue was not properly migrated to the new system. The patentee's Canadian agent received notice from the Commissioner regarding the failure to pay the maintenance fee, which it forwarded it to US Counsel, as US counsel had been the only source of instructions for the agent regarding the patent application.
The Federal Court of Appeal upheld the Commissioner's determination, agreeing that the abandonment could have been avoided if either the Canadian agent or its instructing US counsel had taken due care and forwarded the notice directly to Matco.10 The Federal Court of Appeal was explicit in holding that agents and those authorized to provide instructions to agents are also required to take due care.11
See our in-depth article here.
6. Other Guidance from the Courts
ViiV Healthcare Company v. JAMP Pharma Corporation, 2025 FC 379: Accelerated PM(NOC) litigation timelines and lack of evidence factors in Court dismissing pleading amendment
The Court dismissed JAMPs motion to amend with respect to allegations in the proposed counterclaim that a certificate of supplementary protection was not in compliance with the Patent Act because it was not properly granted in association with the first authorized sale for the combination of dolutegravir/lamivudine (the CSP was granted with respect to the drug DOVATO).
The Court dismissed the motion with respect to these particular allegations, highlighting the tight timelines in actions brought under the Patent Medicines (Notice of Compliance) Regulations, the lack of explanation submitted by JAMP to demonstrate why it delayed in bringing the amendment, lack of evidence to suggest it only recently learned of this allegation, lack of evidence that the trial schedule would be altered.
The Court highlighted that where it is not apparent on its face how the amendments would serve the interests of justice, such as the new and tangential allegations regarding the drug DOVATO, evidence is required to demonstrate such.12
Apotex Inc. v. Eli Lilly and Company, 2025 ONCA 176: Ontario Court of Appeal affirms Dismissal of Apotex's Section 8 Claim
Apotex appealed the trial decision dismissed its action for damages under section 8 of the Patent Medicines (Notice of Compliance) Regulations. The alleged damages were with respect to Apotex's generic atomoxetine product, and Eli Lilly's application which had been dismissed by the Federal Court.13
At trial at first instance, the Court dismissed Apotex's action. The Court held that Apotex was not entitled to section 8 damages in the circumstances, and, in the alternative, held that Apotex would not have come to market earlier than it did in the real world because it was averse to the risk that Eli Lilly would have brought a patent infringement action outside of the Patent Medicines (Notice of Compliance) Regulations.14 See our detailed discussion of this decision here.
The Court of Appeal addressed only whether Apotex would have entered the market earlier in the but-for world. It noted that the trial judge's conclusions were based on "the infringement liability risk Apotex faced and its real-world risk aversion."15 The Court of Appeal held that this multifaceted analysis warranted deference and that Apotex had failed to show any palpable and overriding error in the trial judge's determination of mixed fact and law.
Janssen Inc. v. Pharmascience Inc., 2025 FC 718: Amendment to add Gillette Defence dismissed as internally incoherent with skinny label pleading
The Court dismissed Pharmascience's motion to amend its Statement of Defence to include a "Gillette Defence" with respect to the two patents at issue.
A "Gillette Defense" typically alleges that the alleged infringer's product is the same as what was disclosed in the prior art. As the Court noted, it requires the alleged infringer to "clearly state what its product is."16
Regarding the 770 Patent, which claims monotherapy and combination therapy, the Court found Pharmascience's proposed pleading to be internally incoherent. The Court reasoned that Pharmascience could not simultaneously plead that its product was for monotherapy only while also raising a "Gillette Defence" based on prior art that allegedly discloses combination therapy.17
Adeia Guides Inc. v. Videotron Ltd., 2025 FC 1725: First application of infringement by common design
This decision marks the first time patent infringement by common design has been found in Canada. The Court noted that liability for common design is an established part of Canadian law,18 with courts often relying on the UK Supreme Court's decision in Fish & Fish v Sea Shepherd, [2015] UKSC 10, and its general acceptance in the Federal Court.19
The Court found Videotron liable for infringement by common design because its agreement with its US-based partner, Comcast, showed both were actively engaged in providing the infringing service. Although redactions obscured Comcast's specific acts, the Court found Videotron was not a passive party. The Court also stated that it was not prevented from finding Videotron liable simply because Comcast was not a named defendant.
In contrast, the Court found Videotron not liable for infringement by common design with respect to another infringing service. Here, the Court found there was insufficient evidence of the contractual relationship between Videotron and its other partner, Brightcove, to support that Videotron was involved in or participated in the design of the infringing service. Again, the Court did not detail what parts of the infringement were attributable to each of Videotron and Brightcove.
While the details of the infringement analysis are will be of interest to practitioners in the telecommunication space, the Court's finding of infringed by common design will be of interest to life science sector as well.
See our in-depth article here.
Footnotes
1 Alexion v Amgen, 2025 FC 754 at para 55.
2 Alexion v Amgen, 2025 FC 754 at para 56.
3 Alexion v Amgen, 2025 FC 754 at paras 86-91.
4 Alexion v Amgen, 2025 FC 754 at paras 92-112.
5 Alexion v Amgen, 2025 FC 754 at paras 162-163, paras 171-173.
6 Patent Act, RSC 1985, c P-4, s 46(1)-(4).
7 Patent Act, RSC 1985, c P-4, s 46.
8 Taillefer, 2025 FCA 28 at para 8.
9 Taillefer, 2025 FCA 28 at para 10.
10 Matco Tools, 2025 FCA 156, paras 39-49, 55-59.
11 Matco Tools, 2025 FCA 156 at paras 41-46.
12 Viiv Healthcare v JAMP Pharma, 2025 FC 379 at para 31.
13 Eli Lilly Canada Inc. v. Apotex Inc., 2010 FC 1065.
14 Apotex v Eli Lilly, 2025 ONCA 176at paras 19-22.
15 Apotex v Eli Lilly, 2025 ONCA 176at para 36.
16 Janssen v Pharmascience, 2025 FC 718 at para 8.
17 Janssen v Pharmascience, 2025 FC 718 at para 12.
18 See Botiuk v. Toronto Free Press Publications Ltd., 1995 CanLII 60 at paras 73-77; Fullowka v. Pinkerton's of Canada Ltd., 2010 SCC 5, at para 154.
19 Adeia Guides v Videotron
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