On 17 July 2026, the Supreme Court of Canada released its long-awaited decision in Pharmascience Inc. v. Janssen Inc., 2026 SCC 26. The case concerned the patentability of dosing regimens for Janssen’s schizophrenia treatment INVEGA SUSTENNA® (paliperidone palmitate) but evolved into a broader examination of whether methods of medical treatment (MMTs) remain a distinct category of unpatentable subject matter under Canadian law.
FICPI intervened in the appeal because the issues extended well beyond Canada. The case raised fundamental questions about international harmonisation of patent law, the treatment of pharmaceutical inventions, and the extent to which Canadian patentability standards should remain aligned with those of other major patent jurisdictions. FICPI was represented by Andrew Skodyn, Sean Jackson and Eleanor Wilson of Cassels.
The Court maintained the Canadian methods-of-medical-treatment doctrine but rejected the bolder position FICPI took with regards to methods of medical treatment. The decision contains important developments that will be of significant interest to innovators and patent practitioners worldwide.
The patent and the dispute
The patent at issue, Canadian Patent No. 2,655,335, covers dosing regimens for a long-acting injectable formulation of paliperidone palmitate used to treat schizophrenia and related disorders. The claimed regimen specifies loading doses administered at defined times and maintenance doses administered monthly, with different dosage strengths depending on whether the patient has impaired kidney function.
Pharmascience sought approval to market a generic version of the product and challenged the patent's validity, arguing that the claims constituted an unpatentable method of medical treatment. Janssen succeeded before both the Federal Court and the Federal Court of Appeal. The sole issue before the Supreme Court was whether the patent claimed unpatentable subject matter.
Why FICPI intervened
Unlike several other interveners who focused primarily on Canadian doctrine or healthcare policy, FICPI approached the appeal from the perspective of the international patent system. Our factum emphasised that inventors frequently seek protection for the same invention in multiple jurisdictions and that patent attorneys and their clients depend upon a coherent and predictable global patent framework.
FICPI argued that Canada's current approach to methods of medical treatment was already out of line with some key jurisdictions and risked becoming isolated from international norms. We submitted that global availability of patent protection for inventions that are new, inventive and useful encourages innovation and facilitates international investment in technologies such as pharmaceuticals and biotechnology.
A central theme of FICPI's intervention was harmonisation. We submitted that patentability standards should be consistent across jurisdictions wherever possible and that uniquely Canadian judge-made exclusions undermine certainty and predictability for innovators.
FICPI’s principal arguments
FICPI advanced three closely connected propositions.
1. There is no statutory basis for an MMT exclusion
FICPI argued that methods of medical treatment fit comfortably within the statutory definition of an "invention" in the Canadian Patent Act and that the Act contains no express exclusion for such subject matter. In FICPI's view, MMT claims should be assessed using the same patentability criteria that apply to all other inventions: novelty, inventiveness and utility. Any special exclusion should be created by Parliament rather than by judicial doctrine.
2. Canada should align with international practice
Much of FICPI's submission focused on comparative law and international treaty frameworks. We highlighted Canada's participation in both the Patent Cooperation Treaty (PCT) and the TRIPS Agreement, arguing that Canada's further divergence from major jurisdictions would create unnecessary complexity and uncertainty for patent applicants.
FICPI stressed that if Canada wishes to exclude methods of medical treatment from patentability, it should do so through clear legislation, as occurs in some jurisdictions, rather than through evolving judicial tests.
3. Dosing regimens should be patentable
FICPI devoted substantial attention to dosing-regimen claims. The factum argued that major patent systems routinely recognise patents for novel and inventive dosing regimens and that Canada should do likewise. It warned that the appellant's proposed "how and when" test would place at risk a broad range of pharmaceutical inventions that would be patentable elsewhere.
The international picture
FICPI's intervention included a review of foreign law of method of method treatments and dosing regimens.
Europe
FICPI explained that Article 53(c) EPC excludes methods of treatment from patentability but expressly preserves protection for products used in such methods. Through the development of European jurisprudence, particularly the Enlarged Board of Appeal decision in Abbott Respiratory (G 2/08), claims directed to pharmaceutical uses and dosing regimens remain patentable when properly drafted.
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FICPI highlighted that European law treats new dosing regimens as potentially patentable inventions and does not impose a broad exclusion comparable to the approach urged by Pharmascience.
United Kingdom
The UK has implemented a statutory exclusion modelled on the EPC while expressly preserving protection for products and medical-use inventions. UK courts have confirmed the patentability of novel dosing regimens where the normal requirements of patentability are satisfied.
United States
FICPI noted that US patent law contains no specific exclusion for methods of medical treatment. Such claims are assessed under the ordinary statutory framework and dosing-regimen patents are routinely enforced where valid. Medical practitioners benefit from limited statutory protections, but patentability itself is not denied.
Australia
The High Court of Australia has recognised the patentability of methods of medical treatment, provided the usual statutory requirements are met. Australia therefore represents another major common-law jurisdiction that does not apply a broad judge-made exclusion.
The Supreme Court’s decision
The Supreme Court unanimously upheld the validity of Janssen's patent but split sharply on the broader legal issue.
Majority judgment
The seven-judge majority held that methods of medical treatment remain unpatentable in Canada because they constitute a subset of unpatentable professional skills and judgment. The Court concluded that the doctrine survives notwithstanding repeal of the former statutory provisions that featured prominently in Tennessee Eastman.
The majority endorsed the “ultimate question”, stated by the Federal Court of Appeals, for future cases:
Does the claimed subject matter amount to professional medical skill and judgment?
To answer that question, the Court identified three non-exhaustive considerations:
* whether professional judgment is merely involved in deciding whether a treatment is appropriate;
* whether the invention requires tailoring to particular patients; and
* whether medical professionals would naturally develop or refine the subject matter during ordinary clinical practice.
Importantly, the Court rejected Pharmascience's proposed “how and when” test and also rejected the traditional fixed-versus-variable dosage distinction as a decisive rule. Dosing regimens can be patentable and must be analysed on their particular facts.
Minority judgment
Justices O'Bonsawin and Moreau reached the same result but through fundamentally different reasoning.
They concluded that methods of medical treatment should no longer be treated as inherently unpatentable subject matter. In their view:
* the foundations of Tennessee Eastman have eroded;
* the Patent Act contains no exclusion for MMTs;
* policy concerns should not be used to create categories of non-patentable subject matter; and
* such claims should instead be examined using the ordinary statutory tests of patentability.
This reasoning closely mirrored many of the positions advanced by FICPI.
What did FICPI achieve?
Although we did not achieve our bolder objective, which was to persuade the Supreme Court to decline to abolish the methods-of-medical-treatment doctrine and to bring Canadian law into line with jurisdictions such as the United States and Australia, the intervention appears to have had several important effects.
First, the Court engaged directly with the international context, including TRIPS and comparative foreign law. The majority specifically discussed Article 27(3)(a) TRIPS and surveyed approaches taken in foreign jurisdictions.
Second, the Court rejected the appellant's expansive "how and when" test, which FICPI had criticised as a uniquely Canadian and non-statutory doctrine analogous to the former Promise Doctrine.
Third, the Court confirmed that dosing regimens remain capable of patent protection and refused to adopt a categorical rule that variable dosage regimes are unpatentable. This outcome preserves meaningful protection for pharmaceutical innovation and keeps Canadian law considerably closer to international practice than Pharmascience's proposed approach would have done.
Finally, the minority judgment endorsed many of the ideas advanced by FICPI, creating a well-developed judicial framework that may support future legislative reform or judicial reconsideration.
Conclusion
The Court rejected the appellant's attempt to expand the doctrine through a broad "how and when" test, confirmed that dosing regimens remain capable of patent protection, and produced a substantial minority judgment advocating the very harmonised, statute-based approach urged by FICPI.
Most importantly, the case demonstrates the continuing importance of FICPI's role as a global voice for internationally coherent intellectual property law. The Court's decision leaves Canadian law significantly closer to international norms than it might otherwise have been and preserves meaningful protection for pharmaceutical and life-sciences innovation.
FICPI’s view
The FICPI community is built on trusted, global relationships. It uniquely combines education and advocacy on topics around patents and trade marks, with a focus on developing the professional excellence of its individual member who are independent IP attorneys from across the world.
Next steps
Join us at the 23rd FICPI Open Forum in Budapest (16-19 September 2026): https://ficpi.org/ficpi2026
Consider becoming involved with FICPI's working parties and Committees: https://ficpi.org/organisation/committees