On July 17, 2026, the Supreme Court of Canada released its decision in the landmark Pharmascience v Janssen Inc, 2026 SCC 26 appeal, deciding that methods of medical treatment (MMTs) remain unpatentable in Canada. The Supreme Court reaffirmed that MMTs are not eligible for patent protection under s.2 of the Patent Act, as they constitute unpatentable subject- matter. Nonetheless, the Court upheld the patentability of the pharmaceutical dosing regimen claims at issue, determining that they were not claims to MMTs.
The majority decision of the Supreme Court anchored the prohibition against patenting MMTs in the Patent Act's definition of "invention" and the principle that professional skill and judgment cannot and should not be patented. The crucial question is not whether a patent claim is directed to economic activities or to a vendible product, but whether it claims professional skill and judgment, which does not and should not, require the incentives and privileges of the patent bargain.
In minority reasons concurring in the result only, two Supreme Court justices opined that MMTs should not be categorically excluded from patent eligibility In their opinion, whether a claimed MMT satisfies the requirements of the Patent Act should depend on whether it satisfies principles of operability, reproducibility and control, which requirements should be read into the utility requirement of the Patent Act.
Background
The respondent Janssen's 335 Patent claimed a dosing regimen for the drug paliperidone palmitate, the active ingredient in the antipsychotic drug INVEGA SUSTENNA. The appellant, Pharmascience, challenged the validity of the 335 Patent on two grounds, including that it claimed an unpatentable MMT. The only remaining issue on appeal to the Supreme Court was whether the 335 Patent claimed an unpatentable MMT.
After the Federal Court and the Federal Court of Appeal held that the 335 Patent claimed a patentable invention, Pharmascience further appealed to the Supreme Court of Canada, arguing that a claim directed to "how" and "when" a medical practitioner administers a drug or treatment is presumptively ineligible for patent protection as claiming an MMT. Janssen counter-argued that the Canadian Patent Act no longer excludes MMTs from patentable subject-matter following the repeal of the former section 41(1).
Key Holdings
1. MMTs are Not Patentable in Canada
The Supreme Court's majority held that MMTs remain unpatentable in Canada because they are directed to the skill and judgment of professionals. The majority opinion rejected the view that the now-repealed section 41(1) of the Patent Act was the sole basis for the prohibition against patenting MMTs, and that the repeal of this legislative provision expressed Parliament's intent to displace settled jurisprudence.
By contrast, the concurring opinion was that a blanket prohibition on patenting MMTs has lacked a principled statutory foundation since the repeal of the former section 41(1), and that such a prohibition is unworkable in its application in any event.
2. Professional Skills and Judgment are Excluded from the Patent Bargain
The legal foundation for the ineligibility of MMTs is that professional skills are not inventions that can be patented under the Patent Act. In the majority's view, professionals do not require the incentives of the Patent Act given their existing legal and ethical obligations, and they should not be permitted to benefit from the patent bargain. It follows that pharmaceutical companies and other interested parties should likewise not be permitted to secure patents over the skill and judgment of health professionals.
By grounding its holding about MMTs in an analysis of the skill and judgment of professionals, the majority opinion rejected the argument that the central question is whether a patent claim is for "non-economic" or "economic" activities. In the majority's opinion, the only relevance of asking whether a patent claims a "vendible product" or "economic activity in the field of trade, industry, or commerce" is to understand whether it claims the exercise of professional skill and judgment and therefore responds to the economic incentives of the patent bargain]. The majority also rejected the "how and when" test proffered by the respondent..
3. Identifying Ineligible MMTs depends on the Evidence
The majority of the Supreme Court agreed with the Federal Court of Appeal's observation that the test for identifying MMTs calls for a "factually suffused" analysis that "depends on the evidence". It is not a bright-line test.
The majority highlighted three, non-exhaustive considerations to assist in identifying patent-ineligible MMTs:
- Whether the claimed subject-matter amounts to professional skill and judgment as opposed to whether professional judgment is involved in deciding whether to use the invention. A physician's decision to select or continue a treatment does not itself render the treatment unpatentable.
- Whether the claimed subject-matter needs to be individualized. The more a claimed invention requires tailoring treatment to individual patients, the more likely it is to involve professional skill and judgment. Conversely, inventions that can be applied at scale to a broad patient population are less likely to constitute MMTs.
- Whether the claim reflects innovation that medical professionals would ordinarily develop or improve through treating patients. The more incentivized medical professionals already are to develop or improve subject-matter in the course of their practice, the more likely the subject matter amounts to an ineligible MMT.
Following this approach, the majority of the Supreme Court concluded that the dosing regimen patent claims at issue had been properly granted over eligible subject-matter.
Key Takeaways
The majority decision of the Supreme Court re-affirmed Canada's prohibition against patenting MMTs and the principle that professional skill and judgment cannot, and should not, be patented. The crucial question is whether a patent claims professional skill and judgment, but there is no bright-line test for determining whether a patent claim is directed to an MMT.
In the case on appeal, the Supreme Court upheld the dosing regimen patent claims at issue. The majority also observed that, depending on the evidence, a medical innovation that can be conducted at scale without needing to be customized to individual patients, and is directed to matter that would otherwise be unlikely to be developed or improved through professional practice, is more likely to be eligible for patent protection in Canada.
By resisting the respondent's argument that all MMTs should be eligible for patent protection, the majority signals that it will remain the function of trial courts to assess the patent eligibility of therapeutic methods on a case-by-case basis, with an eye to allowing health professionals to act in the best interests of their patients.
