In its decision released today in Pharmascience Inc. v. Janssen Inc., 2026 SCC 26, a majority of the Supreme Court of Canada upheld the lower court decisions finding that methods of medical treatment are unpatentable subject matter but the dosage regime at issue patentable.
Pharmascience Inc. v. Janssen Inc., 2026 SCC 26.
From the majority:
[1] … At issue is whether s. 2 allows a physician’s professional skill and judgment to be patented.
[5] … I would reject Janssen’s invitation to depart from the settled interpretation of s. 2 that methods of medical treatment are unpatentable. Under Canadian law, a physician’s professional skill and judgment cannot be patented because this would be inconsistent with the purpose of the Patent Act. …
[55] … For more than half a century, it has been settled law in Canada that methods of medical treatment are not patentable subject matter. I reach that conclusion for four reasons:
(1) professional skills are not patentable under Canadian law;
(2) Canadian courts have continued to affirm that methods of medical treatment are unpatentable even after the repeal of s. 41(1);
(3) the repeal of s. 41(1) did not address the patentability of methods of medical treatment; and
(4) international law leaves that question to be decided by each state in accordance with its own public policy. …
[59] … Allowing professional skills to be patentable would not advance the purpose of the Patent Act, which is to stimulate innovation. Professionals are already under ethical obligations to exercise their skills in their clients’ best interests and to share those skills widely. They neither need nor should they receive patent protection to do so. Because professional skills do not respond to the incentives of the patent bargain, patenting them is unjustified. The exercise of professional skills is simply not the kind of inventiveness that the Patent Act is intended to encourage.
[91] T analysis for methods of medical treatment is then applied to “the real subject matter of the claim”, regardless of how the claim is drafted (Novartis, at para. 101; see also Bayer Inc. v. Cobalt Pharmaceuticals Co., 2013 FC 1061, 121 C.P.R. (4th) 14, at para. 162). For example, the drafting of a claim as a product claim does not mean that its subject matter is necessarily a “vendible product”. I agree with the Court of Appeal that “it would be an error to focus on form over substance” (para. 42).
[106] Determining the patentability of a dosing regimen is a factually suffused exercise that depends on the evidence and how the dosing regimen is intended to be, or has been, applied. The appropriate evidence could include, for example, expert or other “evidence to contradict th[e] claimed dosage”, which could suggest that the dosing regimen requires individualized adjustment and potentially constitutes a method of medical treatment …
The minority, O’Bonsawin and Moreau JJ. wrote:
[129] To be clear, these reasons do not endorse the patenting of all MMTs. Rather, these reasons recognize that MMTs are not inherently unpatentable. By removing the prohibition on patenting MMTs, we propose that the criteria for patentability set out in the Patent Act can filter out all subject matter that does not meet the relevant requirements. In particular, the utility criterion already operates to preclude the patentability of certain MMTs in a manner that aligns with the broader patent regime.
[217] … The only unifying principle that holds together the case law to justify the doctrine’s existence is the idea that patenting MMTs will interfere with a physician’s ability to treat patients. This rationale, along with the others identified earlier in this section, is a conclusory assertion lacking evidentiary support, and it does not withstand close scrutiny.
[271] … Upon closer examination, however, it becomes apparent that the current MMT doctrine, because of its reliance on skill and judgment, is in fact grounded in considerations that are more closely associated with the utility requirement for patentability (see Lipkus and Albanese, at p. 96). Accordingly, we offer some general observations below on the interaction of the utility requirement and the patentability of MMTs.
[280] A process that relies on human skill, judgment, interpretation, and reasoning is unpatentable not because it falls outside of patentable subject matter, but because it lacks utility. As such, it is more than likely that a new and complex surgical method, or any other complex medical method, is unpatentable by virtue of its irreproducibility flowing from its heavy reliance on the skill and judgment of a professional, honed through years of practice. In these cases, demonstrating that a claimed invention will achieve its practical purpose — in other words, its utility — will be impossible because of the necessity of subjective human involvement in operating the claimed invention.