On July 17, 2026, the Supreme Court of Canada dismissed the appeal in Pharmascience Inc. v. Janssen Inc., finding that, while methods of medical treatment remain unpatentable in Canada, Janssen’s claims to a dosing regimen were not a method of medical treatment and constituted patentable subject matter.
Pharmascience Inc. v. Janssen Inc., 2026 SCC 26
This was the first time the SCC has addressed the patentability of so-called “methods of medical treatment” in decades. This ruling clarifies some of the inconsistencies that have developed in this area since the Tennessee Eastman decision in the 1970s while, at the same time, leaves considerable room for debate and uncertainty in how this ruling should be applied moving forward.
Background
The patent at issue relates to uses of paliperidone palmitate (which Janssen sells under the brand INVEGA SUSTENNA®) in the treatment of schizophrenia. The claims at issue were to a dosing regimen for treating schizophrenia that required patients to receive:
- A first loading dose of 150 milligrams equivalent [mg-eq.] of paliperidone palmitate administered into the deltoid muscle on Day 1 of treatment;
- A second loading dose of 100 mg-eq. of paliperidone palmitate administered into the deltoid on Day 8 ± 2 days; and
- Maintenance doses of 75 mg-eq. of paliperidone palmitate administered into the deltoid or gluteal muscle monthly ± 7 days after the second injection.
The only issue on appeal was whether the claims constituted patentable subject matter.
The Federal Court of Appeal held that the claims constituted patentable subject matter because they did not require a physician to exercise skill and judgment in deciding how to use the claimed invention.
You can read our blog summarizing the underlying FCA decision here.
Patentable Subject Matter, Tennessee Eastman and Methods of Medical Treatment
Section 2 of the Patent Act defines an “invention” for the purpose of the Act as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement” thereof. These categories of “patentable subject matter” have been interpreted broadly but have also defied bright line definitions or tests.
In the 1970s, the SCC in Tennessee Eastman denied a patent for a surgical method because it was an unpatentable method of medical treatment. Since that decision, scholars, litigants, and courts have debated the basis for that finding, often resorting to brief – and sometimes inconsistent – summaries or characterizations of the decision by the SCC in later cases.
Some argued that Tennessee Eastman stood for the proposition that methods of medical treatment are not patentable because they are a subcategory of unpatentable professional skill – unrelated to trade or commerce. Others argued that Tennessee Eastman hinged on section 41 of the Patent Act (since repealed) which precluded patents on “medicines”. This led to a variety of difficult-to-reconcile rationales and doctrines. Without a clear basis, courts struggled to define precisely why or when a claim crossed into unpatentable territory.
Summary of the SCC Decision
Methods of medical treatment are not patentable
The SCC directly addressed Tennessee Eastman and the decades of case law that followed it. While the entire SCC agreed on the ultimate result, there was a 7-2 split in the Court’s reasons.
Writing for the majority, Jamal J. confirmed that, independent of the decision in Tennessee Eastman, methods of medical treatment are not patentable because they do not relate to trade, industry, or commerce but rather to professional skill which are, and have always been, unpatentable. For the Court, methods of medical treatment are part of a broader category of unpatentable professional skill and not an “art” or a “process” as required in the Act.
The test for methods of medical treatment
The SCC next considered how to identify an unpatentable method of medical treatment.
The Court rejected Pharmascience’s argument that any claim to “how and when” a drug should be administered constitutes a method of medical treatment. The Court found this would be inconsistent with existing authority. The Court also rejected Janssen’s argument that the test should focus on whether the medical patent is for “non-economic” or “economic” activities finding that “the treatment of patients by a medical professional will always have an economic value, broadly construed”.
In the Court’s view, the “ultimate question” for patentability is whether the subject matter of the claim “amounts to professional skill and judgment” which need not be incentivized by the patent bargain. The Court stopped short of setting out a definitive test for distinguishing unpatentable professional skill from patentable innovations (either in the medical field or in general) because that determination is “factually suffused” and dependent on the particulars and evidence of each case. The Court nonetheless highlighted three points to provide guidance in the context of medical professionals:
First, the focus must be on “whether the claimed subject matter amounts to professional medical skill and judgment, not whether professional medical skill and judgment would be applied in selecting the claimed invention for a particular patient or use”.
Second, “the more the practice of a claimed invention involves tailoring it to the circumstances of a particular patient, the more likely it is that its subject matter amounts to professional medical skill and judgment.”
Third, “the more a medical professional would already be incentivized to develop or improve a given subject matter in the course of their professional practice, the more likely it is that the subject matter amounts to a method of medical treatment.”
The claims at issue were not a method of medical treatment
The SCC agreed with the courts below that the claims at issue were not directed to professional skill for the following reasons:
- Skill and judgment were not required to implement the claimed dosing regimen once the physician had chosen it;
- The dosing regimen did not require skill or judgment to implement. What little individualization the regimen called for was objective (in that the regimen differed for patients with and without kidney disease); and
- Choices that did exist within the regimen (precise timing, injection site) did not have clinical implications and were intended to allow flexibility.
Concurring reasons
The concurring justices O’Bonsawin and Moreau JJ. held that Tennessee Eastman hinged on a repealed section of the Patent Act and should be reconsidered. For those justices, an independent question of whether claimed subject-matter is a method of medical treatment is unhelpful, not grounded in the Patent Act, difficult to apply, and “no longer fit for its purpose”. They suggested that professional skill (including methods of medical treatment) should not be considered as a stand-alone inquiry of patentability, but should be addressed as a matter of utility during the validity analysis.
Commentary
There will continue to be debates surrounding patentable subject matter, methods of medical treatment, and professional skill following this highly anticipated decision. We have highlighted a few reflections based on our initial read of the decision:
The SCC provided much needed clarity around why methods of medical treatment are not patentable
For the SCC, methods of medical treatment are a subcategory of unpatentable professional skill rather than a stand-alone exclusion. This clarity is important.
Some decisions and commentators suggested that methods of medical treatment were a stand-alone exclusion and pointed to rationales that were particular to medical doctors and human patients: policy concerns around access to surgical techniques and the fact that such techniques are applied to humans. These policy-based rationales were particularly difficult to justify given the Patent Act’ssilence on methods of medical treatment as a defined category. Some of the categorical distinctions from these cases between what is and is not patentable subject matter may no longer apply.
For example, in the past, CIPO drew a distinction between unpatentable methods of medical treatment that cure, prevent or ameliorate a disease or pathology and patentable methods for “natural conditions such as ageing, pregnancy, baldness and wrinkles”. This distinction, which focuses on the nature of the condition being addressed, may not be consistent with the SCC’s focus on whether the claim amounts to professional skill.
The scope of the professional skills doctrine, even within the medical context, remains unclear
The Court’s refusal to set out a definitive test for distinguishing patentable innovations from unpatentable professional skill leaves courts and practitioners with little guidance.
There is little Canadian case law on unpatentable professional skills outside of medical fields. And while there is considerable case law on medical methods, those cases are encumbered by rationales and bright line rules that no longer apply, such as the Federal Court’s categorical distinction between a fixed dose regimen (patentable) and a dosage regimen with a range (not patentable). The existing cases may provide little guidance going forward.
Parties and litigants will have little guidance when assessing their existing patent portfolios in view of the SCC’s guidance.
Does this decision apply to professional skill outside of the medical field?
The SCC’s rationale that methods of medical treatment are a subcategory of a broader exclusion for professional skill suggests that the Court’s comments would apply equally to other professionals. That said, the Court repeatedly pointed to factors that, while not specific to medical professionals, are not necessarily common to all professional fields.
The Court believed it to be relevant that physicians “already benefit from a state-granted monopoly to practice and share their skills for the public benefit” and that in the practice of medicine, “economic value does not drive the exercise of skill and judgment”. This decision leaves open whether these factors are necessary conditions for the professional skills exception to apply and what qualifies as a “professional skill” outside of trade, commerce, and industry versus a professional skill that may fall within trade, commerce, and industry and may be patentable.
Does the “actual invention” matter?
In the underlying trial decision, the Federal Court considered that claims to prefilled syringes, dosage forms and other physical embodiments for use with the dosing regimen were patentable because they claimed vendible products.
The SCC held that this fact was not dispositive. In its view, the “analysis for methods of medical treatment [must be] applied to ‘the real subject matter of the claim’, regardless of how the claim is drafted…the drafting of a claim as a product claim does not mean that its subject matter is necessarily a ‘vendible product’”.
This raises the spectre of the “actual invention” that has plagued patentable subject matter cases in the context of computer implemented inventions. It will be interesting to see: (a) to what extent the SCC’s comments impact that separate line of cases; and (b) whether we will see arguments that claims to physical products should nevertheless be construed as claiming professional skill.
Conclusion
This decision provides some clarity as to how the question of methods of medical treatment should be approached but, for many, falls short of the definitive and practical guidance litigants and patent owners were looking for. Time will tell if the SCC’s guidance meaningfully moves this area forward or whether the SCC has largely affirmed the status quo.