Dosing Regimens Survive but the SCC Keeps Canada’s Bar on Patenting Methods of Medical Treatment

On July 17, 2026, the Supreme Court of Canada released Pharmascience Inc. v. Janssen Inc., 2026 SCC 26, the first word in decades from Canada’s apex Court on whether methods of medical treatment remain unpatentable subject matter, which the majority (7-2) confirmed.

Key takeaways

• The exclusion survives. Methods of medical treatment remain unpatentable when they monopolize professional skill and judgment.
• Dosing regimens can be patentable. The determinative question is whether the claim monopolizes professional skill and judgment. Non-exhaustive considerations include how the invention is claimed (e.g., fixed vs. variable, and degree of individualization or tailoring required by the physician), and whether professionals could have developed or improved the claimed invention in the ordinary course.

Background

Janssen alleged Pharmascience’s generic version of Invega Sustenna would infringe the 335 Patent, which claimed the following dosing regimen: a day 1 deltoid dose, a day 8 (±2 days) deltoid dose, and monthly (±7 days) maintenance doses in the deltoid or gluteal muscles, with differing dose amounts for patients with impaired versus normal renal function.

Pharmascience alleged the claims were an unpatentable method of medical treatment. Both the Federal Court and the Federal Court of Appeal rejected that allegation.

Before the SCC, Pharmascience proposed a “how and when” test—a claim dictating how or when a physician treats a patient should be invalid. Janssen argued that the exclusion on patenting methods of medical treatment was bad law and did not survive the 1993 repeal of section 41(1) of the Patent Act, on which Tennessee Eastman, the foundational case on this issue, rested. Janssen also argued that dosing is integral to commercial product offerings and is expressly contemplated by the patent-listing provisions of the Patented Medicines (Notice of Compliance) Regulations, Canada’s patent-linkage regime.

The exclusion survives

Writing for the majority, Justice Jamal held that claims to methods of medical treatment remain unpatentable in Canada where they seek to monopolize professional medical skill and judgment.

The governing “skill and judgment” test

The majority rejected both parties’ proposed tests, preferring to adopt the Federal Court of Appeal’s approach. The ultimate question is whether the subject matter amounts to professional medical skill and judgment—whether the claim seeks to “fence in” an area of medical treatment.^[1]

The majority set out three non-exhaustive considerations for assessing that issue:

1. The focus is on whether the claimed subject matter itself amounts to skill and judgment, not whether skill and judgment are used in selecting or monitoring the claimed treatment for a given patient;
2. The more the subject matter involves tailoring treatment to individual patients, the more likely the exclusion applies. By contrast, where the subject matter of the claimed invention can be applied generally to a broad class of patients without individual adjustment, it is less likely to be a method of medical treatment; and
3. The more a medical professional could develop or improve the subject matter in the ordinary course of treating patients, the more likely the exclusion applies.^[2]

No bright line for dosing regimens

The majority held that drug-dosing regimens can be patentable subject matter. The ultimate question is whether the claimed dosing regimen monopolizes the physician’s professional medical skill and judgment, as set out above.

Key points from the majority’s analysis include:

• Patentability is a “factually suffused” inquiry that depends on both the evidence and how the regimen is applied in practice.^[3]
• Whether a regimen is “fixed” or “variable” remains relevant but is not determinative.^[4]
• The fixed-versus-variable distinction is “at best, an evidentiary proxy” that may assist in assessing the degree of individualization.^[5]
• A dosing regimen does not become unpatentable merely because it may not be appropriate for every patient, or because some physicians might choose to depart from it. The Court cautioned that such a standard would be “impossible” to satisfy.^[6]

Applying that framework, the majority held that the trial judge correctly found that no professional skill or judgment was required to implement the claimed regimens in the 335 Patent once a physician decided to use it. The separate regimens for renally impaired patients did not improperly constrain clinical judgment, and the dosing windows and injection-site options had no meaningful clinical significance.^[7]

The concurring opinion

O’Bonsawin and Moreau JJ. agreed that the 335 Patent is valid, but would have overruled prior SCC jurisprudence and held methods of medical treatment to be patentable, addressing underlying policy concerns through the doctrine of utility instead.

The majority expressly disagreed with this framework, holding that: no party sought to overturn the jurisprudence or advanced that framework, and that the proposed utility framework risks making utility more stringent and confusing for all patents, medical or otherwise.^[8]

^[1] 2026 SCC 26 at para. 89.

^[2] 2026 SCC 26 at paras. 93-100.

^[3] 2026 SCC 26 at para. 106.

^[4] 2026 SCC 26 at paras. 104-105.

^[5] 2026 SCC 26 at para. 105.

^[6] 2026 SCC 26 at para. 107.

^[7] 2026 SCC 26 at paras. 118-123.

^[8] 2026 SCC 26 at paras. 111, 115-116.