SCC Clarifies When Drug Dosing Regimens Can Be Patented

The Supreme Court of Canada (SCC) decision in Pharmascience Inc. v. Janssen Inc., released on July 17, 2026, is about the patentability of methods of medical treatment.

Janssen owns a patent for dosing regimens for a certain formulation used to treat schizophrenia and related disorders. The appeal addresses this question: Is such a patent covering specific dosing regimens for a schizophrenia drug unpatentable as a method of medical treatment?

The SCC dismissed Pharmascience's appeal and upheld the validity of Janssen's patent. The Court concluded that the patent's claims were not directed to a method of medical treatment, even though they specified how and when the drug should be administered.

Janssen developed and patented dosing regimens for a long-acting injectable form of paliperidone palmitate, used to treat schizophrenia and related disorders. The patent prescribed:

• A first dose on Day 1 of treatment.
• A second dose on Day 8 (± 2 days).
• Subsequent monthly maintenance doses (± 7 days).

Pharmascience sought approval for a generic version of the drug, and Janssen alleged patent infringement.  Pharmascience challenged the validity of the patent because it effectively claimed a method of medical treatment, which Canadian law has treated as non-patentable subject matter. According to the SCC, Canadian courts "have recognized the broader principle that professional skills are not proper subject matter for a patent. The principle that methods of medical treatment are not patentable is a specific application of the broader principle that professional skills — which are unrelated to trade, industry, or commerce — are not patentable subject matter."

However, the Court reasoned that not every patent involving the administration of medicine is necessarily a method of medical treatment.  Quoting from the judgement, the SCC provided three key principles:

1. First, the analysis should focus on whether the subject matter of the claimed invention 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. The need for professional skill and judgment in determining whether the subject matter is or continues to be an appropriate treatment option for a particular patient will generally not affect its patentability.
2. Second, the more the subject matter involves tailoring treatment to individual patients, the more likely it is that it amounts to a method of medical treatment. Treating a patient based on their individual characteristics engages professional skill and judgment in making treatment decisions. 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.
3. 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.

It's worth noting that these three principles are not exhaustive and the SCC is not establishing bright-line rules. Applying this guidance to this case, the SCC found that Janssen's patent covered a specific regimen which did not require a physician’s exercise of professional skill and judgment.  Therefore it was outside the realm of methods of medical treatment. The SCC confirmed that methods of medical treatment cannot be patented in Canada. But Janssen's patent is valid.

If you need assistance protecting, managing or enforcing your patent rights, contact Shohini Bagchee, Richard Stobbe or any member of our Intellectual Property + Technology Group.

Link to decision: Pharmascience Inc. v. Janssen Inc., 2026 SCC 26