In an important decision for Canada’s life sciences industry, on July 17, 2026, the Supreme Court of Canada confirmed that innovative pharmaceutical dosing regimens can constitute patentable subject matter.
The Court’s decision provides long-awaited guidance on the relationship between dosing-regimen patents and the prohibition against patenting methods of medical treatment (“MMTs”), bringing clarity to pharmaceutical patent law. It also strengthens Canada’s position as a jurisdiction that recognizes and protects meaningful pharmaceutical innovation.
The ruling provides greater certainty for pharmaceutical manufacturers, enhances the protection available for valuable research and development investments, and aligns Canadian law more closely with major international jurisdictions that recognize the patentability of dosing-regimen inventions.
Julie Desrosiers and Eliane Ellbogen of the Fasken IP litigation team acted as co-counsel to Janssen.
Decision in a Snapshot
- The Supreme Court confirmed that pharmaceutical dosing regimens can constitute patentable subject matter.
- The Court confirmed that MMTs are not patentable subject matter in Canada.
- The Court unanimously upheld Janssen’s patent for the INVEGA SUSTENNA® dosing regimen for paliperidone palmitate, a long-acting injectable treatment for schizophrenia.
- The Court rejected Pharamscience’s “how and when” test as the incorrect approach to dosing regimen patentability.
The Issue Before the Supreme Court
The core issue before the Court was whether pharmaceutical dosing regimens constitute patentable subject matter, or whether they cross the line into unpatentable MMT. The Court also looked at whether the MMT exclusion is still valid in Canadian patent law.
An MMT is generally understood to be a claim that seeks to monopolize a physician’s professional skill, judgment, or discretion when treating patients. Canadian courts have long recognized that physicians must remain free to exercise their clinical judgment without patent-related constraints. By contrast, a dosing regimen refers to a specific and defined protocol identifying how a drug is to be administered, including the amount, timing, frequency, and sequence of doses used to achieve a particular therapeutic outcome.
The Court was therefore required to determine whether Janssen’s patented regimen constituted a concrete pharmaceutical innovation capable of patent protection, or whether it improperly restricted the professional judgment of healthcare providers. The short answer was that Janssen’s patented regimen was patentable.
Background
The dispute concerned Janssen’s Canadian Patent No. 2,655,335 relating to INVEGA SUSTENNA® (the “335 Patent”), a long-acting injectable treatment for schizophrenia. The patented invention claims a specific dosing regimen for paliperidone palmitate, involving initial loading doses followed by scheduled monthly maintenance doses, including dosing adjustments for certain patient populations. The regimen was designed to improve treatment adherence and deliver a consistent therapeutic profile for patients suffering from schizophrenia.
In the Federal Court, Janssen brought an action under the Patented Medicines (Notice of Compliance) Regulations to prevent Pharmascience from marketing its generic product before expiry of the 335 Patent. Pharmascience challenged the validity of the patent, arguing in particular that the claims were directed to a MMT and were therefore not patentable. The Federal Court held that the claims at issue did not constitute unpatentable MMT because the claimed dosing regimen was sufficiently specific and did not require a physician to exercise professional judgment in order to implement it.
In the Federal Court of Appeal, Pharmascience maintained that the patent claims were invalid because they were directed to MMTs. The Federal Court of Appeal dismissed the appeal and confirmed the validity of the patent. The Federal Court of Appeal clarified that the key question is not simply whether a claim provides for a fixed or variable dose, but rather whether the use of the claimed invention requires the exercise of a physician’s professional skill and judgment as to how to administer the treatment. In other words, a patent does not automatically become invalid simply because it relates to a dosing regimen; the question is whether it protects a specific pharmaceutical innovation or instead seeks to monopolize physicians’ clinical decisions.
The Supreme Court Decision
The Supreme Court rejected Pharmascience’s challenge and confirmed that dosing regimens are not inherently excluded from patentability merely because they involve the administration of a pharmaceutical product.
The Court’s majority held that a patent impermissibly claims an MMT only where it seeks to monopolise professional medical skill and judgment. A dosing regimen that defines a concrete pharmaceutical innovation, without constraining how physicians exercise their professional discretion, remains patentable.
Moreover, while the Court rejected the categorical “fixed versus variable dosage” distinction, which at best is an evidentiary proxy that may sometimes be useful but never dispositive of whether the claims are for an unpatentable MMT, the Court did not outright exclude the patentability of variable dosing ranges, confirming that the determination must ultimately be guided by the facts of each case.
Three guiding principles inform the analysis:
- Selection vs. implementation: The need for professional skill and judgment in deciding whether a treatment is appropriate for a particular patient will generally not affect patentability. The focus is on the subject matter of the invention itself, not on the clinical judgement exercised in selecting it.
- Degree of individualisation: The more the subject matter involves tailoring treatment to individual patients, the more likely it is to constitute an MMT. Conversely, where the invention can be applied broadly to a class of patients without individual adjustment, it is less likely to cross that line.
- Professional incentive to innovate: The more a medical professional would already be incentivised to develop or improve the subject matter in the ordinary course of treating patients, the more likely it is to constitute an MMT.
These three points are not exhaustive and do not establish bright-line rules. The determination must ultimately be guided by the specific claims and facts of each case.
Finally, while the result was unanimous (7-2 on the core MMT rule, 9-0 on the outcome), the Court was divided on the underlying principle:
- The majority reaffirmed that MMTs remain unpatentable as a category, because professional skills are unrelated to trade, industry, or commerce and do not require the incentive of the patent bargain.
- The concurring minority went further, concluding that the blanket prohibition on MMTs should be abandoned entirely, and that all medical inventions, including dosing regimens, should be assessed under the ordinary patentability framework, with utility serving as the primary filter.
This division signals that the law in this area may continue to evolve, and that the minority’s broader approach could gain traction in future cases.
Key Impacts for the Pharmaceutical Industry
Key takeaways from the Pharmascience v. Janssen decision, for all stakeholders in the life sciences space, include:
- Greater certainty for dosing regimen innovation: A clearer, principled framework now exists for assessing whether a dosing regimen patent is valid. The central question is whether the claimed subject matter amounts to professional medical skill and judgment not whether it describes how or when a drug is administered.
- Patent validity challenges remain a possibility: The ruling should not be read as a green light for all dosing regimen patents – the analysis remains fact-specific. While generic challengers can no longer rely on the “how and when” framing as a standalone ground to invalidate a dosing regimen patent, challenging a dosing regimen patent on MMT grounds still remains a potential route, particularly where the evidence demonstrates that the regimen requires individualized physician adjustment.
- Closer alignment with international practice: Canada’s approach now more closely reflects certain key jurisdictions where dosing regimens are generally patent-eligible, facilitating more coherent global portfolio management.
- Portfolio drafting and enforcement strategy: Patent holders should pay close attention to how their claims are drafted and patents subsequently enforced:
- Emphasize the concrete, commercial character of the dosing innovation (product, dosage form, precise administration protocol).
- Demonstrate that the regimen can be implemented without individualized physician adjustment after initial prescribing decisions are made.
- Avoid framing claims in ways that highlight clinical discretion or patient-by-patient tailoring.
- Do not rely solely on the “fixed dosage” form of a claim as a proxy for patentability; courts will look beyond drafting form to the substance of the invention.
- When defending dosing regimen patents, innovators should clearly distinguish between the clinical judgment a physician exercises in deciding whether to prescribe or continue a regimen, and the defined protocol that constitutes the actual subject matter of the patent.
- The product monograph and clinical evidence adduced at trial about how a regimen is actually implemented will likely carry significant weight. Patent holders should ensure that the evidence demonstrates that, once prescribed, the regimen is implemented without the need for further individualized professional judgment.
Fasken is proud to have contributed to this important matter for pharmaceutical innovation in Canada.
