Pharmascience Inc v Janssen Inc, 2026 SCC 26
On July 17, 2026, the Supreme Court of Canada released its decision in Pharmascience Inc v Janssen Inc, 2026 SCC 26, with a 7-2 majority dismissing Pharmascience’s appeal and holding that Canadian Patent No. 2,655,335 (the 335 Patent), which claims new injectable products and new dosing regimens for paliperidone palmitate (INVEGA SUSTENNA) to treat schizophrenia, does not claim an unpatentable method of medical treatment (MOMT).
This decision marks the most significant statement on the MOMT doctrine from Canada’s highest court in over fifty years, providing long-awaited guidance on how dosing-regimen claims should be evaluated in Canada, while reaffirming the prohibition against patenting MOMT.
Cassels lawyers Andrew Skodyn, Sean Jackson, and Eleanor Wilson represented the International Federation of Intellectual Property Attorneys (FICPI), an intervener in this appeal.
Procedural History
The 335 Patent, owned by Janssen, covers a long-acting injectable formulation of paliperidone palmitate used to treat schizophrenia and a specific dosing regimen for using it. The claimed regimen involves a first loading dose in the deltoid muscle on Day 1, a second loading dose in the deltoid on Day 8 (plus or minus two days), followed by monthly maintenance doses (plus or minus seven days) in either the deltoid or gluteal muscle. Separate dosage strengths are specified depending on whether the patient has normal or impaired kidney function.1
Pharmascience challenged the validity of the 335 Patent on the basis that it claimed unpatentable subject matter. Manson, J for the Federal Court rejected Pharmascience’s argument, finding that once a physician selects this product and dosing regimen for a particular patient, no further professional skill and judgment is required to implement it.2
On appeal, the Federal Court of Appeal affirmed the Federal Court’s decision, holding that the proper inquiry focuses on whether use of the invention (i.e., how to use it, not whether to use it) requires the exercise of professional skill and judgment.3
Supreme Court Decision
Justice Jamal, writing for the majority, confirmed that MOMT remain unpatentable subject matter in Canada.4 The Court rejected Janssen’s argument that the MOMT exclusion lost its statutory foundation when Parliament repealed former subsection 41(1) of the Patent Act in 1993, holding that the prohibition rests on a broader principle, affirmed in Shell Oil Co v Commissioner of Patents [1982] and Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77.5 The Court held that even after the repeal of subsection 41(1), the Supreme Court continued to apply the rule that MOMT are unpatentable subject matter, and more broadly, has affirmed that professional skills are not patentable; no court at any level has held otherwise.6 This rule, according to the Court, rests on the public policy rationale that medical professionals do not require the incentives of the patent bargain to exercise skill and judgement in their patients’ best interests, or to disseminate their knowledge.7
The majority also flatly rejected Pharmascience’s proposed “how and when” test, which would have created a presumption that claims whose essential elements relate to how and when a drug is administered are unpatentable MOMT.8
The Court endorsed the Federal Court of Appeal’s approach – the ultimate question when determining whether a patent impermissibly claims a MOMT is whether that subject matter amounts to professional medical skill and judgement.9 The answer to this question depends on the nature of the specific claims of the facts of each case.
The Court identified three non-exhaustive guiding considerations:10
- the need for professional judgment in deciding whether a treatment is appropriate for a particular patient (the prescribing decision) does not itself affect patentability. Medical judgment is often required in deciding whether a claimed invention is appropriate for any given patient, but this does not automatically make it unpatentable. That decision is distinct from the claimed invention;
- the more a claim requires tailoring to individual patients, the more likely it is to constitute an MOMT. Conversely, inventions that can be applied broadly without individualized adjustment are less likely to be MOMTs; and
- the more a medical professional would already be incentivized to develop or improve the subject matter in the course of ordinary practice (without patent incentives) the more likely the subject matter is an MOMT.
The real question in every case is whether use of the claimed invention requires the exercise of professional medical skill and judgment, assessed on the specific facts.11 The question must be approached by construing the claims purposively.
With respect to drug dosing claims, the Court held that the categorical distinction between fixed and variable dosages skirts the ultimate issue of whether the claimed dosing regimen amounts to professional medical skill and judgment.12 The Court held that determining the patentability of a dosing regimen is a factually suffused exercise that depends on the evidence and how the dosing regiment is intended to be, or has been, applied.13
Applying this framework, the majority upheld the trial judge’s finding that the 335 Patent claims patentable subject matter.14 Once a physician selects the patented dosing regimen, no further skill and judgment is required to implement it.15 The distinction between patients with normal and impaired kidney function is an objective, binary determination rather than an exercise of individualized clinical judgment.16 The dosing windows and choice of injection site have no clinical implications and therefore do not constrain physician judgment.17
Justices O’Bonsawin and Moreau concurred with the majority in the result, but disagreed with the majority’s approach. In particular, Justices O’Bonsawin and Moreau agreed with Janssen and the overwhelming majority of the interveners in concluding that the precedential value of Tennessee Eastman is doubtful, and that it was based on repealed law that is no longer applicable to the modern statutory patent scheme, nor aligned with subsequent jurisprudence from the Supreme Court.18 Instead, the concurring justices argued that so-called MOMTs should be assessed under the ordinary patentability criteria under the Patent Act, namely, novelty, non-obviousness, and utility, rather than being subjected to a special threshold test.19 As described by Justices O’Bonsawin and Moreau, these factors would still capture MOMTs, and the 335 Patent would still be found valid on ordinary patentability grounds.20
Overall, the takeaway here is that when presented with an opportunity to eliminate an obsolete, complicated and unnecessary extra step for certain pharmaceutical patents, the Supreme Court declined to do so. This is unfortunate, but given the analysis and result of the case will ultimately have little practical effect. The guidance provided by the Court resulted in the dosing regimen patent at issue being found valid and should result in future similar patents being found valid as well. The kinds of patents that would run afoul of the new guidance, if they even exist, are few and far between. The MOMT argument will therefore likely continue to be a minor annoyance, rather than a significant factor for life sciences companies looking to bring new products to market in Canada and protect them appropriately.
_____________________________
1 Pharmascience Inc v Janssen Inc, 2026 SCC 26 (“Invega Sustenna SCC”) at paras 12-13.
2 Invega Sustenna SCC at paras 21-22; see also: Janssen Inc v Pharmascience Inc, 2022 FC 1218.
3 Invega Sustenna SCC at para 25; see also: Pharmascience Inc v Janssen Inc, 2024 FCA 23.
4 Invega Sustenna SCC at para 68.
5 Invega Sustenna SCC at paras 30 and 69.
6 Invega Sustenna SCC at para 44.
7 Invega Sustenna SCC at para 44.
8 Invega Sustenna SCC at paras 29 and 82.
9 Invega Sustenna SCC at paras 5 and 89.
10 Invega Sustenna SCC at paras 92-97.
11 Invega Sustenna SCC at para 100.
12 Invega Sustenna SCC at para 105.
13 Invega Sustenna SCC at para 106.
14 Invega Sustenna SCC at para 119.
15 Invega Sustenna SCC at paras 120-121.
16 Invega Sustenna SCC at para 121.
17 Invega Sustenna SCC at para 122.
18 Invega Sustenna SCC at para 162.
19 Invega Sustenna SCC at para 268.
20 Invega Sustenna SCC at para 284.