Intellectual Property: Patents
Pharmascience Inc. v. Janssen Inc., 2024 FCA 23, 2026 SCC 26 (41209)
“Janssen owns a patent for dosing regimens for a long-acting injectable formulation of paliperidone palmitate used to treat schizophrenia and related disorders. The patent teaches a first dose administered in the deltoid muscle on Day 1 of treatment; a second dose administered in the deltoid muscle on Day 8 of treatment ± 2 days; and then doses administered in either the deltoid or gluteal muscle monthly ± 7 days. For patients without impaired kidney function, the first and second doses are 150 and 100 mg-eq., respectively, and the subsequent monthly doses are 75 mg-eq. For patients with impaired kidney function, the first and second doses are 100 and 75 mg-eq., respectively, and the subsequent monthly doses are 50 mg-eq. The product monograph for Janssen’s formulation of paliperidone palmitate sets out the dosing regimens disclosed in the patent.
Pharmascience attempted to obtain approval to market its generic version Janssen’s formulation of paliperidone palmitate. This gave rise to proceedings before the Federal Court. The Federal Court rejected Pharmascience’s argument that Janssen’s patent is invalid on the basis that its claims involve unpatentable subject matter, namely methods of medical treatment. The Court of Appeal dismissed Pharmascience’s appeal and affirmed that the patent claims patentable subject matter.”
The SCC (9:0, one joint concurring judgment) dismissed the appeal.
Justice Jamal wrote as follows (at paras. 1, 4-5, 75-76, 78):
“This appeal examines whether methods of medical treatment are patentable subject matter under the Patent Act, R.S.C. 1985, c. P-4 and how such methods should be defined. Section 2 of the Patent Act defines a patentable “invention” as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”. At issue is whether s. 2 allows a physician’s professional skill and judgment to be patented.
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Pharmascience invites this Court to invalidate Janssen’s patent by broadening the test for an unpatentable method of medical treatment. Accepting Pharmascience’s position would dramatically reduce the number and scope of medical patents in Canada. For its part, Janssen invites the Court to uphold its patent by ruling that all methods of medical treatment are patentable and asserts that the contrary ruling in Tennessee Eastman rested entirely on the now-repealed s. 41(1). Janssen effectively submits that the vast body of jurisprudence holding that methods of medical treatment are unpatentable notwithstanding the repeal of s. 41(1) has been based on a mistake. Accepting Janssen’s position would dramatically increase the number and scope of medical patents in Canada.
…I would not give effect to either party’s position. I would reject Janssen’s invitation to depart from the settled interpretation of s. 2 that methods of medical treatment are unpatentable. Under Canadian law, a physician’s professional skill and judgment cannot be patented because this would be inconsistent with the purpose of the Patent Act. The Act seeks to incentivize desirable inventiveness by granting a temporary monopoly to those who share their new knowledge with the public. Physicians already benefit from a state-granted monopoly to practise and share their skills for the public benefit and do not require the prospect of extracting monopoly profits under a patent to do so. I would also reject Pharmascience’s invitation to broaden the test for an unpatentable method of medical treatment. A patent impermissibly claims a method of medical treatment only if it seeks to monopolize professional medical skill and judgment. Although some drug-dosing patents may seek to do so, the trial judge’s findings support the conclusion that the 335 Patent does not and, therefore, claims patentable subject matter.
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Finally, contrary to Janssen’s claim, international law does not support the view that methods of medical treatment are patentable in Canada. Janssen notes that Article 27(3)(a) of the Agreement on Trade-Related Aspects of Intellectual Property Rights, 1869 U.N.T.S. 299 (“TRIPS Agreement”), to which Canada is a signatory, expressly permits — but does not require — signatories to exclude “diagnostic, therapeutic and surgical methods for the treatment of humans” from patentability (R.F., at para. 51). As Janssen points out, some signatories, such as the United Kingdom, have enacted legislation expressly providing for such an exclusion (see Patents Act 1977 (U.K.), 1977, c. 37, s. 4A(1)). Janssen further observes that although Canada amended the Patent Act and other statutes in response to the TRIPS Agreement, it did not enact legislation providing expressly that methods of medical treatment are unpatentable. Janssen says that this omission is “highly significant” (R.F., at para. 51). I respectfully disagree. Canada’s decision not to enact legislation expressly excluding methods of medical treatment as a patentable invention is of no significance because it has been settled law since 1972 — when this Court rendered its judgment in Tennessee Eastman — that methods of medical treatment are unpatentable in Canada. That conclusion flows from the consistent judicial interpretation of s. 2 of the Patent Act. No legislative amendment was required to preserve the status quo.
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In short, Parliament has not sought to disturb the consistent interpretation of the Patent Act reflected in Tennessee Eastman (S.C.C.), Wellcome, and the federal courts’ jurisprudence. Any change to the law would unsettle more than a half-century of commercial expectations built on that case law. If such a change is to occur, it must come from Parliament, not this Court.”