SCC affirms 7-2 that methods of medical treatment cannot be patented in Canada | Canadian Lawyer

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SCC affirms 7-2 that methods of medical treatment cannot be patented in Canada

However, the court ruled that a dosing regimen for a Janssen Inc. schizophrenia treatment is patentable

Andrew Skodyn

By Jessica Mach

Jul 17, 2026 / Share

Methods of medical treatment cannot be patented under Canadian law, the Supreme Court of Canada ruled in a split decision Friday, affirming Canada’s approach to medical patents for the past half-century.

In a blow to Pharmascience Inc., however, the SCC said this principle does not entitle the Quebec-based pharmaceutical company to market a generic version of a Janssen Inc. drug by advising patients to use the latter company’s patented dosing regimens. According to the SCC, Janssen’s dosing regimens do not amount to a method of medical treatment.

“To determine whether a given subject matter is unpatentable as a method of medical treatment, the ‘ultimate question’ is whether that subject matter amounts to professional medical skill and judgment,” SCC Justice Mahmud Jamal wrote for the majority in Pharmascience Inc. v. Janssen Inc.

In determining that Janssen’s dosing regimens do not amount to professional skill and judgment, Jamal upheld previous rulings in the case by both the Federal Court and the Federal Court of Appeal.

Justices Michelle O’Bonsawin and Mary Moreau authored a concurring opinion, agreeing with the majority that the patent for Janssen’s dosing regimens is valid.

However, the two justices disagreed with the majority that methods of medical treatment are inherently unpatentable.

The case involves the drug paliperidone palmitate, which can be used to treat schizophrenia. Janssen began developing a long-lasting, injectable version of the drug and accompanying dosing regimens in the 1990s, filed a patent application for the dosing regimens in 2008, and received the patent in 2016.

Under the patented dosing regimens, patients administer their second dose of the drug – marketed under the brand name INVEGA SUSTENNA – about a week after the first dose. Subsequent doses need only be administered a month apart, eliminating the need for daily medication.

In 2020, Pharmascience tried to secure approval to market its version of the drug, called pms-PALIPERIDONE PALMITATE. Janssen filed multiple lawsuits against Pharmascience in federal court, arguing that Pharmascience’s proposed generic drug would infringe its patent. In response, Pharmascience countered that Janssen’s patent is invalid because it protects methods of medical treatment, which have historically been unpatentable in Canada.

The court decisions

The Federal Court sided with Janssen, finding that Pharmascience’s drug would infringe Janssen’s patent for its dosing regimens. Pharmascience then appealed on the grounds that Janssen’s patent covered unpatentable subject matter. When the Federal Court of Appeal dismissed the appeal, Pharmascience brought the same argument before the SCC.

The SCC also dismissed Pharmascience’s appeal.

In the high court’s decision on Friday, Jamal said Canadian law has long considered methods of medical treatment to be unpatentable. He pointed to the high court’s 1974 decision in Tennessee Eastman Co. v. Commissioner of Patents, which found that patents cannot extend to methods of medical treatment. The high court based its conclusion on s. 41(1) of the Patent Act, which barred patents for substances intended for food or medicine, except when they are prepared or produced by specific methods or processes.

S. 41(1) was repealed in 1993. Jamal noted that the repeal merely removed restrictions on patenting pharmaceutical substances. It did not make methods of medical treatment patentable.

Throughout the years, the SCC and other courts have recognized that professional skills cannot be patented, Jamal said. He added that Canada does not have legislation that explicitly excludes methods of medical treatment as a patentable invention, because it has been settled law since Tennessee Eastman Co.

The justice characterized proposed patents for methods of medical treatment as attempts to “monopolize professional medical skill and judgment.” To determine whether Janssen’s dosing regimens count as methods of medical treatment, the question is whether they amount to professional medical skill and judgment.

Jamal said courts can answer this question using a three-pronged analysis. First, courts should focus on whether the regimens, the subject matter in question, amount to professional medical skill and judgment, not whether medical skill and judgment would be used to select them for a specific patient or use.

Second, courts should keep in mind that subject matter is more likely to be considered a method of medical...