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

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 treatment if it is more tailored to individual patients.

Third, courts should understand that the more medical professionals are expected to develop or improve any given subject matter, the more likely it is to be considered a method of medical treatment.

However, Jamal emphasized that these guidelines are not exhaustive and do not establish bright-line rules. “Cases involving methods of medical treatment are factually suffused and must be decided accordingly, drawing on the considerable expertise of the federal courts in patent matters,” he wrote.

The justice agreed with the Federal Court’s conclusion that Janssen’s dosing regimens do not amount to professional medical skill and judgment. Quoting the Federal Court, Jamal wrote that “‘skill and judgment are not required to implement the claimed dosing regimens’ after a physician has chosen a specific dosing regimen.”

“In my view, the trial judge correctly focused on professional skill and judgment when applying the test for methods of medical treatment,” Jamal wrote. “His findings disclose no reviewable error.”

Reconsidering a 52-year-old precedent

In their concurring opinion, O’Bonsawin and Moreau said they would have reconsidered Tennessee Eastman Co. The justices noted the decades-old SCC hinges on a provision of the Patent Act that was repealed long ago, and that the Patent Act no longer contains any restrictions on the patentability of methods of medical treatment.

The principles used to determine whether subject matter qualifies as a method of medical treatment “are unworkable, lack internal coherency, and produce inconsistent results,” the justices wrote.

“This warrants reconsideration of the following question: Can MMTs [methods of medical treatment] be considered patentable subject matter?” the justices wrote. “Interpreting the Patent Act using the modern approach to statutory interpretation leads to the conclusion that MMTs, and dosing regimens specifically, can qualify as valid subject matter for patent protection.”

The justices argued that rather than issuing a “blanket prohibition” against patenting methods of medical treatment, those methods “should be subject to the same rigorous analysis as other inventions: if the subject matter comes within the definition of ‘invention’ in s. 2 of the Patent Act and is novel, useful, and non-obvious, then a patent ‘shall’ be issued.”

The justices added, “the patent regime, as it currently operates in Canada, is well equipped to filter out subject matter that should not be protected through patent.”

A 'missed opportunity,' lawyer says

Andrew Skodyn, an intellectual property partner at Cassels Brock & Blackwell LLP who represented the International Federation of Intellectual Property Attorneys, one of the intervenors in the case, calls the majority opinion a “missed opportunity” on Friday. Skodyn says he is not speaking on behalf of his client.

While his overall takeaway is that the SCC came to the right conclusion, “in my view, the concurring decision really seems to have captured the essence of the issue more accurately,” Skodyn says.

“Why have this artificial category of ‘methods of medical treatment’?” he asks. Echoing O’Bonsawin and Moreau’s argument that courts should simply assess the patentability of subject matter by using the criteria laid out in s. 2 of the Patent Act, the lawyer added, “the question should be: is it useful and new and unobvious?”

Skodyn notes that “methods of medical treatment” may be the “only category of patents that has its own unique test.

“Given that the Patent Act doesn’t say anything about this, the hope for most people, other than counsel for pharmascience, perhaps… would be that the court would have said what the concurrence said, which is that this is a relic of another age, based on a section of the Patent Act that isn’t there anymore,” Skodyn says.

“Why are we still doing this? Why not just get rid of that step, which isn’t helping anybody, and then just deal with this patent like you would any other patent?” he asks.

In a statement on Friday, a spokesperson for Johnson & Johnson, which owns Janssen, said, “We are pleased with the Supreme Court of Canada’s decision to uphold our Canadian patent for the once-monthly schizophrenia medication INVEGA SUSTENNA.

“This decision recognizes the importance of intellectual property protections that support continued investment in the discovery and development of innovative medicines,” the spokesperson added.

A spokesperson for Pharmascience said the company is still reviewing the decision and has no comment at this time.