Supreme Court of Canada Affirms Methods of Medical Treatment Are Unpatentable, Upholds Janssen's INVEGA SUSTENNA Dosing Patent
核心洞察
The Supreme Court of Canada ruled 7-2 that methods of medical treatment cannot be patented under Canadian law, reaffirming a half-century precedent.
The Court upheld Janssen's patent for paliperidone palmitate dosing regimens, finding they do not amount to professional medical skill and judgment.
A concurring opinion argued the prohibition is a "relic of another age" and that methods of medical treatment should be assessed under standard patentability criteria.
The Supreme Court of Canada (SCC) has ruled in a 7-2 split decision that methods of medical treatment cannot be patented under Canadian law, while simultaneously upholding Janssen Inc.'s patent for dosing regimens of its long-acting injectable schizophrenia (搜索) drug INVEGA SUSTENNA (paliperidone palmitate). The ruling, delivered Friday, affirms Canada's approach to medical patents that has stood for the past half-century.
The decision represents a significant moment in Canadian pharmaceutical intellectual property law, with the majority reaffirming the prohibition on patenting methods of medical treatment while the concurring minority characterized the ban as an outdated relic warranting reconsideration.
The Dispute: Dosing Regimens at the Center of Patent Challenge
The case centers on paliperidone palmitate, an injectable antipsychotic used to treat schizophrenia (搜索). Janssen developed a long-lasting injectable formulation and accompanying dosing regimens beginning in the 1990s, filed a patent application for the dosing regimens in 2008, and received Canadian patent 2,655,335 in 2016.
Under the patented dosing regimens, patients receive a second dose approximately one week after the first loading dose, with subsequent maintenance doses administered only once monthly—eliminating the need for daily medication.
In 2020, Quebec-based Pharmascience Inc. sought approval to market its generic version, pms-PALIPERIDONE PALMITATE. Janssen filed infringement lawsuits in Federal Court, and Pharmascience countered that Janssen's patent was invalid because it protected methods of medical treatment, which have historically been unpatentable in Canada.
The Majority Decision: Professional Skill and Judgment as the Test
Writing for the majority, Justice Mahmud Jamal articulated the framework for determining whether subject matter constitutes an unpatentable 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," Jamal wrote.
The majority provided a three-pronged analytical approach: first, courts should focus on whether the regimens themselves amount to professional medical skill and judgment, not whether such skill would be used to select them for a specific patient; second, subject matter is more likely to be considered a method of medical treatment if it is more tailored to individual patients; and third, the more medical professionals are expected to develop or improve the subject matter, the more likely it constitutes a method of medical treatment.
Jamal emphasized 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.
Applying this framework, the majority agreed with the Federal Court's conclusion that Janssen's dosing regimens do not amount to professional medical skill and judgment. Quoting the lower court, Jamal noted that "'skill and judgment are not required to implement the claimed dosing regimens' after a physician has chosen a specific dosing regimen."
The majority traced the prohibition on patenting methods of medical treatment to the SCC's 1974 decision in Tennessee Eastman Co. v. Commissioner of Patents, which relied on former section 41(1) of the Patent Act. Although that section was repealed in 1993, Jamal noted the repeal merely removed restrictions on patenting pharmaceutical substances and did not make methods of medical treatment patentable.
The Concurring Opinion: A Call for Reconsideration
Justices Michelle O'Bonsawin and Mary Moreau authored a concurring opinion agreeing that Janssen's patent is valid but disagreeing with the majority's position that methods of medical treatment are inherently unpatentable.
The concurring justices argued that the Tennessee Eastman precedent hinges on a provision of the Patent Act repealed long ago, and that the Patent Act no longer contains any restrictions on the patentability of methods of medical treatment. They described the current principles as "unworkable, lack internal coherency, and produce inconsistent results."
"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 wrote. Rather than a "blanket prohibition," they argued methods of medical treatment "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."
Reactions: A 'Missed Opportunity'
Andrew Skodyn, an intellectual property partner at Cassels Brock & Blackwell LLP who represented the International Federation of Intellectual Property Attorneys, an intervenor in the case, called the majority opinion a "missed opportunity."
"In my view, the concurring decision really seems to have captured the essence of the issue more accurately," Skodyn said. "Why have this artificial category of 'methods of medical treatment'? The question should be: is it useful and new and unobvious?"
Skodyn noted that methods of medical treatment may be the "only category of patents that has its own unique test," adding, "Given that the Patent Act doesn't say anything about this, the hope for most people... 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."
A spokesperson for Johnson & Johnson, which owns Janssen, stated: "We are pleased with the Supreme Court of Canada's decision to uphold our Canadian patent for the once-monthly schizophrenia (搜索) medication INVEGA SUSTENNA. This decision recognizes the importance of intellectual property protections that support continued investment in the discovery and development of innovative medicines."
A spokesperson for Pharmascience said the company is still reviewing the decision and had no comment at the time of the ruling.
Broader Implications for Canadian Patent Law
The decision leaves intact the jurisprudential prohibition on patenting methods of medical treatment in Canada, distinguishing the country from jurisdictions like the United States where such methods may be patentable. Under the TRIPS Agreement, member countries are permitted—but not required—to exclude "diagnostic, therapeutic and surgical methods for the treatment of humans or animals" from patentable subject matter. Unlike the European Patent Convention, which explicitly codifies this exclusion in Article 53(c), Canada has no such statutory provision, a point emphasized by both the concurring justices and legal commentators.
The ruling provides clarity for the pharmaceutical industry regarding the boundaries of patentable subject matter for dosing regimens, while leaving open the possibility that future legislative action or judicial reconsideration could reshape the landscape for medical method patents in Canada.