On October 9, 2025, the Supreme Court of Canada will hear arguments in Pharmascience Inc. v Janssen Inc., et al. (Supreme Court File No. 41209). While the proceeding is addressing a single legal issue, whether patents can validly claim a method of medical treatment, a number of positions have been advanced by the two parties and four interveners.
The hearing will be available by webcast, starting at 9:30 a.m. Eastern Time. The webcast information will be listed on the Court File entry (here), and can also be found on the Supreme Court of Canada's "live hearing" page on the day of the hearing.
The issue under appeal
This proceeding involves a challenge to Janssen's "335 Patent", which was found to be valid and infringed in a proceeding before the Federal Court. On appeal, Pharmascience advanced the single issue that the claims of the 335 Patent were invalid as they claimed a "method of medical treatment," which they argued is not permissible under the Patent Act.
The Federal Court of Appeal rejected Pharmascience's appeal, providing an overview of the history of prohibitions to claiming a method of medical treatment. It found that while there was a prohibition against claiming a method of medical treatment, claims which relate to a "commercial offering," or "trade, industry or commerce" (which was the case for the 335 Patent) are permissible.
The Federal Court of Appeal ultimately concluded that determining whether a patent impermissibly claimed a method of medical treatment was based upon the following inquiry:
[37] To summarize, whether or not a patent claim to a dosing regimen relates to a method of medical treatment cannot be based exclusively on whether its dosing and schedule is fixed or not. The proper inquiry remains whether use of the invention (i.e., how to use it, not whether to use it) requires the exercise of skill and judgment, and the burden remains on the party challenging the patent. It is difficult to provide more detailed guidance than this for parties involved in future litigation and courts faced with allegations of invalidity of patent claims due to unpatentable subject matter, namely methods of medical treatment. Such allegations will generally turn on the particulars of the case and the evidence on the record.
With its appeal dismissed, Pharmascience sought leave to appeal to the Supreme Court of Canada, which was granted on September 19, 2024.
Arguments raised on appeal
In addition to the positions of Pharmascience and Janssen, four interveners were granted leave to make written and oral submissions before the Supreme Court of Canada. The written submissions of all parties and interveners can be accessed via the "factums" tab on the Court File (here). Below is a brief overview of the arguments raised by the parties and interveners.
Pharmascience Inc. (Appellant)
Pharmascience is seeking to have Janssen's 335 Patent declared invalid for claiming a method of medical treatment. Pharmascience raises two main questions in its arguments:
(1) Are methods of medical treatment patentable in Canada? and
(2) What is a method of medical treatment or what test should guide its determination?
Pharmascience submits that methods of medical treatment are not patentable, as established by the Supreme Court of Canada in the 1974 decision of Tennessee Eastman v Commissioner of Patents ([1974] SCR 111). Pharmascience contends that this principle remains settled law, and is rooted in the Patent Act's requirement that a patent may only be granted for an "invention," which it argues does not encompass methods of medical treatment.
For the second question, Pharmascience proposes that determining whether a patent claims a method of medical treatment involves the following process:
(a) Construing the claim in accordance with normal procedures,
(b) Identifying whether any of the essential elements of the claim can properly be said to be "therapeutic" or "medical,"; and
(c) Identifying whether any of those essential elements relate to how and when a drug or treatment is to be administered by a medical practitioner.
According to Pharmascience's submissions, if the answer to (b) and (c) are "yes," then the claims are invalid for claiming unpatentable subject matter. Pharmascience submits that based on this test, the claims of the 335 Patent are invalid.
Janssen Inc. and Janssen Pharmaceutical N.V. (Respondents)
Janssen opposes Pharmascience's position and submits that either:
(1) The Patent Act does not prohibit claims to methods of medical treatment, or
(2) If any such prohibition exists, it is limited to methods involving the exercise of professional skills and does not extend to claims to commercial offerings.
Janssen argues that the historical basis for excluding claims to methods of medical treatment, stemming from the Tennessee Eastman decision, is based upon a provision of the Patent Act that has since been repealed. As patent law is wholly statutory, Janssen submits that there is no longer any valid legal basis to preclude claims for a method of medical treatment.
Janssen also submits that methods of medical treatment fall within the broad interpretation of "invention" as defined in the Patent Act. As such, Janssen asks the Supreme Court to declare that there is no legal bar in Canada to claiming methods of medical treatment.
Janssen separately submits that, if a preclusion exists, it should be limited in scope to apply only to non-economic medical activities unrelated to commercial products. Janssen submits that the 335 Patent is not directed to such non-economic activities and is therefore valid.
Canadian Generic Pharmaceutical Association (Intervener)
The Canadian Generic Pharmaceutical Association (CGPA) is an industry association of manufacturers and distributors in Canada's generic pharmaceutical industry for both small molecule and biosimilar products. The CGPA advocates for facilitating competitive drug pricing through policies that provide access to generic and biosimilar drugs in Canada.
The CGPA argues that dosing regimens are merely methods of treating patients and do not constitute an "invention" within the meaning of the Patent Act. Accordingly, the CGPA submits that there is no need for an explicit preclusion to claiming dosage regimens, as such claims fall outside of the scope of permissible patentable subject matter.
While the CGPA acknowledges that Tennessee Eastman was decided under a now-repealed provision of the Patent Act, it argues that the underlying policy rationale of the decision remains valid and continues to preclude claims directed to dosage regimens. The CGPA further asserts that granting patents for dosage regimens unduly extends the monopoly over a drug and prejudices Canadians by contributing to higher prices for medicines.
The Canadian Organization for Rare Disorders (Intervener)
The Canadian Organization for Rare Disorders (CORD) is a network of organizations representing patients with rare disorders, with a membership of nearly 100 patient groups, foundations, and societies. CORD advocates for health policy and a healthcare system that works for patients with rare disorders.
CORD submits that the Patent Act permits claims directed to methods of medical treatment. CORD submits that such methods qualify as an "invention" as defined in the Patent Act, and are not precluded by any express statutory provision (in contrast to the statutory preclusion against claiming a "mere scientific principle or abstract theorem"). CORD also submits that although the Patent Act once prohibited claims "relating to substances prepared or produced by chemical processes and intended for food or medicine" (the statutory basis central to the Tennessee Eastman decision), Parliament has since repealed this provision, and as such the prohibition no longer applies.
Dr. David Homuth, Dr. Marco Solmi, and Dr. Pierre Bleau (Interveners)
Drs. Homuth, Solmi, and Bleau are Canadian physicians involved in treating patients with dosing regimens such as those described in the 335 Patent.
These physicians submit that new medicines and dosing regimens are not developed by physicians, but instead are the result of commercial innovation by pharmaceutical manufacturers. These physician interveners submit that recognizing the patentability of dosing regimens is essential to incentivizing pharmaceutical companies to develop new treatments for the betterment of Canadian patients.
Fédération Internationale des Conseils en Propriété Intellectuelle (Intervener)
The Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI) is an international non-political organization composed of IP lawyers from around the globe. FICPI advocates for the global harmonization of patent laws, where possible, to result in consistent and predictable application of globally-applicable innovations in the context of global patent laws.
FICPI submits that Canada's Patent Act differs from that of various European countries, including the United Kingdom, which contain explicit and narrow prohibitions to claiming some forms of methods of medical treatment. FICPI submits that these express prohibitions are required because claims to methods of medical treatment are otherwise patentable subject matter in those jurisdictions.
In the absence of a similar provision in Canada's Patent Act, FICPI argues that these claims are not precluded. FICPI also submits that prohibiting claims to dosing regimens in Canada would diverge from the approach taken in comparable jurisdictions such as Europe, the UK, Australia, and the United States where claims to dosing regimens are considered patentable subject matter.
Innovative Medicines Canada and BIOTECanada (Intervenors)
Innovative Medicines Canada (IMC) is a national association representing innovative pharmaceutical companies, advocating for laws, regulations, and policies that support the discovery, development and delivery of new medicines in Canada. BIOTECanada (BTC) is a national association promoting Canada's biotechnology industry, with members working in all aspects of biotechnology, healthcare, and pharmaceuticals, who advocate for a globally competitive Canadian biotechnology ecosystem.
IMC and BTC argue that although methods of medical treatment were historically held to be non-patentable, the repeal of the express statutory prohibition has removed any legal basis under the Patent Act for such a prohibition. They also argue that the prohibition against claims to methods of medical treatment improperly subjects pharmaceutical inventions to a different standard than those in other areas of technology.
They alternatively submit that dosage regimens are patentable, as they possess economic and commercial value and do not monopolize professional skill, thereby falling within the definition of "invention" under the Patent Act.
Anticipated guidance from the Supreme Court's decision
The Federal Courts have long been seeking guidance from the Supreme Court on the patentability of so-called methods of medical treatments.
The broad range of arguments advanced by the parties and interveners can allow the Supreme Court the opportunity to provide guidance to the Courts below and to the pharmaceutical industry at large. In doing so, it is anticipated that the Supreme Court will need to address the threshold question of whether the Patent Act precludes claims to methods of medical treatment.
One possible path is for the Supreme Court to adopt an approach similar to its reasoning in AstraZeneca v Apotex, where it abolished the so-called "promise doctrine" on the basis that patent law is wholly statutory and there was no basis in the text of the Patent Act to support such an elevated utility requirement. In this case, the Supreme Court could conclude that the absence (and repeal) of an explicit prohibition against claiming methods of medical treatment likewise means that there is no statutory basis to invalidate a patent solely on that ground.
Alternatively, the Court may find that some form of preclusion does exist under the Patent Act, and would then need to define the scope and application of such a preclusion. Multiple parties have proposed different tests in that regard, or the Supreme Court could opt to adopt the framework set out by the Federal Court of Appeal.
The Supreme Court's decision in this case is expected to attract close attention from both the intellectual property bar and the Canadian pharmaceutical industry, and the Supreme Court's reasoning will likely extend far beyond the validity of the 335 Patent itself. Should the Supreme Court abolish the prohibition against claiming methods of medical treatment, it would eliminate significant uncertainty surrounding an argument that has been inconsistently applied by the Federal Court to invalidate otherwise novel, inventive, and useful patents.
Conversely, a finding that claims to methods of medical treatment are precluded by the Patent Act (in whole or part), and any new test crafted by the Court on how to apply that preclusion, will likely prompt continued legal debate in future patent litigation over how this preclusion is to be classified against various types of patent claims commonly used in pharmaceutical patents.
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