Update: The webcast of the oral arguments is available on the Supreme Court website.
Over ten years have passed since the Federal Court of Appeal (FCA) flagged the patentability of methods of medical treatment as being worthy of full consideration by the Supreme Court of Canada. This issue has finally come before the Court. Today, the Supreme Court heard oral arguments in Pharmascience Inc v Janssen Inc (Supreme Court File No 41209) and reserved its decision.
The sole issue on appeal is whether Janssen’s Canadian Patent No 2,655,335 (the 335 Patent) relating to paliperidone palmitate (INVEGA SUSTENNA) is invalid for claiming an unpatentable method of medical treatment. The claims at issue include the features of a paliperidone palmitate formulation dosing regimen for treatment of schizophrenia.
As previously reported, the FCA had affirmed the finding of the Federal Court that the claims are not unpatentable methods of medical treatment, holding that the proper inquiry for such claims is “whether use of the invention (i.e., how to use it, not whether to use it) requires the exercise of skill and judgment”: Pharmascience Inc v Janssen Inc, 2024 FCA 23.
Pharmascience has submitted that the FCA erred in holding the 335 Patent did not monopolize a method of medical treatment, and had proposed a new test that would find a claim invalid if it encompassed a “therapeutic” or “medical” essential element relating to how and when a drug or treatment is to be administered by a medical practitioner. Janssen has submitted the Supreme Court should hold either (i) there is no basis in the Patent Act for an exclusion of a method of medical treatment if the claim satisfies the general criteria under the Act, or (ii) alternatively, if such an exclusion is read into the Act, it should not extend to commercial offerings but rather be limited to attempts to patent non-commercial professional activities.
In addition to hearing from the parties, the Supreme Court heard submissions from intervenors, the Canadian Generic Pharmaceutical Association (CGPA), Fédération Internationale des Conseils en Propriété Intellectuelle (FICPI), Innovative Medicines Canada (IMC) and BIOTECanada, the Canadian Organization for Rare Disorders (CORD) and Dr. David Homuth, Dr. Marco Solmi, and Dr. Pierre Bleau (Canadian physicians).
We will report further when the Supreme Court’s decision is released.
Should you have any questions, please do not hesitate to contact a member of the Patents, Pharmaceutical Litigation or Life Sciences Regulatory & Compliance groups.
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