Update: As provided in our update article, factums are available and the appeal was heard on October 9, 2025 and a decision is under reserve.
On September 19, 2024, the Supreme Court of Canada granted Pharmascience leave to appeal a Federal Court of Appeal decision affirming a trial decision that upheld the validity of Janssen’s patent relating to paliperidone palmitate (INVEGA SUSTENNA).
Pharmascience asserted that Janssen’s patent claiming formulations for a dosing regimen of paliperidone palmitate for the treatment of schizophrenia was invalid as it claimed an unpatentable method of medical treatment. The Federal Court of Appeal held that the inquiry into whether a claimed dosing regimen is an unpatentable method of medical treatment cannot be based exclusively on whether the dosing regimen is fixed or variable. Rather, the proper inquiry is “whether use of the invention (i.e., how to use it, not whether to use it) requires the exercise of skill and judgment”. The Federal Court of Appeal affirmed the Federal Court’s decision that the claims in issue were not invalid for claiming an unpatentable method of medical treatment.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
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