The Top Line
In an upcoming case, Supreme Court of Canada will be deciding whether methods of medical treatment (and in particular, dosing patents) are properly patentable subject matter under s. 2 of the Patent Act. This represents the first time in over 50 years in which the Court will address the issue.
In a rare opportunity, on September 19, 2024, the Supreme Court of Canada granted leave to appeal in Pharmascience v Janssen, 2024 FCA 23, a case that turned on the validity of a patent for methods of medical treatment.
The patent at issue claims, in brief, a dosing regimen for paliperidone palmitate (Janssen’s INVEGA SUSTENNA) to treat schizophrenia and related disorders. The regimen includes a first loading dose on day 1, a second loading dose on day 8, and monthly maintenance doses thereafter, with particular dosage amounts set out for each step.
The Federal Court and Federal Court of Appeal both held that the patent was not directed to methods of medical treatment (which would be otherwise unpatentable) on the basis that at least some claims were construed to be “product claims”, and in part on the basis that the claims did not require skill and judgment of a physician due to the “fixed” nature of the dosing regimen in terms of specific schedule and doses.
The patentability of medical methods has been a long-standing debate in Canadian patent law. The Supreme Court has not addressed this issue directly since Tennessee Eastman (1972), [1974] SCR 111, where it seemingly held that methods of medical treatment were not contemplated within the definition of “invention” under s. 2 of the Patent Act.
Since Tennessee Eastman, the Patent Act has undergone several revisions, and the case law has developed significantly. This case will be of great interest to the drug industry as it has the potential to upend and impact the scope of patentable subject matter for “new medical use” patents. Based on typical timelines, the appeal is anticipated to be heard in mid to late 2025.