This spring, the Supreme Court of Canada (SCC) will consider the scope of patentable subject-matter as it relates to “methods of medical treatment”.
In the underlying action, Janssen asserted that Pharmascience would infringe its Canadian Patent No. 2,655,335 (335 Patent) relating to paliperidone palmitate (INVEGA SUSTENNA) with its generic version. Pharmascience argued that the claims of the 335 Patent were invalid including because their subject-matter was an unpatentable method of medical treatment. The Federal Court and Federal Court of Appeal disagreed with Pharmascience. 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. 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 SCC granted Pharmascience leave to appeal the Federal Court of Appeal decision on September 19, 2024. Pharmascience and Janssen’s factums are available on the SCC website (FM010, FM020).
Several organizations and individuals have been granted leave to intervene in the case, including:
- Innovative Medicines Canada and BIOTECanada,
- the Canadian Organization for Rare Disorders,
- the Canadian Generic Pharmaceutical Association,
- the International Federation of Intellectual Property Attorneys, and
- physicians, David Homuth, Marco Solmi, and Pierre Bleau.
The hearing is tentatively scheduled to take place within the timeframe of May 12 - 23, 2025. We will continue to monitor the case and provide the official hearing date and a link to the interveners’ factums when available.
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.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.