As previously reported, the Federal Court (FC) dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent No. 3,113,837 on the Patent Register with respect to two supplementary new drug submissions (SNDSs) for Janssen’s STELARA (ustekinumab). On November 21, 2023, the Federal Court of Appeal (FCA) dismissed Janssen’s appeal: Janssen Inc v Canada (Health), 2023 FCA 229.
Janssen appealed the decision in respect of SNDS 224739 (739 submission). OSIP had determined that:
- the patent list for another submission that was submitted within the 30-day deadline did not relate to the 739 submission, and;
- a submission that did mention the 739 submission was outside of the 30-day period contemplated by subsection 4(6) of the Patented Medicines Notice of Compliance Regulations (Regulations).
In a brief decision delivered from the bench, the FCA dismissed the appeal, finding that there was no reviewable error in OSIP’s decision to refuse to add a previously submitted patent list against the 739 submission. The FCA also stated that Janssen could not add a different SNDS to an existing patent list under the guise of keeping information on the patent list up to date pursuant to subsection 4(7) of the Regulations.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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