Federal Court Affirms OSIP Decision To Not List STELARA' On Patent Register

• Jurisdiction: United States,Federal
• Law Firm: Gowling WLG
• Subject Matter: Intellectual Property, Patent
• Author: Ms Alycia No' and Frédéric Lussier
• Published date: 08 August 2023

The Federal Court in Janssen Inc. v. Canada (Health), 2023 FC 870 dismissed Janssen's application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) to not list Canadian Patent No. 3,113,837 (837 Patent) on the Patent Register. The 837 Patent relates to the use of ustekinumab, marketed in Canada under the brand name STELARA', to treat moderate to severe ulcerative colitis (UC).

The decision comments on the standard of review for administrative decisions and product specificity requirement related to patent listing, as specified by sections 4(3)(c), 4(5), and 4(6) of Patented Medicine (Notice of Compliance) Regulations("PM (NOC) Regulations").

Background

In February 2019, Janssen filed SNDS 224739 (SNDS 739) seeking approval for a new use of STELARA for the treatment of adults with moderate to severe ulcerative colitis and corresponding updates to the product monograph. The Minister approved the new use and issued a Notice of Compliance (NOC) in January 2020. The updates to the product monograph included a detailed treatment regime and 44 weeks of data from a UNIFI-M maintenance clinical trial. Although the study detailed treatment up to 44 weeks, the product monograph and issued NOC did not restrict the duration of treatment.

In October 2020, Janssen filed SNDS 244670 (SNDS 670) seeking to update the STELARA product monograph with 96 weeks of data from the same UNIFI-M study previously included in SNDS 739. Health Canada issued an NOC for SNDS 670 in September 2021 approving updates to the product monograph. Janssen had stated in the Product Information Regulatory Process Form for SNDS 670 that there were no changes to the indication, use, or dosage of STELARA with the supplement.

In September 2019, Janssen had filed the application for the 837 Patent entitled "Safe and effective method of treating UC with anti-IL12/IL23 antibody." The application claims priority to three US provisional patent applications, the earliest of which was filed in September 2018. The 837 Patent was issued in July 2022 and Janssen sought to list the 837 Patent in relation to SNDS 670. No Form IVs were submitted for the 837 Patent in relation to SNDS 739.

OSIP denied the listing of the 837 Patent citing that SNDS 670 did not constitute a change in use of medicinal ingredient and as such, could not provide the basis to list a patent on the Register. OSIP also stated that even if SNDS 670 was considered to be an approved change in use...