On July 17, 2023, the Federal Court of Canada (the Court) issued its public judgement and reasons for Janssen Inc. v Canada (Health), 2023 FC 870, dismissing Janssen Inc.’s (Janssen’s) application for judicial review of a decision from the Office of Submissions and Intellectual Property (OSIP), in which OSIP refused to list Canadian Patent No. 3,113,837 (the 837 Patent) on the Patent Register against the drug, STELARA.

STELARA is a biologic drug containing the medicinal ingredient ustekinumab that was first approved in Canada for the treatment of psoriasis. In February 2019, Janssen filed a supplemental new drug submission (SNDS) to seek approval for a new use of STELARA to treat moderately to severely active ulcerative colitis (SNDS 739). Janssen also filed another SNDS in October 2020, seeking to update the Product Monograph of STELARA with safety and efficacy data that demonstrated continued clinical response in the treatment of adult patients over a longer timeframe (SNDS 670).

In September 2019, Janssen filed a patent application for the 837 Patent, which is generally directed towards the use of an anti-IL-12/IL23p40 antibody (including ustekinumab) for the treatment of moderately to severely active ulcerative colitis. The 837 Patent was issued in July 2022, and Janssen sought to list the 837 Patent in relation to both SNDS 670 and SNDS 739.

OSIP found that the 837 Patent was not eligible to be added to the Patent Register. With respect to SNDS 670, OSIP determined that the SNDS did not enable the listing of a patent on the Patent Register in accordance with subsection 4(3) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations), as SNDS 670 was not approved for a change in formulation, change in dosage form or a change in use of the medicinal ingredient. OSIP also determined that there were many reasons why the 837 Patent could not be listed in relation to SNDS 739, including that Janssen had not followed the appropriate filing procedure when requesting the 837 Patent to be added to the Patent Register and, even if this had occurred, subsection 4(6) of the Regulations prohibited the 837 Patent from being listed because it was filed after the filing date of SNDS 739.

In Janssen’s application for review of OSIP’s decision, the Court saw two key issues: whether (i) SNDS 670 indeed did not offer “a change in use of the medicinal ingredient” as prescribed by subsection 4(3) of the Regulations; and (ii) the filing date requirement in subsection 4(6) of the Regulations was illogical, arbitrary and ultra vires the scheme of the Patent Act. Ultimately, the Court dismissed Janssen’s application, finding that OSIP acted reasonably in concluding that though SNDS 670 may provide clinicians with more confidence in prescribing a drug long-term, the drug’s indication never included a temporal restriction on its use and SNDS 670 cannot be considered “a change in use”. The Court also found that the Canadian filing date requirement in Subsection 4(6) of the Regulations is not unreasonable and is intra vires the Patent Act.

Summary By: Claire Bettio


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