Federal Court of Appeal (Locke JA writing) holds that PMNOC Regulations do not allow a first person to amend an existing patent list to create a new patent linkage.
Janssen Inc. v. Canada (Health) – Federal Court of Appeal (fca-caf.ca)
Janssen Inc. v. Canada (Health) – Federal Court (fct-cf.gc.ca)
This decision concerns the arcane timing and substantive requirements for submitting patent lists to the Minister of Health (“Minister”) under the PMNOC Regulations. The facts set out below are central to the analysis.
The Drug: Janssen Inc. (“Janssen”) has approval to sell STELERA (ustekinumab) for various indications.
The Drug Submissions: On February 15, 2019, Janssen filed SNDS #1 for a new use, viz. treatment of ulcerative colitis (“UC”). On October 1, 2020, Janssen filed SNDS #2 to update the STELARA product monograph with two-year safety and efficacy data from a UC clinical study. These submissions were approved by the Minister through the issuance of separate notices of compliance.
The Patent: On July 12, 2022, Janssen obtained a Patent with claims that are “generally directed to the use of an anti-IL-12/IL-23p40 antibody (including ustekinumab) for the treatment of moderately to severely active [UC]”. The Patent application was filed in Canada after SNDS #1 was filed but before SNDS #2.
The Minster’s Decision: On July 25, 2022, within 30 days of the Patent issuing, Janssen filed a Form IV Patent list to link the Patent to SNDS #2. The Minister rejected the patent list for two reasons: (a) SNDS #2 was not the type of submission that allows for the filing of new patent lists, viz. change in use, dosage form or formulation; and, even if it were an SNDS for a change in use, (b) the Patent did not contain a claim for the very change sought in SNDS #2. The Minister held that even if Janssen had sought to link the Patent to SNDS #1, the patent list would have been rejected because the Patent application was filed in Canada after SNDS #1 had been submitted, contrary to the strict timing requirements in the PMNOC Regulations. The fact that the Patent claimed priority to applications filed prior to SNDS #1 was irrelevant.
Janssen subsequently tried to amend its patent list for SNDS #2 to refer to both SNDS #2 and SNDS #1. However, the Minister held that this was contrary to the patent listing requirements of the Regulations (ss. 4(1)-(6)) and is not permitted by the general regulatory obligation to “keep its patent list up to date” (s. 4(7)).
The Judicial Review: The Federal Court (per Aylen J) held that the Patent was not eligible to be added to the patent register because SNDS #2 was not a submission for a “change in use of the medicinal ingredient”; rather, it was among the types of submissions that will support a new patent linkage under the PMNOC Regulations. The Court held that the Minister’s decision was based on an “internally coherent and rational chain of analysis” and was “justified in relation to the facts and law”. The Court also held, in obiter, that: (a) the Minister reasonably determined that the Patent did not claim the very use sought in SNDS #2; (b) the Minister did not err in refusing to allow Janssen to amend its patent list for SNDS #2 to create a linkage to SNDS #1; and (c) the Minister’s interpretation of the PMNOC “filing date” requirements was reasonable.
The Appeal: On appeal, the Court of Appeal “stepped into the shoes” of the Federal Court judge and determined if the Minister’s decision was reasonable, as required. In brief reasons delivered from the Bench, the Court dismissed the appeal with costs. The Court held that one issue raised by Janssen was dispositive: the PMNOC Regulations do not permit a first person to “add a different SNDS to an existing patent list” “under the guise of updating it.” As such, the patent list linking SNDS #2 to the newly issued Patent could not be amended after the 30-day period prescribed by the PMNOC Regulations to establish a linkage to SNDS #1. The Court did not address any of the other issues raised by Janssen, including the legislative vires of the timing requirements.
Janssen has a statutory right to file an application for leave to appeal to the Supreme Court of Canada within 60 days of the FCA decision.