Long-Term Safety Data ≠ Longer Patent List for STELARA

The Federal Court upheld a decision of the Office of Submissions and Intellectual Property that Canadian Patent No. 3,113,837 was not eligible to be added to the Patent Register against STELARA (ustekinumab) with respect to Janssen Inc.’s two supplementary new drug submissions.

On February 15, 2019, Janssen filed SNDS 224739 (“SNDS 739”), seeking approval for a new use of STELARA for the treatment of adults with moderately to severely active ulcerative colitis. The supporting documents for SNDS 739 included approximately one year of data (44 weeks) from a maintenance study.

On October 1, 2020, Janssen filed SNDS 244670 (“SNDS 670”), seeking to update the Product Monograph with two-year safety and efficacy data (96 weeks) from the same ongoing maintenance study.

Meanwhile, on September 24, 2019, Janssen filed the application that would become the 837 Patent. The earliest priority date claimed was September 24, 2018. The 837 Patent generally claims the treatment of ulcerative colitis, including numerous claims where the clinical response of the subject “continues at least 44 weeks after week 0.” The 837 Patent issued on July 12, 2022, and on July 25, 2022, Janssen sought to list the patent in relation to SNDS 670.

OSIP found that SNDS 670 was not approved for a “change in use of the medical ingredient” pursuant to s 4(3) of the Patented Medicines (Notice of Compliance) Regulations, and therefore the 837 Patent could not be listed in relation to that submission. In any event, the 837 Patent did not contain a claim for the “very change approved” in SNDS 670, as required by s 4(3) and the case law.

Although Janssen had not submitted a Form IV in relation to SNDS 739, OSIP nevertheless found that the 837 Patent could not be listed against that submission, in part because the 837 Patent was filed in Canada after SNDS 739.

The Federal Court upheld OSIP’s decision as reasonable. The Court found no error in OSIP’s conclusion that “a submission approved for additional data that could provide a clinician more confidence in prescribing a drug long-term is not sufficient for the submission to be considered as having been approved for a change in use of the drug if the indication never included a temporal restriction on its use”.

The Court also found OSIP properly followed the test in Canada (Attorney Generalv Abbott Laboratories Limited, 2008 FCA 244 to conclude that the 837 Patent did not claim the “very change approved” in SNDS 670, even on Janssen’s interpretation that SNDS 670 allowed physicians to prescribe STELARA up to 96 weeks. In particular, the Court affirmed that the Regulations “require that a patent specifically claim the change in use, as opposed to broader claims that are wide enough to subsume the specific change in use.” It was not unreasonable to find that claiming the use of ustekinumab for an indefinite period of time (for 44 weeks or more) was not claiming the very change in use approved in SNDS 670.

With respect to SNDS 739, the Court upheld OSIP’s finding that Janssen did not file a patent list in relation to this submission because it did not use the prescribed Form IV.

The Court also held, in obiter, that the Canadian filing date requirement in s 4(6) of the Regulations is intra vires the Patent Act. The Court was not satisfied that this date was illogical, arbitrary, or irrational. “[I]n Janssen’s view, the language chosen by the Governor in Council must be the most beneficial to innovators in order to be rationally connected to the purpose of the Patent Act and the PMNOC Regulations.” However, the Court found Janssen’s approach ignored the balancing of interests that must be undertaken and ignored the innovator’s right outside the Regulations to bring infringement actions.

A copy of the decision is available here. Janssen has appealed the Court’s decision.