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 of medicinal ingredient, the 837 Patent did not contain any claim specifying the change detailed in the SNDS. OSIP further stated that SNDS 739 was irrelevant to the potential listing of the 837 Patent as this supplement did not meet the timing requirement of section 4(6) of PM(NOC) Regulations.

OSIP's decision was reasonable.

The Court held that OSIP's decision to not list the 837 Patent on the Patent Register was reasonable. The Court's decision shows deference to the administrative decision maker, highlights importance of previous case law in decisions of judicial review, reinforces the Canadian filing date as the relevant date for the timing requirement of specified by section 4(6) of the PM(NOC) Regulations, and details the high specificity required by patent claims for listing on the Patent register.

What constitutes "change in use of the medicinal ingredient?"

While the Court notes that determining the meaning of "change in use of the medicinal ingredient" falls within the ambit of OSIP's responsibilities,[1] it also noted the similarity of Janssen's request to list the 837 Patent to Solvay Pharma Inc. v. Canada, 2009 FC 102 (Solvay). In the Solvay case, the Minister similarly refused to add a patent to the Patent Register after SNDS approval as the SNDS did not seek a change in the use of medicinal ingredient, rather only sought to update the product monograph with data from a study up to 42 months.

Janssen argued that the Solvay case was distinct as the claims of the 837 Patent addressed the updates by SNDS 670. Janssen provided additional expert evidence that argued that SNDS 670 would change the practices of clinicians and cited two previous studies detailing the need for long-term maintenance trials.[2] The Court found that even if the Janssen assertion is different from the Solvay case, the facts are similar enough for OSIP to cite Solvay as support for their STELARA decision.[3] The Court also noted the OSIP is obliged to follow applicable precedents from the Federal Courts in future decisions.[4]

Understanding the product specificity requirement.

The Court's decision discussed the product specificity requirement for listing on the Patent Register as outlined by section 4(3)(c). The interpretation of the product specificity requirement is guided by Canada (Minister of Citizenship and Immigration) v Mason, 2021 FCA 156. The claim in the patent to be listed on the Patent Register must specifically state the modification in the SNDS. This high threshold for listing is necessary as the protection provided by the Patent Register is strong and not every patent can be eligible for this protection regardless of the money and time invested.[5]

The test for considering if a patent meets the product requirement is the Abbott test laid out by Justice Hughes in Abbott Laboratories Limited v. Canada (Attorney General), 2008 FC 700, confirmed in 2008 FCA 354.[6] The steps are the following:

1) What does the 837 Patent claim?

2) What is the change approved by SNDS 670?

3) Does the 837 Patent claim the very change approved in the SNDS?[7]

OSIP was found to properly apply this test.[8] The Court also distinguished Eli Lilly Canada Inc. v. Canada (Attorney General), 2015 FCA 166 from this case as it addressed a change in formulation, rather than a change in use.[9] This one difference was enough to disregard the case raised by Janssen in support of their assertions.

Addressing the timing requirement.

Finally, the Court addressed Janssen's argument that using the Canadian filing date to calculate the timing requirement specified by section 4(6) of the PM(NOC) Regulations is ultra vires the Patent Act, or at least illogical, irrational, and/or arbitrary. Janssen's main argument in support of this assertion is that the choice of the Canadian filing date to calculate deadlines places those who file patents in other countries at a disadvantage.[10] The judge was not convinced by Janssen's submissions.[11]

Janssen is appealing the Federal Court's decision to the Federal Court of Appeal.

[1] Supra note 1 at para 97.

[2] Supra note 1 at para 78.

[3] Supra note 1 at para 90.

[4] Supra note 1 at para 91.

[5] Supra note 1 at para 98.

[6] Supra note 1 at para 102.

[7] Supra note 1 at para 103.

[8] Supra note 1 at para 117.

[9] Supra note 1 at para 118.

[10] Supra note 1 at para 145.

[11] Supra note 1 at para 151.