On July 17, 2023, Justice Aylen of the Federal Court dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent 3,113,837 (837 patent) on the Patent Register with respect to two supplementary new drug submissions (SNDSs) for Janssen’s STELARA (ustekinumab):
Janssen Inc v Canada (Health), 2023 FC 870.
Janssen filed two SNDSs:
- In February 2019, seeking approval for a new use of STELARA for the treatment of adult patients with moderately to severely active ulcerative colitis, including results from a 44-week study (739 submission); and
- In October 2020, updating the Product Monograph with updated 96-week safety data from the same study included in the 739 submission (670 submission).
The 837 patent was filed in Canada on September 24, 2019, and issued on July 12, 2022.
In refusing to list the 837 patent on the Patent Register, OSIP held:
- In respect of the 739 submission:
a) Janssen had not filed a patent list to add the 837 patent against this submission; and
b) Even if Janssen had submitted a patent list, Janssen would not have met the timing requirements, as the application for the 837 patent was filed in Canada after the 739 submission.
- In respect of the 670 submission:
a) The submission was not approved for a change in formulation, change in dosage form, or change in use of medicinal ingredient, as required for listing under the Patented Medicines Notice of Compliance Regulations (PMNOC Regulations); and
b) Even assuming the submission was for a change in use, the 837 patent did not contain a claim to the change alleged by Janssen to be approved by the NOC.
The Court found that the OSIP’s decision was reasonable on all grounds and dismissed the application for judicial review.
- OSIP’s decision that the 670 submission was not approved for a “change in use” was reasonable
- OSIP’s decision that the 837 Patent did not meet the product specificity requirements for the 670 submission was reasonable
- OSIP’s determination that Janssen failed to provide a patent list in relation to the 739 submission was reasonable
- The Court was not satisfied that the Canadian filing date requirement was unreasonable
For a patent to be eligible for listing on the Register in respect of an SNDS, the PMNOC Regulations require that the supplement must be for a change in formulation, change in dosage form, or change in use of medicinal ingredient (s. 4(3)).
The 670 submission contained updates to the STELARA product monograph containing updated safety results after 96 weeks from an ongoing study. The previously approved product monograph contained results from the study after 44 weeks.
OSIP held that the 670 submission was not for a “change in formulation, change in dosage form or change in use of the medicinal ingredient” and therefore, the 837 patent was ineligible for listing against the 670 submission.
Based on expert evidence provided to OSIP, Janssen argued that the additional data included in the 670 submission would change the prescribing practices of a gastroenterologist by giving more confidence in prescribing the drug. This would
amount to a change in use by some practicing physicians. Janssen also argued that OSIP’s decision unreasonably applied previous jurisprudence to find that the addition of safety data can never be a change in use.
The Court found that OSIP expressly acknowledged that a “change in use of a medicinal ingredient” can include a change to the method of use of a medicinal ingredient, which can be reflected in sections other than the “Indications and Clinical Use” section. However, OSIP found that STELARA was approved for use to treat ulcerative colitis with no temporal limitation on its use, and that a clinician’s reluctance to prescribe a drug is not a limitation on the approved use of that drug. Interpreting the meaning of “change in use of the medicinal ingredient” falls within OSIP’s expertise, who considered the wording and intent of the relevant provisions of the PMNOC Regulations. The decision that Janssen’s change was not a “change in use” in accordance with the PMNOC Regulations was therefore reasonable.
The Court found that the “PMNOC 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.” OSIP determined that a patent having claims to use of ustekinumab for an indefinite period of time (44 weeks or more) is not the very change in use approved by the submission, which included safety data to 96 weeks. The Court held OSIP’s decision in this regard was reasonable.
Janssen did not submit a patent list specifically for the 739 submission. However, Janssen argued that it met the requirements to list the 837 patent, as it requested Health Canada to add the patent to the 739 submission as part of its arguments to OSIP in relation to the listing of the patent against the 670 submission.
OSIP determined that the PMNOC Regulations prescribe one submission per patent list, and allowing Janssen to add a second submission to a pre-existing patent list would be contrary to the language of the PMNOC Regulations. The Court found that this decision was reasonable.
The 837 patent was filed after the 739 submission was filed. However, according to the PMNOC Regulations, in order for a patent to be listed against a submission, the filing date in Canada of the patent must precede the date of
Janssen argued that the filing date requirement is ultra vires, or alternatively, illogical, irrational and arbitrary, and the relevant date should be the priority date, or claim date.
The Court was not satisfied that Janssen met its burden of demonstrating that inclusion of the Canadian filing date as the relevant date in s. 4(6) was unreasonable. Rather, the Court was “satisfied that requiring that a patent meet certain
timing requirements based on its Canadian filing date, which ensures timely market entry of subsequent generic drugs, is reasonably in keeping with the balance of the competing policy interests at issue.”
The Court therefore dismissed Janssen’s application.
Janssen has appealed (A-192-23).
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