Minister Of Health Reasonable In Deciding Patent For Janssen's STELARA Was Ineligible For Listing Against SNDSs

• Published date: 01 August 2023
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Smart & Biggar
• Author: Ms Katie Lee

On July 17, 2023, Justice Aylen of the Federal Court dismissed Janssen's application for judicial review of the Office of Intellectual Property and Submissions (OSIP)'s decision 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.

Background

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.

1. OSIP's decision that the 670 submission was not approved for a "change in use" was reasonable

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...