On July 26, 2024, JAMP Pharma Corporation (JAMP) filed an application to Canada’s Competition Tribunal (Tribunal) against Janssen Inc. (Janssen) relating to an abuse of dominance allegation with respect to Janssen’s biologic drug Stelara, an ustekinumab drug product for the treatment of certain autoimmune diseases.

The Competition Act (Act) was amended in 2022 to allow a private party to bring an abuse of dominance application under section 79 of the Act with leave of the Tribunal pursuant to section 103.1. The Tribunal may grant leave if it has reason to believe that the applicant’s business is directly and substantially affected by the respondent’s anti-competitive acts. If the abuse of dominance application is successful, the Tribunal may award administrative monetary penalties and grant interim relief to the private party. Previously, only the Commissioner of Competition could take enforcement action in such cases.

JAMP’s application marks one of the first few times that the Tribunal is asked to interpret and apply the amendments to sections 103.1 and 79 of the Act. The sole issue is whether JAMP should be granted leave, which requires JAMP to persuade the Tribunal that Janssen’s actions may warrant an order pursuant to section 79 of the Act, including that (i) Janssen possesses a dominant position; and (ii) Janssen’s conduct either is a practice of anti-competitive acts or has had, is having, or is likely to have the effect of preventing or lessening competition substantially.

In its Memorandum of Fact and Law, JAMP claims that Janssen earned revenues of over $2 billion from sales of Stelara from 2008 to 2021. After the final patent listed on the patent register against Stelara expired in 2021, Stelara no longer benefited from any statutory barrier to competitive entry of biosimilars. JAMP argues Janssen abused its dominant position by deterring competitors from launching biosimilars to Stelara, including by developing a fighting brand of ustekinumab and by improper attempts to list another patent on the register for both Stelara and for its fighting brand. JAMP further alleges that after JAMP’s biosimilar, Jamteki, launched in Canada in March 2024, Janssen took actions to prevent or delay physicians from switching patients from Stelara to Jamteki.

It remains to be seen whether the Tribunal grants JAMP’s application for leave. For latest developments of the proceeding, please check the Tribunal’s records available here.

Summary By: Anna Troshchynsky

 

E-TIPS® ISSUE

24 08 21

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