As we previously reported, JAMP sought leave to commence an application against Janssen under the abuse of dominance provisions of the Competition Act (the Act), relating to ustekinumab (Janssen’s STELARA and FINLIUS). This was the first application for leave to commence a proceeding under section 79 of the Act. On November 20, 2024, the Competition Tribunal dismissed JAMP’s application: JAMP Pharma Corporation v Janssen Inc, 2024 Comp Trib 8.
JAMP launched JAMTEKI, its ustekinumab biosimilar of STELARA, on March 1, 2024. Janssen launched its second branded ustekinumab product, FINLIUS, on July 2, 2024. JAMP commenced its application for leave on July 26, 2024.
JAMP’s allegations
JAMP alleged that Janssen engaged in a “practice of anti-competitive acts” that directly and substantially affected JAMP’s business, including:
- “sham” litigation and “gaming of the regulatory system” related to Janssen’s unsuccessful attempt to list the “837 Patent” on the Patent Register;
- development of FINLIUS as a “fighting brand” with predatory pricing; and
- “misleading” communications with physicians, insurers and patients.
JAMP further alleged that these activities have lessened and continue to lessen competition substantially in the market for the supply of ustekinumab in Canada.
Tribunal’s Analysis
A. Legal framework
According to the Tribunal, under subsection 103.1(7) of the Act, it “must determine whether the application for leave is supported by evidence that gives rise to a bona fide belief that the applicant may have been directly and substantially affected in its business by the impugned practice, and that the practice ‘could’ be subject to an order under section 79”.
As a preliminary matter, the Tribunal determined that JAMP was not required to show that a practice has a direct and substantial impact on JAMP’s entire business.
B. Alleged practice of anti-competitive acts
The Tribunal concluded that there was insufficient cogent evidence to support a bona fide belief that Janssen engaged in a practice of anti-competitive acts that could be subject to an order under subsection 79(1)(a) of the Act.
Attempt to list patent: the Tribunal rejected JAMP’s allegation that Janssen’s unsuccessful attempts to list the 837 Patent on the Patent Register against STELARA and FINLIUS were undertaken by Janssen knowing that they were unlikely to succeed and would disincentivize the launch of competing biosimilars. JAMP did not establish that Jansson’s activities were without merit, and there was no evidence that the activities delayed JAMP’s market entry. JAMP’s notice of compliance (NOC) for JAMTEKI issued after the Federal Court’s decision regarding patent listing and about two weeks before Janssen’s appeal was dismissed (our articles on the listing decisions on July 28, 2023 and November 28, 2023). JAMTEKI was launched over three months after the FCA decision.
FINLIUS: the Tribunal did not find sufficient cogent evidence that FINLIUS was used as a “fighting brand”. JAMP did not identify any “negative exclusionary impact” following the launch of FINLIUS and did not allege that it has been forced out of the market. Further, JAMP did not provide direct evidence of Janssen selling FINLIUS at predatory prices.
Communications with physicians, insurers and patients: the Tribunal found no sufficient cogent evidence to support JAMP’s allegations that Janssen’s communications caused “uncertainty and delayed competition”. JAMP’s evidence regarding Janssen’s communications was “very thin” and “based on alleged omissions and vague statements”. In particular, the Tribunal held that there was no evidence from physicians that “they were misled by Janssen’s communications, or by any omission in them.”
C. Alleged conduct substantially lessening competition in a market
Under subsection 79(1)(b), the Tribunal did not find sufficient evidence that Janssen’s conduct had the effect of substantially lessening or preventing competition in a market, where the effect is not the result of superior competitive performance. JAMP did not provide evidence to quantify any substantial effects of Janssen’s activities.
With respect to allegations that biosimilars could have launched earlier, the Tribunal confirmed that no biosimilar could enter the market before receiving an NOC and considered a (redacted) settlement agreement between Janssen and JAMP.
With respect to the period after launch of JAMTEKI, JAMP’s evidence was limited to a “small quantified effect on a single competitor over three months in 2024”, which omitted aspects of the market including e.g., indications for which JAMTEKI was not approved, and significant factors that may impact substantiality.
D. Whether JAMP was directly and substantially affected in its business
For the reasons above, the Tribunal concluded that the evidence did not give rise to a bona fide belief that JAMP was directly and substantially affected in its business by a reviewable practice under section 79. Despite this conclusion, the Tribunal commented on JAMP’s positions regarding the alleged “substantial” effect of Janssen’s activities, dismissing some as vague or speculative. The Tribunal further observed that JAMTEKI’s underperformance of JAMP’s forecast from April to June 2024 could not have been substantially affected by FINLIUS, which had not yet launched.
Conclusion
Therefore, the Tribunal dismissed JAMP’s application for leave to commence an application under section 79 of the Act.
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