Bayer requested a preliminary injunction over J&J’s Erleada marketing, arguing its headline survival claims rely on flawed real-world data, not clinical trials.

The judge ruled that Bayer failed to show a likelihood of success on the merits of its false advertising claims under the Lanham Act

The case tests how far courts should go in policing pharma advertising, as J&J warns intervention could infringe on free speech.

Tucked away in a lower Manhattan courtroom last month, attorneys for Bayer and Johnson & Johnson sparred over the latter’s advertising materials for its prostate cancer drug, with the judge ultimately siding with J&J.

Bayer and J&J compete in the lucrative market for prostate cancer drugs called androgen receptor inhibitors, but Bayer alleges J&J’s promotion of Erleada crosses the line into false advertising.

Ultimately, the judge did not agree with Bayer’s argument that methodological limitations in the study made J&J’s communications misleading and warranted a preliminary injunction. The order specifically denies Bayer’s request for pre-trial intervention, the purpose of such a preliminary injunction, but importantly the case was not dismissed — Bayer is expected to continue pursuing its action against J&J.

The dispute centers on J&J’s headline claim of a 51% reduction in risk of death, which is based on retrospective real-world evidence rather than a randomized clinical trial, raising questions about its use in...

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