Jacksonville Police Officers and Fire Fighters Health Insurance Trust v…

Background

The Jacksonville Police Officers and Fire Fighters Health Insurance Trust and John Doe sued Gilead Sciences, Inc., Cipla, Ltd., and Cipla USA, Inc. The plaintiffs alleged that Gilead and Cipla entered into anticompetitive “reverse-payment” settlement arrangements. Their theory was that Cipla agreed not to produce a co-packaged generic version of Truvada in exchange for other benefits, including licenses involving Gilead drugs and the right to supply tenofovir disoproxil fumarate to Teva Pharmaceuticals USA, Inc.

John Doe asserted claims under California’s Cartwright Act, California’s Unfair Competition Law, and common-law theories including restitution, money had and received, unjust enrichment, and quasi-contract. The Trust asserted a claim under Florida’s Deceptive and Unfair Trade Practices Act. The Trust had previously asserted a Sherman Act claim, but it dropped that claim in the second amended complaint.

Motion and analysis

Gilead and the Cipla entities moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which permits dismissal for failure to state a legally sufficient claim. They argued that the plaintiffs had not adequately alleged antitrust injury and standing. The court elected to address the merits of the motion rather than deny it based on the rule governing successive motions to dismiss.

The plaintiffs alleged that Defendants’ conduct kept a co-packaged generic version of Truvada off the market. They also alleged that Cipla filed applications for generic versions of Viread and Emtriva but did not file one for Truvada, even though Food and Drug Administration guidance allegedly indicated that approval of a co-packaged version could be available without clinical studies.

The court concluded that these allegations provided greater factual support for the plaintiffs’ assertion that approval would have been highly likely. But the court held that the allegations about whether Cipla or another generic manufacturer intended to seek approval for a co-packaged Truvada product were still based on speculation and conjecture. The allegations therefore did not plausibly establish the plaintiffs’ claimed injury.

The court also addressed evidentiary requests. It denied as moot most of Defendants’ request for judicial notice because the court did not rely on most of the submitted materials, though it considered the Gilead-Cipla settlement agreements under the incorporation-by-reference doctrine. It denied as moot both Defendants’ request concerning a patent certification and Plaintiffs’ request to file a sur-reply because the court did not rely on that certification. The court took judicial notice of the existence of certain briefs and statements in them filed in a related antitrust case.

Disposition

The court granted Defendants’ motion to dismiss the second amended complaint. Because the court could not say that amendment would be futile, it gave Plaintiffs one final opportunity to amend by September 26, 2023. If Plaintiffs chose not to amend, the court stated that it would enter a dismissal and judgment. If they amended, Defendants were required to answer or otherwise respond within 21 days after the amended complaint.