Corporate Counsel Daily, Teva’s lawsuit against Corcept allowed to proceed under continuing violation doctrine, (Sep 18, 2025)

By Jeffrey H. Brochin, J.D.

An exception to the statute of limitations bar was properly pleaded by Teva Pharmaceuticals, Inc. where Corcept Therapeutics, Inc. restarted the clock on Teva’s antitrust claims each time it paid a new kickback or bribe.

A federal District Court in California has granted in part and denied in part the Motion to Dismiss filed by Corcept Therapeutics, Inc. (Corcept) in an antitrust lawsuit brought by Teva Pharmaceuticals (Teva) over alleged anticompetitive conduct involving Corcept’s drug Korlym. Although the Sherman Act cites a four-year statute of limitations, the court found that the ‘continuing violation’ exception applied thereby allowing Teva to proceed with its antitrust claims, but not its state unfair competition and unjust enrichment claims, ( Teva Pharmaceuticals, Inc. v. Corcept Therapeutics, Inc. , No. 5:24-cv-03567-NW (N.D. Cal. Sept. 12, 2025)).

Entering the generic Korlym market. Corcept developed the drug Korlym for the treatment of Cushing’s Syndrome, a rare and debilitating disease affecting approximately 20,000 patients in the United States with treatment provided by a small set of doctors. The FDA approved Korlym’s launch on February 17, 2012, and awarded the drug “orphan” status under the Orphan Drug Act of 1983, entitling Corcept to drug exclusivity for seven years. Corcept has sold Korlym at supracompetitive prices for upwards of several hundred thousand dollars per year, and its orphan drug status expired on February 17, 2019.

On December 15, 2017, Teva filed an ANDA seeking approval to manufacture and market a generic version of Korlym once Korlym’s orphan drug exclusivity (ODE) status expired in 2019. Because Corcept had two patents for Korlym listed in the Orange Book (the ‘348 patent and the ‘495 patent), Teva’s ANDA included a Paragraph IV certification explaining why Teva’s generic version would not infringe Corcept’s patents. Based on that certification, Corcept sued Teva for infringement in the District Court of New Jersey in March 2018, thereby triggering the statutory 30-month stay of final approval on Teva’s ANDA. On October 12, 2018, the FDA tentatively approved Teva’s ANDA, but what prevented the FDA from granting final approval was the 30-month stay triggered by Corcept’s March 2018 suit.

Launch and lawsuit. Although there were no barriers to launch beginning in September of 2020, Teva chose not to launch its generic Korlym until January 2024, three weeks after the court in New Jersey found that Teva did not infringe on the two patents that Corcept asserted at trial. Had Teva received final FDA approval in October 2018, Teva acknowledged that it would have launched as early as that date, or shortly thereafter.

In June 2024, Teva filed the instant lawsuit alleging that Corcept’s listing of the ‘348 and the ‘495 patents in the Orange Book were part of a scheme to maintain its monopoly past its permitted period of exclusivity. Teva alleged that the patents were fraudulently listed in the Orange Book because they did not actually read on the Korlym NDA nor its FDA-approved labeling. Accordingly, despite knowing they were doing so in bad faith, Corcept listed the two patents because it gave them the ability to trigger the automatic 30-month stay when a generic attempted to enter the market. In support of its contention, Teva referenced a February 2019 statement by Corcept’s CFO who stated that the ‘348 and the ‘495 patents did not have “a direct read on the Korlym label.’ Teva alleged violations of the Sherman Act as well as California’s Unfair Competition Law, California’s prohibition on contracts in restraint of trade, and various state antitrust and consumer protection laws, as well as a claim for unjust enrichment. In support of those claims they cited illegal kickbacks from Corcept to prescribing physicians for Korlym prescriptions. Presently before the court was Corcept’s Motion to Dismiss the Teva lawsuit.

Statute of Limitations exception. The parties agreed that claims under the Sherman are subject to a four-year statute of limitations. Teva filed their lawsuit on June 13, 2024, and therefore, any claims that accrued prior to June 13, 2020, would be time barred unless an exception to the statute of limitations applied. Two such exceptions are: the continuing violation doctrine and the speculative damages doctrine. Teva argued that the exceptions permitted their claims to proceed.

The court noted that under the continuing violation doctrine, each overt act that is part of the antitrust violation and that causes injury, starts the statutory period running again. In other words, a cause of action in antitrust would accrue each time Teva was injured by an act of Corcept and the statute of limitations would run anew from the commission of each act. The question therefore arose as to whether Corcept’s conduct constituted a continuing violation.

A series of continuing overt wrongs. An overt act restarts the statute of limitations if it: (1) is a new and independent act that is not merely a reaffirmation of a previous act; and (2) it inflicts new and accumulating injury. The standard is meant to differentiate those cases where a continuing violation is ongoing—and an antitrust suit can therefore be maintained—from those where all of the harm occurred at the time of the initial violation. Therefore, Teva needed to plausibly allege a series of continuing overt wrongs, as opposed to mere ripple effects of a single past act.

Here, the court found all of the conduct alleged to be part of one continuing violation of the Sherman Act, and they agreed with Teva that this was a case of a “multifaceted scheme to suppress generic competition” predicated on a “multitude of unlawful tactics to stifle competition and keep prices high. Therefore, the application of the continuing violation doctrine was clear: Corcept restarted the clock on Teva’s antitrust claims each time it paid a new kickback or bribe, and each such violation constituted a new and independent act that inflicted new and accumulating injury.

Based on the foregoing, the court ruled that the continuing violation doctrine exception applied and that Teva’s Sherman Act claims were not time-barred. However, Corcept’s Motions to Dismiss were granted as to Teva’s state unfair competition claims and their unjust enrichment claims, for which they were granted leave to amend.

The case is No. 5:24-cv-03567-NW.

Judge: Wise, N.

Attorneys: Devora Allon (Kirkland and Ellis LLP) for Teva Pharmaceuticals USA, Inc. Adam Bryan Wolfson (Quinn Emanuel Urquhart Sullivan LLP) for Corcept Therapeutics, Inc.

Companies: Teva Pharmaceuticals USA, Inc.; Corcept Therapeutics, Inc.

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