Antitrust Law Daily Wrap Up, ANTITRUST—N.D. Cal.: Teva’s antitrust claims over Corcept’s Cushing’s syndrome drug survive dismissal, (Sep 15, 2025)

By Martin A. Steinberg, J.D.

Though Teva’s antitrust claims are subject to a four-year statute of limitations, the continuing violation doctrine preserved events occurring before June 13, 2020; however, the court limited recoverable damages to injuries occurring after that date.

The federal court in San Jose partially granted Defendants Corcept Therapeutics, Inc. and Optime Care, Inc.’s motion to dismiss Teva Pharmaceuticals USA, Inc.’s complaint alleging a multifaceted scheme to maintain monopoly power over Korlym (mifepristone) used to treat Cushing’s syndrome. The court held that Teva adequately pleaded claims under Sherman Act §§ 1 and 2, as well as California’s Unfair Competition Law and related restraint-of-trade provisions, based on allegations of an exclusive-dealing arrangement with Optime and physician kickback practices. While the court found that specific Orange Book listing and sham litigation allegations could not independently sustain relief and dismissed several state law counts as time-barred or insufficient, it declined to dismiss the monopolization and exclusive-dealing theories (Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., No. 5:24-cv-03567-NW (N.D. Cal. Sept. 12, 2025)).

Background. Korlym treats endogenous Cushing’s syndrome, a rare and debilitating disease affecting approximately 20,000 patients in the U.S., 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 the seven years that followed its FDA approval. Since launch, Corcept has sold Korlym at supracompetitive prices for upwards of several hundred thousand dollars per year. Corcept’s orphan drug status expired on February 17, 2019.

Under the Hatch–Waxman Act, brand manufacturers must file NDAs and list relevant patents in the FDA’s Orange Book. In contrast, generics may file ANDAs with Paragraph IV certifications asserting non-infringement or invalidity. Such certifications trigger patent suits and a 30-month stay of FDA approval. Teva filed an ANDA in 2017 to market a generic Korlym after its orphan exclusivity expired in 2019. Corcept sued in 2018, delaying approval despite the FDA’s tentative finding that only the litigation—not exclusivity—barred launch. Although final approval was issued in 2020, Teva waited until January 2024, after winning infringement litigation, to launch.

Teva alleges Corcept used multiple tactics to preserve its monopoly: (1) fraudulently listing the ’348 and ’495 patents in the Orange Book to trigger stays; (2) pursuing sham litigation through nine patent suits between 2018 and 2023, most later dismissed; (3) maintaining an exclusive 2017 distribution agreement with Optime, the specialty pharmacy that exclusively distributes Korlym, that foreclosed nearly the entire market and blocked generic substitution; and (4) paying physicians large sums—rising from hundreds of thousands to over a million dollars annually—to secure loyalty and ensure Korlym prescriptions flowed through Optime. Teva characterizes this combination of improper listings, meritless litigation, exclusive dealing, and kickbacks as an overarching scheme to delay and suppress generic competition.

Teva contends that Corcept’s initial listings of two patents in the FDA’s Orange Book were fraudulent because the patents did not actually cover Korlym’s NDA or its approved labeling. According to Teva, Corcept deliberately listed the patents in bad faith to trigger the Hatch–Waxman 30-month stay mechanism when a generic filed a Paragraph IV certification, thereby blocking competition. Teva points to statements from Corcept’s CFO in 2019 acknowledging that the patents had no “direct read” on the Korlym label, suggesting Corcept knew the listings were improper.

Between 2018 and 2023, Corcept asserted nine patents across four separate lawsuits, timing each suit to maximize obstruction. Most of these actions were voluntarily dismissed after years of litigation, and in the single case that went to verdict, the court found Teva had not infringed. Despite FDA final approval of Teva’s ANDA in August 2020, Teva refrained from launching until January 2024, only three weeks after prevailing in the infringement trial. Teva characterizes this cycle of improper Orange Book listings and meritless litigation as the opening phase of Corcept’s larger monopolistic scheme.

Teva filed its action in June 2024, asserting seven causes of action under the Sherman Act, California’s Unfair Competition Law and restraint-of-trade statute, various state laws, and unjust enrichment. Counts I and II (monopolization and attempted monopolization) are based on all four theories, while the remaining counts focus primarily on exclusive dealing and kickbacks.

Statute of limitations. The court held that the statute of limitations does not bar Teva’s antitrust claims due to the continuing violation doctrine, though recovery is limited to post-June 2020 damages. The Sherman Act (Counts I–III), California UCL (Count IV), and California’s restraint-of-trade statute (Count V) all carry a four-year limitations period. Since Teva filed its complaint on June 13, 2024, any claims that accrued before June 13, 2020, are presumptively untimely unless exceptions apply. Two doctrines are central: the continuing violation doctrine and the speculative damages doctrine.

Continuing violation doctrine. An antitrust claim accrues each time a plaintiff suffers injury from a defendant’s act, restarting the statute of limitations with each new overt act. Courts require that the act be (1) new and independent, not merely a reaffirmation, and (2) inflict new and accumulating injury. The key dispute is whether Teva’s allegations should be parsed theory-by-theory (fraudulent patent listings, sham litigation, exclusive dealing, kickbacks) or treated as one overarching monopolistic scheme.

Defendants argued for a separate-theory approach, claiming that fraudulent Orange Book listings could not be revived by later kickbacks or exclusive dealing. Teva argued for a scheme-wide approach, where each act, including kickback payments, restarts the limitations period for the entire monopolistic scheme. The court sided with Teva, reasoning that antitrust violations must be assessed holistically, not compartmentalized. Relying on Ninth Circuit precedent, the court emphasized that plaintiffs should receive the “full benefit of their proof,” and a series of acts may together constitute unlawful monopolization even if not each act independently qualifies.

Thus, the court held that Corcept’s repeated payments of kickbacks and bribes to physicians were new overt acts that inflicted fresh antitrust injury, thereby restarting the clock. As a result, Teva’s Sherman Act and parallel California claims are not time-barred, though damages remain limited to injuries within the four years preceding the filing.

Speculative damages doctrine. Teva argued that its claims could not accrue until it entered the market with generic Korlym in January 2024, because prior damages were speculative. The court rejected this, holding that Teva’s exclusion from the market occurred as early as 2018, when Corcept’s Orange Book listings and infringement litigation blocked FDA approval. At that point, the harm was real because Teva was prevented from launching. The speculative damages doctrine applies only when the injury itself is uncertain, not when the extent of harm is unknown. Thus, while Teva could not defer accrual until its 2024 launch, the continuing violation doctrine preserved its claims, though damages are limited to injuries suffered after June 13, 2020.

Damages. The court clarified that although Teva’s claims survive dismissal, its damages are restricted to the four years before the complaint, that is, June 2020 onward. Earlier damages are unrecoverable even though earlier conduct may still serve as context for liability. Teva will need to prove that specific harms flowed from conduct within the limitations window, which may be challenging given that much of Corcept’s alleged misconduct occurred before 2020. Nonetheless, dismissal is unwarranted at this stage because discovery may allow Teva to substantiate damages tied to timely overt acts.

Restraint of trade claim. The court denied the defendants’ motion to dismiss Count III because Teva had adequately pleaded both an exclusive agreement and substantial foreclosure, sufficient to state a Section 1 claim. Section 1 of the Sherman Act prohibits contracts or conspiracies that unreasonably restrain trade. The court noted that exclusive dealing arrangements are judged under the rule of reason rather than treated as automatically unlawful. To proceed, Teva needed to plausibly allege both the existence of an exclusive agreement and that it foreclosed competition in a substantial portion of the relevant market.

The court first considered market definition. Teva alleged that the relevant product market consisted of Korlym and its AB-rated generic equivalents. Corcept argued this was too narrow, but the court found the definition sufficient. Korlym was the first FDA-approved treatment for Cushing’s syndrome; it had orphan drug status, and both parties conceded there were no real substitutes. Courts have often accepted single-brand markets in the pharmaceutical context where no cross-elasticity exists, so the court determined Teva’s allegations were adequate for the pleading stage. Teva further alleged that all Korlym sales were routed through Optime, leaving its own lower-cost generic effectively foreclosed from prescribers who had come to rely exclusively on that channel.

The court then turned to foreclosure. It emphasized several features of the Corcept–Optime agreement: it began in 2017, had been repeatedly amended, automatically renewed, and could not be terminated unilaterally by Optime. Although nominally set for three years, the contract had endured for nearly a decade and was projected to continue through at least 2027. Teva alleged that Optime refused even to consider its offers of better pricing and terms, demonstrating the binding nature of the exclusivity.

While Teva made its generic available through national and regional wholesalers, those alternative channels proved ineffective because prescribers routed Korlym prescriptions only to Optime. The court noted that in antitrust law, alternatives must be practical and meaningful, not merely theoretical. Based on these allegations, the court concluded that Teva plausibly showed the agreement created near-total foreclosure, as Corcept distributed 100% of Korlym through Optime and prescribers had developed entrenched habits of relying on that channel.

Monopolization. The court denied the defendants’ motion to dismiss Counts I and II. Because Teva had adequately alleged monopolization and attempted monopolization. However, the court clarified that specific factual allegations, particularly older Orange Book listings or litigation events, might not independently support liability. Still, they remained relevant as part of the larger scheme. To prevail under Section 2 of the Sherman Act, Teva had to allege (1) possession of monopoly power, (2) willful maintenance of that power through anticompetitive conduct, and (3) causal antitrust injury. For attempted monopolization, Teva also needed to show predatory conduct, specific intent to monopolize, and a dangerous probability of success.

Monopoly power. Teva alleged that Corcept held monopoly power in the market for Korlym and its AB-rated generics. The court accepted this as plausible at the pleading stage because Korlym was the only FDA-approved treatment for Cushing’s syndrome until Teva’s launch, Corcept controlled nearly 100% of the market, and barriers to entry were high due to regulatory and prescribing hurdles. The allegations, taken as true, established Corcept’s dominance.

Anticompetitive conduct. The court then assessed whether Corcept’s alleged conduct qualified as exclusionary. Teva alleged Corcept listed patents that did not actually cover Korlym, then filed successive infringement suits to trigger 30-month stays. While one case went to trial and Teva prevailed, most others were voluntarily dismissed. The court found these allegations could support a sham litigation theory of monopolization, though it cautioned that courts must avoid post hoc reasoning simply because Corcept lost. Still, Teva alleged facts, including admissions by Corcept’s CFO, that plausibly suggested bad faith.

The court reiterated its earlier analysis, concluding that the long-term, one-sided agreement plausibly foreclosed nearly all generic competition. This conduct could independently sustain a Section 2 claim as anticompetitive. Teva alleged that Corcept’s payments to doctors, rising sharply around the time Teva sought entry and far exceeding industry norms, were bribes designed to secure prescribing loyalty. If true, such payments plausibly distorted physician decision-making, kept prescriptions flowing to Korlym through Optime, and undermined substitution laws. The court noted that courts have treated bribery and kickbacks as potentially anticompetitive conduct under the Sherman Act. Taken together, these practices plausibly demonstrated willful maintenance of monopoly power, rather than legitimate competition.

Causation and injury. Teva alleged direct injury from delayed entry and lost sales. The court agreed that exclusion from the Korlym market, by fraudulent patent listings, sham lawsuits, foreclosure through Optime, and bribery that blocked generic substitution, constituted cognizable antitrust injury. Teva plausibly alleged that, but for these practices, it could have entered the market earlier and more effectively competed.

Attempted monopolization. Even if Corcept’s monopoly power were to diminish following Teva’s launch, Teva plausibly alleged attempted monopolization that Corcept engaged in predatory conduct with the intent to monopolize and had a dangerous probability of maintaining monopoly power through its schemes. The breadth of conduct, spanning fraudulent patents, litigation abuse, exclusivity agreements, and kickbacks, was sufficient at the pleading stage.

State law claims. The court finally addressed Teva’s state law causes of action: California’s Unfair Competition Law (UCL), California Business & Professions Code § 16600 (restraint of trade), and omnibus state antitrust and consumer-protection claims.

The court first noted that these claims are largely derivative of Teva’s federal theories, particularly the exclusive-dealing and kickback allegations. Since the court already found that Teva plausibly alleged those theories under federal law, the UCL and Section 16600 claims could also proceed. Both statutes broadly prohibit unfair or unlawful restraints on trade, and Teva’s allegations of near-total foreclosure and physician bribery, if true, fell within their scope.

However, with respect to the omnibus state law antitrust and consumer-protection claims, the court dismissed them with leave to amend. The problem was not the substance of Teva’s allegations but the lack of specificity. Teva had grouped numerous states’ statutes without clearly identifying the relevant provisions, the governing statutes of limitations, or the basis for each claim. The court emphasized that state antitrust law varies significantly across jurisdictions, so Teva must plead them with greater precision if it intends to pursue them. Suppose Teva elects to proceed with these claims. In that case, it must explicitly provide: (1) a specific citation to the relevant antitrust or consumer protection law giving rise to the claim, (2) the elements for the private right of action created by that provision, (3) the governing statute of limitations and any state-specific tolling/accrual standards, (4) a restatement of, or citation to, the facts currently alleged in the FAC that establish a claim under that provision, and (5) the degree of similarity between the state law claim and the federal claims alleged in the FAC.

Finally, the court held that Teva’s unjust enrichment claim (Count VII) could proceed in the alternative, since it was tied to the same overarching anticompetitive scheme.

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.

Cases: Antitrust StateUnfairTradePractices CaliforniaNews