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What’s at Stake in the Korlym Fight

• Corcept Therapeutics wants testimony from retired Federal Circuit Judge Kathleen O’Malley excluded, arguing her opinions would tell jurors what the law means instead of helping them decide disputed facts.
• Teva claims Corcept used patent litigation and other tactics to delay generic competition for Korlym, a costly treatment for patients with Cushing’s syndrome.
• The fight could help define how far former judges may go when serving as paid experts in cases where the legality of earlier lawsuits is itself part of the alleged antitrust conduct.

CALIFORNIA - A retired federal appellate judge is now at the center of a pharmaceutical antitrust fight involving patents, generic competition and a basic courtroom question with unusually high stakes — can a former judge testify as an expert about whether another company’s litigation crossed the line into unlawful conduct?

Corcept Therapeutics is asking a California federal court to exclude opinions offered by former Federal Circuit Judge Kathleen O’Malley, whom Teva Pharmaceuticals has retained in its antitrust case against Corcept. Corcept argues that O’Malley’s proposed testimony moves beyond ordinary expert analysis and into an area reserved for the trial judge — explaining the law to jurors.

That objection carries extra weight because of O’Malley’s résumé. She spent 16 years as a federal district judge before joining the U.S. Court of Appeals for the Federal Circuit in 2010, the appellate court that hears the nation’s patent appeals. She retired from judicial service in March 2022.

Teva sued Corcept in June 2024 in the Northern District of California, alleging Corcept and specialty pharmacy Optime Care engaged in conduct designed to protect Korlym from generic competition. The case is Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., et al., No. 5:24-cv-03567. Corcept’s latest SEC disclosure says trial is scheduled for March 2027.

The allegations extend beyond one patent case. Teva has accused Corcept of improperly listing patents in the FDA’s Orange Book, pursuing sham infringement litigation, using restrictive distribution arrangements and engaging in other practices that allegedly limited competition. Corcept disputes those accusations.

The sham-litigation claim is particularly important.

Normally, companies have broad protection when they go to court to enforce their rights. Under the Noerr-Pennington doctrine, petitioning the government — including filing lawsuits — generally cannot itself create antitrust liability.

But there is an exception.

In an earlier ruling, the district court explained that litigation may lose that protection when a lawsuit is objectively baseless and is used to interfere with a competitor. The test is demanding. A court first asks whether any reasonable litigant could realistically have expected success. Only if the lawsuit fails that test does the court examine the company’s motive.

The judge previously found Teva had sufficiently alleged that Corcept’s first infringement action could support its sham-litigation theory. But the court rejected that reasoning as to several later patent suits, finding Teva had not adequately shown those cases were objectively baseless.

That history explains why O’Malley’s testimony matters so much.

Jurors may eventually have to examine complicated patent litigation and decide whether conduct that looked like ordinary intellectual-property enforcement was actually part of an anticompetitive strategy. Someone with O’Malley’s Federal Circuit experience could carry enormous persuasive weight.

Corcept’s argument is essentially that the same experience creating that persuasive force is why limits are necessary. Expert witnesses may explain specialized facts, practices and technical subjects. They generally cannot take over the court’s job by instructing jurors what the governing law requires or delivering what amounts to a judicial ruling from the witness stand.

There is another important piece of history. In February 2026, the Federal Circuit affirmed a New Jersey federal court decision finding that Teva’s generic Korlym product did not infringe two Corcept patents.

But losing a patent case does not automatically make the lawsuit a sham. That distinction may become one of the central issues at trial.

The court has not yet ruled that Corcept violated antitrust law, nor does the present dispute establish that O’Malley’s opinions are improper. What the motion does establish is that before jurors ever decide what Corcept did, the court may first have to decide how much a former federal judge can tell them about what those earlier lawsuits legally meant.

About the Author

Samuel López is a reporter and news correspondent for USA Herald who has reported for the publication since 2022. López is also a seasoned legal professional with more than two decades of experience analyzing state and federal litigation, complex civil disputes, insurance matters and appellate issues. His legal background informs his reporting on antitrust litigation, patent disputes, evidentiary issues and the procedural battles that often shape major cases long before a jury reaches a verdict.

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