Invega Korlym® (mifepristone tablets)
Case Name: Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., No. 2024-1346, 2026 WL 468866 (Fed. Cir. Feb. 19, 2026) (Circuit Judges Moore and Stoll and District Judge Wang presiding; Opinion per curiam) (Appeal from D.N.J., Bumb, J.)
Drug Product and Patent(s)-in-Suit: Invega Korlym® (mifepristone tablets); U.S. Pat. Nos. 10,195,214 (“the ’214 patent”) and 10,842,800 (“the ’800 patent”)
Nature of the Case and Issue(s) Presented: Corcept owns the patents-in-suit, which claim methods of coadministering mifepristone with a strong CYP3A inhibitor (e.g., ketoconazole) to treat Cushing's syndrome, a disorder that causes excessive cortisol production. But coadministration of mifepristone with strong CYP3A inhibitors can cause adverse drug-drug interactions. When Korlym was first approved in 2012, the product label warned against coadministration due to safety concerns. The FDA required Corcept to conduct drug-drug interaction studies to determine the effects of coadministration. As a result, Corcept found a physician can safely coadminister up to 900 mg of mifepristone with a strong CYP3A inhibitor without undesirably increasing mifepristone blood levels. The ’214 and ’800 patents are based on this discovery. In 2019, Corcept revised Korlym’s label accordingly, which also included a new subsection on dosage and administration of up to 900 mg of mifepristone with a strong CYP3A inhibitor.
Teva’s ANDA for generic Korlym included a proposed label that is identical in all respects to the revised 2019 Korlym label. Corcept sued Teva for infringement of claims 10–13 of the ’214 patent and claims 1, 6–7, and 9 of the ’800 patent. After a bench trial, the district court found Corcept had not met its burden to prove either direct infringement or specific intent to induce infringement. Corcept appealed, and the Federal Circuit affirmed.
Why Teva Prevailed: The district court relied on outside-the-label evidence to support its finding of no infringement. For past infringement, it found a lack of record evidence showing any physicians had ever practiced the claimed methods. For future infringement, it found it was highly unlikely physicians will practice the claimed methods because: (i) physicians avoid coadministration due to dosing challenges and safety concerns; (ii) the recently approved osilodrostat drug that blocks cortisol production is a safer and more effective non-infringing alternative; and (iii) a physician can follow Teva’s proposed label and not infringe the claims. The Federal Circuit discerned no clear error in the district court’s approach.
Although the label may contain instructions recommending an infringing use, the Federal Circuit has repeatedly affirmed a district court’s findings of no direct infringement based on outside-the-label evidence of physician practice. That evidence may include physicians’ testimony. Here, the district court specifically credited physician testimony that “the benefits of co-administering mifepristone and ketoconazole never outweigh the risks, especially since the introduction of osilodrostat.” The district court also found that Corcept had “no real response” to evidence that the leading authorities on Cushing’s syndrome do not recommend coadministration of mifepristone with other drugs.
