IP Law Daily, PATENT—Fed. Cir.: Teva Pharma’s proposed generic drug for Cushing’s syndrome did not infringe dosing method patents, (Feb 20, 2026)

By Ravindra Kumar Singh, B.L.

The patent owner failed to prove physicians would practice the claimed coadministration methods.

Teva Pharmaceuticals USA, Inc.’s proposed generic version of Korlym® did not infringe asserted claims of two patents directed to methods of co-administering mifepristone with strong CYP3A inhibitors to treat Cushing’s syndrome, the U.S. Court of Appeals for the Federal Circuit has determined. The appellate court agreed with the District of New Jersey that the patentee failed to establish either direct infringement or specific intent to induce infringement. In particular, the Federal Circuit concluded that the district court properly relied on physician testimony and other evidence outside the proposed drug label to determine that infringement was unlikely to occur if the generic product entered the market (Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., No. 24-1346 (Fed. Cir. Feb. 19, 2026)).

Infringement allegations. Patent owner Corcept Therapeutics, Inc., is a biopharmaceutical company that markets Korlym®, a mifepristone product approved to control hyperglycemia secondary to hypercortisolism in patients with endogenous Cushing’s syndrome. Teva Pharmaceuticals USA, Inc., is a generic drug manufacturer that filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Korlym®. Teva’s proposed label mirrored the brand’s 2019 revised label, which permitted coadministration of mifepristone with strong CYP3A inhibitors at specified maximum doses.

The asserted patents were U.S. Patent Nos. 10,195,214 (the ’214 patent) and 10,842,800 (the ’800 patent). Both patents were directed to methods of controlling hyperglycemia secondary to hypercortisolism by adjusting the mifepristone dose when administered with a strong CYP3A inhibitor, such as ketoconazole. Representative claims required reducing a patient’s original daily dose to a lower adjusted dose and administering that adjusted dose together with a specified strong CYP3A inhibitor.

Corcept sued Teva under the Hatch-Waxman Act, asserting 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 that Corcept failed to prove direct infringement and also failed to prove specific intent to induce infringement. The court concluded that the record lacked evidence that physicians had practiced the claimed methods, and that future infringement was highly unlikely. Corcept appealed.

Standard of review and governing law. Reviewing the judgment after a bench trial, the Federal Circuit applied de novo review to legal conclusions and clear-error review to factual findings, citing Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018). The court reiterated that infringement, including induced infringement, is a question of fact. To establish induced infringement, a patentee must prove both direct infringement and specific intent to encourage that infringement, citing Genentech, Inc. v. Sandoz Inc., 55 F.4th 1368 (Fed. Cir. 2022).

Direct infringement. The Federal Circuit agreed that Corcept failed to prove direct infringement. Although Teva’s proposed label described dosing regimens involving coadministration with strong CYP3A inhibitors, the district court considered evidence beyond the label to determine whether physicians would, in practice, perform all the claimed steps.

Relying on Genentech, the appellate court confirmed that district courts may consider “outside-the-label” evidence in ANDA cases. The district court found no evidence that any physician had ever practiced the claimed methods. It further found that future infringement was highly unlikely for several reasons. First, physician testimony established that doctors generally avoid coadministration of mifepristone with strong CYP3A inhibitors due to safety concerns and dosing complexity. Second, a noninfringing alternative therapy, osilodrostat, had become available and was regarded as a safer and more effective means of blocking cortisol production. Third, physicians could follow Teva’s proposed label without performing each step required by the asserted claims.

Citing Vanda, the Federal Circuit emphasized that, even in the hypothetical context of an ANDA case, a patentee must demonstrate that, if the generic product were marketed, it “would infringe the relevant patent.” The court also cited Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U.S. 915 (2014), for the principle that a method patent is infringed only when all the claimed steps are performed. Because the district court credited testimony that physicians would not, in practice, perform the claimed coadministration methods, the Federal Circuit found no clear error in its conclusion that direct infringement had not been established.

Induced infringement. Given the absence of direct infringement, the Federal Circuit declined to address the district court’s additional finding that Corcept failed to prove specific intent to induce infringement. Direct infringement is a prerequisite to liability under 35 U.S.C. § 271(b), and its absence was dispositive.

The court noted that the dispute might have been avoided had Teva pursued a “section viii carve-out” under 21 U.S.C § 355(j)(2)(A)(viii), referencing GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021). Nevertheless, the absence of a carve-out did not relieve Corcept of its burden to prove that infringement would occur.

Thus, the Federal Circuit affirmed the district court’s judgment.

The Case is No. 24-1346.

Judge: Per Curiam.

Attorneys: Brian C. Cannon (Quinn Emanuel Urquhart & Sullivan, LLP) for Corcept Therapeutics, Inc. John Christopher Rozendaal (Sterne Kessler Goldstein & Fox PLLC) for Teva Pharmaceuticals USA, Inc.

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

Cases: Patent FedCirNews