Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., No. 21-1360 (Fed. Cir. 2021)
Annotate this Case
In the 1980s, researchers suggested using mifepristone to treat Cushing’s syndrome, a disease caused by excessive cortisol levels. More than 20 years later, Corcept initiated the first major clinical trial of mifepristone and obtained FDA approval for Korlym, a mifepristone tablet, with postmarketing requirements (21 U.S.C. 355(o)(3)), including a drug-drug interaction clinical trial involving co-administration of ketoconazole. The FDA approved the prescribing information for Korlym on its label, which warned against using mifepristone “with strong CYP3A inhibitors” and limited the “mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.” Corcept conducted the drug-drug interaction study, then obtained the 214 patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor.
Corcept asserted the 214 patent against Teva, Teva sought post-grant review, arguing that certain claims would have been obvious in light of Korlym’s label and the FDA memo describing the required drug interaction study (Lee). The Federal Circuit affirmed the Patent Trial and Appeal Board’s rejection of the obviousness claims. The Board did not err by requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. The general working conditions disclosed in Lee did not encompass the claimed invention. A skilled artisan would not have expected monotherapy and coadministration dosages to behave similarly.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.