Court ruling clears path for Teva generic to challenge Corcept's Korlym
A federal appeals court affirmed a ruling finding no infringement of two Korlym-related patents by Teva's proposed generic. The decision removes a major legal barrier for generic competition.
The U.S. Court of Appeals for the Federal Circuit affirmed a New Jersey district court decision finding no infringement of two Korlym-related patents by Teva Pharmaceutical Industries Ltd’s proposed generic. The ruling removes a major legal barrier for Teva's Korlym generic, increasing the risk of earlier-than-hoped competition to Corcept Therapeutics Inc.'s flagship franchise once regulatory requirements are satisfied.
Corcept had argued that Teva's label for its generic version of Korlym, a drug used to treat Cushing's syndrome, would induce doctors to follow patented dosing methods involving mifepristone and strong CYP3A inhibitors such as ketoconazole. The appeals court agreed with the lower court that there was no proof doctors had used, or were likely to use, those specific regimens, especially given safety concerns and the availability of newer alternatives like osilodrostat.
With the court concluding that Teva's label can be followed without practicing Corcept's claimed methods, the company loses a key patent shield around Korlym's dosing with CYP3A inhibitors. Corcept Therapeutics shares were down 19.79% at $31.95 at the time of publication on Thursday, and the stock was trading at a new 52-week low.