Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE:TEVA) has been served with a lawsuit by Corcept Therapeutics Incorporated (NASDAQ:CORT) for infringing on Korlym patents.
Corcept made the announcement that it filed the lawsuit against Teva on Friday at a U.S. District Court in New Jersey. The lawsuit was filed as a reaction to Teva’s latest Abbreviated New Drug Application (ANDA), which was filed with the Food and Drug Administration (FDA) to facilitate the approval and sale of a generic version of Korlym. The ANDA was filed before the expiration of Patent No. 8,921,348 which Corcept filed in the U.S. The patent is expected to expire in the year 2028 while its other patent filed as no. 9,829,495 is scheduled to expire in 2036.
The two patents are both listed under the Approved Drug Products by the FDA. Corcept claims that Teva’s upcoming generic version of Korlym would violate the two patents. The lawsuit is expected to delay the FDA’s decision to approve Teva’s new ANDA for at least 30 months or until the District Court decides that the patents were not infringed upon. This is in accordance with the provisions made to the FDA’s Cosmetics Act called the Hatch-Waxman amendments.
Prior to the lawsuit, the performance of Corcept’s shares was affected negatively by the announcement of the new ANDA filed by Teva. The announcement which was made on February 5 caused a 25 percent decline on the same day that the announcement was made.
“Corcept intends to vigorously defend its rights on the drug,” stated Corcept.
Korlym was the first drug that was approved by the FDA for treating patients suffering from Cushing’s syndrome and it was initially awarded an orphan drug indication. The treatment is engineered to regulate the activity of the glucocorticoid receptor, thus preventing the presence of excess cortisol in patients suffering from hypercortisolism. Corcept has been working on the development and discovery of treatments for addressing severe psychiatric, metabolic and oncologic disorders by controlling the effects of cortisol.
Teva stock closed the latest trading session on Friday at $18.37 after surging by 1.77 percent from the previous close.