Corcept Therapeutics Incorporated (NASDAQ:CORT) has taken Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE:TEVA) to court for infringement of patents covering the use of Korlym. The lawsuit filed by Corcept was responding to Teva’s Abbreviated New Drug Application (“ANDA”), which was seeking approval from the U.S. Food and Drug Administration (“FDA”). Corcept further claims that the use of Teva’s proposed generic product will not be in line with the industry policies.
Approval of Teva’s ANDA would have given the company the power to market and sell a generic version of Korlym. The patents U.S. Patent No. 8,921,348 and U.S. Patent No. 9,829,495 expires in 2028 and 2036 respectively. However, they are in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations.
Corcept has a large portfolio of proprietary compounds
The pharmaceutical company is just protecting one of its own. It holds composition of matter patents, which cover its selective cortisol modulators. Apparently, Corcept has such a massive portfolio of proprietary compounds and often than not it modulates the effects of cortisol.
The company is largely involved in the discovery, development, and commercialization of drugs for treating severe metabolic, oncologic and psychiatric disorders. On the other hand, Korlym, which restrains the effects of excess cortisol in patients with hypercortisolism is the company’s first FDA-approved medication.
Nonetheless, as per the Federal Food, Drug and Cosmetic Act, the lawsuit by Corcept will stay FDA approval of Teva’s ANDA until the U.S. District Court for the District of New Jersey makes a decision on the invalidity of the patent.
Teva has settled on a strategic alignment of the company
The biotech has restructured its leadership; a move it claims will help in addressing internal inefficiencies. The changes include the combination of the Generic R&D and Specialty R&D organizations into one global group. There is also the formation of a Marketing & Portfolio function to oversee the interface between regions.
There will be an integration of commercial business, which features generics and specialty medicines into one commercial organization. Speaking about the new changes, Teva’s President and CEO, Kåre Schultz indicated that the move aimed at focusing on driving sustainable value creation.