Listen to this article

A U.S. District Court judge in New Jersey ruled in favor of Teva Pharmaceuticals USA, determining that the Parsippany-based drugmaker’s planned generic version of Corcept Therapeutics’ treatment for Cushing’s syndrome doesn’t infringe on any patents.

Judge Renee Marie Bumb in Camden found in a Dec. 29, 2023, decision that Corcept did not meet its burden of proof and failed to demonstrate the likelihood of direct infringement of patents held for Korlym (mifepristone), a synthetic steroid for adult patients with the rare metabolic condition.

The resolution comes about five years after Teva – a leading Israeli manufacturer of generic and proprietary drug products – first sought U.S. Food and Drug Administration approval to market a generic version of Korlym.

Shortly thereafter, Corcept filed a Hatch-Waxman lawsuit, alleging patent infringement and seeking a permanent injunction to restrict Teva from launching. Specifically, the California-headquartered commercial stage company claimed Teva’s version infringed on two patents that cover methods of safely administering mifepristone with drugs that are strong CYP3A4 inhibitors.

In response, Teva asked the United States Patent and Trademark Office’s Patent Trial Board and Appeal Board to cancel patent helds by Concept, but was unsuccessful. In its request, Teva told officials earlier publications made it obvious that the patented method would work to treat the disorder.

Then, in December 2021, the drugmaker failed to convince the U.S. Court of Appeals for the Federal Circuit that the Patent Trial and Appeal Board improperly denied its bid.

The company has not yet brought its product to market through the FDA-approved Teva application from August 2020. However, the new ruling allows it to proceed with plans to sell its own version of Korlym.

A spokesperson for Teva did not immediately respond to a request for comment.

Corcept plans to appeal the decision, saying it is “based on legal and factual errors.”

In a statement, Corcept CEO Dr. Joseph Belanoff said he was confident the “disappointing” ruling “will be reversed.”

“Our patents describe medical discoveries that have greatly expanded the therapeutic options available to patients suffering from Cushing’s syndrome, which is why the FDA added them to Korlym’s prescribing instructions. Doctors have followed these instructions and will continue to do so to safely treat patients. Failure to recognize the novelty and import of discoveries like these would fundamentally change the law, to the detriment of the many patients whom innovative companies seek to serve,” he said.

“We will pursue our appeal vigorously and will continue to assert our intellectual property rights whenever they are infringed,” Belanoff also said.

For Corcept – whose top line solely comprises product sales of Korlym – the company reported $482.4 million in revenue last year, a 20% increase over 2022. 

Introduced in 2012, Korlym is the first therapy approved by the FDA to control high blood sugar in certain adults with Cushing’s syndrome who have glucose intolerance or type 2 diabetes.