Corcept to ‘vigorously appeal’ Teva victory over Cushing’s syndrome drug patents
California-based drugmaker lost Hatch-Waxman Act case after judge ruled it had failed to show patent infringement | Corcept CEO ‘confident’ decision will be reversed on appeal.
Corcept Therapeutics has said it intends to “vigorously” appeal the decision of a New Jersey district court which said it had failed to prove that Teva Pharmaceuticals had infringed two method patents covering a treatment for rare endocrine disorder Cushing’s syndrome.
The US District Court for the District of New Jersey issued its decision on Friday, November 29, dealing a blow to California-based Corcept in its Hatch-Waxman Act case for patent infringement against Israel’s Teva.
Corcept initiated its suit to block Teva’s proposed generic version of Korlym (mifepristone), Corcept’s medication for Cushing’s syndrome, before two patents expired. The condition causes excess production of cortisol which can lead to high blood sugar, hypertension and osteoporosis, among other problems.
Chief US District Judge Renée Marie Bumb concluded that Corcept had failed to show evidence that anyone had previously infringed the claims of the patents-in-suit, or that Teva’s proposed product label clearly encouraged infringement.
The drugmaker’s stock fell over 30% following the ruling. Its chief executive officer, Joseph Belanoff, said: “This disappointing decision is based on legal and factual errors we are confident will be reversed on appeal.
“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.”
“We will pursue our appeal vigorously,” added Belanoff.
Generic ‘poses no infringement’
Corcept’s patents—US patent numbers 10,195,214 and 10,842,800—involve methods of controlling hyperglycemia in certain Cushing’s syndrome patients.
The claims of the patents are based on research conducted by Corcept, which was required by the US Food and Drug Administration (FDA) in connection with Korlym’s approval, into the effect of co-administrating mifepristone with a strong CYP3A inhibitor.
That was because CYP3A inhibitors were being widely used off-label to treat Cushing’s syndrome and the FDA had concerns that the co-administration of mifepristone, which manages the effects of cortisol rather than blocking its production, could lead to dosing problems and health risks to patients.
Corcept’s studies showed that up to 900 mg of mifepristone could be prescribed with a CYP3A inhibitor if dosed appropriately, a discovery which prompted to it file the ‘214 and ‘800 patents and modify the product label for Korlym.
In its patent infringement suit, Corcept contended that the two drugs had been prescribed to seriously ill patients in the past and were likely to be used in combination in the future, and that the label of Teva’s proposed product instructed physicians to perform its patented method when co-administering the treatments.
However, the court said it had not been presented with any specific evidence that a physician had practised the patented methods despite Korlym being available since 2012, and that physicians generally avoided co-administration because of the challenges and risks. This led it to conclude that “future direct infringement is not likely”.
Furthermore, the court found that “a physician could follow the instructions on Teva’s label and not infringe the claims”, and that Teva’s label actually warned physicians against co-administrating mifepristone with a strong CYP3A inhibitor.
LSIPR has approached Teva for comment.
The case is Corcept Therapeutics v Teva Pharmaceuticals. Corcept was represented by Saul Ewing and Quinn Emanuel, and Teva by Walsh and Sterne Kessler.
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