Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.

Korlym® (mifepristone)

December 29, 2023

GENERICally Speaking

Case Name: Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., No. 18-CV-03632 (RMB/LDW), 2023 WL 9017081 (D.N.J. Dec. 29, 2023) (Bumb, J.)

Drug Product and Patent(s)-in-Suit: Korlym® (mifepristone); U.S. Patents Nos. 10,195,214 (“the ’214 patent”) and 10,842,800 (“the ’800 patent”)

Nature of the Case and Issue(s) Presented: Corcept asserted a number of patents against Teva’s ANDA product, two of which remained in suit through a bench trial. Those patents (the ’214 and ’800 patents) cover methods of controlling hyperglycemia in certain patients with Cushing’s syndrome.

The parties presented one issue during the bench trial: whether Teva induces infringement of the ’214 patent and the ’800 patent. The court determined that Corcept had not carried its burden: “it has not demonstrated that there is a likelihood of direct infringement of the asserted claims in the future because it has not established that physicians are likely to coadminister mifepristone with a strong CYP3A inhibitor at an infringing sequence and/or dosage now or in the future. Indeed, Corcept failed to introduce credible record evidence that anyone has ever previously infringed the asserted claims.” Further, Corcept failed to show that Teva possesses the requisite intent to induce—its proposed label does not “encourage, recommend, or promote” infringement.

Why Teva Prevailed: After a fact-intensive analysis, the court determined that Corcept did not satisfy its burden of proof because the evidence did not show that anyone has ever practiced the claimed methods (over a ten-year period since FDA approved Korlym). The court (and Teva) relied on the Genentech case, in which the Federal Circuit considered certain patented methods that, based on the record evidence, no physicians had ever practiced or would ever practice. Here, the court did not find that it must credit the lack of evidence of past infringement in finding no likelihood of future infringement. But the lack of evidence is relevant.

The court also cited record evidence demonstrating that future infringement is unlikely—physicians generally avoid the claimed method (co-administering mifepristone and strong CYP3A inhibitors). Indeed, Teva’s label cautions against coadministration. And at least one non-infringing alternative suggested that physicians are not likely to directly infringe in the future.

The Court separately determined that Teva’s label does not encourage physicians to practice the asserted claims. “The label only provides instructions how to coadminister the substances to achieve an efficacious result if a physician determines that it is medically necessary.” And even if a physician decided to co-administer, the label provides non-infringing options. Thus, the court declined to infer specific intent to induce infringement.

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