The following arguments will be available live to the public, both in-person and through online audio streaming. Access information will be available by 9 AM ET each day of argument at: https://cafc.uscourts.gov/home/oral-argument/listen-to-oral-arguments/.
Monday, July 7, 2025, 10:00 A.M.
Corcept Therapeutics, Inc v. Teva Pharmaceuticals USA, Inc., No. 24-1346, Courtroom 201, Panel A
This case arises from a Hatch-Waxman suit involving Teva's ANDA filing for a generic version of Corcept's Korlym® (mifepristone), a drug for treating cushing's syndrome. At issue are Corcept's U.S. Patent Nos. 10,195,214 and 10,842,800, both covering dosing regimens of mifepristone co-administered with strong CYP3A inhibitors. In 2018, based on Teva's ANDA filing, Corcept sued Teva for infringing its patents.
As validity was separately decided in other proceedings, the district court conducted a bench trial focusing solely on Corcept's induced infringement claim. The court ruled in Teva's favor, concluding that Corcept failed to show (1) that Teva's product, if marketed, would lead to direct infringement; and (2) that Teva had a specific intent to induce infringement. Corcept appealed.
On appeal, Corcept challenges the district court's findings in both aspects. Regarding direct infringement, Corcept argues that the district court erred when it looked to general physician practice (rather than Teva's label itself), required evidence of actual past infringement, and required evidence of prevalent direct infringement. To Corcept, the district court should have begun its analysis with Teva's label, which Corcept contends contains infringing instructions for physicians to perform the claimed methods and thus sufficiently shows likelihood of direct infringement. Teva counters that the district court correctly found no direct infringement based on the lack of evidence showing actual infringing activity. Teva also argues that physicians generally avoid co-administering the claimed combination, that they are unlikely to do so given alternative treatment, and that Teva's label warns against co-administration (although it provides instructions if a physician decides to do so).
Regarding specific intent to induce, Corcept argues that the district court erred by determining that Teva's label did not induce physicians to consider "whether" to co-administer the claimed combination. To Corcept, the correct inquiry is whether the label instructs an infringing use after a doctor decides to co-administer the combination—which doctors will do when treating patients for whom such co-administration is medically necessary. Teva responds that the district court correctly found that a label describing an infringing use is insufficient—it must "encourage" the infringing use. Teva further stresses that its label cautions against co-administration and only provides instructions ifa physician independently decides to co-administer the combination.
The Federal Circuit's decision will provide important guidance on the required showing of both elements of induced infringement, especially when the allegation is based on a proposed ANDA label.
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