Automated Summary
Key Facts
Corcept sued Teva for infringing patents related to mifepristone coadministration with strong CYP3A inhibitors for Cushing's syndrome treatment. The district court found no infringement due to lack of evidence of past physician use, safety concerns with coadministration, and Teva's proposed label allowing non-infringing dosing (up to 900 mg). The Federal Circuit affirmed the decision.
Issues
The court affirmed the district court's finding that Corcept failed to prove direct infringement of U.S. Patents Nos. 10,195,214 and 10,842,800, as physicians are unlikely to practice the claimed methods due to safety concerns and dosing challenges, and a non-infringing alternative (osilodrostat) is preferred.
Holdings
The court affirmed the district court's decision that Corcept Therapeutics, Inc. failed to prove direct infringement of U.S. Patent Nos. 10,195,214 and 10,842,800 by Teva Pharmaceuticals USA, Inc.'s proposed generic version of Korlym. The court found no clear error in the district court's determination that physicians would not practice the claimed methods due to safety concerns, dosing challenges, and availability of safer alternatives like osilodrostat, and that Teva's proposed label would not cause infringement.
Remedies
The court affirmed the district court's judgment of no patent infringement and ruled no costs are awarded.
Legal Principles
- The court applied the preponderance of evidence standard to determine whether Corcept had proven direct infringement and specific intent to induce infringement.
- The court held that Corcept bore the burden to prove direct infringement and specific intent to induce infringement by a preponderance of the evidence, as required for induced infringement claims.
- The court permitted consideration of outside-the-label evidence, including physician testimony about actual and hypothetical practice, to determine whether direct infringement would occur if Teva's product were marketed.
Precedent Name
- Vanda Pharms. Inc. v. W.-Ward Pharms. Int'l Ltd.
- Genentech, Inc. v. Sandoz Inc.
- GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.
- Limelight Networks, Inc. v. Akamai Techs., Inc.
Cited Statute
- Judicial Code
- Food, Drug, and Cosmetic Act
Judge Name
- STOLL
- WANG
- MOORE
Passage Text
- a proposed ANDA label that 'encourages, recommends, or promotes an infringing use without any additional evidence showing such an infringing use will in fact occur, is insufficient for a finding of direct infringement.'
- For past infringement, the court found a lack of record evidence showing any physicians had ever practiced the claimed methods. For future infringement, the court found it was highly unlikely physicians will practice the claimed methods because (1) physicians avoid coadministration due to dosing challenges and safety concerns; (2) the recently approved osilodrostat drug that blocks cortisol production is a safer and more effective non-infringing alternative; and (3) a physician can follow Teva's proposed label and not infringe the claims.
- the benefits of co-administering mifepristone and ketoconazole never outweigh the risks, especially since the introduction of osilodrostat.