ENDO PHARMACEUTICALS INC. v. ACTAVIS LLC
- May 3 2019 |
- Category: CAFC Updates
Endo Pharmaceuticals and Mallinckrodt sued Actavis and Teva, alleging that two Abbreviated New Drug Applications filed by Actavis infringed claims of U.S. Patent No. 8,871,779 relating to morphinan alkaloids, such as oxymorphone, which are used for pain relief. The district court held that Actavis failed to prove by clear and convincing evidence that any of the asserted claims were invalid as obvious or anticipated, and entered final judgment of infringement, based on a stipulation by Actavis. Actavis appealed, challenging the invalidity determination by alleging that the district court erred by (1) misconstruing the claim term 14-hydroxy-morphinone; and (2) determining that the asserted claims were not obvious in light of the prior art. With respect to claim interpretation, the CAFC finds that the district court, relying on intrinsic and extrinsic evidence, properly determined that a PHOSITA would understand the 14-hydroxymorphinone limitations to mean 14-hydroxymorphinone hydrochloride, i.e., the salt form of 14-hydroxymorphinone. With respect to obviousness, the CAFC concludes that the district court did not clearly err in concluding that a PHOSITA would lack a reasonable expectation of success in combining the prior art. Accordingly, the CAFC affirms. Judge Stoll dissents because in his view the district court improperly imposed a requirement that a reference must teach how to solve a problem to provide a motivation to combine, and applied an erroneously heightened standard for reasonable expectation of success by requiring a “definitive solution” and proof of actual success.