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Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc.

No Reasonable Expectation of Success Shown Where Rebuttal Evidence Raised Questions About Adapting Treatment Beyond a Single Individual

Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., __ F.3d __, 2018 WL 3401815 (Fed. Cir. July 13, 2018) (Moore, Linn, CHEN) (D. Del.: Robinson) (2 of 5 stars)

Fed Cir affirms Hatch-Waxman bench determination that Endo’s claims were not proved invalid. Co-plaintiff Bayer holds two patents listed in the Orange Book for Endo’s Aveed product, a drug for treating physiologically low levels of testosterone in men. The district court did not clearly err in rejecting Custopharm’s argument that a person of skill would have had a motivation to lower a reference’s dose amount in view of determinations that patients were being overdosed; contemporaneous guidelines indicated otherwise. The district court also did not clearly err in rejecting Custopharm’s argument that a separate limitation was inherently disclosed. The opinion describes how Custopharm failed to carry its burden to show that the prior art observations could have been obtained only by practicing the limitation in question. Omeprazole Patent Litigation, 483 F.3d 1364 (Fed. Cir. 2007), and Crish, 393 F.3d 1253 (Fed. Cir. 2004), are not contradictory because those cases involved the prior art use of a “known” product with known characteristics. In this case, the actual composition used in the prior art was not actually “known”; Custopharm had failed to demonstrate that the composition employed in the past actually had to be the one claimed. The district court also did not err in concluding that Custopharm had failed to show a reason to combine references, where the prior art showed a need for a co-solvent, but nothing suggesting practicing the limitation rather than using other available co-solvents. The district court also did not err in rejecting Custopharm’s contention that a claimed injection schedule was obvious. The opinion discusses how Custopharm failed to establish a reasonable expectation of success for a practitioner making its proposed modification to the prior art, particularly where Endo presented evidence that the technology in question is unpredictable and experimentation would be necessary to make it safe for an entire population. Custopharm’s contention that the invention should be examined “from the perspective of the individual patient,” and not the larger population, was unsupported.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS (NO); INHERENCY; MOTIVATION TO COMBINE; REASONABLE EXPECTATION OF SUCCESS