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Endo Pharmaceuticals Inc. v. Actavis LLC

Statement of Goal, Without Guidance on Achieving It, May Not Increase Expectation of Success

Endo Pharmaceuticals Inc. v. Actavis LLC, __ F.3d __, 2019 WL 1967605 (Fed. Cir. May 3, 2019) (WALLACH, Clevenger, Stoll (dissenting)) (D. Del.: Andrews) (2 of 5 stars)

Fed Cir affirms infringement judgment in Hatch-Waxman case. Endo’s patent relates to the preparation of “morphinan alkaloids,” used for pain relief, and claimed “hydrochloride salts” of oxymorphone having low levels of an impurity, “14-hydroxymorphinone.” The district court correctly construed “14-hydroxymorphinone” to mean the salt form of that alkaloid. The opinion describes how this was supported by the dependent claims (several of which referred to “the hydrochloride salt of [the parent claim]”, and by the written description and extrinsic evidence. The district court did not clearly err in determining that a person of ordinary skill in the art would not have a reasonable expectation of success in combining the references Actavis had presented so as to reach the patented low-impurity oxymorphone salt. The opinion is detailed and fact-specific. It describes how, though the three references presented by Actavis each contained a piece of the necessary technology, the record was sufficient to support the district court’s determination that combining them would have posed serious technical hurdles, diminishing an expectation of success. And although certain FDA communications were in the record specifically requiring the industry to purify oxymorphone to the claimed levels, those communications merely “recite[d] a goal without teaching how the goal is attained.” Op. at 20. The opinion rejects Actavis’s contention that the district court applied too high a test for the expectation of success, noting that the district court cited the correct legal standard and was generally careful in assessing the evidence. The opinion also rejects Actavis’s argument that there had been evidence of simultaneous invention (indicating nonobviousness); the evidence at issue was in patent applications relating not to oxymorphone but oxycodone and “the one successful purification of oxymorphone [in the applications] to the level of that claimed . . . is unpersuasive with regard to obviousness.” Op. at 24 n.14.

Dissent: Judge Stoll would have vacated and remanded for a new obviousness analysis under corrected standards, and revised treatment of the FDA communications. Her opinion notes evidence that the development of the patented technology was a direct response to the FDA’s mandate, criticizes the district court for applying a heightened standard to the “reasonable expectation of success” test, and criticizes the district court for “conflat[ing] the requirements of reasonable expectation of success and motivation to combine.” Dissent at 4.

KEYWORDS: HATCH-WAXMAN; INVALIDITY (NO); REASONABLE EXPECTATION OF SUCCESS; OBVIOUSNESS (NO)