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UCB, Inc. v. Accord Healthcare, Inc.

Lack of Reasonable Expectation of Success in Substituting Groups for Anti-Epilepsy Compound Preserves Patentability

UCB, Inc. v. Accord Healthcare, Inc., __ F.3d __, 2018 WL 2324751 (Fed. Cir. May 23, 2018) (Prost (dissenting), Bryson, STOLL) (D. Del.: Stark) (2 of 5 stars)

Fed Cir affirms Hatch-Waxman bench determination that UCB’s patent was not proved anticipated or obvious. UCB’s patent covers Vimpat (lacosamide), an anti-epileptic drug. Addressing obviousness-type double patenting, it was proper for the district court to evaluate the differences between the claims in the asserted patent and those in the reference patent, as Accord had proposed per AbbVie, 764 F.3d 1366 (Fed. Cir. 2014). It was also proper for the district court to decline to consider those differences in “isolation,” but to consider them in their context within the claims, as per Eli Lilly, 689 F.3d 1368 (Fed. Cir. 2012). Acknowledging a “close case,” the opinion finds no clear error in the district court concluding that a PHOSITA would not have been motivated to modify a molecule described in the reference patent claims so as to reach the molecule in the asserted claims. Specifically, the evidence supported a finding of no reasonable expectation in success that the proposed substitution (placing certain molecular groups at certain locations) would have yielded a compound effective for the claimed purpose. The opinion describes how the district court properly considered a graduate thesis (“LeGall”) in its consideration of obviousness-type double patenting. While LeGall speculated that a certain compound “may” be useful for the targeted purpose (anticonvulsant medication), the district court did not err in crediting expert testimony that a PHOSITA looking to LeGall “would have had no interest in pursuing that compound[.]” Op. at 22.

Addressing obviousness, the district court did not err by applying a lead compound analysis (as in Otsuka, 678 F.3d 1280 (Fed. Cir. 2012)) to evaluate patentability. “We are not aware of any authority holding that a lead compound analysis is or is not required in cases involving purifying mixtures.” Op. at 27. Aventis, 499 F.3d 1293 (Fed. Cir. 2007), neither requires nor bars lead compound analysis in such a case. In any event, the district court’s findings were supported by the record.

Addressing anticipation, the district court did not clearly err in rejecting argument that LeGall anticipated. Per May, 574 F.2d 1082 (CCPA 1978), disclosure of a racemic mixture does not necessarily establish disclosure of a specific enantiomer within the mixture.

Dissent: Chief Judge Prost would have held that the district court clearly erred in finding that there would have been no reasonable expectation of success in making the chemical group substitutions separating the claims from the prior art. She views the claims as not patentably distinct from the reference patent claims.

KEYWORDS: REASONABLE EXPECTATION OF SUCCESS; OBVIOUSNESS-TYPE DOUBLE PATENTING (NO); OBVIOUSNESS (NO); ANTICIPATION (NO)