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Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc.

Description of Technique Equivalent to Claim Limitation May Satisfy Written Description Requirement

Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc., __ F.3d __, 2019 WL ___ (Fed. Cir. Aug. 15, 2019) (Prost (dissenting in part), LOURIE, Wallach) (D. Del.: Andrews) (4 of 5 stars)

In appeal from Hatch-Waxman case involving three Nalpropion patents, Fed Cir affirms confirmation of compliance with the written description requirement for one patent’s sole asserted claim, and reverses determination that claims of other patents were not proved obvious. Nalpropion’s patents are listed in the Orange Book for Contrave (naltrexone HCl/bupropion HCl), which Nalpropion markets for weight management in overweight adults.

Written description: The district court correctly determined that one patent’s asserted claim had sufficient written description. The opinion describes how there was sufficient evidence to support the district court’s determination that a person of ordinary skill would have viewed two dissolution profiles (“USP Apparatus 2 Paddle Method” and “USP Apparatus 1 Basket Method”) as substantially equivalent for purposes of evaluating written description, and to support its determination that the dissolution data in two described tables (both using “USP 1”) adequately supported the claimed dissolution data ranges (requiring “USP 2”). “While as a general matter written description may not be satisfied by so-called equivalent disclosure, in this case, buttressed by the district court’s fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps, we affirm the district court’s conclusion. Rigidity should yield to flexible, sensible interpretation.” Op. at 12.

Obviousness: The record did not support the district court’s determination that Actavis had failed to prove claims of other patents obvious. The opinion discusses how the record showed that both naltrexone and bupropion had weight loss effects, and concluded “that a person of ordinary skill would have been motivated to combine them.” Op. at 17. It rejects Nalpropion’s argument that the evidence for bupropion’s weight loss efficiency was insufficient to obtain FDA approval by itself. Per Allergan, 726 F.3d 1286 (Fed. Cir. 2013), there is no requirement that an obviousness rationale in this type of case form the basis for FDA approval. “The inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss.” Op. at 19. It also rejects Nalpropion’s proffer of evidence of unexpected success because “[b]oth drugs were known to affect weight loss.” Id. at 21. And even if others had tried and failed to find an effective combination for weight loss, “that factor alone cannot overcome the clear record in this case that the combination of the two drugs was known and that both drugs would have been understood to be useful for this purpose.” Id.

Dissent: Chief Judge Prost would have reversed the district court’s written description determination. In her view the majority’s determination that a “substantially equivalent” disclosure may satisfy the written description requirement is incompatible with Ariad, 598 F.3d 1336 (Fed. Cir. 2010) (en banc), and Lockwood, 107 F.3d 1565 (Fed. Cir. 1997). And even if the approach were permissible, in Chief Judge Prost’s view the district court’s determination of equivalence was supported by “not a shred of record evidence,” and refuted by other evidence.

KEYWORDS: HATCH-WAXMAN; WRITTEN DESCRIPTION (YES); OBVIOUSNESS (NO)