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Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy’s Laboratories Inc.

Pharma Claim Requiring Efficacy Needs Written Description Demonstrating Possession of Invention

Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy’s Laboratories Inc., __ F.3d __, 2019 WL ___ (Fed. Cir. May 15, 2019) (Prost, CLEVENGER, Wallach) (D.N.J.: Cooper) (3 of 5 stars)

Fed Cir reverses Hatch-Waxman judgment confirming validity, and dismisses cross-appeal from summary judgment of noninfringement as to a certain product on a certain patent. The patents relate to therapies combining NSAIDs with acid inhibitors for pain relief, and are embodied by Nuvo’s Vimovo (naproxen/esomeprazole) product. The district court erred in determining that Nuvo’s claims were supported by written description, particularly as to their requirements of “effective” dosing for the acid inhibitor. The opinion rejects Nuvo’s various arguments that the claims recite no efficacy requirement for the acid inhibitor itself, finding several of the arguments forfeited for not being presented below. The opinion then closely reviews the record and finds no description of efficacy for the claimed acid inhibitor. Sections of the written description calling for an “amount effective” to raise gastric pH were insufficent; per Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002), the written description requirement cannot be satisfied merely by repeating claim language. The opinion also notes that it was undisputed that skilled artisans at the time of the invention “would not have known or understood” the effectiveness of the acid inhibitor at issue. Op. at 18. “In light of the fact that the specification provides nothing more than the mere claim that [a certain inhibitor] might work, even though persons of ordinary skill in the art would not have thought it would work, the specification is fatally flawed.” Id. at 19.

The opinion also rejects Nuvo’s argument that efficacy was inherent, since its patents taught how to make and use the claimed invention. The opinion describes how the focus of the written description inquiry is to demonstrate that the inventor was in actual possession of all aspects of the claimed invention. Alcon Research, 745 F.3d 1180 (Fed. Cir. 2014), is not contradictory because in that case, the patent expressly described how the discovery was unexpected, gave exemplary formulations, and disclosed data. None of that was present here. “Under those circumstances [in Alcon], it was not necessary for the patentee to demonstrate or otherwise ‘prove’ beyond the data disclosed in the specification that the invention works. Here, there is no similar hook or disclosure in the specification that an ordinarily skilled inventor can rely on to understand that the inventor possessed effective [acid inhibitor].” Op. at 22. Allergan, 796 F.3d 1293 (Fed. Cir. 2015), is also distinguishable because in that case it was undisputed that the inherent properties of the claimed formulation would have the necessary effect. Here, there was a dispute around the inherent properties of the acid inhibitor, and no written description to guide.

KEYWORDS: HATCH-WAXMAN; WRITTEN DESCRIPTION (NO)