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Sumitomo Dainippon Pharma Co. v. Emcure Pharmaceuticals Ltd.

No Need to Resolve Full Claim Scope Upon Determining Coverage Over Dispositive Compound

Sumitomo Dainippon Pharma Co. v. Emcure Pharmaceuticals Ltd., __ F.3d __, 2018 WL 1787667 (Fed. Cir. Apr. 16, 2018) (Moore, Mayer, STOLL) (D.N.J.: Chesler) (2 of 5 stars)

Fed Cir affirms stipulated judgment of infringement in Hatch-Waxman case. The case involved Emcure’s ANDA seeking approval for a generic version of plaintiff Sunovion Pharmaceuticals’ Latuda (lurasidone) schizophrenia and bipolar depression drug. Claim 14 of Sunovion’s patent recited “an imide compound of the formula,” followed by a drawing of lurasidone. The district court correctly determined that that claim at least covered lurasidone (specifically, “the (–)-enantiomer” of a compound in the written description). This was sufficient to affirm the judgment below.

The opinion discusses how defendants had argued that the claim should have been restricted to “a racemic mixture of two enantiomers of which the structural formula [the drawing] is representative.” This argument was based on a close reading of the written description, and its disclosed process for making the various compounds of interest. Defendants’ argument would have “excluded the specific enantiomer depicted in claim 14,” and both the district court and the Fed Cir rejected it as lacking support in the specification. The opinion describes how lingering questions remain about what materials/mixtures besides lurasidone might be covered by claim 14. These were based on uncertainty as to whether the compounds of interest in the description were racemic mixtures or not. It was unnecessary to resolve these lingering questions.

KEYWORDS: CLAIM CONSTRUCTION; INFRINGEMENT (YES); HATCH-WAXMAN