Necessity of Testing “Billions” of Variant Compounds to Fully Possess Claim Leads to Non-Enablement
Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., __ F.3d ___, 2019 WL 5583543 (Fed. Cir. Oct. 30, 2019) (PROST, Newman (dissenting), Wallach) (D. Del.: Stark) (3 of 5 stars)
Fed Cir affirms Hatch-Waxman JMOL of invalidity for lack of enablement, and reverses denial of JMOL of invalidity for lack of written description. Idenix claimed infringement by Gilead’s upcoming hepatitis C (“HCV”) treatment sofosbuvir.
Enablement: Under the district court’s undisputed construction, Idenix’s claim encompasses all nucleosides of a certain type (“β-D nucleosides”) having a certain structure (a methyl group at the “2′-up” location) that are effective in treating HCV. The structural limits comprised “billions of potential 2′-methyl-up nucleosides,” and the record was legally insufficient to support Idenix’s contention that undue experimentation was not required for a person of skill to identify those effective in treating HCV. Applying the seven factors in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), the opinion analyzes the record and determines that the record required weighing in favor of non-enablement for six (quantity of experimentation, specific working examples in the patent, guidance in the patent, unpredictability of the art, scope of the claims), on could weigh against non-enablement only for one (routine nature of experimentation). The opinion notes similarities between this case and Wyeth & Cordis, 720 F.3d 1380 (Fed. Cir. 2013). That the state of the arts in screening and synthesis had advanced in the time since the patent application in Wyeth did not require a different determination.
The opinion criticizes the dissent as “making an argument not advanced by Idenix at trial or before us, . . . disregarding the district court’s binding claim construction, ignoring the resulting stipulation of infringement, and analyzing a case that is not the one presented to us.” Op. at 7 n.3.
Written description: Addressing Gilead’s cross-appeal, the record required a determination that Idenix’s disclosure did not convey to other reasonably skilled artisans possession “of those 2′-methyl-up nucleosides that fall within the boundaries of the claim (i.e., are effective against HCV), but are not encompassed by the explicit formulas or examples provided in the specification.” Op. at 22. The opinion particularly discusses how Idenix’s disclosure did not address the specific structure in Gilead’s product (“2′-methyl-up 2′-fluoro-down nucleosides). Though the specification had various position-by-position formulas, it “provid[ed] no indication that any nucleosides outside of those disclosed in its formulas could be effective to treat HCV—much less any indication as to which of those undisclosed nucleosides would be effective.” Id. at 23. Though a species-by-species recitation is not required per Ariad, 598 F.3d 1336 (Fed. Cir. 2010) (en banc), the absence of the compound in question amid Idenix’s disclosure of “tens or hundreds of thousands of possible nucleosides, . . . with dozens of distinct stereochemical structures” raises questions about the sufficiency of Idenix’s description. Taking the record into account, the specification “could not demonstrate to a POSA that the inventor had possession of that embodiment [Gilead’s accused product] at the time of filing.” Op. at 25.
Dissent: Judge Newman views Idenix’s claims as “narrow,” and the specification as having a “large number of unclaimed chemical variants[.]” “It is incorrect to include those variants in the claims and then to invalidate the claims because these variants are not described and not enabled.” Op. at 1. “[A] reasonable jury could have understood the claims as directed to the nucleosides that are specifically described and that are shown to have the claimed antiviral activity.” Id. at 2. On that basis, JMOL of non-enablement was not warranted in her view.
KEYWORDS: HATCH-WAXMAN; JUDGMENT AS A MATTER OF LAW; CLAIM CONSTRUCTION; ENABLEMENT (NO); WRITTEN DESCRIPTION (NO)