Idenix Pharms. LLC v. Gilead Sciences, Inc.

The court granted judgment of invalidity as a matter of law based on lack of enablement, and denied defendant’s motions for judgment as a matter of law based on lack of written description and for reduced damages.

February 16, 2018

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Idenix Pharms. LLC v. Gilead Sciences, Inc., Civ. No. 14-846, 2018 U.S. Dist. LEXIS 25663 (D. Del. Feb. 16, 2018) (Stark, J.) 

Drug Product and Patent(s)-in-Suit: Solvaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir); U.S. Patent No. 7,608,597 (“the ’597 patent”)

Nature of the Case and Issue(s) Presented: Solvaldi and Harvoni are indicated for treatment of Hepatitis C. Idenix sued Gilead alleging patent infringement based on its marketing and sale of Solvaldi and Harvoni. Gilead stipulated to infringement of the ’597 but asserted that the patent was invalid. After a two-week trial, a jury found that Gilead failed to prove the asserted claims invalid and awarded Idenix $2.54 billion in damages. Gilead renewed its motion for judgment as a matter of law (“JMOL”), asking the court to set aside the jury’s verdict because Idenix’s claims were invalid under 35 U.S.C. § 112. In the alternative, Gilead asked the court to reduce the jury’s damages award as unsupported by the evidence. The court granted the former and denied the latter.

Why Gilead Prevailed: The court first addressed Gilead’s request to reduce the damages award. Gilead made two arguments in support of its motion. First, Gilead argued that Idenix’s expert failed to establish that the license agreements he relied on were sufficiently comparable. Second, Gilead argued that Idenix’s damages case violated the Entire Market Value Rule (“EMVR”). The court disagreed with both arguments. With respect to comparability of the license agreements, the court found that the jury was free to accept the expert’s opinion that the licenses he relied on were comparable to the hypothetical license. Substantial evidence was present to support a finding of sufficient comparability. With respect to the EMVR, Gilead argued that the royalty base that Idenix’s expert used failed to account for Gilead’s own contributions to its products. The court found that the EMVR did not apply. Substantial evidence supported the jury’s finding that the ’597 covered sofosbuvir and that there was no unpatented or non-infringing feature in the accused product as the active ingredient is sofosbuvir. Thus, the court denied Gilead’s motion with respect to damages.

Next, the court addressed Gilead’s § 112 arguments. Gilead first argued that the asserted claims failed to meet the written description requirement. The court noted that written description is a question of fact. The court concluded that substantial evidence supported the jury’s finding that the record did not contain clear and convincing evidence of lack of written description. Thus, the court denied this portion of Gilead’s motion.

Gilead next argued that the asserted claims were not enabled. The court noted that enablement is a question of law based on underlying facts, and ultimately concluded that the asserted claims were not enabled. The independent claim at issue required “an effective amount of a purine or pyrimidine β-D-T-methylribofuranosyl nucleoside.” The court construed the term β-D-T-methylribofuranosyl nucleoside as a structural limitation encompassing any β-D-nucleoside with a certain configuration of a methyl group and non-hydrogen substituents. The court construed the term “effective amount” as a functional limitation meaning “an amount that is effective to treat HCV.”

The undisputed facts showed that the structural limitations of the claims were satisfied by billions of compounds. Idenix argued that a POSA would know not to use just any element that literally satisfied the structural limitations, e.g., elements that a POSA would not use in a pharmaceutical formulation. The court pointed out that Idenix’s argument only reduced the scope of the structural limitations to millions or many thousands of compounds -- still a very large number. The functional limitation, on the other hand, encompassed a much smaller number of compounds. Thus, the court noted that the functional limitation greatly reduced the scope of the claims.

The court next addressed the disputed factual record, holding that on those disputes, a reasonable fact finder could have only found in favor of Gilead. First the court found that in order to determine which compounds were embodiments of the claims, a POSA would have had to synthesize them. The vast majority were not available “off the shelf.” And synthesis of just one candidate could have taken years on its own. Moreover, the court concluded that synthesis of this type of compound was not routine or simple, but would have required extensive experimentation.

Additionally, the court found that while nucleoside synthesis was well known, the more specialized task of synthesizing modified nucleosides for the treatment of HCV was in its infancy. Thus a POSA could not simply and readily ascertain which structures would have that activity. Next, the court found that determining whether a compound that met the structural limitations also met the functional limitation required screening, another significant, rate-limiting factor. The court noted, “screening would have been necessary, takes time, yields unpredictable results, and would need to be undertaken repeatedly.”

Finally, the court found that a POSA could not predict or “visualize” whether a compound satisfying the structural limitations would also meet the functional limitation. Idenix’s experts testified that a POSA would not know if a nucleoside had activity against HCV until she were to have made it and tested it. Thus, the court concluded that testing “played an indispensable and exploratory – rather than confirmatory – role in a POSA’s attempts to practice the ’597 patent’s claims.” Therefore, the asserted claims were not enabled because the amount of experimentation required of a POSA was undue.

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