By Opinion entered by The Honorable Leonard P. Stark in Idenix Pharmaceuticals LLC et al. v. Gilead Sciences, Inc., Civil Action No. 14-846-LPS (D.Del. February 16, 2018), the District Court granted in part Defendant Gilead Sciences, Inc.’s renewed motion for judgment as a matter of law (“JMOL Motion”) after finding that the asserted claims of the patent-in-suit, U.S. Patent No. 7,608,597 (“the ‘597 patent”) are invalid for failure to meet 35 U.S.C. § 112’s enablement requirements. The Court denied Defendant’s JMOL Motion as to damages and written description. Id. at *2 and 51.

By way of background, the science involved in this case involves groundbreaking work by both parties in the field of treatments for the Hepatitis C virus infection. The ‘597 patent is entitled “Methods and Compositions for Treating Hepatitis C Virus. It was issued on October 27, 2009. Id. at *1. Prior to trial, Defendant Gilead stipulated that, under the Court’s claim construction, its accused products, Harvoni and Sovaldi, infringe the asserted claims of Idenix’s ‘597 patent. Id. At the end of a two week trial in December 2016, the jury found that Gilead failed to prove that the asserted claims are invalid and awarded Idenix $2.54 billion in damages. Id. Thereafter, Gilead renewed its JMOL motion, which the Court had taken under advisement during trial and later denied as moot and with the opportunity to renew following entry of judgment. Id.

In its JMOL motion, Gilead asked the Court to set aside the jury’s verdict on grounds that Idenix’s asserted patent claims are invalid for failure to meet 35 U.S.C. §112’s written description and enablement requirements. Id. Alternatively, Gilead requested the Court to reduce the $2.54 billion damages award as unsupported by the evidence. Id.

After reviewing the record and evaluating the JMOL motion, the Court found that “a reasonable jury, even taking all the evidence in the light most favorable to Idenix and drawing all reasonable inferences in favor of Idenix, could only have concluded that Idenix’s ‘597 patent is invalid due to lack of enablement. The only reasonable finding, based on the trial record, is that Gilead met its burden to prove nonenablement by clear and convincing evidence. The trial revealed that there are no genuinely disputed material facts with respect to enablement.” Id. at *50-51. Accordingly, the Court concluded that Gilead is entitled to judgment as a matter of law that the asserted claims of the ‘597 patent are invalid for lack of enablement. Id. at *51.

The effect of the Court’s Order will be the setting aside of the jury’s $2.54 billion damages award to Idenix.  A copy of the Opinion is attached.

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