Idenix Pharms. LLC v. Gilead Scis., Inc.

IDENIX PHARMACEUTICALS LLCand UNIVERSITA DEGLI STUDI di CAGLIARI, Plaintiffs, v. GILEAD SCIENCES, INC., Defendant.

C.A. No. 14-846-LPS

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

February 16, 2018

Steven J. Balick, John G. Day, and Andrew C. Mayo, ASHBY & GEDDES, Wilmington, DE

Calvin P. Griffith, Ryan B. McCrum, Michael S. Weinstein, and Bradley W. Harrison, JONES DAY, Cleveland, OH

Anthony M. Insogna and John D. Kinton, JONES DAY, San Diego, CA

John M. Michalik and Lisa L. Furby, JONES DAY, Chicago, IL

Stephanie E. Parker, JONES DAY, Atlanta, GA

Jennifer L. Swize, JONES DAY, Washington, DC

Attorneys for Plaintiffs

Martina Tyreus Hufhal, Douglas E. McCann, Elizabeth M. Flanagan, Joseph B. Warden, and Santosh V. Coutinho, FISH & RICHARDSON P.C., Wilmington, DE

Frank E. Scherkenbach and Jenny Shmuel, FISH & RICHARDSON P.C., Boston, MA

W. Chad Shear, FISH & RICHARDSON P.C., San Diego, CA

Jonathan E. Singer and Tasha M. Francis, FISH & RICHARDSON P.C., Minneapolis, MN

Corrin N. Drakulich, FISH & RICHARDSON P.C., Atlanta, GA

Attorneys for Defendant

OPINION

February 16, 2018

Wilmington, Delaware

STARK, U.S. District Judge:

In this patent infringement case involving groundbreaking work by both parties in the field of treatments for the Hepatitis C virus ("HCV") infection, Plaintiffs Idenix Pharmaceuticals LLC and Universita Degli Studi di Cagliari (together, "Idenix") sued Defendant Gilead Sciences, Inc. ("Gilead"). Prior to trial, Gilead stipulated that, under the Court's claim construction, its accused products, Harvoni and Sovaldi, infringe the asserted claims of Idenix's patent, U.S. Patent No. 7,608,597 ("'597 patent").¹ (D.I. 452 at 8 n.2) After a two week-trial in December 2016, a jury found that Gilead failed to prove that the asserted claims are invalid and awarded Idenix $2.54 billion in damages. (D.I. 518)

Gilead now renews its motion for judgment as a matter of law ("JMOL") (D.I. 535), which the Court took under advisement during trial and later denied as moot and with the opportunity to renew following entry of judgment (D.I. 533). In its JMOL motion, Gilead urges the Court to set aside the jury's verdict on the basis that Idenix's asserted patent claims are invalid for failure to meet 35 U.S.C. § 112's written description and enablement requirements. Gilead alternatively asks the Court to reduce the jury's damages award as unsupported by the evidence.

The Court addresses each of Gilead's JMOL arguments in turn, beginning with damages and then moving on to validity.² For the reasons that follow, the Court finds that, whilejudgment as a matter of law is improper on damages and written description, the '597 patent is invalid for lack of enablement. Accordingly, the Court will grant in part and deny in part Gilead's motion.

I. BACKGROUND

HCV is a serious chronic liver disease that affects millions of people around the world. Cirrhosis and liver cancer caused by HCV infection claim thousands of lives every year in the United States alone. Until recently, the best treatment available for HCV infection involved use of interferon and ribavirin. In addition to the significant side-effects of interferon treatment, this course of treatment often failed to cure the disease. (See generally '597 patent; Carter Tr. at 770-71; McHutchison Tr. at 1234-38)

HCV is a member of the Hepacivirus genus and Flaviviridae family. Because its genetic material consists of ribonucleic acid, it is referred to as an RNA virus. Throughout the 1990s and into the new millennium, scientists were carrying out significant research on the use of modified nucleosides as antiviral agents. Some antivirals are developed as chain terminators, which bind to (and block off) the enzymes that allow the target virus to replicate. HCV was among the viruses being targeted for a possible cure that would act directly against the virus itself. (See generally Sommadossi Tr. at 365-74; McHutchison Tr. at 1239-40)

In 2000, Idenix discovered an important modification and filed a provisional patent application at the United States Patent and Trademark Office ("PTO"). (See Provisionalapplication No. 60/206,585, filed May 23, 2000 (PX311)) Idenix's work addressed the placement of a methyl group (CH₃) at the nucleoside's 2' (pronounced "two prime") up position. The application eventually led to, among others, U.S. Patent Nos. 6,914,054³ ("'054 patent") and the '597 patent.

Around the same time, a company called Pharmasset was pursuing similar research. Pharmasset was eventually acquired by Gilead. It worked on modified nucleosides that, like Idenix's, included a methyl group at the 2' up position. Pharmasset's work also involved placing a fluorine atom at the 2' down position. This compound - 2'-methyl up 2'-fluoro down - led to the groundbreaking "miracle" treatment that has cured HCV for millions who are afflicted with it, without the debilitating side effects that resulted from interferon treatments, and has produced billions of dollars in revenue for Gilead. Gilead named its drug containing 2' methyl up 2' fluoro down - which acts on HCV's NS5B polymerase - sofosbuvir, which Gilead markets under the trade name Sovaldi. Gilead also markets a combination of sofosbuvir and ledipasvir, which also inhibits the virus's NS5A protein activity, under the trade name Harvoni. (See generally McHutchison Tr. at 1238-70)

Given the importance of these medical breakthroughs, as well as the massive revenues Gilead has earned, it is perhaps unsurprising that Idenix and Gilead have for years been fighting patent disputes against one another all around the world. The instant suit began in 2013, when Idenix sued Gilead for infringement of the '054 and '597 patents in the United States District Court for the District of Massachusetts. (See generally D.I. 1) The case was later transferred tothis Court. (See D.I. 39)

The parties engaged in extensive discovery and the Court construed the relevant disputed claim terms. (See D.I. 237) On June 1, 2016, Gilead moved for summary judgment on several issues, including lack of written description in both the '054 and '597 patents. (See D.I. 287) The Court denied the motion. (See D.I. 367) Among the Court's reasons for denying summary judgment based on lack of written description was that there remained unresolved claim construction disputes. The Court ordered supplemental claim construction briefing, held a supplemental claim construction hearing, construed two additional disputed claim terms, and, on November 16, 2016, denied Gilead's renewed motion for summary judgment of invalidity due to lack of written description. (See D.I. 371, 410, 447)

Thereafter, as the parties prepared for trial, Gilead stipulated to infringement of the '597 patent based on the Court's claim constructions, and Idenix dropped the '054 patent from the case. (D.I. 452 at 4-5, 8 n.2) The parties proceeded to trial on willfulness, damages, and invalidity with respect to several claims of the '597 patent. (See id. at 4-5)

The trial lasted nine days. The parties called a total of 27 witnesses, including four experts. Idenix's expert witnesses included Dr. Chris Meier, a professor of organic chemistry, and Dr. Raffaele De Francesco, a virologist. Gilead's expert witnesses included Dr. John Secrist, a medicinal chemist, and Dr. Christoph Seeger, a virologist. The parties also moved 179 exhibits into evidence. (See D.I. 586 ("Arg. Tr.") at 34)

During trial, both parties moved for judgment as a matter of law (see D.I. 509, 514), which the Court took under advisement (Tr. at 2043). The jury then returned a verdict finding that Gilead's infringement was willful, that Gilead had failed to prove the patent claims areinvalid, and that Idenix is entitled to $2.54 billion in damages. (See D.I. 518)

The Court entered judgment on the verdict. (D.I. 533) Thereafter, both parties filed post-trial motions. Idenix's motion - which is addressed in a separate Opinion (D.I. 587) - sought enhanced damages for Gilead's willful infringement, a higher ongoing royalty than the royalty on which the damages for past infringement were based, an award of attorney fees, and prejudgment interest at the prime rate. (D.I. 538) Gilead's motion, which is addressed here, asks the Court to find the '597 patent invalid for lack of enablement and/or written description. Gilead also contends that Idenix presented a legally insufficient damages case and seeks remittitur to a damages figure of no greater than $380 million. (D.I. 535 at 1) Alternatively, Gilead seeks a new trial.⁴

After the parties completed their principal briefing on Gilead's motion (see D.I. 536, 554, 565), the parties submitted several letters notifying the Court of subsequent authority (see D.I. 570, 572, 576-79, 583-84). At the Court's direction, the parties also submitted letter briefs addressing the impact of two of this Court's recent decisions in other cases finding patents invalid due to lack of enablement. (See D.I. 581, 582) The Court heard extensive argument during a hearing on September 7, 2017. (See Arg. Tr.)

On September 22, 2017, the Court issued its Opinion on Idenix's motion, denying Idenix's request to enhance damages for willful infringement as well as its request to declare this case exceptional and award Idenix attorney fees. (D.I. 587 at 3-17) The Court granted Idenix'srequest that the pre-judgment interest it was being awarded be compounded at 3.25 - 3.75 % (prime rate) instead of 0.10 - 0.14 % (T-bill rate). (Id. at 17-18) The Court expressly stated that its rulings on Idenix's motion were based on the assumption - which it emphasized was by no means a ruling - that Gilead's pending motion would be denied in full. (See id. at 2 n.4)

The Court now turns to the issues raised in Gilead's motion.

II. LEGAL STANDARDS

A. Judgment as a Matter of Law

Judgment as a matter of law is appropriate if "the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party" on an issue....