Sofosbuvir - USA

On Feb 16, 2018, Judge Stark of District of Delaware held that Idenix’s patent is invalid for lack of enablement & thus granted Gilead's renewed motion for judgment as a matter of law.

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 ldenix's patent, U.S. Patent No. 7,608,597 ("'597 patent"). 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. Gilead now renews its motion for judgment as a matter of law ("JMOL"). 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.

Background:

In 2000, Idenix discovered an important modification to HCV compounds and filed a provisional patent application at the United States Patent and Trademark Office ("PTO"). 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. 6,914,054 ('"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. Pharmassets 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 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 NSSB 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.

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. The case was later transferred to Delaware court. 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. The parties proceeded to trial on willfulness, damages, and invalidity with respect to several claims of the '597 patent. The jury then returned a verdict finding that Gilead's infringement was willful, that Gilead had failed to prove the patent claims are invalid, and that Idenix is entitled to $2.54 billion in damages. 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. The Court granted Idenix's request 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).

Current issue:

The Court then turned to the issues raised in Gilead's motion. With respect to damages, Gilead requests judgment as a matter of law, remittitur of the jury's damage award-to an amount not to exceed $380 million. Gilead contends that Idenix' s damages presentation was fatally deficient in two respects. First, Idenix's damages expert, Andrew Carter, failed to establish that the patent license agreements on which he relied were sufficiently comparable. Second, Carter and Idenix's damages case violated the Entire Market Value Rule ("EMVR"). The Court disagrees with Gilead.

Gilead's motion next asked the Court to conclude that Idenix's '597 patent is invalid due to its failure to comply with the requirements of 35 U.S.C. § 112. Gilead challenges the jury's finding that the '597 patent sufficiently described and enabled its claimed subject matter. With respect to written description, which is a factual issue, the Court found that there was substantial evidence to support the jury's conclusion that clear and convincing evidence does not support a finding of lack of written description. Hence, the Court denied this portion of Gilead's motion.

With respect to enablement, which presents a question of law, the Court concluded, as a matter of law, that no reasonable fact finder could find anything other than that the '597 patent is not enabled. Gilead argued that the term "B-D-2'-methyl-ribofuranosyl nucleoside" encompasses any B-D-nucleoside that includes "a five member sugar ring with a methyl group in the 2' up position and non-hydrogen substituents at the 2' down and 3' down positions. Second, at Idenix' s urging, the Court construed the claims to contain a functional limitation, through claim 1 's preamble ("A method for the treatment of a hepatitis C virus infection") and its "effective amount" term. Combining these two limitations, the claims cover all those nucleosides, but only all those nucleosides, that meet the Structural Limitations - including a methyl group at the 2'-up position - and the Functional Limitations of exhibiting effective anti-HCV activity. Thus, as further explained below, the claims as construed combine Structural Limitations that are satisfied by an enormous number of compounds with Functional Limitations that are satisfied by an unknown, but far smaller, number of undisclosed compounds.

Court held that POSA would ask the crucial question: which of the compounds meeting the Refined Structural Limitations also satisfy the Functional Limitations? A reasonable fact finder could only conclude that the patent fails to provide this necessary information. The accused embodiment - 2' methyl up 2' fluoro down - which, undisputedly, comes within the scope of the claims as construed is not expressly disclosed in the '597 patent. While fluorine is disclosed as a candidate for the 2' up position, it is not disclosed as a candidate for the 2' down position. Even the inventor of the '597 patent, Dr. Michael Somadossi, testified that there is no disclosure of the 2' methyl up 2' fluoro down nucleoside in either the May 2000 provisional patent application or the May 2001 patent application.

This conclusion further compelled by application of the Wands factors to the record. First, with respect to "the quantity of experimentation necessary," significant work is necessary to synthesize and screen the full scope of the compounds that fall within the claims, or even to synthesize and screen any particular compound coming within the scope of the claims. The next factors -the disclosure in the patent of "specific working examples" and the "amount of guidance presented in the patent" - also favor a finding of non-enablement. While the patent discloses working embodiments, routes for making the claimed nucleosides, and assays for screening candidates, the claims' Structural Limitations are enormously broad, the Refined Structural Limitations are also quite broad, and the patent's examples disclose a significant number of possible arrangements.

Because the Structural Limitations are satisfied by such a large number of compounds, and because of the other Wands factors as applied here, the amount of experimentation to refine this broad set of compounds to those that also satisfy the Functional Limitations, given the limited teachings on this point in the patent and the state of the prior art, is an "undue" amount. Thus, the only conclusion that can be reached based on the trial record is that the asserted claims of the '597 patent are invalid for lack of enablement.

For the reasons given above, the Court found that, while judgment as a matter of law is improper on damages and written description, the '597 patent is invalid for lack of enablement. Accordingly, the Court granted in part and denied in part Gilead’s motion.