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Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.

United States District Court, D. Delaware

February 16, 2018

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

          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

          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, 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 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 Provisional application 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, 054[3] ("'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 to this 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 are invalid, 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'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). (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. Fed.R.Civ.P. 50(a)(1). "Entry of judgment as a matter of law is a sparingly invoked remedy, " one "granted only if, viewing the evidence in the light most favorable to the nonmovant and giving it the advantage of every fair and reasonable inference, there is insufficient evidence from which a jury reasonably could find liability." Marra v. Phila. Hous. Auth., 497 F.3d 286, 300 (3d Cir. 2007) (internal quotation marks omitted).

         To prevail on a renewed motion for judgment as a matter of law following a jury trial, the moving party "must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusions implied [by] the jury's verdict cannot in law be supported by those findings." Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 1998) (internal quotation marks omitted). "'Substantial' evidence is such relevant evidence from the record taken as a whole as might be accepted by a reasonable mind as adequate to support the finding under review." Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984).

         In assessing the sufficiency of the evidence, the Court must give the non-moving party, "as [the] verdict winner, the benefit of all logical inferences that could be drawn from the evidence presented, resolve all conflicts in the evidence in his favor, and in general, view the record in the light most favorable to him." Williamson v. Consol Rail Corp., 926 F.2d 1344, 1348 (3d Cir. 1991); see also Perkin-Elmer Corp., 732 F.2d at 893. The Court may not assess the credibility of witnesses nor "substitute its choice for that of the jury between conflicting elements of the evidence." Perkin-Elmer Corp., 732 F.2d at 893. Rather, the Court must determine whether the evidence reasonably supports the jury's verdict. See Dawn Equip. Co. v. Ky. Farms Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998); Gomez v. Allegheny Health Servs. Inc., 71 F.3d 1079, 1083 (3d Cir. 1995) (describing standard as "whether there is evidence upon which a reasonable jury could properly have found its verdict"); 9B Wright & Miller, Federal Practice & Procedure § 2524 (3d ed. 2008) ("The question is not whether there is literally no evidence supporting the party against whom the motion is directed but whether there is evidence upon which the jury properly could find a verdict for that party.").

         B. New Trial

         Federal Rule of Civil Procedure 59(a) provides in pertinent part, "[t]he court may, on motion, grant a new trial on all or some of the issues - and to any party - as follows:... after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court." New trials are commonly granted where "the jury's verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice, " where "newly-discovered evidence exists that would likely alter the outcome of the trial, " where "improper conduct by an attorney or the court unfairly influenced the verdict, " or where the jury's verdict was "facially inconsistent." Zarow-Smith v. N.J. Transit Rail Operations, 953 F.Supp. 581, 584-85 (D.N.J. 1997) (internal citations omitted).

         The decision to grant or deny a new trial is committed to the sound discretion of the district court. See Allied Chem. Corp. v. Daiflon, Inc., 449 U.S. 33, 36 (1980); Olefins Trading, Inc. v. Han Yang Chem Corp., 9 F.3d 282, 289 (3d Cir. 1993) (reviewing "district court's grant or denial of a new trial motion" under "abuse of discretion" standard). Although the standard for granting a new trial is less rigorous than the standard for granting judgment as a matter of law -in that the Court need not view the evidence in the light most favorable to the verdict winner -ordinarily a new trial should only be granted "where a miscarriage of justice would result if the verdict were to stand, " the verdict "cries out to be overturned, " or the verdict "shocks [the] conscience." Williamson, 926 F.2d at 1352-53.

         III. DAMAGES

         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, which was the figure Gilead's expert, Dr. Putnam, testified was the maximum fully-paid-up royalty for the life of the patent that Gilead could owe Idenix - or a new trial. 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.

         A. Applicable Law

         Under 35 U.S.C. § 284, patentees are entitled to damages "adequate to compensate for the infringement, but in no event less than a reasonable royalty." Under the "hypothetical negotiation" approach to calculating a reasonable royalty, the finder of fact "attempts to ascertain the royalty upon which the parties would have agreed had they successfully negotiated an agreement just before infringement began." Asetek Danmark A/S v. CMI USA Inc., 852 F.3d 1352, 1362 (Fed. Cir. 2017). For purposes of this calculation, the negotiating parties are assumed to carry a mutual understanding that the asserted patent is valid and infringed. See Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301, 1325 (Fed. Cir. 2009).

         In litigating this issue, parties often point to "[t]he rates paid by the licensee for the use of other patents comparable to the patent in suit." Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F.Supp. 1116, 1120 (S.D.N.Y. 1970). The "licenses relied upon" must be "sufficiently comparable to the hypothetical license at issue." Lucent, 580 F.3d at 1325. The comparability analysis must account for relevant "technological and economic differences." Wordtech Sys., Inc. v. Integrated Networks Solutions, Inc., 609 F.3d 1308, 1320 (Fed. Cir. 2010) (internal quotation marks and citation omitted). "[A]lleging a loose or vague comparability between different technologies or licenses does not suffice." LaserDynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51, 79 (Fed. Cir. 2012).

         To prevail on its JMOL, Gilead must show that the jury's damages award "is, in view of all of the evidence ... so outrageously high ... as to be unsupportable as an estimation of a reasonable royalty." Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1345 (Fed. Cir. 2011). In evaluating Gilead's motion, the Court must remain mindful that "a reasonable royalty analysis necessarily involves an element of approximation and uncertainty." Ironworks Patents, LLC v, Apple, Inc., 255 F.Supp.3d 513, 528 (D. Del. 2017) (internal quotation marks omitted).

         B. Comparability

         At trial, Idenix sought (and the jury awarded) a 10% royalty on net sales of Gilead's Harvoni and Sovaldi products. During his testimony, Carter supported this royalty rate by pointing to two "Roche licenses" - one between Pharmasset and Roche, and another between Merck (which is now Idenix's parent company) and Roche. (See PX1132; PX1606; Carter Tr. 742-44) Gilead argues that Carter's comparability analysis was improper because he failed to "account[] for the technological and economic differences between each agreement and the hypothetical license" Idenix and Gilead are presumed to have negotiated with respect to Gilead's use of Idenix's '597 patent. (D.I. 536 at 18) More specifically, Gilead asserts that Carter did not: (i) account for the Roche licenses' inclusion of a patent portfolio, as opposed to the single patent that would have been involved in the hypothetical negotiation; (ii) specifically identify the licensed patents; (iii) properly address the relative timing and risks involved (e.g., whether FDA approval had been obtained); and (iv) account for the inclusion in the Roche licenses of nonpatent assets. (See Id. at 18-19)

         Idenix responds that the Roche licenses were both "entered into before the 2013 hypothetical negotiation and relatively close in time" to the date of the hypothetical negotiation between Idenix and Gilead. (D.I. 554 at 19-22) The Roche licenses also both involved similar technology to that covered by the '597 patent and "similarly situated parties with similar bargaining power." (Id.) Further, in Idenix's view, the distinctions Gilead points to - such as the number of patents involved, timing and risks, and inclusion of non-patent assets - were all presented to the jury, and substantial evidence supports the jury's implicit decision to credit Carter's comparability opinion. (See id.) Nor, according to Idenix, has Gilead identified any basis to conclude as a matter of law that the Roche licenses are not comparable to the hypothetical license Idenix and Gilead would have negotiated. (See id.)

         While Gilead has leveled powerful factual attacks on Carter's analysis, they are just that: factual attacks. None of them, individually or collectively, renders Carter's analysis flawed as a matter of law. See ActiveVideo Networks, Inc. v. Verizon Commc'ns, Inc., 694 F.3d 1312, 1333 (Fed. Cir. 2012) (affirming denial of motion to strike damages expert, stating the "degree of comparability of [certain] license agreements as well as any failure on the part of [the] expert to control for certain variables are factual issues best addressed by cross examination and not by exclusion."). The jury was free to accept Carter's opinion that the Roche licenses were technologically and otherwise comparable to the hypothetical license, notwithstanding hearing Gilead's (and its expert's) strong critiques of that opinion. The jury's implicit finding is supported by substantial evidence, including Carter's own testimony on each of the topics on which Gilead's motion is based. (See, e.g., Carter Tr. at 779-80 (portfolio), 788-91 (identifying specific patents), 785-87 (timing and risks, including FDA approval), 800-01, 809-13 (non-patent assets))[5] Furthermore, Carter supported his 10% royalty rate with testimony about several Georgia-Pacific factors. (See Carter Tr. at 752-57)

         While Gilead is correct that comparability "cannot focus just on the covered product, " but must also "describe the relationship between the patented technology licensed therein and the licensee's products" (D.I. 536 at 19 n. 11) (quoting Uniloc USA, Inc. v. Microsoft Corp., 632 F.3d 1292, 1316 (Fed! Cir. 2011) (emphasis added)), substantial evidence was present to support a finding of sufficient comparability between the '597 patent's technology and Gilead's accused products. Moreover, the jury could reasonably have found comparability between the technology involved in the hypothetical license - a license to compounds useful in the treatment of HCV -and the technology involved in the Roche licenses - one between Pharmasset and Roche and another between Merck (Idenix's parent company now) and Roche. (See PX1132; PX1606)

         In sum, comparability issues do not provide a basis for granting Gilead any relief.

         C. Entire Market Value Rule

         Infringement damages must '"separate or apportion the defendant's profits and the patentee's damages between the patented feature and the unpatented features.'" LaserDynamics, 694 F.3d at 67 (quoting Garretson v. Clark, 111 U.S. 120, 121 (1884)). For that reason, reasonable royalties must generally "be based not on the entire product, but instead on the smallest salable patent-practicing unit." Id. (internal quotation marks omitted). The Entire Market Value Rule ("EMVR") allows for an exception to this general requirement when the patentee shows that "the patented feature drives the demand for an entire multi-component product, " in which case the patentee may obtain damages "as a percentage of revenues or profits attributable to the entire product." Id.

         Gilead contends that Carter's use of a royalty base consisting of "Gilead's adjusted net sales" of Harvoni and Sovaldi was improper and violated the EMVR. Gilead's position is based on its contention that Carter failed to account for, among other things, Gilead's substantial contribution of placing fluorine at the 2' down position as well as Gilead's development of the prodrug[6] necessary for the accused product's administration. (D.I. 536 at 20-24)

         Idenix counters that the EMVR does not apply in cases where, as here, the accused products are pharmaceuticals "covered in full by the claim" and the "active ingredient... provides the claimed therapeutic benefit." (D.I. 554 at 23) For this proposition, Idenix cites to AstraZeneca AB v. Apotex Corp., 782 F.3d 1324 (Fed. Cir. 2015). AstraZeneca involved a branded pharmaceutical patentee's suit against a generic competitor. The patent on the drug's active ingredient had expired, but the plaintiff still held "formulation patents claim[ing] three key elements - the drug core, the enteric coating, and the subcoating, " which encompassed the "complete omeprazole product" accused of infringement. Id. at 1338. The generic manufacturer defendant argued that, unless the active ingredient was excluded from the damages calculation, the EMVR would be violated. The Federal Circuit declined to apply the EMVR because "the [asserted] patents cover the infringing product as a whole, not a single component of a multi-component product." Id. It further concluded that, because the "formulation ... created a new, commercially viable omeprazole drug ... previously unknown in the art and ... novel in its own right, " the district court did not err in declining to "exclude the value of the active ingredient when calculating damages." Id. at 1340.

         In response, Gilead correctly observes (see D.I. 565 at 9) that AstraZeneca explicitly refused to adopt a rule making the EMVR "per se inapplicable in the pharmaceutical context, " AstraZeneca, 782 F.3d at 1337-38, and it further notes that the facts in this case are very different from those relating to the infringing generic product in AstraZeneca. Nevertheless, the Court agrees with Idenix that under the circumstances presented in this case, the EMVR does not apply, a conclusion that is supported by AstraZeneca. Here, there is substantial evidence to support the jury's implicit findings that the '597 patent covers sofosbuvir (which, at trial, was undisputed) and that "there is no unpatented or non-infringing feature in the [accused] product[s], " as their active ingredient is sofosbuvir. Id.

         Gilead further contends that Carter's analysis was legally flawed because it failed to "apportion his base to account for the relative value of 2' methyl up, " Idenix's contribution to the accused products, "in comparison to 2' fluoro down and the prodrug, " which were Gilead's contributions. (D.I. 565 at 10) Gilead is correct that, even now that the Court has found that the EMVR does not apply, AstraZeneca still requires a "related inquiry" if the asserted claims "recite both conventional elements and unconventional elements." AstraZeneca, 782 F.3d at 1337. In particular, one must "account for the relative value of the patentee's invention in comparison to the value of the conventional elements recited in the claim, standing alone." Id.

         Carter sufficiently performed this analysis, in a manner on which the jury was free to rely - conclusions the Court reached even before trial. In denying Gilead's motion to exclude Carter's opinions (see D.I. 297; D.I. 298 at 13-17), the Court explained:

... [W]ith respect to damages and the Entire Market Value Rule, the Court finds that plaintiffs' expert [Carter] gives a reasonable reliable opinion that fits and is consistent with the law, including that for use of the medication to treat an ailment, the smallest saleable unit may be the pill with the patented active ingredient. The patented feature may not, under the circumstances, be segregated out and that the patented feature may be found to drive demand. Really on all of these points, the plaintiffs' expert expresses an opinion that is consistent with the law and is based on inferences that may reasonably be drawn in plaintiffs' favor on the evidence.

(D.I. 368 at 145-46; see also Tr. at 535 (Gilead's counsel remarking that "this was the subject of Gilead's Daubert motion with respect to Mr. Carter, " which the Court denied))

         Gilead argues that the Court's pre-trial decision relied on representations made by Idenix but subsequently broken at trial. In Gilead's telling, Idenix made "a promise" to establish at trial that the '597 patent's "cover[age of] the active metabolite ... was the basis of customer demand" (D.I. 536 at 21), something Idenix never proved. But, even assuming that Gilead's portrayal of the pre-trial litigation is correct, the failure to fulfill that "promise" does not mean the Court should grant the relief Gilead now seeks, because Carter did not ask the jury to award damages based on the EMVR. (See Carter Tr. at 792-95) An unfulfilled promise that does not also render an expert's analysis deficient, which at most is what occurred here, is not a meritorious basis for JMOL, remittitur, or a new trial.

         Gilead's motion with respect to damages will be denied.

         IV. INVALIDITY

         Gilead's motion asks 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, [7] which provides, in pertinent part:

The specification shall contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same ....

         Section 112 sets out separate requirements for written description and enablement. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010) (holding that written description and enablement requirements are separate). Still, these requirements "often rise and fall together." Id. at 1352.

         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 finds 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. Just as the Court twice declined to grant Gilead summary judgment on lack of written description, so, too, does the Court again conclude that this was an issue on which a factfinder could have found for either side. With respect to enablement, which presents a question of law, the Court concludes, as a matter of law, that no reasonable factfinder could find anything other than that the '597 patent is not enabled. This being the Court's first occasion to evaluate whether any genuine disputes of material fact preclude resolution of the enablement issue as a matter of law, the Court concludes - based on the trial record - that no such disputes exist.

         A. Written Description

         1. Applicable Law

         Whether a specification satisfies the written description requirement is a question of fact. See GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.,744 F.3d 725, 729 (Fed. Cir. 2014); see also Alcon, Inc. v. Teva Pharms. USA, Inc., 664 F.Supp.2d 443, 468 (D. Del. 2009) ("Satisfaction of the written description requirement is a fact-based inquiry, depending on 'the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.'") (quoting Carnegie Mellon Univ. v. Hoffmann-La Roche Inc.,541 F.3d 1115, 1122 (Fed. Cir. 2008)). To comply with the written description requirement, a patent's specification "must clearly ...


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