United States District Court, D. Delaware
IDENIX PHARMACEUTICALS LLC and UNIVERSITA DEGLI STUDI di CAGLIARI, Plaintiffs,
GILEAD SCIENCES, INC., Defendant.
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
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
U.S. DISTRICT JUDGE.
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"). (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.
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.
Court addresses each of Gilead's JMOL arguments in turn,
beginning with damages and then moving on to
validity. 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.
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)
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
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 ("'054 patent") and the
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)
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)
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)
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.
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)
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)
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
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.)
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)
Court now turns to the issues raised in Gilead's motion.
Judgment as a Matter of Law
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).
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.
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.").
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
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.
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.
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).
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.
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).
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)
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.)
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)) Furthermore, Carter supported his
10% royalty rate with testimony about several
Georgia-Pacific factors. (See Carter Tr. at
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)
comparability issues do not provide a basis for granting
Gilead any relief.
Entire Market Value Rule
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."
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 necessary for the accused product's
administration. (D.I. 536 at 20-24)
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
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.
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
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))
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.
motion with respect to damages will be denied.
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,  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
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.
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 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 ...