Idenix Pharmaceuticals Inc. et al v. Gilead Sciences Inc. et al

Filing 431

MEMORANDUM OPINION re claim construction of two disputed terms and renewed motion for summary judgment on written description. Signed by Judge Leonard P. Stark on 11/16/16. Associated Cases: 1:13-cv-01987-LPS, 1:14-cv-00109-LPS, 1:14-cv-00846-LPS (ntl)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

IDENIX PHARMACEUTICALS LLC, .
UNIVERSITA DEGLI STUDI di CAGLIARI,
CENTRE NATIONAL de la RECHERCHE
SCIENTIFIQUE, and
L'UNIVERSITE de MONTPELLIER,
Plaintiffs,
v.

Civil Action No. 13-1987-LPS

GILEAD SCIENCES, INC. and GILEAD
PHARMASSET LLC,
Defendants.

IDENIX PHARMACEUTICALS LLC,
UNIVERSITA DEGLI STUDI di CAGLIARI,
CENTRE NATIONAL de la RECHERCHE
SCIENTIFIQUE, and
L'UNIVERSITE de MONTPELLIER,
Plaintiffs,
Civil Action No. 14-109-LPS

v.
GILEAD PHARMASSET LLC,
Defendant.

IDENIX PHARMACEUTICALS LLC and
UNIVERSITA DEGLI STUDI di CAGLIARI,
Plaintiffs,
v.

Civil Action No. 14-846-LPS

GILEAD SCIENCES, INC.,
Defendant.

Steven J. Balick, John G. Day, and Andrew C. Mayo, ASHBY & GEDDES, Wilmington, DE
Calvin P. Griffith, Ryan B. McCrum, Leozino Agozzino, and Michael
DAY, Cleveland, OH

s.· Weinstein, JONES

Anthony M. Insogna and John D. Kinton, JONES DAY, San Diego, CA
John M. Michalik and Lisa L. Furby, JONES DAY, Chicago, IL
Jennifer L. Swize, JONES DAY, Washington, DC
Tharan G. Lanier, JONES DAY, Palo Alto, CA
Attorneys for Plaintiffs.

Martina Tyreus Hufual, 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 and Craig E. Countryman, 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 Defenqants.

MEMORANDUM OPINION

November 16, 2016
Wilmington, Delaware

~~~·
S~

.

U.S. District ucige:

Plaintiffs Idenix Pharmaceuticals LLC, Universita Degli Studi di Cagliari, Centre
National de la Recherche Scientifique, and L'Uriiversite Montpellier (together, "Plaintiffs" or
Idenix) filed three actions against -Defendants Gilead Pharmassett LLC and Gilead Sciences, Inc. ·
(together, "Gilead" or "Defendants"): (i) an action for a declaration of patent infringement and
adjudication of Plaintiffs' priority of invention with respect to U.S. Patent No. 7,608,600 1 over
U.S. Patent No. 8,415,322 (C.A. 13-1987 D.I. 1); (ii) an appeal of a decision and judgment of
priority by the Patent Trial and Appeal Board ("PTAB") regarding U.S. Patent Application Serial
No. 12/131,868 (C.A. No. 14-109 D.I. 1); and (iii) an action for a declaration of patent
infringement of U.S. Patent Nos. 6,914,0542 (the '"054 patent") and 7,608,5973 (the '''597
patent") (C.A. No. 14-846 D.I. 1). 4
The Court previously construed a number of contested claim terms in this matter. (See
D.I. 237) On June 1, 2016, Defendants moved for summary judgment on multiple issues,
includinglack of written description in the '054 and '597 patents. (See D.I. 287) The Court
denied the motion. (See D.I. 367) The Court's denial was withoutprejudice to renew following
· additional claim construction, as the Court determined that a claim construction dispute was at

1

The '600 patent is entitled "Modified 2' and 3'-Nucleoside Prodrugs for Treating
Flaviviridae Infections." It was issued on October 27, 2009. (C.A. No. 13-1987 D.I. 1, Ex. A)
2

The '054 patent is entitled "Methods and Compositions for Treating Hepatitis C Virus."
It was issued on July 5, 2005. (C.A. No. 14-846 D.I. 1, Ex. A)
3

The '597 patent is entitled "Methods and Compositions for Treating Hepatitis C Virus."
It was issued on October 27, 2009. (C.A. No. 14-846 D.I. 1, Ex. B)
4

Hereinafter, all citations to the record are to C.A. No. 14-846.

1

least one of the reasons summary judgment was not warranted. (See D.I. 368 at 138-39) The
Court ordered supplemental claini construction briefing and allowed Gilead to renew its motion
if desired. (See id. at 138-140)
Pending before the Court is claim construction of two disputed terms in the'054 and '597
patents as well as Defendants' renewed motion for summary judgment on written description
grounds., (D.I. 377) The parties completed briefing on these issues on September 16, 2016. (See
D.I. 376, 378, 380, 390, 392, 393, 398) The Court heard oral argument on October 7, 2016. (See
D.I. 410 ("Tr."))

I.

LEGAL STANDARDS
A.

Claim Construction

The ultimate question of the proper construction of a patent is a question oflaw. See

TevaPharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 837 (2015) (citing Markman v. Westview
Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "It is a bedrock prindple of patent law that the
claims of a patent define the invention to which the patentee is entitled the right to exclude."

Phillips v. AWJI Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted).
"[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324.
Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the
statutes and policies that inform patent law." Id.
"[T]he words of a claim are generally given their ordinary and customary meaning ...
[which is] the meaning that the term would have to a person of ordinary skill in the art in
question at the time of the invention, i.e., as of the effective filing date of the patent application."

Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a
2

claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 13 21
· (internal quotation marks omitted). The patent specification "is always highly relevant to the
claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of
a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d lS-76, 1582 (Fed. Cir.1996).
While "the claims themselves provide substantial guidance as to the meaning of particular
claim terms," the context of the surrounding words of the claim also must be considered.

Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted
and unasserted, can also be valuable sources of enlightenment ... [b] ecause claim terms are
normally used consistently throughout the patent .... " Id. (internal citation omitted).
It is likewise true that."[d]ifferences among claims can also be a Useful guide .... For
example, the presence of a dependent claim that adds a particular limitation gives rise to a
presumption that the limitation in question is not present in the independent claim." Id. at 131415 (internal citation omitted). This "presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim, and one
party is urging that the limitation in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "the specification may reveal a special definition given to a claim
term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven
when the specification describes only a single embodiment, the claims of the patent will not be
read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope
using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker

3

Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent's prosecution

history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir.
1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence,"
"consists of the complete record of the proceedings before the PTO [Patent and Trademark
Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d
at 1317. "[T]he prosecution history can often inform the mean~ng of the claim language by
demonstrating how the inventor understood the invention and whether the inventor limited the
in~ention in the course of prosecution, making the claim scope narrower than it would Qtherwise

be." Id.
In some cases, "the district court will need to look beyond the patent's intrinsic evidence

and to consult extrinsic evidence in order to understand, for example, the background science or
the meaning of a term in the relevant art during the relevant time period." Teva, 135 S. Ct. at
841. Extrinsic evidence "consists of all evidence external to the patent and prosecution history,
including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d
at 980. For instance, technical dictionaries can assist the court in determining the meaning ofa
term to those of skill in the relevant art because such dictionaries "endeavor to collect the
accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d
at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of
the technical aspects of the patent is consistent with that of a person of skill in the art, or to
establish that a particular term in the patent or the prior art has a particular meaning in the
pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and

4

testimony [are] generated ·at the time of and for the purpose of litigation and thus can suffer from
bias that is not present in intrinsic evidence."· Id. Overall, while extrinsic evidence "may be
useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely
to result in a reliable interpretation of patent claim scope unless considered in the context of the
intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the
scope of the patented invention, reliance on any extrinsic eviden.ce is improper. See Pitney
Bowes, Inc. v. Hewlett-Packard Co., 182F.3d1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
F.3d at 1583).
Finally, "[t]he construction that stays true to the claim language and most naturally aligns
with the patent's description of the invention will be, in the end, the correct construction."
Renishaw PLC v. Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998): It follows
that "a claim interpretation that would exclude the inventor's device is rarely the correct
interpretation." Osram GmbH v. Int'! Trade Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007)
(internal quotation marks omitted).

B.

Motion for Summary Judgment

Pursuant to Rule 56(a) of the Federal Rules of Civil Procedure, "[t]he court shall grant
summary judgment if the movant shows that there is no genuine dispute as to

~y material

fact

and the movant is entitled to judgment as a matter oflaw." The moving party bears the burden of ,
demonstrating the absence of a genuine issue of material fact. See Matsushita Elec.1ndus. Co.,
Ltd.

V;

Zenith Radio Corp., 475 U.S. 574, 585-86 (1986). An assertion that a fact cannot be - or,

alternatively, is - genuinely disputed must be supported either by citing to "particular parts of
materials in the record, including depositions, documents, electronically stored information,

5

affidavits or declarations, stipulations (including those made for purposes of the motion only),
admissions, interrogatory answers, or other materials," or by "showing that the materials cited do
not establish the absence or presence of a genuine dispute, or that an adverse party cannot
produce admissible evidence to support the fact." Fed. R. Civ. P. 56(c)(l)(A) & (B). If the
moving party has carried its burden, the nonmovant must then "come forward with specific facts
showing that there is a genuine issue for trial." Matsushita, 475 U.S. at 587 (internal quotation
marks omitted). The court will "draw all reasonable inferences in favor of the nonmoving party,
and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson
Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).

To defeat a motion for summary judgment, the nonmoving party must "do more than.
simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475.
U.S. at 586; see also Podobnik v. U.S. PostalServ., 409 F.3d 584, 594 (3d Cir. 2005) (stating
party opposing summary judgment "must present more than just bare assertions, conclusory
allegations or suspicions to show the existence of a genuine issue") (internal quotation marks
omitted). The "mere existence of some alleged factual dispute between the parties will not defeat
an otherwise properly supported motion for summary judgment;" a factual dispute is genuine
only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving
party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). "If the evidence is merely
colorable, or is not significantly probative, summary judgment may be granted." Id. at 249-50
(internal citations omitted); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (stating
entry of summary judgment is mandated "against a party who fails to make a showing sufficient
to establish the existence of an element essential to that party's case, and on which that party will

6

!

bear the burden of proof at trial"). Thus, the "mere existence of a scintilla of evidence" in
support of the nonmoving party's position is insufficient to defeat a motion for summary
judgment;. there must be "evidence on which the jury could reasonably find" for the nonmoving
party. Anderson, 477 U.S. at 252.
·C.

Written Description

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)). Nevertheless, the issue of
invalidity for lack of written description is amenable to summary judgment under certain
circumstances. See, e.g., Carnegie Mellon, 541 F.3d at 1126-28 (affirming summary judgment of
invalidity for lack of written description); see also Helicos Biosciences Corp. v. Illumina, Inc.,
888 F. Supp. 2d 519, 530-31 (D. Del. 2012) ("While compliance with the written description
requirement is a question of fact, the issue is 'amenable to summary judgment in cases where no
reasonable fact finder could return a verdict for the non-moving party."') (quoting PowerOasis,

Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008)).
To comply with the written description requirement,' a patent's specification "must clearly
allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed."

Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (internal brackets and

7

quotation marks omitted). "[T]he test for sufficiency is whether the disclosure of the application
relied upon reasonably conveys to those skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date." Id. "[T]he hallmark of written description is
disclosure. Thus, 'possession as shown in the disclosure' is a more complete formulation" of the
written description requirement. Id. "[T]he test requires an objective inquiry into the four
corners of the specification from the perspective of a person of ordinary skill in the art." Id.
"[T]he written description requirement does not demand either examples or an actual reduction
to practice; a constructive reduction to practice that in a definite way identifies the claimed
invention can satisfy the written description requirement." Id. at 1352. However, "a description
that merely renders the invention obvious does not satisfy the requirement." Id.
II.

CONSTRUCTION OF DISPUTED TERMS
A.

"method for [the] treatment of a Hepatitis C virus infection" 5

Plaintiffs
The preambles are limitations: plain and ordinary meaning. Alternatively, a method in which
an HCV infection is treated.
Defendants
Plain and ordinary meaning: given for the purpose of stopping or slowing the progression of
HCV. (Non-limiting preamble)

Court
The preambles are claim limitations and will be given their plain and ordinary meaning.
The parties dispute whether the relevant claims' preambles "limit the claims to methods
in which an HCV infection is treated," as Plaintiffs contend (D.I. 376 at 1-2), or merely recite a
purpose or an intended use in a non-limiting fashion, which is Defendants' position (D.I. 380 at

5

This term appears in claim 26 of the '054 patent and claim 1 of the '597 patent.
8

1). Generally, a preamble is not limiting unless it recites an "essential structure or steps" or is
"necessary to give life, meaning, and vitality to the claim." Catalina Mktg. Int'!, Inc. v.
Coo/savings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (internal quotation marks omitted).
Put another way, "[a] preamble is not limiting where a patentee defines a structurally complete
invention in the claim body and uses the preamble only to state a purpose or intended use for the
invention." Id. (internal quotation marks omitted). "Whether to treat a preamble as a claim
limitation is determined on the facts of each case in light of the claim as a whole and the
invention described in the patent." Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831
(Fed. Cir. 2003).
Idenix emphasizes that the "essence of the invention" is the treatment of the Hepatitis C
-virus infection ("HCV") and that the specifications "expressly teach that a method using a
compound that is ineffective (e.g., it has no anti-HCV activity) is not within the bounds of the
invention." (D.I. 376 at 3) Idenix suggests that, ifthe preambles are not claim limitations, then
"performing the method steps of the claims would be a purely academic exercise," because the
remaining steps of the claims "do not recite what the ribonucleosides are effective for." (Id. at 5)
Gilead responds that the preambles require at most that the nucleosides "be used to try to slow or
stop the progression ofHCV," without regard to the actual efficacy of the compounds. (D.I. 392
at 2 (emphasis added); see also Tr. at 15)
The Court finds the preambles here to be claim limitations because they are "essential to
understand[ing] limitations or terms in the claim body." Catalina Marketing, 289 F.3d at 808.
The preambles "give life" to these claims because a full understanding of the "effective amount"
terms (as discussed further below) depends on what the relevant compounds must be effective

9

for. Put another way, the bodies of the relevant claims do not, in the absence of a limiting
preamble, "define[] a structurally complete invention." Id. (internal quotation marks omitted).
Gilead, pointing to the prosecution history, argues that the "'core of the invention' was a
class of compounds." (D.I. 392 at 2 (quoting D.I. 376-4 at 11)) But emphasizing this supposed
"core" is not the most reasonable characterization of the intrinsic record as a whole. Gilead's
view is in tension with the plain language and form of the method claims at issue and with the
patentees' representation that "[a]pplicants are not aware of any prior disclosure of the use of a
pyrimidine nucleoside with a '2'-branched' carbon to treat [HCV]." (D.I. 376-4 at 11 (emphasis
added))
Because "deletion of the preamble phrase[s]" would "affect the structure or steps of the
claim-ed invention," the preambles are not "merely duplicative." TomTom, Inc. v. Adolph, 790
F.3d 1315, 1324 (Fed. Cir. 2015) (internal quotation marks omitted). The Court will construe the
preambles as limitations, which are given their plain and ordinary meaning.

B.

"[antivirally] effective amount" 6

Plaintiffs
Plain and ordinary meaning; an amount [of the claimed ribonucleoside ('054 patent) I
ribofuranosyl nucleoside ('597 patent)] that is effective to treat HCV
Defendants
an amount [of a claimed nucleoside] that produces an antiviral effect I an amount [of a claimed
nucleoside] that is effective
Court
an amount [of the claimed ribonucleoside ('054 patent) I ribofuranosyl nucleoside ('597
patent)] that is effective to treat HCV

6

The term "effective amount" appears in claim 1 of the '597 patent, and the term
"antivirally effective amount" appears in claim 26 of the '054 patent.
10

The parties present a related disputed over whether the "effective amount" terms "narrow
the chemical structure of the nucleosides recited later in the claim[ s]" to those that are in fact
effective for the treatment ofHCV. (D.I. 392 at 3) Idenix contends .that the claims are narrowed
in this manner, while Gilead disagrees. Although Gilead agrees with Idenix that the compounds

"are to be used for [treatment of HCV]," Gilead nonetheless insists that these ''effective amount"
terms do not constrain the chemical structure of the compounds the patentee claimed. (Id.) In
Gilead's view, "the term refers only to how much of a claimed nucleoside is administered."
(D.I. 380 at 2) The Court disagrees with Gilead.
The term "[antivirally] effective" modifies the word "amount." Ina vacuum, Gilead's
view that these "effective amount" terms are solely quantitative limitations might prevail. But
claim language must be construed in the context of the c~aim as· a whole. See !GT v. Bally .
.Gaming Int'!, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011). "Extracting a single word from a

claim divorced from the surrounding limitations can lead construction astray." Id. Given the
Court's finding that the preambles are limiting, the claims are explicitly directed to· - and, as
explained above, limited to - methods for the treatment ofHCV. The patents' abstracts disclose
"[a] method and composition for treating a host infected with hepatitis C comprising
administering an effective hepatitis C treatment amount of a described 1', 2', or 3 '-modified
nucleoside." (E.g., '597 patent at abstract) The specifications are replete with references to
·treatment ofHCV, including that "it is an object of the present invention to provide a compound,
method and composition for the treatment of [HCV]." (E.g., '054 patent at 5:23-25)
Crucially, as Plaintiffs explain, "if no amount of a particular ribonucleoside can be
administered to effectively treat HCV, then administering that ribonucleoside does not practice

11

the claims." (D.I. 376 at 7) In other words, because some amount of the composition must be
"effective," the overall scope of the claims does not include compounds that are not effective
(for the claimed purpose) at any amount. In this way, Plaintiffs' proposed construction, which
the Court adopts, "stays true to the claim language and most naturally aligns with the patent's
description of the invention." Renishaw, 158 F.3d at 1250.
At oral argument, counsel for Gilead asserted that none of cases Idenix cites in support of
its proposed construction "interprets the term 'effective amount' to impose a structural limitation
of any kind on the claimed compound." (Tr. at 21) But neither does Gilead direct the Court to
any cases that reject such a construction.
Gilead also attacks Idenix's construction for excluding preferred embodiments. (See,
e.g., Tr. at 25) Idenix disputes whether this is the result of adoption of its proposed construction.
(See Tr. at 33 ("I don't agree that a preferred embodiment is not covered by these claims."))
Either way, any "reluctan[ce] to exclude an embodiment" cannot "outweigh the language of the
claim, especially when the court's construction is supported by the intrinsic evidence."
Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325, 1334 (Fed. Cir. 2010) (internal
quotation marks omitted); see also Kara Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341, 1347--48
(Fed. Cir. 2009) ("It is the claims that define the metes and bounds of the patentee's invention.
The claims, not specification embodiments, define the scope of patent protection.") (internal
citation omitted). The claims' language logically requires that "[m]ethods that administer
ineffective compounds" fall "outside the scope of the claims." (D.I. 376 at 8)
Gilead also highlights what it contends is tension between Plaintiffs' expert, Dr. Meier,
and the disclosures of the specifications. (See D.I. 380 at 3 ("Idenix's experts have used ...

12

phantom limitations to exclude many compounds that the specification itself suggests are
effective.")) But even Gilead's expert "agree[d] that the methods of the asserted claims of the
'597 patent only 'cover compounds that are effective' to treat HCV." (D.I. 285-4 at 21-22, 4142, ~~ 52, 96 (quoting Dr. Meier's rebuttal report)) Given that the Court's task at claim
construction is to construe the disputed terms "as an ordinary artisan would have understood
them," Wi-LAN USA, Inc. v. Apple Inc., 830 F.3d 1374, 1381 (Fed. Cir. 2016), it is significant
that both sides' experts appear to agree that the scope of the claims is limited to effective
compounds.
The claims' language requires that the Court construe the preambles and effective amount
terms to limit the scope of the claims to the use of some set of compounds that are effective for
treatment of HCV.

C.

Indefiniteness .
Gilead contends that the constructions proposed by Idenix, and now adopted by the Court,

render the claims invalid as indefinite. "[A] patent is invalid for indefiniteness if its claims ...
fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention."
Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2124 (2014). Gilead bears the burden
of proving "any fact critical to a holding on indefiniteness" by clear and convincing evidence.
Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366 (Fed. Cir. 2003). Gilead argues that the
claims as construed fail the Nautilus test because the patents do not "provide sufficient guidance
regarding whether a nucleoside is 'effective' against Hepatitis C or 'mimics' a natural
nucleoside." (D.I. 380 at 6) The Court is not persuaded that Gilead has proven, by clear and
convincing evidence, that the claims must be deemed invalid as indefinite.

13

Gilead points to this Court's recent decision in BASF Corporation v. Johnson Matthey
Inc., 2016 WL 661407 (D. Del. Feb. 9, 2016). That case involved construction of claim language

that included, for example, "material composition A effective for catalyzing NH3 oxidation." Id. .
at *2. The Court found this language indefinite, observing that it recited "a performance property
the composition must display, rather than its actual composition." Id.
BASF is distinguishable for numerous reasons, most prominent being the overwhelming

breadth of the claim language involved there. The claim found to be indefinite in BASF lacked ,
any sort of structural limitation, leading the Court to observe that "a practically limitless number
of materials" existed that would exhibit the claimed performance property. Id. at *2 n.10. By
contrast, the claims here explicitly limit the methods to use of B-D-2'-C-branched or B-D-2'methyl-ribofuranosyl nucleosides. While this evidently captures ari extremely large m1mber of
compounds, it is not "practically limitless" but is, instead, meaningfully bound by the explicit
chemical structure identified in the claims.
Gilead also relies on Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d
1373 (Fed. Cir. 2003). In Geneva, the Federal Circuit rejected as indefinite a proposed reading of
a claim that would have "ma[ d] e the dosage range depend on the particular antibiotic and
bacteria."· Id. at 1384. Under such a construction, "a formulation ... might infringe or not
depending on its usage in changing circumstances;" "a given embodiment would simultaneously
infringe and not infringe the claims, depending on the particular bacteria chosen for analysis."
Id. There is no similar result here. Instead, a compound meeting the structural and other

limitations of the claim that is also effective to treat HCV is within the scope of the claims, while
compounds meeting only the structural limitations (but not being effective to treat HCV) are

14

outside the scope of the claims. Thus, the claims "afford clear notice of what is claimed."

Nautilus, 134 S.Ct. at 2129. Accordingly, Gilead has failed to persuade the Court that the claims
are invalid as indefinite.

III.

SUMMARY JUDGMENT
In addition to providing supplemental claim construction briefing, Gilead has again

moved for summary judgment that the claims of the '054 and '597 patents are invalid due to lack
of written description. Gilead bases its motion on the lack of antiviral data in the '054 and '597
patents, along with the specifications' inclusion of a broad set of nucleosides that are ineffective
against HCV, resulting in "an utter failure to describe the claimed invention." (D.I. 378 at 1) In
Gilead's view, the claims - as the Court has now construed them -.cover use of a subgenus, but
the specifications "provide no blaze marks that would direct the skilled artisan to this subgenus."
(D.I. 378 at 4)
Gilead faults Idenix for relying, improperly, on expert testimony to "supply the blaze
marks that the specification lacks." (D.I. 398 at 4) In Gilead's view, Idenix's expert, Dr. Meier,
excludes certain embodiments, configurations, and subembodiments disclosed in the
specifications, without any valid basis to do so. (See generally D.I. 289-7) Gilead also takes
issue with the specifications' lack of "[a]ntiviral data showing which nucleosides work and
which do not." (D.I. 398 at 1) Gilead relies principally on two cases in support of its position:

Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed. Cir. 2011), and Novozymes
A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013).
Idenix appears to accept that there is some

incon~istency -

or at least a difference in

breadth - between the specifications and the scope of the claims as construed. Idenix contends

15

that any such discrepancy is irrelevant to the issue of written description (although allowing that
it may be pertinent to the issue of enablement, which is not presently ripe for the Court's
attention). In response to Gilead's arguments concerning the lack of "blaze marks," Idenix points
to Dr. Meier's reliance on, among other things, the disclosure that the invention's nucleosides
"may inhibit HCV polymerase activity" (D.I. 391~11 at 19 ljf 63), his examination of the patents'
formulas (see, e.g., id. at 22-23), and toxicity data (see, e.g., id. at 42-43). 7 With respect to
antiviral data, Idenix notes the specifications' discussion of assays and disclosure of .
"phosphorylation data, oral bioavailability data, pharmacokinetics data, and toxicity data (both
bone marrow and mitochondrial)." (D.I. 390 at 13)8 Idenix also attempts to distinguish the
Boston Scientific and Novozymes cases.

Written description is about whether the "inventor had possession of the claimed subject
matter." Ariad Pharm., 598 F.3d at 1351. On that point, Idenix's expert, Dr. Meier, has opined,
for example, that the '054 patent "demonstrates that the inventors had possession of a definite
class of compounds ... useful in the treatment of HCV, namely those ... that resemble the
naturally occurring substrate of the HCV polymerase sufficiently to be useful for inhibiting HCV
polymerase." (D.I. 391-11 at 18 ljf 59) Dr. Meier provided a variety ofreasons in support of his
conclusion, asserting that "the skilled artisan reading the '054 patent would have identified as the

7

The patents explicitly note that "[t]he compounds of this invention either possess .
antiviral (i.e., anti-HCV) activity, or are metabolized to a compound that exhibits such activity."
(E.g., '054 patent at 15:38-40)
8

As Gilead points out, certain portions of the specifications were added in May 2001 and
were not present at the original May 2000 filing date. At oral argument, the parties agreed that
this distinction was not directly relevant to the binary question of whether the invention is
adequately described. (See Tr. 52-53)
16

inventors' invention ... modified ribonucleoside analogues ... that otherwise mimic the
naturally occurring ribonucleosides closely enough to be recognized and used by the HCV
polymerase." (Id. at 24-25

~

82) A reasonable factfinder could credit Dr. Meier's opinion and

analysis and find, as he opines, that the inventors had possession of the claimed invention (as the
Court has construed it). The record also contains Gilead documents, from which a reasonable
factfinder might conclude that Gilead (and/or its predecessor) recognized that the inventors of the
patents-in-suit were in possession of their claimed invention. (See D.l. 391-1 at 24of28; D.I.
391-3 at 27of36)
The Federal Circuit has explained that patents can be categorized as those relating to
"generic inventions that are adequately supported, those that are merely a

'wi~h'

or 'plan' ... and

those in between." Capon v. Eshhar, 418 F.3d 1349, 1360 (Fed. Cir. 2005) (internal citation
omitted). In Gilead's view, "Idenix's inventors didn't know themselves which compounds
would be effective," so the patents-in-suit are invalid, as they are nothing more than "an
invitation to conduct research with no blaze marks to the subgenus that Idenix has concocted in
hindsight." (D.I. 398 at 7) This appears to be one reasonable interpretation of the record, one
which a reasonable factfinder might credit. But the record as a whole does not compel this as the
only supportable conclusion that could be drawn by a reasonable factfinder.
Boston Scientific and Novozymes are of limited value to Gilead because both cases
involved even less written description support than is found in the specifications here. In Boston
Scientific, the Federal Circuit affirmed a finding of invalidity of a patent that "disclosed a
genus ... , but claimed a narrower sub-genus." Boston Sci., 647 F.3d at 1367. The Court found
"nothing in [the patent] indicat[ing] that the claimed [narrower sub-genus] might be of special

17

interest." Id. In Novozymes, 723 F.3d 1336, the Federal Circuit affirmed a finding of invalidity
where the patent involved contained '~no disclosure of any variant that actually satisfies the
claims, nor ... anything to suggest that Novozymes actually possessed such a variant at the time
of filing." Id. at 1348. Here, by contrast, a reasonable factfinder could agree with Dr. Meier that
there is not "nothing" or "no disclosure;" instead, a reasonable factfinder could find that the
specifications show the inventors were in possession of nucleosides with certain structural
characteristics that were also effective to treat HCV.
Gilead has not met its burden to establish that· "no finder of fact could reasonably
determine that the asserted claims of the patents-in-suit contained an adequate written
description." Boston Sci., 647 F.3d at 1356. Summary judgment is therefore inappropriate. The
Court will deny Gilead's motion.
IV.

CONCLUSION

The Court will construe the disputed terms in the manner explained above. Gilead's
renewed motion for summary judgment will be denied. An appropriate Order follows.

18