Idenix Pharmaceuticals Inc. et al v. Gilead Sciences Inc. et al
Filing
248
MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 12/16/15. 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, INC.,
UNIVERSITA DEGLI STUDI DI CAGLIARI,
CENTRE NATIONAL DE LA RECHERCHE
SCIENTIFIQUE and L ' UNIVERSITE
MONTPELLIER II,
Plaintiffs,
Civil Action No. 13-1987-LPS
v.
GILEAD SCIENCES, INC . and GILEAD
PHARMASSET LLC,
Defendants.
IDENIX PHARMACEUTICALS , INC. ,
UNIVERSITA DEGLI STUDI DI CAGLIARI,
CENTRE NATIONAL DE LA RECHERCHE
SCIENTIFIQUE and L ' UNIVERSITE
MONTPELLIER II,
Plaintiffs,
Civil Action No. 14-109-LPS
v.
GILEAD PHARMASSET LLC,
Defendant.
IDENIX PHARMACEUTICALS , INC. and
UNIVERSITA DEGLI STUDI DI CAGLIARI,
Plaintiffs,
Civil Action No. 14-846-LPS
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, and Michael S. Weinstein, JONES DAY, Cleveland, OH.
Anthony M. Insogna and John D. Kinton, JONES DAY, San Diego, CA.
John M. Michalik, JONES DAY, Chicago, IL.
Attorneys for Plaintiffs.
Douglas E. McCann, Martina Tyreus Hufnal, and Santosh V. Coutinho, FISH & RICHARDSON
P.C., Wilmington, DE.
W. Chad Shear, FISH & RICHARDSON P.C., San Diego, CA.
John M. Farrell and Rebecca Chamas Grant, FISH & RICHARDSON P.C., Redwood City, CA.
Rebecca Shult and Tasha M. Francis, FISH & RICHARDSON P.C., Minneapolis, MN.
Corrin N. Drakulich, FISH & RICHARDSON P.C., Atlanta, GA.
Attorneys for Defendants.
MEMORANDUM OPINION
December 16, 2015
Wilmington, Delaware
1
U.S. District Judge:
Plaintiffs Idenix Pharmaceuticals, Inc. ("Idenix"), Universita Degli Studi di Cagliari
("Cagliari"), Centre National de la Recherche Scientifique ("Centre National"), and L' Universite
Montpellier II ("Montpellier") (collectively, "Plaintiffs") filed three actions against Defendants
Gilead Pharmassett LLC and Gilead Sciences, Inc. (collectively, "Gilead" or "Defendants") : an
action for a declaration of patent infringement and adjudication of Plaintiffs ' priority of invention
of U. S. Patent No. 7,608,600 1 ("the ' 600 patent") over U. S. Patent No . 8,415 ,322 ("the ' 322
patent") (C.A. 13-1987, D.I. 1), 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 ("the
' 868 application") (C.A. No. 14-109, D.I. 1), and an action for a declaration of patent
infringement of U.S. Patent Nos. 6,914,0542 ("the ' 054 patent") and 7,608 ,597 3 ("the ' 597
patent") (C.A. No. 14-846, D.I. 1).
Pending before the Court is the issue of claim construction of various disputed terms of
the ' 600, ' 054, and ' 597 patents. 4 The parties completed briefing on claim construction on
August 6, 2015. (D.I. 128, 129, 138, 140) In addition to the briefing, the parties submitted
technology tutorials. (D.I. 126, 127) The Court held a Markman hearing on October 19, 2015.
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. 13-1987.
1
("Tr.")
I.
LEGAL STANDARDS
The ultimate question of the proper construction of a patent is a question of law. See
Teva Pharm. 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 principle of patent law that the
claims of a patent define the invention to which the patentee is entitled the right to exclude."
Phillips v. AWH 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
claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
(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 1576, 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
2
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." Liebel-Flarsheim Co. v.
Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), aff'd, 481
F.3d 1371 (Fed. Cir. 2007) .
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 131 7. " [T]he prosecution history can often inform the meaning of the claim language by
3
demonstrating how the inventor understood the invention and whether the inventor limited the
invention in the course of prosecution, making the claim scope narrower than it would otherwise
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 of a
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
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 evidence is improper. See Pitney
Bowes, Inc. v. Hewlett-Packard Co. , 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
4
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)
(quoting Modine Mfg. Co. v. US. Int '/ Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).
II.
CONSTRUCTION OF DISPUTED TERMS
A.
The '054 Patent: "8-D-2'-C-branched pyrimidine nucleoside"
Plaintiffs
A B-D-pyrimidine nucleoside having two non-hydrogen substituents at the 2' position, at least
one of which is connected at the 2' position through a carbon-to-carbon bond.
Defendants
A B-D-pyrimidine nucleoside having two non-hydrogen substituents at the 2' position, at least
one of which is connected at the 2' position through a carbon-to-carbon bond, and no fluorine
at the 2' down position.
Court
A B-D-pyrimidine nucleoside having two non-hydrogen substituents at the 2' position, at least
one of which is connected at the 2' position through a carbon-to-carbon bond.
The parties ' only dispute with respect to this term is whether, as Defendants propose, it
should be construed to include the negative limitation "and no fluorine at the 2' down position."
It is undisputed that the plain and ordinary meaning of this term includes fluorine at the 2' down
position. (D.I. 19 at 16; D.I. 129 at 4; Tr. at 30, 38) To depart from this ordinary meaning, the
Court must find that the patentee expressed a clear intent to exclude fluorine at the 2' down
position by acting as his own lexicographer or by intentionally disclaiming or disavowing
fluorine at the 2' down position. See Phillips, 415 F .3d at 1316 (citing SciMed Lif Sys. Inc. v.
e
5
Advanced Cardiovascular Sys. Inc., 242 F.3d 1337, 1343-44 (Fed. Cir. 2001)).
Here, Gilead does not argue that the patentee acted as its own lexicographer, but does
argue that the patentee disavowed fluorine at the 2' down position. Though Gilead acknowledges
that the patent does not expressly disclaim or disavow fluorine at the 2' down position (see Tr. at
12, 45-46), see Abbott Labs v. Baxter Pharm. Prods., Inc. , 334 F.3d 1274, 1278-79 (Fed. Cir.
2003 ); Home Diagnostics, Inc. v. Lif
eScan, Inc., 381F.3d1352 (Fed. Cir. 2004), Gilead contends
that the patentee implicitly disclaims fluorine at the 2' down position, see Astrazeneca AB v. Mut.
Pharm. Co., 384 F.3d 1333, 1340 (Fed. Cir. 2004); see also SkinMedica, Inc. v. Histogen, Inc. ,
727 F.3d 1187, 1204 (Fed. Cir. 2013).
The standard for finding implicit disclaimer is "exacting." Thorner v. Sony Computer
Entm 't Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012). When determining whether a patent
implicitly redefines a claim term, a court must be careful not to read limitations from the
specification into the claims. See id. at 1366-67. Ultimately, an implicit disclaimer must be " so
clear that it equates to an explicit one." Id. at 1368.
Hence, implicit disclaimers have been found only when the patentee clearly and
unmistakably intends to exclude the relevant feature, such as when: (i) in describing the
invention in a manner that does not include the relevant feature, the patent uses language such as
"the present invention is," "the present invention requires," or "all embodiments of the present
invention are," see SciMed, 242 F.3d at 1343-44; Regents of Univ. of Minn. v. AGA Med. Corp .,
717 F.3d 929, 936 (Fed. Cir. 2013); Honeywell Int '!, Inc. v. ITT Indus., Inc., 452 F.3d 1312,
1316-19 (Fed. Cir. 2006); (ii) in describing a particular embodiment that does not include the
relevant feature, the patent' s specification makes clear that the particular embodiment
6
nonetheless contains another feature or element that is necessary, very important, or critical to the
invention, see Andersen Corp v. Fiber Composites, LLC, 674 F.3d 1361 , 1367 (Fed. Cir. 2007) ;
or (iii) the patentee repeatedly disparages embodiments that include the relevant feature or
otherwise makes clear that the feature caililot be part of the claimed invention, see Chi. Bd.
Options Exch. , Inc. v. Int '! Sec. Exch. , LLC, 677 F.3d 1361 , 1372 (Fed. Cir. 2012); SafeTCare
Mfg. , Inc. v. TeleMade, Inc., 497 F.3d 1262, 1269-70 (Fed. Cir. 2007); SciMed, 242 F.3d at
1342-45.
None of these circumstances is present here. Defendants caililot point to language in the
specification to the effect that "the present invention is" or "requires" an embodiment excluding
fluorine at the 2' down position. Nor do they identify anywhere the intrinsic evidence makes
clear that an embodiment lacking fluorine at the 2' down position is critical to the invention.
Defendants likewise fail to show where the patentee repeatedly disparaged embodiments that do
or may include fluorine at the 2' down position.
Instead, Gilead points to the specification' s disclosure of the preferred embodiment of 2'C-branched ribonucleosides. The patent discloses many possible substituents for the 2' down
position of this embodiment, including three of the five halogens (chlorine, bromine, and iodine),
but never mentions fluorine - even though fluorine is a halogen and is disclosed as a possible
substituent for the 2' up position. (See, e.g. , ' 054 patent at 43:53 -44:26, 47:5-43 , 50:39-51 :13;
Tr. at 33-35) However, the specification does not describe the preferred embodiment of 2'-Cbranched-ribonucleosides as defining the invention. Rather, this section is introduced by the
statement, " [t]he following non-limiting embodiments illustrate some general methodology to
obtain the nucleosides of the present invention." (' 054 patent at 43:50-52; ' 597 patent at 43:51-
7
53) (emphasis added)
Gilead observes that although fluorine is mentioned a total of 332 times in each
specification, not one of these mentions has fluorine in the 2' down position. (See D.I. 128 at 17)
(citing D.I. 28, Ex. B) The patent's failure to expressly disclose fluorine at the 2' down position
does give the Court pause. But the patent' s silence in this respect (i.e., whether fluorine could be
in the 2' down position and still be within the scope of the claims) does not amount to a
disclaimer. Because "[a]n invention is not limited to its examples," Netcraft Corp. v. eBay, Inc.,
549 F.3d 1394, 1400 (Fed. Cir. 2008); see also Info-Hold, Inc. v. Applied Media Techs. Corp.,
783 F.3d 1262, 1267 (Fed. Cir. 2015), "silence is not a sound basis on which to limit claims,"
Honeywell Int '!, Inc. v. Nikon Corp., 589 F. Supp. 2d 433 , 446 (D. Del. 2008).
Defendants can point to nowhere in the intrinsic record where a person of ordinary skill in
the art would find "words or expressions of manifest exclusion or restriction." Liebel-Flarsheim ,
358 F.3d at 906. The inventors stated multiple times during prosecution that the "core of the
invention" is "a pyrimidine nucleoside that has two non-hydrogen substituents" without further
excluding fluorine (which is a non-hydrogen substituent, and therefore within the scope of the
claims). (E.g., D.I. 128, Ex. 4) Additionally, when the examiner rejected a claim including nonhydrogen substituents at the 2' position in view of U.S . Patent No. 6,348,587 ("the Schinazi
patent"), which disclosed fluorine at the 2' down position (see D.I. 129 at 6; Tr. at 48, 51 ), the
patentee added a new claim that it distinguished from the Schinazi patent on a basis other than it
not having fluorine at the 2' down position. (See D.I. 129, Ex. 8 at 3; D.I. 129, Ex. 6 at 13 ; Tr. at
51) Had the patentee understood its invention to exclude any embodiment with fluorine at the 2'
down position, the patentee easily could have distinguished its patent on this basis.
8
In further support of its position, Gilead contends that the ' 054 and ' 597 patents fail to
adequately describe or enable embodiments with fluorine at the 2' down position. (See D.I. 146
at 9-10; Tr. at 43) This may be so - but the Court is not at this stage addressing these issues.
Generally, questions of validity such as inadequate written description or enablement are
premature at the claim construction stage. See Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d
1367, 13 74 (Fed. Cir. 2014) ("Enablement concerns do not justify departing from the plain and
ordinary meaning of [a term] ."); Phillips, 415 F.3d at 1327 ("While we have acknowledged the
maxim that claims should be construed to preserve their validity, . .. we have certainly not
endorsed a regime in which validity analysis is a regular component of claim construction . . . .
Instead, we have limited the maxim to cases in which the court concludes, after applying all the
available tools of claim construction, that the claim is still ambiguous.") (internal citations and
quotation marks omitted). 5
Accordingly, the Court will adopt Plaintiffs' proposed construction of this term.
5
Defendants rely on Wang Labs., Inc. v. Am. Online, Inc., 197 F.3d 1377, 1381 (Fed. Cir.
1999), in which the Federal Circuit construed a disputed claim term in a manner that excluded
features that were neither described nor enabled in the specification. This pre-Phillips case does
not alter the Court's conclusion. In Liebel-Flarsheim , the Federal Circuit explained that in
Wang, the lack of enablement was consistent with a prosecution history disclaimer, and that
" Wang therefore does not stand for the proposition that if a patent specification describes only a
particular embodiment, the claims·must be limited to that subject matter." 358 F.3d at 907.
Moreover, as Defendants acknowledge, the Wang Court had adequate extrinsic evidence before it
to support exclusion of certain embodiments. (See Tr. at 41 ) Here, the record does not justify
the exclusion sought by Defendants. Finally, the intrinsic evidence does not leave any ambiguity
in the scope of the claim language. See Vitronics, 90 F.3d at 1583.
9
B.
The '054 Patent: "6-D-2'-C-branched pyrimidine ribonucleoside"
Plaintiffs
A 13-D-pyrimidine ribonucleoside having a non-hydrogen substituent at the 3' down position
and two non-hydrogen substituents at the 2' position, at least one of which is connected at the
2' position through a carbon-to-carbon bond.
Defendants
A 13-D-pyrimidine ribonucleoside with a non-hydrogen substituent at the 2' up position that is
connected at the 2' position through a carbon-to-carbon bond, and hydroxyl groups at the 2'
down and 3' down positions. [To the extent the term is not construed to require a hydroxyl
group at the 2' down position, the construction should specify that there is no fluorine in the 2'
down position.]
Court
A 13-D-pyrimidine ribonucleoside having a non-hydrogen substituent at the 3' down position
and two non-hydrogen substituents at the 2' position, at least one of which is connected at the
2' position through a carbon-to-carbon bond.
The parties' principal dispute regarding this term is whether the 2' down and 3' down
positions are limited to hydroxyl ("OH") groups, as Defendants contend. In the alternative,
Defendants request a construction that at least excludes fluorine at the 2' down position.
Plaintiffs oppose both of Defendants' proposals, contending that the claims encompass any nonhydrogen substituents at the 2' and 3' down positions.
It is undisputed that OH is required at the 2' and 3' down positions of a natural
ribonucleoside. (D.I. 148 at 12-13 ; D.I. 148, Ex. 23 at 141:13-143:6, 184:21-185 :1; Tr. at 98)
However, the term the Court is being asked to construe does not refer to a natural ribonucleoside,
and the Court is not convinced that the term is limited to a single species rather than a genus of
compounds. 6 (See D.I. 148 at 13 ; Tr. at 83)
6
Defendants provided extrinsic evidence, as well as much argument, to the effect that
persons of ordinary skill in the art would understand the chemical nomenclature at the pertinent
time to be consistent with Defendants' proposed construction, and not with Plaintiffs' proposal.
(See, e.g., D.I. 131 at 12-14, Tr. at 75-76) As the intrinsic evidence does not persuade the Court
10
Claims 1-24 of the ' 054 patent expressly require OH at the 2' and 3' down positions, but
claim 26 does not. (Compare ' 054 patent at 160:2-164:35 with id. at 164:40-45) Defendants '
contention that "[ c]laim 26 simply describes the ribonucleosides depicted by claims 1-24, albeit
with the potential for a wider range of modifications at the 2' up position" (D.I. 146 at 12) is
unsupported. See Vitronics, 90 F.3d at 1583 (explaining that interpretations reading out preferred
embodiments are "rarely, if ever, correct"). The specification's description of2'-C-branched
ribonucleosides includes various non-OH compounds at the 2' and 3' down positions. ('054
patent at 47:6-23 ; ' 597 patent at 47:2-23) During prosecution, the patentee referred to this
description of 2'-C-branched-ribonucleoside including non-OH compounds at the 2' and 3' down
positions. (D.I. 129, Ex. 6 at 11 ; D.I. 129, Ex. 9 at 66) Therefore, Defendants' construction
would improperly exclude a preferred embodiment disclosed in the specification from the claim
language.
Defendants point to the ribonucleosides depicted in Figure 1 of the specification, entitled
"Chemical Structure of Illustrative Nucleosides," which show OH at the 2' and 3' down positions
('054 patent at Fig. 1; ' 597 patent at Fig. 1), and other parts of the specification that likewise
have OH at the 2' and 3' down positions ofribonucleosides (' 054 patent at 54:30-55:17 (Example
1), 159:40-62 (Table 5), 91:1-30 (Example 2), 125:24-60 (Example 3), 44:57-45:45 (Scheme 1),
46:37-65 (Scheme 2), 48:24-29 (Scheme 3), 49:47-50:31(Scheme4), 51 :65-52 :49 (Scheme 5),
53 :12-54:22 (Scheme 6)) While these many embodiments are consistent with Defendants '
construction, they do not constitute a disclaimer nor otherwise compel the Court to reject
that the patentee intended to claim a species rather than a genus, the extrinsic evidence does not
alter the Court's conclusion.
11
Plaintiffs' proposed construction. Because the Court finds the support for Plaintiffs' construction
(including claim 26) to be more persuasive than the support for Defendants' construction, the
Court will adopt Plaintiffs' proposal.
C.
The '597 Patent: "8-D-2'-methyl-ribofuranosyl nucleoside"
Plaintiffs
A B-D-nucleoside that includes a five member sugar ring with a methyl group in the 2' up
position and non-hydrogen substituents at the 2' down and 3' down positions.
Defendants
A B-D-nucleoside that includes a five member sugar ring with a methyl group in the 2' up
position and hydroxyl groups at the 2' down and 3' down positions. [To the extent the term is
not construed to require a hydroxyl group at the 2' down position, the construction should
specify that there is not fluorine in the 2' down position.)
Court
A B-D-nucleoside that includes a five member sugar ring with a methyl group in the 2' up
position and non-hydrogen substituents at the 2' down and 3' down positions.
The parties agree that the dispute over this term is essentially the same as that over the
previous term. (Tr. at 70, 73) The only additional intrinsic evidence for this term is a statement
made by the patentee during prosecution identifying a compound with OH at the 2' and 3' down
positions as a B-D-2'-methyl-ribofuranosyl nucleoside. (See D.I. 131 , Ex. H at 5) Defendants
point to this as evidence that the patentee intended to limit B-D-2'-methyl-ribofuranosyl
nucleosides to compounds with OH at the 2' and 3' down positions. Again, however, this is not
an unmistakable disclaimer of B-D-2'-methyl-ribofuranosyl nucleosides with something other
than OH at the 2' and 3' down positions. Accordingly, the Court will adopt Plaintiffs ' proposed
construction of this term.
12
D.
The '054 and '597 Patents: "Nucleoside"
Plaintiffs
A compound comprising a base linked to a sugar.
Defendants
A compound comprising base and sugar moieties, with a hydroxyl group at the 5' position.
Court
A compound comprising a base linked to a sugar.
The parties disagree about whether the 5' positions are limited to hydroxyl ("OH")
groups, such that nucleosides exclude nucleotides, which have phosphate (a non-OH substituent)
at the 5' position. It is "not disputed that a nucleotide is simply a phosphorylated version of a
nucleoside." (Tr. at 106)
Plaintiffs rely on claim differentiation in support of their view that nucleosides should not
be limited to compounds including OH at the 5' position. As Plaintiffs emphasize, claims 1-24 of
the ' 054 patent expressly require OH at the 5' position, whereas claim 25 does not. (Compare
' 054 patent at 160:2-164:35 with id. at 164:36-39) Defendants contend that claim 25 differs
from claims 1-24 because it allows for modifications at the 2' position. Defendants again
emphasize Figure 1 of the specifications, which shows the "Chemical Structure of Illustrative
Nucleosides" and depicts OH in the 5' position (' 054 patent at Fig. 1; ' 597 patent at Fig. 1);
elsewhere, the specifications refer to the " 5'-0H position of the nucleoside" ('054 patent at 40:89; ' 597 patent at 40:9-10).
However, reading selected specification references into a claim limitation requiring OH at
the 5' position, while ignoring many other parts of the specification that are inconsistent with
such a limitation, would be improper. See, e.g., Vitronics, 90 F.3d at 1583. The specifications'
description of 2'-C-branched ribonucleosides expressly includes embodiments with various non13
OH compounds at the 2' and 3' down positions. (' 054 patent at 47:6-23 ; ' 597 patent at 47:2-23)
Similarly, the specifications explain that " [t]he active nucleoside can also be provided as a 5'phosphoether lipid or a 5'-ether lipid," neither of which have OH at the 5' position. (' 054 patent
at 39:48-51) Many other preferred embodiments of nucleosides also do not have OH at the 5'
position. (See, e.g. , ' 054 patent at 10:10-54, 21:37-22:13, 11:41-12:17, 24:5-44, 12:22-64, 29:141 , 13:1 -38, 32:52-33:25) During prosecution, claims were presented for nucleoside
embodiments having substituents other than OH at the 5' position. (D.I. 129, Ex. 6 at 11 ; D.I.
129, Ex. 9 at 66; D.I. 129, Ex. 5 at 7) Defendants' proposal would read various preferred
embodiments out of the claim language.
Defendants also argue that because the claims of the ' 597 patent - unlike those of the
' 054 patent - explicitly refer to "nucleoside or a phosphate thereof' (compare ' 597 patent at
142:63-144:47 with '054 patent at 162:2-164:45), construing nucleoside to include nucleotide
would (in the context of the ' 597 patent) render the language "or a phosphate thereof' (i.e., "or a
nucleotide") superfluous. " [W]hile interpretations that render some portion of the claim
language superfluous are disfavored, where neither the plain meaning nor the patent itself
commands a difference in scope between two terms, they may be construed identically." Power
Mos/et Techs., L.L.C. v. Siemens AG, 378 F.3d 1396, 1410 (Fed. Cir. 2004). Here, although
Defendants' argument suggests these patents were drafted with something short of perfection, it
does not persuade the Court that it should adopt Defendants' proposed constructions.
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E.
The '054, '597, and '600 Patents: "Administering"
Plaintiffs
Making available.
Defendants
Providing externally. A metabolite of an administered compound that is created by in vivo
transformation is not administered.
Court
Making available.
The parties disagree about whether administering includes in vivo (inside the body)
administration, such that the claims cover the use of prodrugs that metabolize into
pharmaceutically effective compounds once inside of the body. Defendants' proposed
construction would read in vivo out of the claims. The Court rejects Defendants' proposal.
The claims refer to in vivo administration. Claim 1 of the ' 600 patent does so
specifically. ("R 2 is .. . a pharmaceutically acceptable leaving group which when administered
in vivo provides a compound wherein R2 is H") (emphasis added) The claim language of the
patents also refers to administration in a "host'', a term which, according to the specification,
encompasses living cells. ('054 patent at 38:50-53 ; ' 597 patent at 38:54-57, ' 600 patent at
109:36-39) ("The term host specifically refers to infected cells, cells transfected with all or part
of the HCV genome and animals .... ") Defendants argue that such cells must refer to cells in a
petri dish, as opposed to the human body. (See Tr. at 110) But nothing in the patent requires
such a limitation. In fact, each patent's specification explains that the claimed compounds can be
administered in vivo ('054 patent at 10:38-41 ; '597 patent at 10:38-41 ; '600 patent at 105:1-4),
15
including in the form of a prodrug7 ('054 patent at 15 :38-40; '597 patent at 15 :48-50, '600 patent
at 109:64-67) ("The compounds of this invention either possess antiviral (i.e., anti-HCV)
activity, or are metabolized to a compound that exhibits such activity.") (emphasis added);
'600 patent at 38:50-54 ("The invention further provides at least one of the described 2' and 3'prodrugs in combination or alteration with second nucleoside that exhibits activity against a
Flaviviridae, including but not limited to a parent drug of any of the prodrugs defined
here . ... ").
The Court does not read other parts of the specifications discussing external
administration as excluding in vivo administration. (See, e.g., '054 patent at 36:53-56; '600
patent at 110:2-5) ("The active compound can be administered as any salt or prodrug that upon
administration to the recipient is capable of providing directly or indirectly the parent compound,
or that exhibits activity itself.")
IV.
CONCLUSION
The Court will construe the disputed claim terms of the patents-in-suit consistent with this
Memorandum Opinion. An appropriate Order follows.
7
The patents describe a pro-drug form of the invention as "a compound that is
metabolized, for example hydrolyzed or oxidized, in the host to form the compound of the
present invention." ('054 patent at 39:2-5; ' 597 patent at 39:5-8; '600 patent at 109:54-57)
(emphasis added)
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