Gilead Sciences, Inc. v. Merck & Co, Inc. et al
Filing
140
ORDER CONSTRUING CLAIMS. Signed by Judge Beth Labson Freeman on 5/1/2015. (blflc3S, COURT STAFF) (Filed on 5/1/2015)
1
2
UNITED STATES DISTRICT COURT
3
NORTHERN DISTRICT OF CALIFORNIA
4
SAN JOSE DIVISION
5
6
GILEAD SCIENCES, INC.,
Case No. 13-cv-04057-BLF
Plaintiff,
7
v.
8
9
MERCK & CO, INC., et al.,
Defendants.
ORDER CONSTRUING CLAIMS IN
U.S. PATENT NOS. 7,105,499 AND
8,481,712
[Re: ECF 86, 91, 96, 99, 113]
10
United States District Court
Northern District of California
11
12
Plaintiff Gilead Sciences, Inc. brings this declaratory relief action, asking the Court to
13
declare that the manufacture, sale, and use of its drug sofosbuvir does not infringe two patents
14
owned by Defendants, Merck & Co., Merck Sharp and Dohme Corp., and Isis Pharmaceuticals,
15
Inc. (collectively “Merck”), U.S. Patent Nos. 7,105,499 (“the ’499 Patent”) and 8,481,712 (“the
16
’712 Patent”). Presently before the Court is a dispute between the parties as to how to construe the
17
term “administering” used in claim 1 of the ’499 Patent.
18
19
20
21
I.
BACKGROUND
The parties provided the Court with a tutorial on the technology at issue on March 27,
2015, and appeared for a Markman hearing on April 3, 2015.
The two patents at issue in this case address treatment for Hepatitis C virus (“HCV”)
22
infections. The claims of the ’712 Patent are directed to compounds having a specific structural
23
formula, while the claims of the ’499 Patent are directed to methods of treating HCV infections by
24
administering therapeutically effective amounts of those compounds.
25
26
27
28
Claim 1 of the ’499 Patent provides:
1. A method of treating hepatitis C virus (HCV) infection comprising
administering to a mammal in need of such treatment a therapeutically
effective amount of a compound of structural formula III, or a
pharmaceutically acceptable salt or acyl derivatives thereof,
1
2
3
4
wherein B is
5
6
7
8
9
10
United States District Court
Northern District of California
11
12
13
14
15
16
17
W is O or S;
Y is H, C1-10 alkylcarbonyl, P3O9H4, P2O6H3, or P(O)R9R10;
R1 is CF3, or C1-4 alkyl and one of R2 and R3 is OH or C1-4 alkoxy
and the other of R2 and R3 is fluoro;
R6 is H, OH, SH, NH2, C1-4 alkylamino, di(C1-4 alkyl)amino, C3-6
cycloalkylamino, halogen, C1-4 alkyl, C1-4 alkoxy, or CF3;
R5 is H, C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, C1-4 alkylamino, CF3,
or halogen; and
R9 and R10 are each independently hydroxy, OCH2CH2SC(═O)t-butyl,
or OCH2O(C═O)iPr.
On December 6, 2013, Gilead received approval from the Food and Drug Administration
18
to market and sell Solvaldi®, an orally-administered prescription drug containing the active
19
ingredient sofosbuvir, to treat chronic HCV infection in patients. Sofosbuvir is a prodrug, and is
20
inactive and has little to no therapeutic effect until transformed by enzymes in the body into an
21
active form. Sofosbuvir has a specific chemical structure called a “phosphoramidate” that converts
22
into an active form inside the body’s liver cells. Once inside a liver cell, sofosbuvir is converted
23
into three analogs, each with different structures: a monophosphate analog, a diphosphate analog,
24
and a triphosphate analog (collectively the “sofosbuvir metabolites”). The triphosphate analog is
25
the therapeutically effective form, and can target and effectively cure HCV infection in patients.
26
See Gilead’s Resp. Br., ECF 96 at 4.
27
28
The sofosbuvir phosphoramidate is not described by “compound[s] of structural formula
III” in claim 1 of the ’499 Patent, but all three sofosbuvir metabolites are so described. See id. at 7.
2
1
2
II.
LEGAL STANDARD
Claim construction is a matter of law. See, e.g., Markman v. Westview Instruments, Inc.,
3
517 U.S. 370, 387 (1996). It is a “bedrock principle of patent law” that the “claims of a patent
4
define the invention to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp.,
5
415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). As such, the “appropriate starting point” for a
6
court interpreting the patent “is always with the language of the asserted claim itself.” Comark
7
Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998). In construing the claims of
8
a patent, a disputed term is generally given “the meaning that the term would have to a person of
9
ordinary skill in the art in question at the time of the invention.” Phillips at 1313. The Court reads
claims in light of the specification, which is the “single best guide to the meaning of a disputed
11
United States District Court
Northern District of California
10
term.” Id. at 1315.
12
The interpretation given to a term “can only be determined and confirmed with a full
13
understanding of what the inventors actually invented and intended to envelop within the claim.”
14
Id.at 1316; see also Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir.
15
1998). The claim language, written description, and patent prosecution history form the intrinsic
16
record that is most significant when determining the proper meaning of a disputed claim. Vitronics
17
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). In some cases, the ordinary
18
meaning of claim language, as understood by a person of skill in the art, may be readily apparent.
19
Claim construction in such cases involves little more than application of the widely accepted
20
meaning of commonly understood words. See, e.g., Phillips at 1314. In CCS Fitness, Inc. v.
21
Brunswick Corp., the Federal Circuit stated that “[g]enerally speaking, we indulge a ‘heavy
22
presumption’ that a claim term carries its ordinary and customary meaning.” 288 F.3d 1359, 1366
23
(Fed. Cir. 2002). It continued, however, that “a claim term will not receive its ordinary meaning if
24
the patentee acted as his own lexicographer and clearly set forth a definition of the disputed claim
25
term in either the specification or prosecution history.” Id. (citing Johnson Worldwide Assocs.,
26
Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999)).
27
28
To act as his own lexicographer, a “patentee must clearly set forth a definition of the
disputed claim term other than its plain and ordinary meaning.” Phillips at 1316. When a patentee
3
1
“provide[s] a definition of [the disputed term] in the specification, the definition in the
2
specification controls . . . regardless of any potential conflict with the term’s ordinary meaning as
3
reflected in technical dictionaries.” 3M Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d
4
1365, 1374 (Fed. Cir. 2003). Absent a “clear disavowal in the specification or prosecution history,
5
the patentee is entitled to the full scope of its claim language.” Home Diagnostics v. LifeScan, 381
6
F.3d 1352, 1358 (Fed. Cir. 2004).
7
III.
In their initial joint claim construction statement, see ECF 86, the parties agreed on the
8
9
AGREED UPON CONSTRUCTIONS
construction of a single term, “in combination with,” used in the ’499 Patent. The Court
accordingly adopts and approves the following construction:
11
United States District Court
Northern District of California
10
Patent
Term
Construction
12
7,105,499: claim 2
in combination with
The term “in combination
with” means “together with,”
whether given separately at
different times during the
course of therapy or
concurrently in divided or
single combination forms.
13
14
15
16
The parties’ initial joint claim construction statement identified two disputed claim terms:
17
18
“administering,” used in claim 1 of the ’499 Patent, and “compound,” used in claims 1 and 2 of
19
the ’499 Patent and claims 1, 2, 3, 5, 7, 9, 10, and 11 in the ’712 Patent. Following briefing,
20
however, the parties agreed to the following construction of “compound,” which the Court also
21
adopts and approves:
22
Patent
Term
Construction
23
7,105,499: claims 1-2
compound
24
8,481,712: claims 1-3, 5, 7, 9-11
a substance that consists of two
or more chemical elements in
union.
25
26
27
28
4
CONSTRUCTION OF THE DISPUTED TERM “ADMINISTERING”
1
IV.
2
Plaintiffs’ Proposal
providing a compound of the
invention or a prodrug of a
compound of the invention to
the individual in need without
reference to in vivo
transformations of those
compounds or prodrugs.
3
4
5
6
7
8
9
Defendants’ Proposal
providing a compound of the
invention or a prodrug of a
compound of the invention to
the individual in need.
Court’s Construction
providing a compound of the
invention or a prodrug of a
compound of the invention to
the individual in need.
The phrase ‘prodrug of a
compound’ means those
prodrugs that are expressly
claimed.
This disputed term is found in claim 1 of the ’499 Patent, which claims “[a] method of
10
United States District Court
Northern District of California
11
treating hepatitis C virus (HCV) infection comprising administering to a mammal in need of such
12
treatment a therapeutically effective amount of a compound of structural formula III or a
13
pharmaceutically acceptable salt or acyl derivatives thereof.” ’499 Patent, col. 137 ll. 1-6
14
(emphasis added).
As Merck explained at the Markman hearing:
15
16
[O]ur theory of infringement is when sofosbuvir is provided, it is a
prodrug that converts after it’s swallowed into the monophosphate,
the diphosphate, and the triphosphate. The monophosphate and the
diphosphate are compounds of the invention also but are not
themselves active drugs. They are, in fact, prodrugs that convert to
the triphosphate which is active.
17
18
19
And so we would view this as literally performing this claimed
method by providing a prodrug, sofosbuvir, of a compound of the
invention. It’s, in fact, a prodrug of three compounds of the
invention, the monophosphate, the diphosphate, and the
triphosphate.
20
21
22
23
Hearing Tr., ECF 122 at 14:8-19.1 Merck’s infringement theory is based on the definition of
24
“administering” found in the ’499 Patent:
The terms “administration of” and “administering a” compound
25
26
1
27
28
Although the Court does not consider the accused products as extrinsic evidence when
construing the claims, the court may refer to the accused products for context and to inform itself
“of the specific issues presented by the infringement inquiry.” See Wilson Sporting Goods Co. v.
Hillerich & Bradsby Co., 442 F.3d 1322, 1331 (Fed. Cir. 2006)
5
1
2
should be understood to mean providing a compound of the
invention or a prodrug of the compound of the invention to the
individual in need.
3
’499 Patent, col. 32 ll. 5-9. The parties’ claim construction arguments thus focus on whether the
4
term “administering” could encompass the administration of prodrugs that are not themselves
5
“compounds of the invention.” The parties agree that “compound of the invention” means the
6
compounds claimed, i.e., any “compound of structural formula III, or a pharmaceutically
7
acceptable salt or acyl derivatives thereof.” See Hearing Tr. at 25:19-24 (Merck); see also id. at
8
58:11-15 (Gilead).
The parties also agree that the ’499 Patent includes a definition of the term administering.
10
See ’499 Patent, col. 32 ll. 5-9; see also id. at col. 30 ll. 4-5 (“Throughout the instant application,
11
United States District Court
Northern District of California
9
the following terms have the indicated meanings . . .”). Where a patent includes a definition, “the
12
inventor’s lexicography governs” and “the inventor’s intention, as expressed in the specification,
13
is regarded as dispositive.” Phillips, 415 F.3d at 1316. That is the case even where the inventor’s
14
definition differs from the term’s plain and ordinary meaning to a person of ordinary skill. Id.; see
15
also CCS Fitness, 288 F.3d at 1366. Nonetheless, the court should read the definition in light of
16
the specification as a whole. Allergan, Inc. v. Apotex, Inc., 754 F.3d 952, 957-58 (Fed. Cir. 2014)
17
(approving district court’s construction that “read[] the patentee’s own lexicography in light of the
18
whole specification”); Trading Techs. Int’l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1353 (Fed. Cir.
19
2010) (“The district court’s definition may seem narrower than the inventors’ express definition at
20
first glance. However, the claims, the rest of the specification, and the prosecution history support
21
the district court’s definition.”).
22
Gilead’s proposed construction begins with the definition and seeks to add two further
23
limitations, which Gilead contends both reflect the plain and ordinary meaning of “administering”
24
and are supported by the specification of the ’499 Patent. Gilead argues that the first limitation,
25
“without reference to in vivo transformations of those drugs or compounds,” is necessary because
26
“[n]othing in the intrinsic record suggests that the patentees altered the ordinary meaning of
27
‘administering’ to refer to in vivo compound transformations,” and because “Defendants’
28
infringement theory for the ’499 patent relies on the fact that the body transforms sofosbuvir—
6
1
which is not expressly covered by the claims—into other compounds that are expressly claimed.”
2
Gilead’s Br. at 14. Gilead further argues that the second sentence, “The phrase ‘prodrug of a
3
compound’ means those prodrugs that are expressly claimed,” is necessary because the intrinsic
4
record shows that the patentee claimed only a limited set of prodrugs – those explicitly recited in
5
the claim – and not all prodrugs. See id. at 21-22.2
6
The Court considers both of these disputes below.
7
A.
8
Merck argues that the Court should adopt its construction of “administering” because its
Whether “administering” encompasses in vivo transformation
proposed construction is identical to the definition of administering included in the ’499 Patent. It
10
argues that because the patent itself includes no pre-ingestion limitation, the Court should not limit
11
United States District Court
Northern District of California
9
the claim in the manner suggested by Gilead. In response, Gilead argues that the Court should
12
alter the definition provided in the ’499 Patent to conform the definition to the plain and ordinary
13
meaning of “administering.” Gilead contends that “administration is complete at the point when
14
the patient swallows a tablet . . . [and] does not extend beyond [] to encompass whether and how
15
the body transforms a drug.” Gilead’s Br. at 15. It also argues that a review of the entire intrinsic
16
record shows that Merck intended “administering” to mean only providing a compound to an
17
individual in need, and not what happens to that compound after it is ingested. See id. at 18. The
18
Court finds neither of Gilead’s arguments persuasive.
The Court begins with the definition included in the specification of the ’499 Patent.
19
20
“Administering” is specifically defined in the ’499 Patent to mean “providing a compound of the
21
invention or a prodrug of a compound of the invention to the individual in need.” A “prodrug of a
22
compound” is, the parties agree, a precursor drug that must be transformed in the body before it
23
becomes an active therapeutic compound. See, e.g., V.J. Stella et al., Prodrugs: Do They Have
24
25
26
27
28
2
Though the phrase “prodrug of a compound” does not itself appear in the claim, the Court may
nonetheless construe the term if it is necessary to elucidate the claim’s meaning. See Adv. Fiber
Techs. (AFT) Trust v. J&L Fiber, 674 F.3d 1365, 1373 (Fed. Cir. 2012) (“We note, as an initial
matter, that ‘we do not ordinarily construe words that are not in claims.’ However, in those cases
in which the correct construction of a claim term necessitates a derivative construction of a nonclaim term, a court may perform the derivative construction in order to elucidate the claim’s
meaning.”) (internal citations omitted).
7
1
Advantages in Clinic Practice?, 29 Drugs 455, 455 (1985). The Court is persuaded by Merck’s
2
argument that the use of the term “prodrug of a compound” within the definition of
3
“administering” in the ’499 Patent necessarily includes what happens once a prodrug enters the
4
patient’s body and transforms through metabolism from the inactive prodrug form into the active
5
therapeutic form. See Merck’s Reply Br. at 10 (“The ability to undergo metabolism in the body is
6
the very hallmark of a prodrug, and distinguishes prodrugs from mere drugs.”); see also Adv.
7
Fiber, 674 F.3d at 1373. Gilead’s construction would read out the words “prodrug of a compound”
8
from the definition of “administering” in the patent, which is inappropriate. See Phillips, 415 F.3d
9
at 1316; CCS Fitness, 288 F.3d at 1366.
10
Gilead nonetheless argues that the definition should be read in conjunction with other
United States District Court
Northern District of California
11
language in the ’499 Patent that it contends supports an ex vivo limitation. But the language
12
Gilead points to does not support such a reading. Gilead argues that the ’499 Patent states that
13
“[t]he compounds of the present invention may be administered in the form of a pharmaceutically
14
acceptable salt,” and since pharmaceutically acceptable salts are “prepared by man,” the word
15
“administering” only includes “a timeframe before the body transforms the compounds.” Gilead’s
16
Br. at 17. This reading, however, ignores the word “may”; this disclosure identifies one way in
17
which the invention can be practiced, not the only way in which the invention can be practiced.
18
Additionally, the two District of New Jersey cases Gilead cites in support of its argument,
19
Hoffman-La Roche Inc. v. Apotex and Schering Corp. v. Glenmark Farms, are inapposite. In
20
Apotex, the patent at issue did not include a definition of the term “administering,” see 2010 WL
21
1875569, at *8 (D.N.J. May 10, 2010) (“[E]xamination of the intrinsic evidence does not indicate
22
that the patentee acted as his own lexicographer.”), and the claim language itself suggested that
23
administering ended at the point at which the compound entered the patient’s body. A careful
24
reading of Apotex, in fact, supports Merck’s argument here: the court noted that because the
25
specification stated that the compound could be “administered in solid form,” the claim
26
“suggest[ed] that administering a solid would end when the solid itself ended.” Id. at *9. The
27
Apotex court thus explicitly looked to the manner in which the compound was being provided to
28
the patient in order to determine how to construe “administering.” This Court does the same.
8
1
Because Merck expressly states that the treatment can be administered through a “prodrug of the
2
compound,” which requires metabolism into a therapeutically effective form in the body, the claim
3
should not be limited to only what occurs ex vivo. Similarly, in Schering, the district court also
4
looked to extrinsic evidence and ordinary meaning of the term “administering” because the patent
5
at issue did not include a definition of the term. 2008 WL 4307189, at *8 (D.N.J. Sept. 16, 2008).3
Gilead is correct that the Court must read the definition included in the specification in
6
light of the entire intrinsic record. See Allergan, 754 F.3d at 957-58; see also Trading Techs., 595
8
F.3d at 1353. Such a review supports Merck’s construction. Per the definition of administering,
9
the treatment claimed by the ’499 Patent can be given to the patient in the form of a compound of
10
the invention or a prodrug of a compound of the invention. Gilead’s proposal of limiting the ’499
11
United States District Court
Northern District of California
7
Patent’s definition of administering by adding “without reference to in vivo transformations of
12
those compounds of prodrugs” cannot be squared with the use of the phrase “prodrug of a
13
compound” in the definition of administering. Gilead does not persuasively point to any language
14
in the written description that supports limiting administration to include only what happens up to
15
the point of ingestion.
B.
16
Whether “administering” encompasses only those prodrugs referenced in the
’499 Patent
17
The second limitation Gilead’s proposed construction adds to the definition of
18
19
“administering” is the sentence: “The phrase ‘prodrug of a compound’ means those prodrugs that
20
are expressly claimed.” Gilead contends that the ’499 Patent claims “a limited group of prodrug
21
moieties,” specifically acyl derivatives and SATE prodrugs. See Gilead’s Br. at 21 (citing ’499
22
Patent at col. 137 ll. 2-6, col. 138 ll. 14-15). Acyl derivatives and SATE prodrugs are both
23
“compound[s] of structural formula III, or a pharmaceutically acceptable salt or acyl derivatives
24
thereof.” Gilead argues that by including these limited categories of prodrugs in claim 1 and the
25
26
27
28
3
Gilead’s further argument that the Court should interpret “administering” based on evidence
contained in the Merck Manual is not persuasive. Gilead’s Br. at 18-19. As Merck correctly points
out, the Merck Manual does not address the specific definition of administering set forth in the
’499 Patent. This extrinsic evidence, even to Merck’s own technical manual, cannot overcome the
definition included in the specification. See, e.g., Vitronics, 90 F.3d at 1585.
9
1
written description of the ’499 Patent, Merck has claimed only these specific prodrug forms. Id. at
2
21-22. As Merck’s counsel put it, “[Gilead is] trying to turn ‘prodrug of a compound of the
3
invention’ to ‘prodrug that is a compound of the invention.’” Hearing Tr. at 30:20-22 (emphasis
4
added). Gilead’s proposed construction thus invites the Court to commit “one of the cardinal sins
5
of patent law—reading a limitation from the written description into the claims.” SciMed Life Sys.,
6
Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1340 (Fed. Cir. 2001).
The ultimate problem with Gilead’s position is that the phrase “prodrug of a compound of
7
8
the invention” is not limited to those prodrugs that are also compounds of the invention. A
9
“prodrug of a compound” is any derivative of the compound which converts into the compound
after it is ingested into the body. See, e.g., Stella, 29 Drugs 455, 455-73. The ’499 Patent claims a
11
United States District Court
Northern District of California
10
method of “administering” “a compound of structural formula III, or a pharmaceutically
12
acceptable salt or acyl derivatives thereof.” The definition of “administering” explains that
13
administration is accomplished by providing the actual compound claimed or a prodrug of that
14
compound. There is no indication from the definition of administering that Merck intended to limit
15
itself to only administering certain prodrugs—those prodrugs that are also “compound[s] of the
16
invention.”4
17
Finally, Gilead argues that the file history supports its proposed construction because the
18
patentee “disclaim[ed] prodrugs that [we]re not expressly covered by the claims.” Gilead’s Br. at
19
22. It points to the amendment to pending claim 53 (which issued as claim 1) during prosecution
20
to replace the phrase “ester prodrug” with “acyl derivative,” and argues that this replacement
21
“shows a clear disclaimer of any kind of prodrug in favor of just those that were both described
22
and expressly claimed.” Id. at 23 (citing Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed.
23
Cir. 2003)). This argument is unpersuasive for two reasons. First, in Omega Engineering, the
24
Federal Circuit held that prosecution disclaimer is inappropriate where the “alleged disavowal of
25
26
27
28
4
The Court notes that Merck’s preferred construction could pose invalidity problems for Merck
down the road. It rejects, however, Gilead’s argument that it should adopt Gilead’s proposed
construction in order to preserve the claims’ validity. See Gilead’s Br. at 24; see also Phillips at
1327 (“[W]e have certainly not endorsed a regime in which validity analysis is a regular
component of claim construction.”).
10
1
claim scope is ambiguous.” Id. at 1325. The history Gilead points to is too spare to support a
2
finding of unambiguous disavowal of all non-recited prodrugs. Second, because the definition of
3
“administering” included the phrase “prodrug of a compound”, the phrase “ester prodrug” in the
4
claim was redundant. Cf. Merck’s Reply Br. at 12.
5
In sum, Gilead fails to show prosecution disclaimer, and the intrinsic record shows that
6
Merck did not intend to limit claim 1 to include only those prodrugs expressly referenced. The
7
Court rejects Gilead’s attempt to read the additional limitation “the phrase ‘prodrug of a
8
compound’ means those prodrugs that are expressly claimed” into the definition of
9
“administering” found in the ’499 Patent.
Accordingly, the Court adopts Merck’s construction of “administering” and construes the
10
United States District Court
Northern District of California
11
term to mean “providing a compound of the invention or a prodrug of a compound of the
12
invention to the individual in need.” As is clear from the Court’s analysis, this construction does
13
not include the two limitations that Gilead sought in its proposed construction.
14
V.
15
ORDER
For the reasons set forth above, the Court construes the following terms:
16
Claim Term
Court’s Construction
17
in combination with
The term “in combination with” means
“together with,” whether given separately
at different times during the course of
therapy or concurrently in divided or
single combination forms.
compound
a substance that consists of two or more
chemical elements in union.
administering
providing a compound of the invention or
a prodrug of a compound of the invention
to the individual in need.
18
19
20
21
22
23
24
25
26
27
IT IS SO ORDERED
Dated: May 1, 2015
______________________________________
BETH LABSON FREEMAN
United States District Judge
28
11
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?