Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 1 of 24 PageID #: 630
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
`
`Plaintiffs,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
`
`REDACTED -- PUBLIC VERSION
`
`PLAINTIFFS BAYER HEALTHCARE LLC AND
`BAYER HEALTHCARE PHARMACEUTICALS INC.’S
`ANSWERING CLAIM CONSTRUCTION BRIEF
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`Anthony D. Raucci (#5948)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`dfahnestock@mnat.com
`araucci@mnat.com
`
`Attorneys for Plaintiffs Bayer HealthCare LLC
`and Bayer HealthCare Pharmaceuticals Inc.
`
`OF COUNSEL:
`
`Bruce R. Genderson
`Adam L. Perlman
`Dov P. Grossman
`Jessica B. Rydstrom
`Seth R. Bowers
`Ben Picozzi
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW
`Washington, DC 20005
`(202) 434-5000
`
`Original Filing Date: July 11, 2018
`Redacted Filing Date: July 17, 2018
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 2 of 24 PageID #: 631
`
`
`I. 
`
`II. 
`
`TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................................1 
`
`ARGUMENT .......................................................................................................................2 
`
`A. 
`
`Bayer’s Construction of “an effective amount” Should be Adopted .......................2 
`
`1. 
`
`2. 
`
`Bayer’s Construction Is Consistent with the Express Definition in
`the Specification and the Claim Language ..................................................2 
`
`Teva’s Construction Is Unsupported ...........................................................2 
`
`a. 
`
`b. 
`
`The Specification Contradicts Teva’s Construction ........................3 
`
`The Express Definition Is Not Ambiguous ......................................5 
`
`B. 
`
`Bayer’s Proposal for “a subject who has been treated with imatinib”
`Should Be Adopted ..................................................................................................7 
`
`1. 
`
`2. 
`
`The Phrase “a subject who has been treated with imatinib”
`Requires No Further Construction ...............................................................7 
`
`Teva’s Construction Is Unsupported ...........................................................8 
`
`a. 
`
`b. 
`
`c. 
`
`The Claim Language Contradicts Teva’s Construction ...................8 
`
`The Specification and Prosecution History Contradict
`Teva’s Construction .........................................................................9 
`
`Teva’s Remaining Arguments Are Unavailing ..............................14 
`
`3. 
`
`Teva’s Non-Infringement Position Is Incorrect .........................................15 
`
`III. 
`
`CONCLUSION ..................................................................................................................16 
`
`
`
`i
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 3 of 24 PageID #: 632
`
`
`
`TABLE OF AUTHORITIES
`
`Cases 
`
`Abbott Labs. v. Baxter Pharm. Prods., Inc.,
`334 F.3d 1274 (Fed. Cir. 2003)........................................................................................... 5
`
`Absolute Software, Inc. v. Stealth Signal, Inc.,
`659 F.3d 1121 (Fed. Cir. 2011)......................................................................................... 10
`
`Acorda Therapeutics v. Alkem Labs. Ltd.,
`C.A. No. 14-882-LPS, 2016 WL 1045356 (D. Del. Mar. 16, 2016) .................................. 6
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012)........................................................................................... 8
`
`Allergan, Inc. v. Teva Pharm. USA, Inc.,
`C.A. No. 15-1455-WCB, 2016 WL 7210837 (E.D. Tex. Dec. 13, 2016) .......................... 5
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010)......................................................................................... 16
`
`Bristol-Myers Squibb Co. v. Merck & Co.,
`C.A. No. 14-1131-GMS (D. Del. June 6, 2016) ................................................................. 6
`
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002)........................................................................................... 3
`
`Dealertrack, Inc. v. Huber,
`674 F.3d 1315 (Fed. Cir. 2012)........................................................................................... 3
`
`Enzo Biochem, Inc. v. Applera Corp.,
`599 F.3d 1325 (Fed. Cir. 2010)........................................................................................... 8
`
`Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co.,
`C.A. No. 15-1202-WCB, 2016 WL 7042234 (E.D. Tex. Aug. 11, 2016) .......................... 5
`
`Helmsderfer v. Bobrick Washroom Equip., Inc.,
`527 F.3d 1379 (Fed. Cir. 2008)........................................................................................... 3
`
`Honeywell Int’l, Inc. v. ITT Indus.,
`452 F.3d 1312 (Fed. Cir. 2006)......................................................................................... 13
`
`Imagenetix, Inc. v. Robinson Pharma, Inc.,
`C.A. No. 15-599-JLS, 2016 WL 6395941 (C.D. Cal. Apr. 14, 2016) ................................ 5
`
`In re Mobile Telecomm. Techs., LLC,
`265 F. Supp. 3d 454 (D. Del. 2017) .................................................................................. 14
`
`ii
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 4 of 24 PageID #: 633
`
`LifeNet Health v. LifeCell Corp.,
`837 F.3d 1316 (Fed. Cir. 2016)......................................................................................... 12
`
`Meds. Co. v. Mylan, Inc.,
`853 F.3d 1296 (Fed. Cir. 2017)......................................................................................... 13
`
`Merck Sharp & Dohme Corp. v. Xellia Pharm. ApS,
`C.A. No. 14-199-RGA, 2015 WL 82386 (D. Del. Jan. 6, 2015) ........................................ 5
`
`Minn. Min. & Mfg. Co. v. Chemque, Inc.,
`303 F.3d 1294 (Fed. Cir. 2002)........................................................................................... 5
`
`Moore U.S.A., Inc. v. Standard Register Co.,
`229 F.3d 1091 (Fed. Cir. 2000)......................................................................................... 15
`
`Pacing Techs., LLC v. Garmin Int’l, Inc.,
`778 F.3d 1021 (Fed. Cir. 2015)......................................................................................... 13
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ........................................................... 3, 7, 10, 12
`
`Pitney Bowes, Inc. v. Hewlett-Packard Co.,
`182 F.3d 1298 (Fed. Cir. 1999)................................................................................... 14, 15
`
`Poly-Am., L.P. v. API Indus., Inc.,
`839 F.3d 1131 (Fed. Cir. 2016)......................................................................................... 13
`
`Purdue Pharm. Prods., L.P. v. Actavis Elizabeth, LLC,
`C.A. No. 12-5311-JLL, 2014 WL 2624787 (D.N.J. June 11, 2014) .................................. 6
`
`Regents of the Univ. of Minn. v. AGA Med. Corp.,
`717 F.3d 929 (Fed. Cir. 2013)........................................................................................... 13
`
`Retractable Techs., Inc. v. Becton, Dickinson & Co.,
`653 F.3d 1296 (Fed. Cir. 2011)......................................................................................... 13
`
`Sanofi v. Glenmark Pharm. Inc., USA,
`204 F. Supp. 3d 665 (D. Del. 2016) .................................................................................. 16
`
`Script Sec. Sols. LLC v. Amazon.com, Inc.,
`No. C.A. 15-1030-WCB, 2016 WL 3959804 (E.D. Tex. July 22, 2016) ................... 12, 14
`
`ScriptPro LLC v. Innovation Assocs., Inc.,
`833 F.3d 1336 (Fed. Cir. 2016)........................................................................................... 9
`
`Summit 6, LLC v. Samsung Elecs. Co.,
`802 F.3d 1283, 1291 (Fed. Cir. 2015)................................................................................. 7
`
`iii
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 5 of 24 PageID #: 634
`
`Takeda Pharm. Co. v. Mylan Inc.,
`C.A. No. 13-4001-LHK, 2014 WL 5862134 (N.D. Cal. Nov. 11, 2004) ........................... 6
`
`Teleflex, Inc. v. Ficosa N. Am. Corp.,
`299 F.3d 1313, 1327 (Fed. Cir. 2002)................................................................................. 9
`
`Thorner v. Sony Comput. Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012)........................................................................................... 3
`
`U.S. Surgical Corp. v. Ethicon, Inc.,
`103 F.3d 1554 (Fed. Cir. 1997)........................................................................................... 4
`
`Unwired Planet, LLC v. Apple Inc.,
`829 F.3d 1353, 1358-60 (Fed. Cir. 2016) ............................................................... 9, 12, 14
`
`Verizon Servs. Corp. v. Vonage Holdings Corp.,
`503 F.3d 1295 (Fed. Cir. 2007)......................................................................................... 13
`
`Voda v. Cordis Corp.,
`536 F.3d 1311 (Fed. Cir. 2008)......................................................................................... 10
`
`Wyeth v. Abbott Labs.,
`C.A. No. 9-4850-JAP, 2011 WL 5873373 (D.N.J. Nov. 22, 2011) .................................... 6
`
`Regulations 
`
`Manual of Patent Examining Procedure § 606.01 ........................................................................ 14
`
`
`
`iv
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 6 of 24 PageID #: 635
`
`I.
`
`INTRODUCTION
`
`Bayer and Teva agree that the specification of the ’124 patent expressly defines
`
`“effective amount” to mean “the amount of [regorafenib] which is effective to treat any symptom
`
`or aspect of the cancer.” Bayer’s construction faithfully applies that definition, with a minor
`
`modification to account for express claim language. By contrast, Teva’s more elaborate
`
`construction is unsupported, as it (1) relies on the mistaken premise that the specification defines
`
`which aspects of the cancer must be treated in order for a dose to constitute “an effective
`
`amount” and (2) improperly assumes that the phrase “an effective amount” is ambiguous, an
`
`assertion that is routinely rejected by courts. Accordingly, the phrase “an effective amount”
`
`should be construed to mean “an amount which is effective to treat any symptom or aspect of the
`
`cancer or the tumor.”
`
`With respect to the second contested phrase, Teva does not dispute that the ordinary
`
`meaning of “a subject who has been treated with imatinib” unambiguously encompasses any
`
`subject who has been treated with imatinib, regardless of whether that subject was initially
`
`sensitive to or acquired resistance to imatinib. Instead, Teva asserts that the patent disavows the
`
`ordinary meaning of “a subject who has been treated with imatinib” by narrowly limiting the
`
`scope of the “present invention” to treating subjects who have “acquired resistance” to imatinib.
`
`To the contrary, the claim language, specification, and prosecution history establish that the
`
`“acquired resistance” limitation applies to only certain embodiments of the invention. The
`
`phrase “a subject who has been treated with imatinib” therefore means what is says and requires
`
`no further construction.
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 7 of 24 PageID #: 636
`
`II.
`
`ARGUMENT
`A.
`
`Bayer’s Construction of “an effective amount” Should be Adopted
`1.
`
`Bayer’s Construction Is Consistent with the Express Definition in the
`Specification and the Claim Language
`
`As explained in Bayer’s Opening Brief, the ’124 patent expressly defines “effective
`
`amount” to mean “the amount of [regorafenib] which is effective to treat any symptom or aspect
`
`of the cancer.” U.S. Patent No. 8,680,124 (D.I. 53, Ex. B) (“’124 patent”) col. 6, ll. 4-6; Bayer’s
`
`Opening Br. (D.I. 56) at 6-7. Teva apparently agrees. See Teva’s Opening Br. (D.I. 57) at 7.
`
`Moreover, claims 30 and 31 state that an “effective amount” of regorafenib can be used to treat a
`
`“malignant” or “benign” gastrointestinal stromal tumor; as such, the definition of “effective
`
`amount” applies to “benign” tumors as well. Teva does not identify any flaw in that logic. That
`
`warrants adopting Bayer’s proposed construction.1 See D.I. 56 at 6-7.
`
`2.
`
`Teva’s Construction Is Unsupported
`
`Teva asserts that Bayer’s construction is insufficient because (1) the specification further
`
`defines the specific “aspects” of “cancer” that can be “treated” using “an effective amount” of
`
`regorafenib; and (2) the meaning of “an effective amount” is ambiguous unless it expressly
`
`includes those “aspects” of treating cancer. Neither argument has merit.
`
`
`1
`Teva asserts that although it believes the term “an effective amount” is indefinite, “[t]he
`parties agreed that they [would] not brief indefiniteness as part of claim construction.” D.I. 57 at
`5 n.2. Bayer did not agree to any such arrangement, however. As reflected in the materials
`submitted with Teva’s Opening Brief, Teva unilaterally decided not to brief indefiniteness at the
`claim-construction phase. See Decl. of Jennell C. Bilek, Ex. C (D.I. 58-3) at 5. In any event,
`Bayer disagrees that the phrase “an effective amount” is indefinite.
`
`2
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 8 of 24 PageID #: 637
`
`a.
`
`The Specification Contradicts Teva’s Construction
`
`Teva’s construction relies on the premise that the specification provides a “definition” of
`
`particular “aspects of the cancer that must be treated in order for a dose to be considered ‘an
`
`effective amount.’” D.I. 57 at 12. To support that premise, Teva quotes the following sentence:
`
`Administering effective amounts of [regorafenib] can treat one or
`more aspects of the cancer disease, including, but not limited to,
`causing tumor regression; causing cell death; causing apoptosis;
`causing necrosis; inhibiting cell proliferation; inhibiting tumor
`growth; inhibiting tumor metastasis; inhibiting tumor migration;
`inhibiting tumor invasion; reducing disease progression; stabilizing
`the disease; reducing or inhibiting angiogenesis; prolonging patient
`survival; enhancing patient’s quality of life; reducing adverse
`symptoms associated with cancer; and reducing the frequency,
`severity, intensity, and/or duration of any of the aforementioned
`aspects.
`
`
`’124 patent, col. 6, ll. 9-24; D.I. 57 at 8. However, that passage is plainly not definitional—it
`
`does not contain any of the language or other hallmarks indicative of lexicography. See Thorner
`
`v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (“To act as its own
`
`lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term’ other
`
`than its plain and ordinary meaning” and “must ‘clearly express an intent’ to redefine the term.”
`
`(quoting Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008);
`
`CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). To the contrary,
`
`the inclusion of the phrase “including, but not limited to” demonstrates that the aspects of cancer
`
`described in the sentence are exemplary, not definitional. The fact that Teva ignores language
`
`that appears in the very sentence it relies upon demonstrates that its construction is an improper
`
`attempt to limit the scope of the claims to particular examples described in the specification. See
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc); Dealertrack, Inc. v.
`
`Huber, 674 F.3d 1315, 1320-24 (Fed. Cir. 2012) (reversing the district court’s construction of
`
`“communications medium” based on a list of examples described in the specification).
`
`3
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 9 of 24 PageID #: 638
`
`Moreover, Teva omits the first sentence of the paragraph at issue, which states, “The term
`
`‘treating’ is used conventionally, e.g., the management or care of a subject for the purpose of
`
`combating, alleviating, reducing, relieving, improving, etc., one or more of the symptoms
`
`associated with a cancer, including all cancers mentioned herein.” ’124 patent, col. 6, ll. 9-13.
`
`To the extent that the paragraph at issue “defines” anything, it would be the word “treating.” But
`
`as explained in Bayer’s Opening Brief, the only “definition” is that the word “treating” is used
`
`conventionally, which does not support importing Teva’s extensive construction into the
`
`meaning of “an effective amount.” See D.I. 56 at 9-10. Given the specification’s clear language,
`
`it is unnecessary, and would be incorrect, to modify the definition of “an effective amount” in the
`
`manner that Teva proposes. See U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed.
`
`Cir. 1997) (“Claim construction is a matter of resolution of disputed meanings and technical
`
`scope, to clarify and when necessary to explain what the patentee covered by the claims, for use
`
`in the determination of infringement. It is not an obligatory exercise in redundancy.”).
`
`Furthermore, even if one were to accept Teva’s erroneous premise that the specification
`
`further defines the specific “aspects” of cancer that can be “treated” using “an effective amount”
`
`of regorafenib, Teva’s construction does not accurately reflect the specification. As explained in
`
`Bayer’s Opening Brief, Teva’s construction (1) omits certain phrases that appear in the same
`
`paragraph (“e.g., the management or care of a subject for the purpose of,” “etc.,” “including all
`
`cancers mentioned herein,” “aspects of the cancer disease,” “reducing adverse symptoms
`
`associated with cancer”), ’124 patent, col. 6, ll. 9-14, 21-22; (2) modifies other phrases (“and/or
`
`duration of any of the aforementioned aspects”), ’124 patent, col. 6, ll. 12, 23-24; and (3) adds
`
`phrases that do not appear in the paragraph at all (“and/or reduce,” “or activities”). Teva’s
`
`construction thus fails on its own terms. See D.I. 56 at 9.
`
`4
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 10 of 24 PageID #: 639
`
`b.
`
`The Express Definition Is Not Ambiguous
`
`Teva also asserts that its construction is warranted because the express definition of
`
`“effective amount” is ambiguous, as it does not identify the specific “aspects” of “cancer” that
`
`can be treated using “an effective amount” of regorafenib. See D.I. 57 at 8-9. Precedent directly
`
`contradicts that assertion. Indeed, numerous courts—including this Court and another court from
`
`this Judicial District—have construed “an effective amount” or similar phrases without
`
`identifying particular aspects of the disease to be treated. See, e.g., Acorda Therapeutics v.
`
`Alkem Labs. Ltd., C.A. No. 14-882-LPS, 2016 WL 1045356, at *3 (D. Del. Mar. 16, 2016)
`
`(construing “therapeutically effective concentration” to mean the “blood plasma level of drug
`
`that ameliorates a symptom” based on an express definition in the specification); Merck Sharp &
`
`Dohme Corp. v. Xellia Pharm. ApS, C.A. No. 14-199-RGA, 2015 WL 82386, at *3-4 (D. Del.
`
`Jan. 6, 2015) (concluding that the “customary usage of ‘effective amount’” is “an amount
`
`sufficient to achieve the claimed effect” and declining to construe the phrase (citing Abbott Labs.
`
`v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 1277-78 (Fed. Cir. 2003)); Allergan, Inc. v. Teva
`
`Pharm. USA, Inc., C.A. No. 15-1455-WCB, 2016 WL 7210837, at*8 (E.D. Tex. Dec. 13, 2016)
`
`(Bryson, J.) (construing an “effective amount” to mean “an amount effective to treat the
`
`underlying condition” and holding the phrase not indefinite); Erfindergemeinschaft UroPep GbR
`
`v. Eli Lilly & Co., C.A. No. 15-1202-WCB, 2016 WL 7042234, at *5-6 (E.D. Tex. Aug. 11,
`
`2016) (Bryson, J.) (declining to construe “an effective amount” and holding the phrase not
`
`indefinite).2 Those decisions reject any suggestion that the express definition is somehow
`
`ambiguous because it does not include Teva’s proposed language.
`
`
`2
`See also Minn. Min. & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1304 (Fed. Cir. 2002)
`(construing an “effective amount” to mean “a sufficient amount of the specified component to
`form an encapsulant having the specified properties under the specified conditions, if any”);
`Imagenetix, Inc. v. Robinson Pharma, Inc., C.A. No. 15-599-JLS, 2016 WL 6395941, *4-6 (C.D.
`
`5
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 11 of 24 PageID #: 640
`
`The lone decision that Teva relies upon for its “ambiguity” argument—Bristol-Myers
`
`Squibb Co. v. Merck & Co., C.A. No. 14-1131-GMS (D. Del. June 6, 2016) (D.I. 58-1)—does
`
`not actually support its construction. See D.I. 57 at 8-9. In that case, the court construed the
`
`phrase “pharmaceutically effective amount”—which was not defined in the specification—to
`
`mean an “amount sufficient to reduce proliferation or metastasis of cancer cells in the [tumor /
`
`melanoma / metastatic melanoma and melanoma metastases].” See D.I. 58-1 at 2-3 n.2
`
`(alterations in original); U.S. Patent No. 8,728,474. As evidence, the court relied on language in
`
`the specification that clearly limited the invention’s pharmacological effect to “reducing the
`
`proliferation or metastasis of cancer cells.” See id. at 3 n.2. Here, by contrast, the specification
`
`not only contains a definition of “an effective amount,” but also makes clear that the invention is
`
`not limited to treating the particular aspects or symptoms of the cancer that Teva includes in its
`
`construction. See ’124 patent, col. 6, ll. 4-24; supra pp. 3-4. Accordingly, Bristol-Myers Squibb
`
`does not guide the claim-construction exercise here. See Acorda Therapeutics, 2016 WL
`
`1045356, at *3; Purdue Pharm. Prods., 2014 WL 2624787, *7 (construing “an effective amount”
`
`to mean an “amount of Zolpidem that is capable of achieving a therapeutic effect in a subject in
`
`need thereof,” as expressly defined in the specification).
`
`
`Cal. Apr. 14, 2016) (construing a “therapeutically effective amount” to mean “an amount of a
`substance sufficient to alleviate a symptom of a disease” and holding the phrase not indefinite);
`Purdue Pharm. Prods., L.P. v. Actavis Elizabeth, LLC, C.A. No. 12-5311-JLL, 2014 WL
`2624787, *7 (D.N.J. June 11, 2014) (construing an “effective amount of Zolpidem” to mean an
`“amount of Zolpidem that is capable of achieving a therapeutic effect in a subject in need
`thereof” as expressly defined in the specification); Wyeth v. Abbott Labs., C.A. No. 9-4850-JAP,
`2011 WL 5873373, at *8-9 (D.N.J. Nov. 22, 2011) (construing an “effective amounts of a
`therapeutic and/or pharmaceutical agent” to mean “an amount of a therapeutic and/or
`pharmaceutical agent that is capable of producing a result” and holding the phrase not
`indefinite); Takeda Pharm. Co. v. Mylan Inc., C.A. No. 13-4001-LHK, 2014 WL 5862134, at *7-
`8 (N.D. Cal. Nov. 11, 2004) (construing an “effective amount” to mean “an amount sufficient to
`help ameliorate or cure reflux esophagitis” and holding the phrase not indefinite).
`
`6
`
`

`

`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 12 of 24 PageID #: 641
`
`Finally, although not relevant to the Court’s construction of “an effective amount,” but
`
`because Teva appears to want to make an issue of it, Bayer did not refuse to identify “anything it
`
`believed to be inaccurate” with Teva’s construction. D.I. 57 at 9. During the parties’ exchanges,
`
`Bayer argued, as it does here, that Teva’s construction was unjustified because Teva had not
`
`explained why the express definition in the patent should be altered in the manner Teva
`
`suggested. See D.I. 58-3 at 3 (“Bayer has not ‘refuse[d] to tell’ Teva what Bayer’s position is
`
`regarding ‘effective amount.’ We have told you that our construction is based on the definition
`
`of ‘effective amount’ in the specification. Teva has proposed a different construction which is
`
`not that definition and has offered no explanation as to why the definition from the specification
`
`should be altered. We therefore disagree with Teva’s construction.”). Given the presumption
`
`that an “inventor’s lexicography governs,” Phillips, 415 F.3d at 1316, there was nothing more to
`
`say—it is Teva, not Bayer, that seeks to avoid the express definition of “an effective amount.”
`
`B.
`
`Bayer’s Proposal for “a subject who has been treated with imatinib” Should
`Be Adopted
`1.
`
`The Phrase “a subject who has been treated with imatinib” Requires
`No Further Construction
`
`Teva does not dispute that the ordinary meaning of “a subject who has been treated with
`
`imatinib” unambiguously encompasses treating any subject who has been treated with imatinib,
`
`regardless of whether that subject was initially sensitive to or acquired resistance to imatinib.
`
`See D.I. 57 at 9. Instead, Teva asserts that the inventors disavowed the ordinary meaning of that
`
`phrase by limiting the scope of the “present invention” to treating cancers that have acquired
`
`resistance to kinase inhibitors, such as imatinib. See D.I. 57 at 9-12. Because the intrinsic record
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`contradicts that assertion, the Court should construe “a subject who has been treated with
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`imatinib” according to its ordinary meaning, which requires no further construction. See Summit
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`6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1291 (Fed. Cir. 2015) (“Because the plain and
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`7
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`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 13 of 24 PageID #: 642
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`ordinary meaning of the disputed claim language is clear, the district court did not err by
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`declining to construe the claim term.”); ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
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`694 F.3d 1312, 1325-26 (Fed. Cir. 2012); D.I. 56 at 10-11.
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`2.
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`Teva’s Construction Is Unsupported
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`Teva’s construction of “a subject who has been treated with imatinib” (“a subject that is
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`resistant and/or substantially less responsive to the effects of imatinib compared to that subject’s
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`initial responsiveness to imatinib”) improperly limits the scope of the claims to treating subjects
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`who have “acquired resistance” to imatinib.3 See D.I. 57 at 4; D.I. 52, Ex. A at 2. The claim
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`language, specification, and prosecution history establish that the “acquired resistance” limitation
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`applies to only certain embodiments of the invention.
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`a.
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`The Claim Language Contradicts Teva’s Construction
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`As explained in Bayer’s Opening Brief, Teva’s construction is inconsistent with the claim
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`language for at least two reasons. See D.I. 56 at 12-13.
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`First, whereas claims 1, 2, 4, and 29 expressly require the treated subject to have
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`“acquired resistance” to imatinib or another kinase inhibitor, claims 30 and 31 do not recite this
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`limitation. The import of this difference is that claims 30 and 31 are not limited to treating
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`subjects who have acquired resistance to imatinib. See, e.g., Enzo Biochem, Inc. v. Applera
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`Corp., 599 F.3d 1325, 1333 (Fed. Cir. 2010) (“The applicants knew how to claim a linkage
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`group that does not substantially interfere with hybridization, as they did in the ’824 and ’767
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`
`3
`As explained in Bayer’s Opening Brief, the parties have agreed that the phrase “acquired
`resistance,” which appears in some, but not all of the claims, means “resistant and/or
`substantially less responsive to the effects of the drug compared to initial responsiveness.” See
`D.I. 56 at 11; Joint Claim Construction Chart (D.I. 52), Ex. A at 1. That construction reflects the
`express definition of “acquired resistance” in the specification. See ’124 patent, col. 2, ll. 14-17
`(“The term ‘acquired resistance’ indicates that the cancer becomes resistant and/or substantially
`less respons[ive] to the effects of the drug after being exposed to it for a certain period of time.”).
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`8
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`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 14 of 24 PageID #: 643
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`patents, but specifically omitted that language from the claims of the related ’928 patent.”); D.I.
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`56 at 12.
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`Second, like claims 30 and 31, claim 27 recites “treating” the same subject with both
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`imatinib and regorafenib, regardless of whether that subject has become resistant or less
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`responsive to imatinib. ’124 patent, claim 27; D.I. 53, Ex. C at 34. As filed, that claim was
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`materially identical. D.I. 53, Ex. C at 34. Again, the only reasonable conclusion is that the
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`scope of the claims is not limited to treating subjects who have acquired resistance to imatinib.
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`See, e.g., ScriptPro LLC v. Innovation Assocs., Inc., 833 F.3d 1336, 1342 (Fed. Cir. 2016) (“Not
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`every claim must contain every limitation or achieve every disclosed purpose. Here, the original
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`claims filed as part of the application for the ’601 patent did not include a requirement that
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`sorting and storing be done by use of patient-identifying information.”); D.I. 56 at 13-14.
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`b.
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`The Specification and Prosecution History Contradict Teva’s
`Construction
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`Although Teva acknowledges the claim language discussed above, it does not attempt to
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`address that language directly. See D.I. 57 at 9. Instead, Teva argues that the claim language is
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`of “no consequence” because the specification limits the scope of the “present invention” to
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`treating subjects who have “acquired resistance” to imatinib. D.I. 57 at 9. Teva is incorrect.
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`Given the claim language discussed above, Teva’s argument is, in essence, that the
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`inventors disclaimed or disavowed any claim scope beyond circumstances of “acquired
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`resistance” to imatinib. See D.I. 57 at 11. The law is clear, however, that any “disclaimer or
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`disavowal of claim scope must be clear and unmistakable, requiring ‘words or expressions of
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`manifest exclusion or restriction’ in the intrinsic record.” Unwired Planet, LLC v. Apple Inc.,
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`829 F.3d 1353, 1358-60 (Fed. Cir. 2016) (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d
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`1313, 1327 (Fed. Cir. 2002)). That requirement is not satisfied here. As discussed in Bayer’s
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`9
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`Case 1:16-cv-01221-LPS Document 69 Filed 07/17/18 Page 15 of 24 PageID #: 644
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`Opening Brief, the specification makes clear that the “acquired resistance” limitation does not
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`apply to all embodiments of the “present invention.” See D.I. 56 at 13-14. Indeed, it expressly
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`distinguishes between (1) the “present invention,” which “provides methods of treating cancers
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`comprising, e.g., comprising administering to a subject in need thereof an effective amount of
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`[regorafenib], wherein the cancer is treated,” ’124 patent, col. 4, ll. 51-54, and (2) “one
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`embodiment” of the “present invention,” which “provides methods of treating a cancer in a
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`subject in need thereof, comprising administering an effective amount of [regorafenib] to a
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`subject having a cancer, wherein said cancer has acquired resistance to a KIT tyrosine kinase
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`inhibitor [e.g., imatinib],” ’124 patent, col. 1, l. 67–col. 2, l. 4. That distinction—between the
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`“present invention” and “one embodiment” of the present invention—demonstrates that Teva’s
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`construction improperly limits the scope of the claims. See Phillips, 415 F.3d at 1323; D.I. 56 at
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`12-13.
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`Tellingly—although Teva quotes various portions of the specification concerning use of
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`the phrase “the present invention”—it ignores the above-quoted passages. See D.I. 57 at 9-12.
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`That further undermines Teva’s assertion of a “disavowal” of claim scope, which cannot be
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`established by selectively analyzing certain statements regarding the “present invention” and
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`disregarding those “portions of the intrinsic evidence [that] do not support applying the
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`limitation to the entire patent.” See Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d
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`1121, 1136-37 (Fed. Cir. 2011) (citing Voda v. Cordis Corp., 536 F.3d 1311, 1320-22 (Fed. Cir.
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`2008)).
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`Other aspects of the specification reinforce the conclusion that the “present invention” is
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`not limited to treating subjects who have “acquired resistance” to imatinib—as Teva asserts—but
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`rather includes, for example, trea