Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 1 of 21 PageID #: 466
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
`
`Defendants.
`
`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`APOTEX INC., and APOTEX CORP.,
`
`
`
`
`
`Plaintiffs,
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`
`
`
`
`
`
`
`
`v.
`
`
`
`PLAINTIFFS BAYER HEALTHCARE LLC AND
`BAYER HEALTHCARE PHARMACEUTICALS INC.’S
`OPENING CLAIM CONSTRUCTION BRIEF
`
`
`
`
`
`
`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
`
`June 13, 2018
`
`
`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`Anthony D. Raucci (#5948)
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`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.
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 2 of 21 PageID #: 467
`
`TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................................1
`
`BACKGROUND .................................................................................................................1
`
`SUMMARY OF ARGUMENT ...........................................................................................4
`
`ARGUMENT .......................................................................................................................6
`
`A.
`
`The Court Should Adopt Bayer’s Construction of “an effective amount” ..............6
`
`1.
`
`2.
`
`Bayer’s Construction Is Consistent with the Express Definition in
`the Specification and the Claim Language ..................................................6
`
`Teva’s Construction Is Unsupported ...........................................................7
`
`B.
`
`The Court Should Adopt Bayer’s Construction of the Phrase “a subject
`who has been treated with imatinib” ......................................................................10
`
`1.
`
`2.
`
`The Phrase “a subject who has been treated with imatinib”
`Requires No Further Construction .............................................................10
`
`The Court Should Reject Teva’s Construction of “a subject who
`has been treated with imatinib”..................................................................11
`
`CONCLUSION ..................................................................................................................14
`
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`
`
`i
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 3 of 21 PageID #: 468
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Abbott Labs. v. Baxter Pharm. Prods., Inc.,
`334 F.3d 1274 (Fed. Cir. 2003)......................................................................................... 10
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012)......................................................................................... 11
`
`Carotek, Inc. v. Kobayashi Ventures, LLC,
`C.A. No. 08-5706-NRB, 2011 WL 4056746 (S.D.N.Y. Sept. 8, 2011) ........................... 10
`
`CyberFone Sys., LLC v. Cellco P’ship,
`885 F. Supp. 2d 710 (D. Del. 2012) .................................................................................. 10
`
`Dealertrack, Inc. v. Huber,
`674 F.3d 1315 (Fed. Cir. 2012)........................................................................................... 9
`
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d 1335 (Fed. Cir. 2009)........................................................................................... 7
`
`Enzo Biochem, Inc. v. Applera Corp.,
`599 F.3d 1325 (Fed. Cir. 2010)......................................................................................... 12
`
`Geneva Pharm., Inc. v. GlaxoSmithKline PLC,
`349 F.3d 1373 (Fed. Cir. 2003)......................................................................................... 10
`
`In re Gardner,
`480 F.2d 879 (C.C.P.A. 1973) .......................................................................................... 13
`
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009)........................................................................................... 6
`
`Merck Sharp & Dohme Corp. v. Xellia Pharm. ApS,
`C.A. No. 14-199-RGA, 2015 WL 82386 (D. Del. Jan. 6, 2015) ...................................... 10
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc)............................................................. 6, 8, 9, 14
`
`Sanofi v. Glenmark Pharm. Inc.,
`C.A. No. 14-264-RGA, 2015 WL 5092631 (D. Del. Aug. 28, 2015)............................... 10
`
`Sanofi v. Lupin Atlantis Holdings S.A.,
`C.A. No. 15-415-RGA, 2016 WL 5842327 (D. Del. Oct. 3, 2016) .................................. 10
`
`Semcon Tech, LLC v. Micron Tech., Inc.,
`C.A. No. 12-532-RGA, 2014 WL 4447017 (D. Del. Sept. 9, 2014) ................................ 10
`
`ii
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 4 of 21 PageID #: 469
`
`Straight Path IP Grp., Inc. v. Sipnet EU S.R.O.,
`806 F.3d 1356 (Fed. Cir. 2015)......................................................................................... 12
`
`Summit 6, LLC v. Samsung Elecs. Co.,
`802 F.3d 1283 (Fed. Cir. 2015)......................................................................................... 11
`
`Trading Techs. Int’l, Inc. v. eSpeed, Inc.,
`595 F.3d 1340 (Fed. Cir. 2010)........................................................................................... 7
`
`U.S. Surgical Corp. v. Ethicon, Inc.,
`103 F.3d 1554 (Fed. Cir. 1997)......................................................................................... 10
`
`
`
`iii
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 5 of 21 PageID #: 470
`
`I.
`
`INTRODUCTION
`
`This claim-construction dispute involves two claim terms—“an effective amount” and “a
`
`subject who has been treated with imatinib”—recited in U.S. Patent No. 8,680,124 (“the ’124
`
`patent”). The ’124 patent is one of four patents asserted by Plaintiffs Bayer HealthCare LLC and
`
`Bayer HealthCare Pharmaceuticals Inc. (collectively, “Plaintiffs” or “Bayer”) against Defendant
`
`Teva Pharmaceuticals USA, Inc. (“Teva”) and relates to certain methods of using regorafenib,
`
`the active pharmaceutical ingredient in Bayer’s Stivarga® drug product.
`
`Neither disputed claim term requires elaborate construction. The specification expressly
`
`defines “effective amount” to mean “the amount of [regorafenib] which is effective to treat any
`
`symptom or aspect of the cancer.” The claim language also makes clear that “an effective
`
`amount” can be used to treat a “malignant” or “benign” gastrointestinal stromal tumor. Bayer
`
`therefore proposes that 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.” As for the
`
`phrase “a subject who has been treated with imatinib,” the claim language and specification
`
`confirm that it means exactly what it says. It therefore does not require further construction.
`
`Despite the straightforward nature of the claim-construction exercise here, Teva (1)
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`proposes a lengthy, complex, and unsupported construction for “an effective amount,” and (2)
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`imports a limitation into “a subject who has been treated with imatinib” that improperly restricts
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`the meaning of that phrase to circumstances where the subject’s cancer has developed resistance
`
`to imatinib. Neither construction is warranted. Accordingly, this Court should adopt Bayer’s
`
`proposed constructions.
`
`II.
`
`BACKGROUND
`
`This Hatch-Waxman Act case concerns Bayer’s Stivarga® drug product. As set forth in
`
`more detail in the FDA-approved labeling, Stivarga® is an anti-cancer drug approved to treat
`
`1
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 6 of 21 PageID #: 471
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`certain types of metastatic colorectal cancer; gastrointestinal stromal tumor (“GIST”); and
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`hepatocellular carcinoma. See, e.g., Stivarga® Approved Package Insert, Ex. A, at 1-2.
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`Regorafenib, the active ingredient in Stivarga®, is a kinase inhibitor, i.e., a chemical compound
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`that blocks the action of certain proteins involved in various cellular functions. See, e.g., id. at
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`13.
`
`There are four patents-in-suit: the ’124 patent and U.S. Patent Nos. 7,351,834 (“the ’834
`
`patent”), 8,637,553 (“the ’553 patent”), and 9,458,107 (“the ’107 patent”). All four patents have
`
`been asserted against Teva. See D.I. 1. The ’553 and ’107 patents have also been asserted
`
`against Defendants Apotex Corp. and Apotex Inc. See C.A. No. 16-1222, D.I. 1; C.A. No. 17-
`
`334, D.I. 1.
`
`The present claim-construction dispute concerns two claim terms in the asserted claims of
`
`the ’124 patent: (1) “an effective amount,” and (2) “a subject who has been treated with
`
`imatinib.” The first disputed claim term—“an effective amount”—is found in, for example,
`
`independent claim 30, which recites:
`
`30. A method of treating a malignant gastrointestinal stromal
`tumor (GIST) or a benign gastrointestinal stromal tumor (GIST), in
`a subject who has been treated with imatinib, salts of imatinib
`mesylate, PP1(4-Amino-5-(4-methylphenyl)-7-(t-
`butyl)pyrazolo[3,4-d]pyrimidine); MLN518 (CT53518);
`PD180970; SU112481; SU5416; SU5414; SU6597; SU6663 or
`SU6561, said method comprising administering an effective
`amount of 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-
`fluorophenoxy}-pyridine-2-carboxylic acid methylamide of the
`formula I to said subject
`
`.
`
`2
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 7 of 21 PageID #: 472
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`D.I. 53, Ex. B (hereinafter, “’124 patent”), claim 30 (emphasis added). The phrase “an effective
`
`amount” is also a limitation of claims 1-4, 29, and 31, which Bayer has likewise asserted against
`
`Teva. See ’124 patent, claims 1-4, 29, 31. The claims refer to the regorafenib compound as
`
`“4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic
`
`acid methylamide” or by reference to the chemical structure contained in a given claim. The
`
`patent also refers to regorafenib as “DAST” (Dual Acting Signal Transduction inhibitor). See
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`’124 patent, col. 7, ll. 5-15.
`
`The second disputed claim phrase—“a subject who has been treated with imatinib”—
`
`appears only in independent claims 30 and 31. Claim 31 recites:
`
`31. A method of treating a malignant gastrointestinal stromal
`tumor (GIST) or a benign gastrointestinal stromal tumor (GIST), in
`a subject who has been treated with imatinib, said method
`comprising administering an effective amount of 4{4-[3-(4-chloro-
`3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-
`carboxylic acid methylamide of the formula I to said subject
`
`.
`
`’124 patent, claim 31 (emphasis added). As reflected above, claim 30 also contains the phrase “a
`
`subject who has been treated with imatinib.” See ’124 patent, claim 30. Again, both the
`
`chemical name “4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-
`
`2-carboxylic acid methylamide” and the chemical structure contained in the claim refer to
`
`regorafenib.
`
`3
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 8 of 21 PageID #: 473
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`As shown in the Joint Claim Construction Chart, D.I. 52, the parties propose the
`
`following constructions:
`
`Claim Term/Phrase
`
`Claims 1, 29-31
`“an effective amount”
`
`Bayer’s Proposed
`Construction
`an amount which is effective
`to treat any symptom or
`aspect of the cancer or the
`tumor
`
`Claims 30, 31
`“a subject who has been
`treated with imatinib”
`
`a subject who has been
`treated with imatinib (no
`construction necessary)
`
`
`See D.I. 52, Ex. A, at 1-2.
`
`III.
`
`SUMMARY OF ARGUMENT
`
`Teva’s Proposed
`Construction
`an amount that is effective to
`combat, alleviate, reduce,
`relieve, or improve one or
`more of the symptoms
`associated with a cancer,
`including but not limited to
`amounts that cause tumor
`regression, cell death,
`apoptosis, necrosis; inhibit
`cell proliferation; tumor
`growth, tumor metastasis,
`tumor migration, tumor
`invasion; reduce disease
`progression; stabilize the
`disease; reduce or inhibit
`angiogenesis; prolong patient
`survival; enhance quality of
`life; and/or reduce the
`frequency, severity, intensity,
`and/or duration of any
`adverse symptoms or
`activities
`a subject that is resistant
`and/or substantially less
`responsive to the effects of
`imatinib compared to that
`subject’s initial
`responsiveness to imatinib
`
`The Court should construe the phrase “an effective amount” to mean “an amount which is
`
`effective to treat any symptom or aspect of the cancer or the tumor.” That construction is
`
`consistent with both the specification, which expressly defines “effective amount” to mean “the
`
`amount of [regorafenib] which is effective to treat any symptom or aspect of the cancer,” ’124
`
`4
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 9 of 21 PageID #: 474
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`patent, col. 6, ll. 4-6, and the claim language, which provides that “an effective amount” of
`
`regorafenib can be used to treat a “malignant” or “benign” gastrointestinal stromal tumor, see,
`
`e.g., id. at claims 30-31.
`
`By contrast, Teva’s construction for “an effective amount” is unsupported. Teva’s
`
`construction appears to start with the express definition of “effective amount” discussed above.
`
`But rather than simply apply it, Teva goes on to further construe the word “treat” that is found
`
`within that definition by borrowing language from the specification’s separate discussion of
`
`“treating.” Teva then embeds this further construction into the specification’s definition of
`
`“effective amount,” thereby creating the lengthy and cumbersome construction that they propose.
`
`The specification itself undermines Teva’s approach. The patent explicitly states that
`
`“treating” should be understood “conventionally”—i.e., according to its ordinary and customary
`
`meaning to the person of ordinary skill in the art—and provides examples of what constitutes
`
`“treating.” Contrary to Teva’s construction, that discussion demonstrates that the word “treat”—
`
`and therefore, its use in the definition of “effective amount”—does not require further
`
`explanation.
`
`Moreover, even if one were to agree with Teva that the word “treat” in the definition of
`
`“effective amount” should be further construed, Teva’s proposal fails to achieve that goal.
`
`Teva’s construction (1) captures only a portion of the language of “treating” discussed in the
`
`specification—particularly given that the discussion on its face only provides examples of
`
`“treating”—and simultaneously (2) adds language that is not used in the specification, and (3)
`
`incorrectly paraphrases other language. The resulting construction is not supported by the
`
`specification and is unduly complex.
`
`5
`
`

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`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 10 of 21 PageID #: 475
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`The other disputed claim phrase, “a subject who has been treated with imatinib,” means
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`exactly that and requires no further construction. Although Teva argues that the term should be
`
`construed to mean “a subject that is resistant and/or substantially less responsive to the effects of
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`imatinib compared to that subject’s initial responsiveness to imatinib,” that construction is
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`unwarranted. The phrase “a subject who has been treated with imatinib” says nothing about
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`resistance, and there is no basis to limit its meaning to circumstances where the tumor has
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`acquired resistance to imatinib—thereby excluding, for example, circumstances where the tumor
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`was never sensitive to imatinib in the first instance. Nothing in the claims or the specification
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`mandates a different result. To the contrary, the specification expressly provides that treating
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`cancers with “acquired resistance”—the basis for Teva’s construction—is only “one
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`embodiment” of the “present invention.” Teva’s construction is therefore a classic example of
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`improperly reading a limitation into a claim term based on a particular embodiment.
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`IV. ARGUMENT
`
`A.
`
`The Court Should Adopt Bayer’s Construction of “an effective amount”
`
`1.
`
`Bayer’s Construction Is Consistent with the Express Definition in the
`Specification and the Claim Language
`
`The ’124 patent expressly defines “effective amount” as “the amount of [regorafenib]
`
`which is effective to treat any symptom or aspect of the cancer.” ’124 patent, col. 6, ll. 4-8. That
`
`definition generally controls the construction of that term. Phillips v. AWH Corp., 415 F.3d
`
`1303, 1316 (Fed. Cir. 2005) (en banc); see also Martek Biosciences Corp. v. Nutrinova, Inc., 579
`
`F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee explicitly defines a claim term in the patent
`
`specification, the patentee’s definition controls.”).
`
`In this case, a slight addition is appropriate given the language of the claims. Claims 30
`
`and 31, for example, recite methods for treating a “malignant” or “benign” gastrointestinal
`
`6
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 11 of 21 PageID #: 476
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`stromal tumor using “an effective amount” of regorafenib. ’124 patent, claims 30-31.1
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`Accordingly, Bayer’s proposed construction takes this express claim language into account and
`
`provides that “an effective amount” means “an amount which is effective to treat any symptom
`
`or aspect of the cancer or the tumor.” D.I. 52, Ex. A, at 1 (emphasis added). Modifying the
`
`express definition of “effective amount” in this fashion is consistent with Federal Circuit
`
`precedent, which recognizes that a court may slightly modify the express definition of a claim
`
`term where appropriate. See, e.g., Trading Techs. Int’l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1353
`
`(Fed. Cir. 2010) (modifying the express definition of “static” to more accurately comport with
`
`the intrinsic record); Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 1345 (Fed. Cir. 2009)
`
`(modifying the express definition of “sanitize” to resolve an avoidable ambiguity). With that
`
`exception, however, the express definition of “effective amount” needs no further revision.
`
`Teva’s Construction Is Unsupported
`
`2.
`Teva apparently does not dispute that the specification expressly defines “effective
`
`amount.” Rather, Teva argues that the express definition should be extensively modified in view
`
`of the specification. According to Teva, “an effective amount” should be construed as follows:
`
`an amount that is effective to combat, alleviate, reduce, relieve, or
`improve one or more of the symptoms associated with a cancer,
`including but not limited to amounts that cause tumor regression,
`cell death, apoptosis, necrosis; inhibit cell proliferation; tumor
`growth, tumor metastasis, tumor migration, tumor invasion; reduce
`disease progression; stabilize the disease; reduce or inhibit
`angiogenesis; prolong patient survival; enhance quality of life;
`and/or reduce the frequency, severity, intensity, and/or duration of
`any adverse symptoms or activities.
`
`D.I. 52, Ex. A, at 1-2. Teva’s construction purports to begin with the definition of the term
`
`“effective amount,” and then to construe the word “treat” within that definition to create a single,
`
`1
`The specification explains that “gastrointestinal stromal tumors” include both
`“malignant” and “benign” tumors and that certain kinase mutations are present in both types.
`See ’124 patent, col. 3, ll. 27-29, 37-41.
`
`7
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 12 of 21 PageID #: 477
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`elaborate construction for the disputed term. Thus, Teva’s construction begins with the phrase
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`“an amount that is effective to combat, alleviate, reduce, relieve, or improve one or more of the
`
`symptoms associated with a cancer . . .” (emphasis added)—language which somewhat
`
`resembles the express definition of “effective amount,” i.e., the amount “which is effective to
`
`treat any symptom or aspect of the cancer.” ’124 patent, col. 6, ll. 5-6. Teva then derives the
`
`remainder of its construction from the discussion of the term “treating” in the specification. In
`
`particular, Teva relies on the following paragraph:
`
`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.
`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. For several reasons, that approach should be rejected.
`
`First, the paragraph Teva relies upon does not actually support its position. In contrast
`
`with other terms that are defined in the specification, the patent does not provide an express
`
`definition of “treating” that differs from its ordinary and customary meaning. See Phillips, 415
`
`F.3d at 1316. Rather, the specification states that “treating” should be understood
`
`“conventionally”—that is, according to the ordinary meaning of that term. ’124 patent, col. 6,
`
`l. 9. The specification then goes on to provide examples of “treating” that are consistent with the
`
`conventional understanding of that term—using the phrases “e.g., the management or care of a
`
`subject for the purpose of combating, alleviating, reducing, relieving, improving, etc.,” and
`
`8
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 13 of 21 PageID #: 478
`
`“[a]dministering effective amounts of [regorafenib] can treat one or more aspects of the cancer
`
`disease, including, but not limited to . . . .” ’124 patent, col. 6, ll. 9-15 (emphasis added).
`
`Whereas the specification’s list of conduct that could constitute “treating”—signified by the use
`
`of the phrases “e.g.,” universally recognized to mean “for example,” and “including but not
`
`limited to”—is purely exemplary, Teva’s construction treats it as definitional, violating the well-
`
`established prohibition against importing limitations from the specification. See, e.g.,
`
`Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1320-24 (Fed. Cir. 2012); Phillips, 415 F.3d at 1323-
`
`24.
`
`Second, even if one were to accept the premise of Teva’s approach—that the
`
`specification contains some re-definition of “treating” that should be inserted into the
`
`construction of “an effective amount”—Teva’s proposal does not actually accomplish that goal.
`
`Instead, Teva’s construction paraphrases the discussion of “treating” in the specification by (1)
`
`omitting some of that discussion (“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) modifying
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`other phrases within the discussion (“and/or duration of any of the aforementioned aspects”) to
`
`conflate words found in separate sentences (“symptoms” and “aspects”), ’124 patent, col. 6, ll.
`
`12, 23-24; and (3) adding language that does not appear in the discussion (“and/or,” “or
`
`activities”). The fact that Teva feels compelled to modify the very passage it relies upon to
`
`ascertain the meaning of “treating” only reinforces that its construction cannot withstand
`
`scrutiny.
`
`Third, Teva’s construction should not be adopted—in any event—because it injects
`
`unnecessary complexity into the claims. As the Federal Circuit has explained, “[c]laim
`
`9
`
`

`

`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 14 of 21 PageID #: 479
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`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.” U.S. Surgical Corp. v. Ethicon,
`
`Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). Thus, claim construction is appropriate only where
`
`the “the court would lack a full understanding of the claimed subject matter if it did not first
`
`construe the claims.” CyberFone Sys., LLC v. Cellco P’ship, 885 F. Supp. 2d 710, 715 (D. Del.
`
`2012). Teva’s construction of “an effective amount,” however, does not clarify the conventional
`
`understanding of the word “treating.” ’124 patent, col. 6, l. 9. As the Federal Circuit and this
`
`District have repeatedly held, an “effective amount” is a “common and generally acceptable term
`
`for pharmaceutical claims” and has a “customary usage,” requiring only minimal construction.2
`
`Teva’s lengthy and unduly complicated construction is therefore unwarranted.3
`
`B.
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`The Court Should Adopt Bayer’s Construction of the Phrase “a subject who
`has been treated with imatinib”
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`1.
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`The Phrase “a subject who has been treated with imatinib” Requires
`No Further Construction
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`The claim phrase “a subject who has been treated with imatinib” means exactly what it
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`says: a subject who has been treated with imatinib. Claims 30 and 31 recite methods of
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`“treating a malignant gastrointestinal stromal tumor (GIST) or a benign gastrointestinal stromal
`
`2
`See, e.g., Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1383-84 (Fed.
`Cir. 2003); Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 1277-78 (Fed. Cir. 2003);
`Sanofi v. Lupin Atlantis Holdings S.A., C.A. No. 15-415-RGA, 2016 WL 5842327, at *4 (D. Del.
`Oct. 3, 2016); Sanofi v. Glenmark Pharm. Inc., C.A. No. 14-264-RGA, 2015 WL 5092631, at *5
`(D. Del. Aug. 28, 2015); 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).
`3
`See, e.g., Semcon Tech, LLC v. Micron Tech., Inc., C.A. No. 12-532-RGA, 2014 WL
`4447017, at *3-4 (D. Del. Sept. 9, 2014) (declining to further construe the express definition of
`“tracked finishing cycle time” where “additional judicial guidance” was “not needed”); Carotek,
`Inc. v. Kobayashi Ventures, LLC, C.A. No. 08-5706-NRB, 2011 WL 4056746, at *10-11
`(S.D.N.Y. Sept. 8, 2011).
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`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 15 of 21 PageID #: 480
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`tumor (GIST), in a subject who has been treated with imatinib” comprising “administering an
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`effective amount” of regorafenib. That language unambiguously requires that the subject
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`receiving regorafenib to have been “treated with imatinib,” regardless of whether the subject has
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`become resistant or less responsive to imatinib. The phrase therefore requires no further
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`construction. See, e.g., Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1291 (Fed. Cir.
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`2015) (“‘Being provided to’ is comprised of commonly used terms; each is used in common
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`parlance and has no special meaning in the art. Because the plain and ordinary meaning of the
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`disputed claim language is clear, the district court did not err by declining to construe the claim
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`term.”); ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1325-26 (Fed.
`
`Cir. 2012) (“The district court did not err in concluding that [‘superimposing the first indication
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`over the display of the first anchor channel’ and ‘including with the first indication a second
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`indication’] have plain meanings that do not require additional construction.”).
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`2.
`
`The Court Should Reject Teva’s Construction of “a subject who has
`been treated with imatinib”
`
`Teva argues that the phrase “a subject who has been treated with imatinib” should be
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`construed to mean “a subject that is resistant and/or substantially less responsive to the effects of
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`imatinib compared to that subject’s initial responsiveness to imatinib.” In other words, Teva
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`proposes that the phrase should be interpreted to mean essentially the same thing as a subject
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`who has “acquired resistance” to imatinib. For reference, the parties have agreed—per the
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`definition in the specification—that “acquired resistance” means “resistant and/or substantially
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`less responsive to the effects of the drug compared to initial responsiveness.” See D.I. 52, Ex. A,
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`at 1; see also ’124 patent, col. 2, ll. 14-17 (“The term ‘acquired resistance’ indicates that the
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`cancer becomes resistant and/ or substantially less respons[ive] to the effects of the drug after
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`being exposed to it for a certain period of time.”).
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`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 16 of 21 PageID #: 481
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`Teva’s construction should not be adopted because it improperly reads a limitation into
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`the claim. The phrase itself—“a subject who has been treated with imatinib”—on its face does
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`not say anything about acquiring resistance to imatinib. All it means is what it says: that the
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`subject has been treated with imatinib. The subject could have been responsive to imatinib, non-
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`responsive to imatinib, or have been initially sensitive to imatinib but then acquired resistance to
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`the drug—any of those options is possible under the language of the claim, and nothing requires
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`limiting it to the scenario where a subject has “acquired resistance” to imatinib. See, e.g.,
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`Straight Path IP Grp., Inc. v. Sipnet EU S.R.O., 806 F.3d 1356, 1361 (Fed. Cir. 2015) (“When
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`claim language has as plain a meaning on an issue as the language does here, leaving no genuine
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`uncertainties on interpretive questions relevant to the case, it is particularly difficult to conclude
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`that the specification reasonably supports a different meaning.”).
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`Other claims in the ’124 patent support this position. Unlike claims 30 and 31, claims 1,
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`2, 4, 26, and 29 all expressly require the treated subject to have an “initial sensitivity” to imatinib
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`and/or to have “acquired resistance” to imatinib. If the inventors had intended claims 30 and 31
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`to require the subject to have become resistant or less responsive to imatinib, they would have
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`written this limitation into the claim language, as they did elsewhere. See, e.g., Enzo Biochem,
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`Inc. v. Applera Corp., 599 F.3d 1325, 1333 (Fed. Cir. 2010) (“The applicants knew how to claim
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`a linkage group that does not substantially interfere with hybridization, as they did in the ’824
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`and ’767 patents, but specifically omitted that language from the claims of the related ’928
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`patent.”).
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`Claim 27 likewise contradicts Teva’s effort to limit the scope of the invention to
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`“acquired resistance.” Similar to claims 30 and 31, claim 27 recites a method for administering
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`Case 1:16-cv-01221-LPS Document 56 Filed 06/13/18 Page 17 of 21 PageID #: 482
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`imatinib and regorafenib to the same subject, regardless of whether the subject has become
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`resistant or less responsive to imatinib:
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`27. A method for treating cancer in a human subject with imatinib
`mesylate or salts of imatinib mesylate, which additionally
`comprises: administering to said human subject, an effective
`amount of the compound 4{4-[3-(4-chloro-3-
`trifluoromethylphenyl)-ureido]-3 fluorophenoxy}-pyridine-2-
`carboxylic acid methylamide of the formula I below including all
`polymorphs, hydrates, pharmaceutically acceptable salts,
`metabolites, ester prodrugs, solvates or combinations thereof.
`
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`Claim 27 was materially identical as filed, see D.I. 53, Ex. C, at 34,4 confirming that the
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`inventors discovered and claimed more than just treating subjects with acquired resistance to
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`imatinib, see In re Gardner, 480 F.2d 879, 879-80 (C.C.P.A. 1973) (“[W]e consider the original
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`claim in itself adequate ‘written description’ of the claimed invention. It was equally a ‘written
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`description’ whether located among the original claims or in the descriptive part of the