Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 1 of 17 PageID #: 516
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
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`
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`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
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`
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`
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`Plaintiffs,
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`
`
`v.
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`
`Defendants.
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`
`
`
`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
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`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`David M. Fry (No. 5486)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`dfry@shawkeller.com
`Attorneys for Defendant
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`DEFENDANTS’ OPENING CLAIM CONSTRUCTION BRIEF
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`
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`
`
`
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`OF COUNSEL:
`Mark D. Schuman
`Todd S. Werner
`Samuel T. Lockner
`Jennell C. Bilek
`Shelleaha L. Jonas
`Alexandra J. Olson
`Nathan D. Louwagie
`CARLSON, CASPERS, VANDENBURGH,
` LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street
`Capella Tower, Suite 4200
`Minneapolis, MN 55402
`(612) 436-9600
`
`Dated: June 13, 2018
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 2 of 17 PageID #: 517
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`TABLE OF CONTENTS
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`INTRODUCTION .............................................................................................................. 1
`
`STATEMENT OF FACTS ................................................................................................ 1
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`THE DISPUTED CLAIM TERMS .................................................................................... 3
`
`LEGAL PRINCIPLES FOR CLAIM CONSTRUCTION ................................................ 5
`
`THE LEVEL OF ORDINARY SKILL IN THE ART........................................................ 6
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`
`
`I.
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`II.
`
`III.
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`IV.
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`V.
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`VI.
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`THE COURT SHOULD ADOPT THE DEFINITION OF
`“AN EFFECTIVE AMOUNT” THAT THE INVENTORS
`PROVIDED IN THE SPECIFICATION ............................................................................ 7
`
`
`VII. THE SPECIFICATION DEFINED THE INVENTION AS
`INVOLVING THE TREATMENT OF PATIENTS WITH
`ACQUIRED RESISTANCE ............................................................................................... 9
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`VIII. CONCLUSION ................................................................................................................. 12
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`
`
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`
`i
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 3 of 17 PageID #: 518
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`
`
`TABLE OF AUTHORITIES
`
`Cases
`Multiform Desiccants, Inc. v. Medzam Ltd.,
`133 F.3d 1473 (Fed. Cir. 1998) ................................................................................................ 9
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 1, 9, 10, 11, 12
`
`
`
`Janssen Pharmaceutica N.V. v. Mylan Pharm., Inc., 456 F.Supp.2d 644, 653 (D.N.J. 2006)
`
`(citation omitted), aff’d, 233 Fed. Appx. 999 (Fed. Cir. 2007)…………….……………7
`
`ICU Med., Inc. v. Alaris Med. Sys., 558 F.3d 1368 (Fed. Cir. 2009)…………………………….6
`
`Koepnick Med. & Educ. Research Found. v. Alcon Labs.,
`
`
`
`162 F. App’x 967 (Fed. Cir. 2005)………………………………………………………6
`
`Intel Corp. v. VIA Techs., 319 F.3d 1357 (Fed. Cir. 2003)………………………..……………..6
`
`Multiform Desiccants, Inc. v. Medzam Ltd., 133 F.3d 1473 (Fed. Cir. 1998)………..………..…7
`
`Vitronics Corp. v. Conceptronic, 90 F.3d 1576 (Fed. Cir. 1996)………………………..………7
`
`Sinorgchem Co. v. ITC, 511 F.3d 1132 (Fed. Cir. 2007)................................................................8
`
`Cultor Corp. v. A.E. Staley Mfg. Co., 224 F . 3d 1328 (Fed. Cir. 2000)…………………………8
`
` PDL Biopharma, Inc. v. Alexion Pharm., Inc., 568 F. Supp. 2d 445 (D. Del. 2008) (same)…….8
`
`Bristol-Myers Squibb Co. v. Merck & Co, Civil Action No. 14-1131-GMS,
`
`
`
`ECF 189, slip op. (D. Del. Jun. 6, 2016)………………………………………………..8, 9
`
`Pacing Techs., LLC v. Garmin Int'l, Inc., 778 F.3d 1021 (Fed. Cir. 2015)……………………..10
`
`Regents of the Univ. of Minn. v. AGA Med. Corp., 717 F.3d 929 (Fed. Cir. 2013)……………10
`
`Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295 (Fed. Cir. 2007)……………..10
`
`Honeywell Int’l, Inc. v. ITT Indus., 452 F.3d 1312 (Fed. Cir. 2006) ……………………..…10,11
`
`Meds. Co. v. Mylan, Inc., 853 F.3d 1296 (Fed. Cir. 2017)…………………………………..….10
`
`Retractable Techs., Inc. v. Becton, Dickinson & Co., 653 F.3d 1296 (Fed. Cir. 2011)…………10
`
`Poly-America, L.P. v. API Indus., Inc., 839 F.3d 1131 (Fed. Cir. 2016)………………………..11
`
`
`
`ii
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 4 of 17 PageID #: 519
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`
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`Arris Grp., Inc. v. Mobile Telecomms. Techs., LLC,
`
`
`
`265 F. Supp. 3d 454 (D. Del. 2017)………………………………………………….….12
`
`
`
`iii
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 5 of 17 PageID #: 520
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`
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`I.
`
`INTRODUCTION
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`Defendant Teva Pharmaceuticals USA, Inc., submits this Opening Claim Construction
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`Brief pursuant to paragraph 12 of the Court’s Scheduling Order (ECF 20). Of the four asserted
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`patents, the parties disagree on the construction of two terms, both of which are found in the
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`claims of U.S. Patent No. 8,680,124 (“the ʼ124 patent”). The parties agree that these terms can
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`be construed without resorting to extrinsic evidence, leaving the Court with the task of
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`determining which construction “stays true to the claim language and most naturally aligns with
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`the patent’s description of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed.
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`Cir. 2005). Teva’s constructions, which are taken directly from the inventors’ written
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`description of their invention, readily accomplish that objective. In contrast, Bayer asks the
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`Court to construe the terms more broadly than what is supported by the specification. The Court
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`should adopt Teva’s proposed constructions, which are the most faithful to the intrinsic evidence.
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`II.
`
`STATEMENT OF FACTS
`
`
`
`This patent infringement lawsuit arises under the Hatch-Waxman Act, and involves four
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`patents listed in the Orange Book for regorafenib, a drug sold under the brand name Stivarga®.
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`Stivarga® is indicated for, inter alia, treatment of patients with certain forms of gastrointestinal
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`stromal tumors (GIST) who have been previously treated with imatinib mesylate and sunitinib
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`malate. Stivarga® is administered as a tablet containing regorafenib.
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`
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`The only patent containing disputed claim terms, the ’124 patent, is entitled “Treatment
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`of Cancers with Acquired Resistance to KIT Inhibitors,” and issued on March 25, 2014. The
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`asserted claims of the ’124 patent are generally directed to methods of treating certain cancers by
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`administering an effective amount of regorafenib, identified as 4{4-[3-(4-chloro-3-
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`
`
`1
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 6 of 17 PageID #: 521
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`
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`trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide of
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`formula I (depicted below).
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`
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`In summarizing the prior art, the inventors of the ’124 patent explain that, “[k]inase
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`[(“KIT”)] inhibitors are being used successfully to treat cancers . . . .” (Col. 1:64-65.) One KIT
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`inhibitor that was successfully being used is DAST, or imatinib, a KIT tyrosine kinase inhibitor.
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`(Col. 2:20-22.) Imatinib was known to be a very effective anti-cancer agent in the prior art, and
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`remains a first line therapy drug product to this day. (See col. 1:64-66.)
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`But imatinib therapy does have limitations. As explained in the written description,
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`“[t]here [were] a number of well-documented instances where cancers have acquired resistance
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`to a kinase inhibitor which previously had successfully been used to treat the cancer.” (Col.
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`2:12-15; see also col. 1:66-67 (“However, some patients acquire resistance to the drug’s
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`activity.”).) The inventors defined “resistance” in the specification to mean when “the cancer
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`becomes resistant and/or substantially less responsive to the effects of the drug after being
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`exposed to it for a certain period of time.” (Col. 2:12-17.)1 In other words, after a tumor has
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`been subjected to imatinib therapy for a period of time, its response to the therapy often begins to
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`diminish or cease altogether.
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`After describing this problem, the specification defines “the present invention” as the use
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`of regorafenib “to treat a cancer, . . . such as those mentioned above, which have acquired
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`resistance to a KIT inhibitor.” (Col. 4:47-50.)
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`1 The term “acquired resistance,” appears in a number of asserted claims. The parties stipulated
`that this term shall be construed according to the definition the inventors set forth in the written
`description.
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`
`
`2
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 7 of 17 PageID #: 522
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`Bayer has asserted infringement of claims 1-4 and 29-31 of the ’124 patent. Claims 1
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`and 29 are generally directed to a method of treating a cancer wherein the cancer was initially
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`sensitive to a KIT tyrosine kinase inhibitor and “acquired resistance” to said KIT tyrosine kinase
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`inhibitor, comprising administering an effective amount of regorafenib. Claims 2 and 4, which
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`depend from claim 1, clarify that the drug to which the cancer has acquired resistance is imatinib.
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`Claim 3 narrows the lists of cancers which may be treated, including cancerous gastrointestinal
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`stromal tumors (GIST).
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`
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`The other asserted claims, independent claims 30 and 31, are generally directed to a
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`method of treating a malignant gastrointestinal stromal tumor (GIST) or a benign gastrointestinal
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`stromal tumor (GIST) “in a subject who has been treated with imatinib,” comprising
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`administering to the subject an effective amount of regorafenib.
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`III.
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`THE DISPUTED CLAIM TERMS
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`
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`As discussed, the parties dispute the construction of two terms. With respect to the first
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`term, “effective amount,” the parties agree with a portion of the construction, but Teva believes
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`Bayer’s construction incompletely reflects the inventors’ definition of that term, resulting in
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`needless ambiguity about the scope of the claim. With respect to the second term, “a subject
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`who has been treated with imatinib,” the parties disagree whether that term should be construed
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`to require the cancer to have developed acquired resistance to a KIT inhibitor. More specifically,
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`the parties disagree whether statements made by the inventors characterizing “the present
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`invention,” serve to limit the scope of the claims.
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`The disputed terms and the parties’ proposed constructions are:
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`3
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 8 of 17 PageID #: 523
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`Bayer’s Proposed Construction
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`Teva’s Proposed Construction
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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, 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
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` subject that is resistant and/or
`substantially less responsive to the
`effects of imatinib compared to
`that subject’s initial
`responsiveness to imatinib
`
`
`
`
`Claim
`Term/Phrase
`
`Claims 1, 29-31
`“an effective
`amount”
`
`
`an amount which is effective to
`treat any symptom or aspect of the
`cancer or the tumor
`
`
`
` a
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` subject who has been treated with
`imatinib (no construction
`necessary)
`
`
`Claims 30, 31
`“a subject who has
`been treated with
`imatinib”
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`
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`Teva has advanced a number of defenses to Bayer’s claims of patent infringement. One
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`defense Teva asserts is that it will not induce infringement of the asserted claims of the ’124
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`patent because all claims are directed to subjects who have “acquired resistance” to imatinib and
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`Teva’s product labeling does not instruct physicians to do so.
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`4
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 9 of 17 PageID #: 524
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`Teva has also asserted a number of invalidity defenses with respect to the asserted claims
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`of the ’124 patent.2 Included amongst these defenses, Teva has asserted defenses for failure to
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`satisfy the written description and enablement requirements under 35 U.S.C. § 112. To the
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`extent Plaintiffs contend the prior art lacked sufficient data to give a person of ordinary skill in
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`the art (“POSA”) a reasonable expectation that regorafenib was suitable for use in the claimed
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`invention, Teva does not believe the information provided in the written description of the patent
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`would have indicated to a POSA that the inventors were in possession of the invention. Nor
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`would the written description have provided the POSA with a sufficient scientific basis to
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`reasonably expect that the claimed invention would work. The construction of the term
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`“effective amount,” will help to frame the parties’ dispute over these defenses by clarifying what
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`the claims require the method to accomplish from a therapeutic perspective.
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`IV.
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`LEGAL PRINCIPLES FOR CLAIM CONSTRUCTION
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`Claim terms are to be construed from the perspective of one of ordinary skill in the art
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`(“POSA”) at the time that the patent application was filed. Phillips v. AWH Corp., 415 F.3d
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`1303, 1313 (Fed. Cir. 2005) (en banc).
`
`The claim construction analysis begins with the claim language itself, i.e., the language
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`the patentee chose to particularly point out and distinctly claim as its invention. Phillips, 415
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`F.3d at 1312-13. The Federal Circuit emphasized in Phillips, however, that the claims do not
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`stand alone. Id. at 1315. Instead, the claims “must be read in view of the specification, of which
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`they are a part.” Id. “[T]he specification is always highly relevant to the claim construction
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`analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.”
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`2 Teva believes that certain claim terms of the ’124 patent are indefinite, such as the term “an
`effective amount.” The parties agreed that they will not brief indefiniteness as part of claim
`construction.
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`5
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 10 of 17 PageID #: 525
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`Id. (citation omitted); see ICU Med., Inc. v. Alaris Med. Sys., 558 F.3d 1368, 1374 (Fed. Cir.
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`2009) (“[N]ot only is the written description helpful in construing claim terms, but it is also
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`appropriate to rely heavily on the written description for guidance as to the meaning of the
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`claims”) (internal quotations omitted).
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`In addition to the specification, a court will “also consider the patent’s prosecution
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`history.” Phillips, 415 F.3d at 1317. In this case, however, neither party has identified any
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`excerpts in the prosecution history as informing the proposed claim construction. (ECF No. 52
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`(Jt. Claim Construction Chart).)
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`Finally, the Court may also consider extrinsic evidence, such as treatises and dictionaries,
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`to better understand the background of the technology at issue and what those skilled in the art
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`typically understand a claim term to mean, but only to the extent such evidence is consistent with
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`the intrinsic evidence. Phillips, 415 F.3d at 1318. But when, as here, the meaning of a claim
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`term is clear based on review of the intrinsic record, it is unnecessary to consider any extrinsic
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`evidence. See Koepnick Med. & Educ. Research Found. v. Alcon Labs., 162 F. App’x 967, 972
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`(Fed. Cir. 2005) (“[B]ecause the intrinsic evidence was sufficient to support the claim
`
`construction, it was not necessary to consider extrinsic evidence.”); Intel Corp. v. VIA Techs.,
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`319 F.3d 1357, 1367 (Fed. Cir. 2003) (“When an analysis of intrinsic evidence resolves any
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`ambiguity in a disputed claim term, it is improper to rely on extrinsic evidence to contradict the
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`meaning so ascertained.”)
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`V.
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`THE LEVEL OF ORDINARY SKILL IN THE ART
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`As discussed, claim terms must be construed from the perspective of a POSA as of the
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`filing date of the patent in suit. Phillips, 415 F.3d at 1313. With respect to the ’124 patent, a
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`POSA would be someone having an advanced degree, such as a Ph.D., in medicinal chemistry,
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`biochemistry, and/or pharmacology, along with several years of experience developing new
`6
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 11 of 17 PageID #: 526
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`anticancer drugs and drug products. The person would regularly peruse the relevant literature
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`including, but not limited to, peer-reviewed publications, books, monographs and patents. The
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`person of ordinary skill would likely be part of, or communicate closely with, a drug
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`development team that includes a medicinal chemist, biochemist, pharmacologist, and/or
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`oncologist, as well as the performance of preclinical and clinical testing, to the extent she was
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`not educated and experienced in such disciplines. See, e.g., Janssen Pharmaceutica N.V. v.
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`Mylan Pharm., Inc., 456 F.Supp.2d 644, 653 (D.N.J. 2006) (citation omitted), aff’d, 233 Fed.
`
`Appx. 999 (Fed. Cir. 2007).
`
`VI.
`
`
`
`
`THE COURT SHOULD ADOPT THE DEFINITION OF “AN EFFECTIVE
`AMOUNT” THAT THE INVENTORS PROVIDED IN THE SPECIFICATION
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`Claims 1 and 29-31 are directed to the administration of “an effective amount” of
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`regorafenib. The parties agree that the construction of “an effective amount” should identify
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`what it means to be effective. Plaintiffs’ construction fails to answer this question, while Teva’s
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`construction embraces the inventors’ definition of what it means to be effective.
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`
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`“When the specification explains and defines a term used in the claims, without
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`ambiguity or incompleteness, there is no need to search further for the meaning of the term.”
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`Multiform Desiccants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998); Vitronics
`
`Corp. v. Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“(t)he specification acts as a
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`dictionary when it expressly defines terms used in the claims”). That is exactly what the
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`inventors did here.
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`In the written description of the ’124 patent, the inventors defined the term “effective
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`amount” to mean “the amount of DAST which is effective to treat any symptom or aspect of the
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`cancer.” (Col. 6, ll. 4-6.) The inventors went on to identify “aspects” of cancer that can be
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`“treated” using the invention:
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`
`
`7
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 12 of 17 PageID #: 527
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`Administering effective amounts of DAST 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.
`
`
`
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`
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`
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`(Col. 6:4-24.) In making these statements, the inventors explained to POSAs what a dose of
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`regorafenib must accomplish in order to be considered an “effective amount.” Therefore, the
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`Court should adopt the inventors’ definition, which identifies aspects of the cancer that must be
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`treated in order for a dose to be considered “an effective amount.” See, e..g, Sinorgchem Co. v.
`
`ITC, 511 F.3d 1132, 1136-1138 (Fed. Cir. 2007) (“a definition set forth in the specification
`
`governs the meaning of the claims”); Cultor Corp. v. A.E. Staley Mfg. Co., 224 F . 3d 1328,
`
`1330-1331 (Fed. Cir. 2000)(adopting construction based on statement in the specification that
`
`“explicitly defined [the disputed claim] term”); PDL Biopharma, Inc. v. Alexion Pharm., Inc.,
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`568 F. Supp. 2d 445, 452 (D. Del. 2008) (same).
`
`This Court’s decision in Bristol-Myers Squibb Co. v. Merck & Co., involved the same
`
`claim construction disputed presented by this case and supports Teva’s construction. Civil
`
`Action No. 14-1131-GMS, ECF 189, slip op. at 2-3 (D. Del. Jun. 6, 2016) (Exhibit A). In
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`Bristol-Myers, the parties disputed the construction of the term “pharmaceutically effective
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`amount.” Id. Bristol-Myers proposed a construction of “[a]n amount sufficient to exert the
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`pharmacological action of the drug.” The defendant believed this definition was needlessly
`
`ambiguous because “[w]ithout a construction of the ‘treat’ terms, one does not know what a
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`pharmacological action is.” Id. at n.2. So the defendant proposed a construction of “amount
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`sufficient to reduce proliferation or metastasis of cancer cells . . . .” Id. at n.2. The Court agreed
`
`with the defendant and rejected Bristol-Meyer’s proposed construction, which omitted reference
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`
`
`8
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 13 of 17 PageID #: 528
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`to any treatment outcomes. Id. Since the defendant’s “proposed construction is consistent with
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`the claims and the specification,” the court adopted it to “ensure that there is no confusion about
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`the meaning of the claim term.” Id. That is exactly what the Court should do here.
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`Bayer has not offered any reason for the Court to reach a different outcome. Teva asked
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`Bayer on a number of occasions to identify what aspect of Teva’s proposed construction Bayer
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`believed to be inaccurate or incomplete. See Exhibit B at 1; Exhibit C. Bayer never identified
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`anything it believed to be inaccurate. Instead, Bayer contended that the specification sets forth a
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`definition and Teva’s construction alters that definition. Id. at 3. But Teva’s construction was
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`taken directly from the specification. It appears that Bayer would just prefer to leave the
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`construction vague. There is no reason to do so when the inventors explained what “effective
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`amounts” accomplish. Bristol-Myers, slip op. at 2-3. Accordingly, the Court should adopt the
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`inventors’ complete construction of the term “effective amount” and eliminate the unnecessary
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`ambiguity embraced by Bayer’s definition. After all, Bayer is unable to identify any aspect of
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`Teva’s proposed construction that inaccurately characterizes the scope of the claims of the ’124
`
`patent.
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`VII. THE SPECIFICATION DEFINED THE INVENTION AS INVOLVING THE
`TREATMENT OF PATIENTS WITH ACQUIRED RESISTANCE
`
`
`
`Claims 30 and 31 are directed to a method of treating GIST in “a subject who has been
`
`treated with imatinib.” These claims differ from the other asserted claims, which are limited to
`
`the treatment of a “cancer [that] was initially sensitive to KIT tyrosine kinase inhibitor and
`
`acquired resistance to said KIT tyrosine kinase inhibitor.” These differences are of no
`
`consequence, however, because the inventors confirmed that “the present invention” is limited to
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`the treatment of patients with “acquired resistance.”
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`
`
`9
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`

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`Case 1:16-cv-01221-LPS Document 57 Filed 06/13/18 Page 14 of 17 PageID #: 529
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`The Federal Circuit has repeatedly held that inventors are bound by statements in the
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`specification that identify the “the present invention” as involving a particular feature. For
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`example, in Pacing Techs., LLC v. Garmin Int'l, Inc., the parties disputed whether the claims
`
`required a particular feature. 778 F.3d 1021 (Fed. Cir. 2015). The court acknowledged that the
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`plain and ordinary meaning of the disputed claim language did not require the feature. Id. at
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`1024. But, the specification dictated a limiting construction because it identified the feature as
`
`part of “the present invention.” Id.; see also Regents of the Univ. of Minn. v. AGA Med. Corp.,
`
`717 F.3d 929, 936 (Fed. Cir. 2013) (“[w]hen a patent thus describes the features of the ‘present
`
`invention’ as a whole, this description limits the scope of the invention”); Verizon Servs. Corp. v.
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`Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007) (holding that the district court
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`erred in failing to require a claim term to require a feature identified as part of the “present
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`invention” in the specification); Honeywell Int’l, Inc. v. ITT Indus., 452 F.3d 1312, 1318 (Fed.
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`Cir. 2006) (limiting the claim term “fuel injection system component” to a “fuel filter” because
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`“fuel filter” was identified as being part of “this invention” or “the present invention” at least
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`four times in the written description); Meds. Co. v. Mylan, Inc., 853 F.3d 1296, 1300-01, 1304
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`(Fed. Cir. 2017) (limiting claim to particular process where the written description identified that
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`process as part “of the invention,” even though the disputed claim language did not otherwise
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`require limitation); Retractable Techs., Inc. v. Becton, Dickinson & Co., 653 F.3d 1296, 1305
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`(Fed. Cir. 2011) (limiting the scope of a term where the specification “expressly recit[ed] that
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`‘the invention’” had a particular structure). That is precisely what the inventors did here.
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`In describing the invention in the specification, the inventors consistently defined it as
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`involving the treatment of “cancers which have acquired resistance.” First, the inventors titled
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`their patent “Treatment of Cancers with Acquired Resistance to KIT Inhibitors”. Second, the
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`inventors described “the present invention” as being the treatment of cancers which have
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`acquired resistance in the specification:
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` “The present invention provides compositions and uses thereof for treating
`cancers which have acquired resistance to a KIT inhibitor by administering
`effective amounts of DAST…” (Abstract);
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` “Generally, any cancer having a primary and/or secondary KIT gene mutation
`associated with resistance or acquired resistance to a KIT inhibitor can be treated
`with a compound in accordance with the present invention.” (col. 3:3-6);
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` “Cancers which are initially sensitive to a KIT inhibitor, but which have acquired
`resistance to it, can be treated in accordance with the present invention.” (col.
`3:42-44);
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` “[T]he present invention relates to using DAST to treat a cancer, such as those
`mentioned above, which have acquired resistance to a KIT inhibitor, irrespective
`of the molecular mechanism responsible for it.” (col. 4:36-50);
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` “The ability of DAST to treat a cancer with acquired resistance…” (col. 6:41-
`55).
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`Third, the sole example disclosing the activity of regorafenib as a treatment for cancer in the
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`’124 patent was an in vitro study showing the activity of regorafenib on imatinib resistant cell
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`lines. See ’124 patent, col. 18:36-41.
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`Not only did the inventors define “the present invention” as involving the treatment of
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`cancers with acquired resistance, they distinguished the invention from the prior art based on its
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`efficacy in treating such cancers. (See col. 4:13-49 (explaining that cancers acquire resistance to
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`prior art KIT inhibitors but that “the present invention relates to using [regorafenib] to treat
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`cancer, such as those mentioned above, which have acquired resistance to a KIT inhibitor.”
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`(Col. 4:47-49.)) This too supports Teva’s construction. See, e.g., Poly-America, L.P. v. API
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`Indus., Inc., 839 F.3d 1131, 1136 (Fed. Cir. 2016) (“an inventor may disavow claims lacking a
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`particular feature when the specification distinguishes or disparages prior art based on the
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`absence of that feature”); Honeywell, 452 F.3d at 1318 (“[t]he written description’s detailed
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`discussion of the prior art problem addressed by the patented invention, viz., leakage of non-
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`metal fuel filters in EFI systems, further supports the conclusion that the fuel filter is not a
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`preferred embodiment, but an only embodiment”); Arris Grp., Inc. v. Mobile Telecomms. Techs.,
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`LLC, 265 F. Supp. 3d 454, 461-64 (D. Del. 2017) (relying on discussion of the prior art problem
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`in the written description that was addressed by the patented invention, and identification of a
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`feature as being part of “the present invention,” to limit scope of claim). For all of these reasons,
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`the Court should construe claims 30 and 31 as being limited to the treatment of cancers that have
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`acquired resistance (which the parties agree should be construed to mean cancers that “are
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`resistant and/or substantially less responsive to the effects of imatinib compared to the cancer’s
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`initial responsiveness to imatinib”).
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`VIII. CONCLUSION
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`For the reasons stated herein, Teva respectfully request that the Court adopt Teva’s
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`proposed constructions for the disputed terms.
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`Respectfully submitted,
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`/s/ Karen E. Keller
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`David M. Fry (No. 5486)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`dfry@shawkeller.com
`Attorneys for Defendant
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`OF COUNSEL:
`Mark D. Schuman
`Todd S. Werner
`Samuel T. Lockner
`Jennell C. Bilek
`Shelleaha L. Jonas
`Alexandra J. Olson
`Nathan D. Louwagie
`CARLSON, CASPERS, VANDENBURGH,
` LINDQUIST & SCHUMAN, P.A.
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`225 South Sixth Street
`Capella Tower, Suite 4200
`Minneapolis, MN 55402
`(612) 436-9600
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`Dated: June 13, 2018
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