`
`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
`
`Plaintiffs,
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`) C.A. No. 16-1221 (LPS)
`) CONSOLIDATED
`)
`)
`)
`
`
`
`v.
`
`
`TEVA PHARMACEUTICALS USA, INC. et
`al,
`
`Defendants.
`
`STIPULATION AND ORDER REGARDING INFRINGEMENT
`
`Plaintiffs Bayer HealthCare LLC and Bayer HealthCare Pharmaceuticals Inc.
`
`(collectively, “Bayer”) and Defendants Apotex Inc. and Apotex Corp. (collectively, “Apotex”)
`
`hereby STIPULATE, and request that the Court ORDER, as follows:
`
`1.
`
`The regorafenib oral tablets that are the subject of Apotex’s Abbreviated New Drug
`
`Application (“ANDA”) No. 209765 (including any amendments or supplements thereto)
`
`(“Apotex’s ANDA Product”) infringe each of claims 1, 3, 6, 8, and 13 and 14 of U.S. Patent No.
`
`8,637,553 (“the ’553 patent”), provided that the claim at issue is not proven invalid or
`
`unenforceable;
`
`2.
`
`The use of Apotex’s ANDA Product in accordance with its labeling infringes each
`
`of claims 10, 11, and 12 of the ’553 patent, provided that the claim at issue is not proven invalid or
`
`unenforceable;
`
`3.
`
`Apotex will induce infringement of each of claims 10, 11, and 12 of the ’553 patent,
`
`provided that the claim at issue is not proven invalid or unenforceable, through sale of Apotex’s
`
`ANDA Product;
`
`
`
`Case 1:16-cv-01221-LPS Document 83 Filed 08/20/18 Page 2 of 3 PageID #: 721
`
`
`
`4.
`
`Apotex’s ANDA Product infringes each of claims 1-4, 9-14, and 18-20 of U.S.
`
`Patent No. 9,458,107 (“the ’107 patent”), provided that the claim at issue is not proven invalid or
`
`unenforceable;
`
`5.
`
`As a result of the stipulation of infringement set forth herein, Bayer and Apotex
`
`(together “the Parties”) agree that no supplementation to Apotex’s responses to Bayer’s
`
`Interrogatory Nos. 1-2 is required. In addition, as a result of the stipulation of infringement set
`
`forth herein, the Parties agree that Apotex will produce neither the closed portion of the Drug
`
`Master File for the regorafenib active pharmaceutical ingredient (“API”) used in Apotex’s ANDA
`
`Product, nor any samples of either its finished ANDA Product or the API used in its ANDA
`
`product that were requested by Bayer. Further, as a result of the stipulation of infringement set
`
`forth herein, Bayer withdraws its Interrogatories Nos. 7-8 as to Apotex.
`
`6.
`
`As a result of the stipulation of infringement set forth herein, Bayer agrees that it
`
`will not take any individual depositions of Apotex employees other than Kiran Krishnan. In
`
`addition, as a result of the stipulation of infringement set forth herein, Bayer will withdraw topics
`
`4, 12, 14, 15, 16, 17, 18, 19, 20, 21, and 22 as listed in Attachment A of Plaintiff’s Notice of
`
`Deposition Pursuant to Federal Rule of Civil Procedure 30(b)(6) that was served on Apotex.
`
`7.
`
`Nothing in this stipulation shall preclude Apotex from pursuing any properly
`
`pleaded and disclosed defense contesting the validity and/or enforceability of any claim of the
`
`’553 and/or the ’107 patent(s).
`
`Bayer and Apotex make this stipulation without prejudice to or waiver of their rights on any
`
`appeal of any judgment of this Court, except with respect to the matters of infringement as
`
`stipulated herein.
`
`
`
`
`
`2
`
`
`
`Case 1:16-cv-01221-LPS Document 83 Filed 08/20/18 Page 3 of 3 PageID #: 722
`
`
`
`IT IS HEREBY STIPULATED:
`
`
`/s/ Derek J. Fahnestock
`________________________________
`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.
`
`/s/ Kenneth L. Dorsney
`____________________________
`Kenneth L. Dorsney (#3726)
`MORRIS JAMES LLP
`500 Delaware Ave., Suite 1500
`Wilmington, DE 19801-1494
`(302) 888-6800
`kdorsney@morrisjames.com
`
`Attorneys for Defendants Apotex Corp.
`and Apotex 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
`bgenderson@wc.com
`aperlman@wc.com
`dgrossman@wc.com
`jrydstrom@wc.com
`sbowers@wc.com
`bpicozzi@wc.com
`
`OF COUNSEL:
`
`Stephen R. Auten
`Richard T. Ruzich
`Phillip Y. Kouyoumdjian
`Ian Scott
`TAFT STETTINIUS & HOLLISTER LLP
`111 East Wacker Drive, Suite 2800
`Chicago, IL 60601
`312-527-4000
`sauten@taftlaw.com
`rruzich@taftlaw.com
`pkouyoumdjian@taftlaw.com
`iscott@taftlaw.com
`
`August 20, 2018
`
`SO ORDERED this ____ day of ________________, 2018.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`__________________________________
`United States District Judge
`
`3
`
`
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