Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 1 of 8 PageID #: 712
`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 1 of 8 PageID #: 712
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`EXHIBIT A
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`EXHIBIT A
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 2 of 8 PageID #: 713
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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
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`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
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`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
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`v.
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`Plaintiffs,
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`Defendants.
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`PLAINTIFF BAYER’S OBJECTIONS AND RESPONSES TO
`TEVA’S FIRST SET OF REQUESTS FOR PRODUCTION (NOS. 1-89)
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`Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure, Plaintiffs Bayer
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`HealthCare LLC and Bayer HealthCare Pharmaceuticals Inc. (“Bayer”), by undersigned counsel,
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`hereby object and respond as follows to Defendant Teva Pharmaceuticals USA, Inc.’s (“Teva”)
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`First Set of Requests for Production (Nos. 1-89). Documents produced in response to these
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`requests (as set forth in detail below) will be produced on a rolling basis and in accordance with
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`the Court’s Scheduling Order, which sets a date of May 15, 2018, for substantial completion of
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`document production. Bayer began its rolling production of documents on December 13, 2017.
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`GENERAL OBJECTIONS
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`The following General Objections form a part of, and are hereby incorporated into, the
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`response to each and every request set forth below. Nothing in those responses, including any
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`failure to recite a specific objection in response to a particular request, should be construed as a
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`waiver of any of these General Objections.
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`1
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 3 of 8 PageID #: 714
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`that it refers to documents and electronically stored information relating to paragraph IV
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`certifications not directed to regorafenib. Bayer construes the term “Notice Letters” to be limited
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`to notice letters directed to regorafenib and will respond accordingly.
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`27.
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`Bayer objects to Teva’s definitions of “Asserted claim” and “Accused product” to
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`the extent that they seek documents or electronically stored information regarding contentions
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`that Teva has not yet made in this litigation. Bayer will not prematurely produce documents or
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`information that are to be provided during other stages of the litigation, but will only produce
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`such documents and information in accordance with the Court’s schedule for this action.
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`28.
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`Bayer objects to Teva’s definition of “Prior Art” as vague, ambiguous, overly
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`broad, calling for a legal conclusion, and calling for a subjective determination. Bayer will not
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`search for “prior art,” and neither Bayer’s responses nor any documents or electronically stored
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`information that Bayer produces in response to a request should be construed as an admission
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`that a particular document or thing is prior art to the patents-in-suit.
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`29.
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`Bayer incorporates by reference all objections set forth in the General Objections
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`of Plaintiffs’ Responses and Objections to Teva’s First Set of Interrogatories (Nos. 1-6).
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`30.
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`Bayer expressly reserves the right to supplement these General Objections.
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`DEFINITIONS FOR PURPOSES OF BAYER’S OBJECTIONS AND RESPONSES
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`1.
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`As used herein, “Named Inventors of the ’834 patent” means Bernd Riedl,
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`Jacques Dumas, Uday Khire, Timothy Lowinger, William Scott, Roger A. Smith, Jill E. Wood,
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`Mary-Katherine Monahan, Reina Natero, Joel Renick, and Robert Sibley.
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`2.
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`As used herein, “Named Inventors of the ’553 patent” means Stephen Boyer,
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`Jacques Dumas, Bernd Riedl, and Scott Wilhelm.
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`3.
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`As used herein, “Named Inventors of the ’124 patent” means Scott Wilhelm and
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`Richard W. Gedrich.
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`12
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 4 of 8 PageID #: 715
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`4.
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`As used herein, “Named Inventors of the ’107 patent” means Juergen Stiehl,
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`Werner Heilmann, Michael Lögers, Joachim Rehse, Michael Gottfried, and Saskia Wichmann.
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`5.
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`As used herein, “Mylan Litigation” means Bayer HealthCare LLC, et al., v.
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`Mylan Pharmaceuticals Inc., No. 15-cv-114 (LPS) (D. Del.), and Bayer HealthCare LLC, et al.,
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`v. Mylan Pharmaceuticals Inc., No. 15-cv-1162 (LPS) (D. Del.).
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`6.
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`As used herein, “Files of the Named Inventors” means: (a) the files of the Named
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`Inventors of the ’834 patent that were produced in the Mylan Litigation; (b) any non-privileged
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`documents dated on or before July 22, 2004, that refer or relate to the research and development
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`of regorafenib for use as a kinase inhibitor, located after a reasonable search of the files of the
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`Named Inventors of the ’553 patent that are reasonably accessible to Bayer; (c) any non-
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`privileged documents dated on or before January 18, 2008, that refer or relate to the use of
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`regorafenib for the treatment of gastrointestinal stromal tumor (GIST), located after a reasonable
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`search of the files of the Named Inventors of the ’124 patent that are reasonably accessible to
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`Bayer; and (4) any non-privileged documents generated on or before April 15, 2010, that refer or
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`relate to anilinic impurities in regorafenib, located after a reasonable search of the files of the
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`Named Inventors of the ’107 patent that are reasonably accessible to Bayer.
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`7.
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`As used herein, “Research and Development Documents” means copies of (a) the
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`Files of the Named Inventors; (b) the batch records for regorafenib located after a reasonable
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`search of Bayer’s central repository of batch records; (c) any non-privileged reports for
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`regorafenib located after a reasonable search of Bayer’s electronic database containing Bayer’s
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`Pharma reports; (d) relevant excerpts, not to include any confidential patient information, of New
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`Drug Application (“NDA”) No. 203085, Bayer’s communications with FDA regarding NDA No.
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`203085, and Investigational New Drug Application (“IND”) Nos. 75642 and 113896. For
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`13
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 5 of 8 PageID #: 716
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`clarity, “Research and Development Documents” does not include, and specifically excludes, the
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`documents and electronically stored information identified in exclusions from production and
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`limitations on production as set forth in the General Objections.
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`8.
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`As used herein, “Patent and Prosecution Documents” means copies of (a) each of
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`U.S. Patent Nos. 7,351,834 (the“’834 patent”), 8,637,553 (the“’553 patent”); 8,680,124
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`(the“’124 patent”); and 9,458,107 (the“’107 patent”), their certified file histories, and any
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`provisional or non-provisional applications to which they claim priority; (b) any agreements
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`concerning the ’834, ’553, ’124, and ’107 patents that have been filed with the United States
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`Patent and Trademark Office; (c) any non-privileged documents that refer or relate to any of the
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`’553, ’124, and ’107 patents, and which are located after a reasonable search of (i) the
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`department files of Bayer’s patent department for each of the ’553, ’124, and ’107 patents, and
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`(ii) the patent prosecution files of Millen, White, Zelano and Branigan P.C. for each of the ’553,
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`’124, and ’107 patents; (d) documents from the department file(s) of Bayer’s patent department
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`for the ’834 patent that were produced in the Mylan Litigation; and (e) documents from the
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`prosecution file(s) of Millen, White, Zelano and Branigan P.C. for the ’834 patent that were
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`produced in the Mylan Litigation. For clarity, “Patent and Prosecution Documents” does not
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`include, and specifically excludes, the documents and electronically stored information identified
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`in exclusions from production and limitations on production as set forth in the General
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`Objections.
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 6 of 8 PageID #: 717
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`HealthCare LLC, et al., v. Mylan Pharmaceuticals Inc., No. 15-cv-1162 (LPS) (D. Del.). Bayer
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`is willing to meet and confer to discuss a narrowed request for production.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Derek J. Fahnestock
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`
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`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
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`Attorneys for Plaintiffs Bayer HealthCare LLC
`and Bayer HealthCare Pharmaceuticals Inc.
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`OF COUNSEL:
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`Bruce R. Genderson
`Adam L. Perlman
`Dov P. Grossman
`Jessica B. Rydstrom
`Xiao Wang
`Seth R. Bowers
`Ben Picozzi*
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
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`January 19, 2018
`11596569
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`*Admitted only in California. Practice supervised by DC bar members pursuant to D.C. Court of
`Appeals Rule 49(c)(8).
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`88
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 7 of 8 PageID #: 718
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`CERTIFICATE OF SERVICE
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`I hereby certify that on January 19, 2018, copies of the foregoing were caused to
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`be served upon the following in the manner indicated:
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`John W. Shaw, Esquire
`Karen E. Keller, Esquire
`David M. Fry, Esquire
`SHAW KELLER LLP
`I.M. PEI Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`Attorneys for Defendant Teva Pharmaceuticals
`USA, Inc.
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`Mark D. Schuman, Esquire
`Samuel Lockner, Esquire
`Jennell C. Bilek, Esquire
`Alexandra J. Olson, Esquire
`Nathan D. Louwagie, Esquire
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street
`Capella Tower, Suite 4200
`Minneapolis, MN 55402
`Attorneys for Defendant Teva Pharmaceuticals
`USA, Inc.
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`Kenneth L. Dorsney, Esquire
`Morris James LLP
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801-1494
`Attorneys
`for Defendants Apotex
`and Apotex Corp.
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`Inc.
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`89
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`Case 1:16-cv-01221-LPS Document 82-1 Filed 08/17/18 Page 8 of 8 PageID #: 719
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`VIA ELECTRONIC MAIL
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`Stephen R. Auten, Esquire
`Richard T. Ruzich, Esquire
`Phillip Y. Kouyoumdjian, Esquire
`Ian Scott, Esquire
`Taft Stettinius & Hollister LLP
`111 East Wacker Drive, Suite 2800
`Chicago, IL 60601
`Attorneys
`for Defendants Apotex
`and Apotex Corp.
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`Inc.
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`/s/ Derek J. Fahnestock
`_____________________________________
`Derek J. Fahnestock (#4705)
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`90
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