Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 1 of 9 PageID #: 802
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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)
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` ))))))))))
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`BAYER HEALTHCARE LLC AND BAYER
`HEALTHCARE PHARMACEUTICALS INC.,
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`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`APOTEX CORP. and APOTEX, INC.
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`
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`
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`Defendants.
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`Plaintiffs,
`
`
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`v.
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`DEFENDANTS’ NOTICE OF DEPOSITION TO
`PLAINTIFFS BAYER HEALTHCARE LLC and BAYER HEALTHCARE
`PHARMACEUTICALS INC. PURSUANT TO FED. R. CIV. P. 30(b)(6)
`
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
`
`PLEASE TAKE NOTICE that, pursuant to Rule 30(b)(6) of the Federal Rules of Civil
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`Procedure and the applicable Local Civil Rules of the United States District Court for the District
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`of Delaware, Defendant Apotex Corp.; and Apotex, Inc. (collectively, “Defendants” or
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`“Apotex”), by and through their attorneys, will take depositions upon oral examination of
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`Plaintiffs Bayer Healthcare LLC and Bayer Healthcare Pharmaceuticals Inc. (collectively,
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`“Plaintiffs” or “Bayer”) at a mutually agreed upon date and time by the parties and continuing
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`from day to day thereafter until completed. The depositions will be conducted before an officer
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`authorized by law to administer oaths and will be recorded by stenographic, sound, video,
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`audiovisual, and/or any other appropriate means. The depositions will be taken for the purposes
`
`of discovery, for use at trial in these actions, and for any purposes permitted under the Federal
`
`Rules of Civil Procedure. You are invited to attend and participate.
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`1
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`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 16-1221 (LPS)
`
` ))))))))))
`
`BAYER HEALTHCARE LLC AND BAYER
`HEALTHCARE PHARMACEUTICALS INC.,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`APOTEX CORP. and APOTEX, INC.
`
`
`
`
`
`Defendants.
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`
`DEFENDANTS’ NOTICE OF DEPOSITION TO
`PLAINTIFFS BAYER HEALTHCARE LLC and BAYER HEALTHCARE
`PHARMACEUTICALS INC. PURSUANT TO FED. R. CIV. P. 30(b)(6)
`
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
`
`PLEASE TAKE NOTICE that, pursuant to Rule 30(b)(6) of the Federal Rules of Civil
`
`Procedure and the applicable Local Civil Rules of the United States District Court for the District
`
`of Delaware, Defendant Apotex Corp.; and Apotex, Inc. (collectively, “Defendants” or
`
`“Apotex”), by and through their attorneys, will take depositions upon oral examination of
`
`Plaintiffs Bayer Healthcare LLC and Bayer Healthcare Pharmaceuticals Inc. (collectively,
`
`“Plaintiffs” or “Bayer”) at a mutually agreed upon date and time by the parties and continuing
`
`from day to day thereafter until completed. The depositions will be conducted before an officer
`
`authorized by law to administer oaths and will be recorded by stenographic, sound, video,
`
`audiovisual, and/or any other appropriate means. The depositions will be taken for the purposes
`
`of discovery, for use at trial in these actions, and for any purposes permitted under the Federal
`
`Rules of Civil Procedure. You are invited to attend and participate.
`
`
`
`1
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 2 of 9 PageID #: 803
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`Pursuant to Fed. R. Civ. P. 30(b)(6), Bayer shall designate one or more knowledgeable
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`persons to testify on its behalf with respect to the matters set forth in Schedule A attached hereto,
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`and the person(s) so designated shall be required to testify as to those matters known or
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`reasonably available to Bayer. Bayer shall identify in writing each deponent who shall be
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`designated to testify on its behalf at least ten (10) business days in advance of the deposition,
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`including which portion(s) of this Notice each deponent is prepared to address.
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`Dated: November 1, 2018
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`
`
` /s/ Kenneth L. Dorsney
`Kenneth L. Dorsney (#3726)
`MORRIS JAMES LLP
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801-1494
`(302) 888-6800
`kdorsney@morrisjames.com
`
`Stephen R. Auten
`Richard T. Ruzich
`Ian Scott
`Philip Y. Kouyoumdjian
`Taft Stettinius & Hollister LLP
`111 East Wacker Drive, Suite 2800
`Chicago, IL 60601
`312-527-4000
`sauten@taftlaw.com
`rruzich@taftlaw.com
`iscott@taftlaw.com
`pkouyoumdjian@taftlaw.com
`
`Attorneys for Defendants
`Apotex Inc. and Apotex Corp.
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`
`2
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 3 of 9 PageID #: 804
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`
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`Schedule A
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 4 of 9 PageID #: 805
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`SCHEDULE A
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`DEFINITIONS AND INSTRUCTIONS
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`Defendants hereby incorporate by reference, as though fully set forth herein, the
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`
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`Definitions set forth in Defendants’ First Set of Interrogatories (Nos. 1-6) and First Set of
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`Requests for Production (Nos. 1-89).
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`
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`DEPOSITION TOPICS
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`The conception, development, and reduction to practice of the subject matter of
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`1.
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`the asserted claims of the patents in suit.
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`2.
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`Investigations, evaluations, analyses, studies, reports, and tests conducted by or
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`on behalf of Bayer or received from Onyx involving, underlying, or concerning the following:
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`
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`A.
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`Communication dated December 28, 2011, from the European Examining
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`
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`B.
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`Division. See BAYER_STIVARGA_01088635-36.
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`Response dated July 4, 2012. See BAYER_STIVARGA_01088653-54.
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`3.
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`The preparation, filing, and prosecution of the patents-in-suit and any related
`
`application, including the identification of persons and other entities involved during such
`
`prosecution, any third-party observations submitted, any declarations submitted on behalf of
`
`Bayer or the inventors, and the earliest claimed priority date for each claim of the patents-in-suit
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`asserted in the present litigations.
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`4.
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`Data and information used as the basis for the statements made in the patents-in-
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`suit (including all examples and tables) and during prosecution with the USPTO of the
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`applications that led to the patents-in-suit and related applications, including but not limited to all
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`facts, data, results, testing, experimental conditions, or protocols.
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 5 of 9 PageID #: 806
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`5.
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`The preparation, filing, and prosecution of European Patent Application No. 07
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`818 583.2-2101 (the “2101 application”) and any related application, the identification of
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`persons and other entities involved during such prosecution, any third-party observations
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`submitted, and any declarations submitted on behalf of Bayer or the inventors.
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`6.
`
`Data and information used as the basis for the statements made in the 2101
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`application, including but not limited to the Communication dated December 28, 2011,
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`BAYER_STIVARGA_01088635-36, and the Response dated July 4, 2012,
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`BAYER_STIVARGA_01088653-54. and all examples and tables referred to in the application
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`and during prosecution with the European Patent Office of the applications that led to WO
`
`2008/043446 and related applications, including but not limited to all facts, data, results, testing,
`
`experimental conditions, or protocols.
`
`7.
`
`The first synthesis of regorafenib and regorafenib with a physiologically
`
`acceptable carrier, including when, how, and by whom the synthesis occurred.
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`8.
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`9.
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`The preclinical and clinical studies identified in NDA No. 203085.
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`The basis for the selection of the particular cell lines identified in the Biological
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`Example at columns 18 to 20 of the ’124 patent.
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`10.
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`Any licenses, settlement agreements and other contracts between Bayer and Onyx
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`concerning the patents-in-suit, including negotiations, attempts to license, or offers to license one
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`or more of the patents or any product embodying any of the claims of one or more of the patents.
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`11.
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`The basis for the selection of regorafenib for further development efforts,
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`including but not limited to the experimental data concerning the safety and efficacy of
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`regorafenib relative to other compounds considered or relied upon in support of that decision(s).
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 6 of 9 PageID #: 807
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`12.
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`The decision to develop regorafenib as a commercial pharmaceutical product,
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`including but not limited to the decisions whether to pursue indications for the treatment of
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`gastrointestinal stromal tumor, mesenchymal tumor of the intestinal tract, chronic myelogenous
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`leukemia, mast cell tumor, SCLC, germ cell tumor, breast cancer, and neuroblastoma.
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`13.
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`The first use of regorafenib to treat each of the diseases or conditions referenced
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`in asserted claim 3 of the ’124 patent and documents concerning the same.
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`14.
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`15.
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`The first use of regorafenib in an in vivo study, including when, how, and why.
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`The first use of regorafenib in humans who had previously used a KIT inhibitor,
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`including when, how, and why.
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`16.
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`Experiments, analyses, and data resulting from testing assessing the efficacy of
`
`regorafenib to treat a gastrointestinal stromal tumor, a mesenchymal tumor of the intestinal tract,
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`chronic myelogenous leukemia, a mast cell tumor, SCLC, a germ cell tumor, breast cancer, and a
`
`neuroblastoma.
`
`17.
`
`Data demonstrating the safety and efficacy of the claimed compounds of the ’834
`
`patent other than sorafenib and regorafenib, including but not limited to any preclinical and
`
`clinical testing of such compounds.
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`18.
`
`The need for a drug to treat cancers with acquired resistance to imatinib as of
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`January 19, 2007.
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`19.
`
`All experiments performed by Bayer after January 19, 2007 that assessed, directly
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`or indirectly, the efficacy of regorafenib to treat a gastrointestinal stromal tumor, a mesenchymal
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`tumor of the intestinal tract, chronic myelogenous leukemia, a mast cell tumor, SCLC, a germ
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`cell tumor, breast cancer, and/or neuroblastoma.
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 7 of 9 PageID #: 808
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`20.
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`All studies, experiments, analyses, investigation, or reports concerning any of the
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`claimed compounds of the 834 patent tested by Bayer for their KIT inhibiting properties before
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`January 19, 2007.
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`21.
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`All studies, experiments, analyses, investigation, or reports concerning any
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`metabolites of regorafenib before July 22, 2005.
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`22.
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`The first identification of the metabolite(s) of regorafenib, including when, how,
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`and by whom the identification occurred.
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`23.
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`The first identification of each anilinic impurity of regorafenib, including but not
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`limited to 4-amino-3-fluorophenol and/or 4-(4-amino-3-fluorophenoxy) pyridine2-carboxylic
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`acid methylamide in regorafenib, including when, how, and by whom the identification occurred.
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`24.
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`The development of assays, experiments, or tests to determine the amount of
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`anilinic substances used to synthesize or formed in the synthesis or storage of regorafenib,
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`including but not limited to the anilinic substances specifically referenced in the asserted claims
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`of the ’107 patent, present in a composition comprising regorafenib.
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`25.
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`The facts and circumstances relating to the development of assays, experiments,
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`or tests to determine the amount of anilinic substances used to synthesize or formed in the
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`synthesis or storage of sorafenib, including but not limited to the anilinic substances specifically
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`referenced in the asserted claims of the ’107 patent, present in a composition comprising
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`sorafenib.
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`26.
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`All studies, experiments, tests, analyses, investigation, or reports concerning any
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`toxicity, mutagenicity, or the like for the anilinic substances present in sorafenib or regorafenib.
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 8 of 9 PageID #: 809
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`27.
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`The determination of the amounts of regorafenib required to treat the cancers of
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`claim 3 of the ’124 patent, including the tests performed in order to make that determination, as
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`well as when and by whom those tests were conducted and documents concerning those efforts.
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`28.
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`29.
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`The content of the labels for STIVARGA® and draft labels submitted to the FDA.
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`The marketing and sales of each product that Bayer contends embodies an
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`asserted claim of the patents-in-suit, including but not limited to (for each such product):
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`A.
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`B.
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`C.
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`promotional and marketing efforts;
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`promotional, advertising, and marketing expenditures;
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`gross and net sales in the U.S. market of each such product and all
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`competing products in the United States for use to treat a gastrointestinal stromal
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`tumor(s), a mesenchymal tumor of the intestinal tract, chronic myelogenous leukemia, a
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`mast cell tumor, SCLC, a germ cell tumor, breast cancer, and/or neuroblastoma;
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`D.
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`E.
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`profit and loss data;
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`share of the market in the United States for drug products for use to treat a
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`gastrointestinal stromal tumor, a mesenchymal tumor of the intestinal tract, chronic
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`myelogenous leukemia, a mast cell tumor, SCLC, a germ cell tumor, breast cancer,
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`and/or neuroblastoma, on a monthly, quarterly, and annual basis, since receipt of FDA
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`approval to the present;
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`F.
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`Bayer’s analysis of the relationship, including but not limited to the return
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`on investment, between any promotional, marketing, or education efforts and sales
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`revenue for each such product; and
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`G.
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`pricing, including but not limited to price lists, pricing strategy, discounts,
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`rebates.
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`
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`Case 1:16-cv-01221-LPS Document 101 Filed 11/01/18 Page 9 of 9 PageID #: 810
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`30.
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`The factual basis for any alleged objective indicia of nonobviousness concerning
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`the patents-in-suit, including, but not limited to:
`
`A.
`
`unexpected properties or advantages of the subject matter of the patents-
`
`in-suit;
`
`B.
`
`C.
`
`D.
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`commercial success of the subject matter of the patents-in-suit and sales;
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`long-felt need met by the subject matter of the patents-in-suit;
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`prior failure of others to solve any problem to which the subject matter of
`
`the patents-in-suit would be considered a solution;
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`E.
`
`F.
`
`G.
`
`H.
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`skepticism regarding the subject matter of the patents-in-suit;
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`copying by others of the subject matter of the patents-in-suit;
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`praise by others for the subject matter of the patents-in-suit; and,
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`acceptance by doctors of the subject matter of the patents-in-suit.
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`31.
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`The relationship between Plaintiffs and Onyx Pharmaceuticals Inc. concerning
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`sorafenib, flourosorafenib, regorafenib, STIVARGA®, and/or NEXAVAR®.
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