Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 1 of 7 PageID #: 862
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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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`BAYER HEALTHCARE LLC AND BAYER
`HEALTHCARE PHARMACEUTICALS INC.,
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`APOTEX CORP. and APOTEX, INC.
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`Defendants.
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`Plaintiffs,
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`v.
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`APOTEX’S NOTICE OF DEPOSITION TO
`PLAINTIFFS BAYER HEALTHCARE LLC AND BAYER HEALTHCARE
`PHARMACEUTICALS INC. PURSUANT TO FED. R. CIV. P. 30(b)(6)
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`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
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`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 “Apotex”),
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`by and through their attorneys, will take depositions upon oral examination of Plaintiffs Bayer
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`Healthcare LLC and Bayer Healthcare Pharmaceuticals Inc. (collectively, “Plaintiffs” or “Bayer”)
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`at a mutually agreed upon date and time by the parties and continuing from day to day thereafter
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`until completed. The depositions will be conducted before an officer authorized by law to
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`administer oaths and will be recorded by stenographic, sound, video, audiovisual, and/or any other
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`appropriate means. The depositions will be taken for the purposes of discovery, for use at trial in
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`these actions, and for any purposes permitted under the Federal Rules of Civil Procedure. You are
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`invited to attend and participate.
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`24625635.1
`10820197/1
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`1
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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)
`
` )
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`BAYER HEALTHCARE LLC AND BAYER
`HEALTHCARE PHARMACEUTICALS INC.,
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`
`
`
`
`APOTEX CORP. and APOTEX, INC.
`
`
`
`
`
`Defendants.
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`
`APOTEX’S 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.
`
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`10820197/1
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`Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 2 of 7 PageID #: 863
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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 reasonably
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`available to Bayer. Bayer shall identify in writing each deponent who shall be designated to testify
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`on its behalf at least ten (10) business days in advance of the deposition, including which portion(s)
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`of this Notice each deponent is prepared to address.
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`Date: March 13, 2019
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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) 888-6855
`Kdorsney@morrisjames.com
`
`Stephen R. Auten
`Richard T. Ruzich
`Philip 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
`iscott@taftlaw.com
`pkouyoumdjian@taftlaw.com
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`Attorneys for Defendant Apotex Inc. and
`Apotex Corp.
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`Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 3 of 7 PageID #: 864
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`Schedule A
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`Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 4 of 7 PageID #: 865
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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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`Definitions set forth in Defendants’ First Set of Interrogatories (Nos. 1-6) and First Set of Requests
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`for Production (Nos. 1-89).
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`The following terms are to be interpreted in accordance with these definitions:
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`1.
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`“Regorafenib monohydrate” shall mean 4-[4-({[4-chloro-3-(trifluoromethyl)
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`phenyl]carbamoyl}lamino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate
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`and/or
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`.
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`DEPOSITION TOPICS
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`1.
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`The conception, development, and reduction to practice of the subject matter of the
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`asserted claims of U.S. Patent No. 9,957,232 (“the ’232 patent”).
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`2.
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`The preparation, filing, and prosecution of the ’232 patent and any related
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`application, including the identification of persons and other entities involved during such
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`prosecution, any third-party observations submitted, any declarations submitted on behalf of Bayer
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`or the inventors, and the earliest claimed priority date for each claim of the patents-in-suit asserted
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`in the present litigations.
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`3.
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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 applications
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`Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 5 of 7 PageID #: 866
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`that led to the patents-in-suit and related applications, including but not limited to all facts, data,
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`results, testing, experimental conditions, or protocols.
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`4.
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`The preparation, filing, and prosecution of European Patent Application No.
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`06021296.6 (the “1296 application”) and any related application, the identification of persons and
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`other entities involved during such prosecution, any third-party observations submitted, and any
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`declarations submitted on behalf of Bayer or the inventors.
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`5.
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`Data and information used as the basis for the statements made in the 1296
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`application, including but not limited to all examples and tables referred to in the application and
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`during prosecution with the European Patent Office of the applications that led to WO
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`2008/043446 and related applications, including but not limited to all facts, data, results, testing,
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`experimental conditions, or protocols.
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`6.
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`The first synthesis of regorafenib monohydrate, including when, how, and by whom
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`the synthesis occurred.
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`7.
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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 bases for the data set forth in Tables 1-7 in the 1296 application.
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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 the ’232 patent.
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`10.
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`The basis for the selection of regorafenib monohydrate for further development
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`efforts, including but not limited to the experimental data concerning the safety and efficacy of
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`regorafenib monohydrate relative to other compounds considered or relied upon in support of that
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`decision(s).
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`Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 6 of 7 PageID #: 867
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`11.
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`The decision to develop regorafenib monohydrate as a commercial pharmaceutical
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`product, including but not limited to the decisions whether to pursue indications for the treatment
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`of hyper-proliferative disorders, including but not limited to solid tumors, lymphomas, sarcomas,
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`leukemias, cancers of the breast, respiratory tract, brain, reproductive organs, digestive tract,
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`urinary tract, eye, liver, skin, head and neck, thyroid and/or parathyroid.
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`12.
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`The first use of regorafenib monohydrate to treat each of the diseases or conditions
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`referenced in asserted claim 2 of the ’232 patent and documents concerning the same.
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`13.
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`The first use of regorafenib monohydrate in an in vivo study, including when, how,
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`and why.
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`14.
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`The first use of regorafenib monohydrate in humans, including when, how, and
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`why.
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`15.
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`Experiments, analyses, and data resulting from testing assessing the efficacy of
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`regorafenib monohydrate to treat hyper-proliferative disorders, including but not limited to solid
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`tumors, lymphomas, sarcomas, leukemias, cancers of the breast, respiratory tract, brain,
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`reproductive organs, digestive tract, urinary tract, eye, liver, skin, head and neck, thyroid and/or
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`parathyroid.
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`16.
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`All experiments performed by Bayer that assessed, directly or indirectly, the
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`efficacy of regorafenib monohydrate to treat hyper-proliferative disorders, including but not
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`limited to solid tumors, lymphomas, sarcomas, leukemias, cancers of the breast, respiratory tract,
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`brain, reproductive organs, digestive tract, urinary tract, eye, liver, skin, head and neck, thyroid
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`and/or parathyroid.
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`Case 1:16-cv-01221-LPS Document 114 Filed 03/13/19 Page 7 of 7 PageID #: 868
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`17.
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`The determination of the amounts of regorafenib monohydrate required to treat the
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`cancers of claim 2 of the ’232 patent, including the tests performed in order to make that
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`determination, as well as when and by whom those tests were conducted and documents
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`concerning those efforts.
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`18.
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`The factual basis for any alleged objective indicia of nonobviousness concerning
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`the ’232 patent, including, but not limited to:
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`A.
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`unexpected properties or advantages of the subject matter of the patents-in-
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`suit;
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`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`H.
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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
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`the patents-in-suit would be considered a solution;
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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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