Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 1 of 8 PageID #: 618
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`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
`
`BAYER HEALTHCARE LLC and
`BAYER HEALTHCARE
`PHARMACEUTICALS INC.,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
`
`
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`NOTICE OF DEPOSITION
`PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 30(b)(6)
`
`PLEASE TAKE NOTICE that commencing on July 30, 2018, at the law office of
`
`
`
`Defendants.
`
`Williams & Connolly LLP, 725 Twelfth Street, NW, Washington, DC 20005, or at such time and
`
`place that is agreed upon by the parties, Plaintiffs Bayer HealthCare LLC and Bayer HealthCare
`
`Pharmaceuticals Inc. (collectively, “Bayer”), through their attorneys, will take the deposition of
`
`Teva Pharmaceuticals USA, Inc. pursuant to Rule 30(b)(6) of the Federal Rules of Civil
`
`Procedure.
`
`At the time of the deposition, Teva shall designate one or more of its directors, officers,
`
`managing agents, or other persons who will testify on behalf of Teva as to all information known
`
`or reasonably available to Teva regarding the subject matters set forth in Attachment A.
`
`The deposition will take place upon oral examination before a notary public or other
`
`person authorized to administer oaths, will be recorded by stenographic and/or sound-and-video
`
`means, and will continue from day to day until completed. You are invited to attend and
`
`participate.
`
`
`
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`
`
`
`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
`
`BAYER HEALTHCARE LLC and
`BAYER HEALTHCARE
`PHARMACEUTICALS INC.,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
`
`
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`NOTICE OF DEPOSITION
`PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 30(b)(6)
`
`PLEASE TAKE NOTICE that commencing on July 30, 2018, at the law office of
`
`
`
`Defendants.
`
`Williams & Connolly LLP, 725 Twelfth Street, NW, Washington, DC 20005, or at such time and
`
`place that is agreed upon by the parties, Plaintiffs Bayer HealthCare LLC and Bayer HealthCare
`
`Pharmaceuticals Inc. (collectively, “Bayer”), through their attorneys, will take the deposition of
`
`Teva Pharmaceuticals USA, Inc. pursuant to Rule 30(b)(6) of the Federal Rules of Civil
`
`Procedure.
`
`At the time of the deposition, Teva shall designate one or more of its directors, officers,
`
`managing agents, or other persons who will testify on behalf of Teva as to all information known
`
`or reasonably available to Teva regarding the subject matters set forth in Attachment A.
`
`The deposition will take place upon oral examination before a notary public or other
`
`person authorized to administer oaths, will be recorded by stenographic and/or sound-and-video
`
`means, and will continue from day to day until completed. You are invited to attend and
`
`participate.
`
`
`
`
`
`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 2 of 8 PageID #: 619
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`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Anthony D. Raucci
`
`
`
`
`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
`
`Attorneys for Plaintiffs Bayer HealthCare LLC
`and Bayer HealthCare Pharmaceuticals 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 St. NW
`Washington, DC 20005
`(202) 434-5000
`
`July 12, 2018
`
`2
`
`
`
`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 3 of 8 PageID #: 620
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`
`
`ATTACHMENT A
`
`INSTRUCTIONS AND DEFINITIONS
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`As used herein, the terms “you,” “your,” “yours,” and “Teva” mean jointly and
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`1.
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`severally defendant Teva Pharmaceuticals USA, Inc., its officers, directors, employees,
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`divisions, parent companies, subsidiaries, affiliates, and predecessors or successors-in-interest,
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`any joint venture to which it may be a party, consultants, agents, and accountants, including any
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`person who served in any such capacity at any time.
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`2.
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`As used herein, “Apotex” means jointly and severally defendants Apotex Corp.,
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`Apotex Inc., their officers, directors, employees, divisions, parent companies, subsidiaries,
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`affiliates, and predecessors or successors-in-interest, any joint venture to which they may be a
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`party, consultants, agents, and accountants, including any person who served in any such
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`capacity at any time.
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`3.
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`As used herein, the term “including” means “including but not limited to” or
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`“including without limitation.”
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`4.
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`As used herein, the terms “and” as well as “or” shall be construed either
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`disjunctively or conjunctively, and references shall be construed either as singular or plural, as
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`necessary to bring within the scope of these topics any information that might otherwise be
`
`construed to be outside their scope.
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`5.
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`As used herein, the term “all” shall be construed to mean all or any, and the term
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`“any” shall be construed to mean all or any.
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`6.
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`As used herein, the term “communication” means any transmission of any
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`information from one person to another, including, without limitation, by personal meeting,
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`telephone, facsimile, electronic transmission, including electronic mail, and teleconference.
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`
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`
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`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 4 of 8 PageID #: 621
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`
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`7.
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`As used herein, “Teva’s ANDA Product” shall be construed to include any
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`product that is the subject of Abbreviated New Drug Application (“ANDA”) No. 209728, as well
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`as the active pharmaceutical ingredient drug substance(s) identified therein, including but not
`
`limited to any generic equivalent of Stivarga®.
`
`8.
`
`As used herein, “regorafenib” shall mean the compound of the formula:
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`
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`(also known as, inter alia, 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-
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`pyridine-2-carboxylic acid methylamide), or any salt form (including, but not limited to a
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`hydrochloride salt) of the compound, or any solvate (including, but not limited to, any hydrate)
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`of any of the aforementioned, or any polymorph of the aforementioned, or any other form of any
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`of the aforementioned, or any mixture of two or more of the aforementioned, and includes but is
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`not limited to the active pharmaceutical ingredient (“API”) in Stivarga®.
`
`9.
`
`As used herein, the term “FDA” means the United States Food and Drug
`
`Administration, including without limitation its employees, scientists, technicians, agents,
`
`examiners, and laboratories.
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`10.
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`As used herein, the terms “person” and “entity” mean any natural person and any
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`other cognizable entity, including, without limitation, corporations, proprietorships, partnerships,
`
`joint ventures, businesses, consortiums, clubs, associations, foundations, governmental agencies
`
`or instrumentalities, societies, and orders.
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`11.
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`As used herein, “Teva’s Notice Letter” means the Notice Letter sent from Teva to
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`Bayer on or about November 22, 2016.
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`2
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`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 5 of 8 PageID #: 622
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`
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`12.
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`13.
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`14.
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`15.
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`16.
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`As used herein, the term “’834 patent” means United States Patent No. 7,351,834.
`
`As used herein, the term “’553 patent” means United States Patent No. 8,637,553.
`
`As used herein, the term “’124 patent” means United States Patent No. 8,680,124.
`
`As used herein, the term “’107 patent” means United States Patent No. 9,458,107.
`
`As used herein, the term “Patents-in-Suit” means the ’834, ’553, ’124, and ’107
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`patents.
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`17.
`
`The use of the singular form of any word includes the plural and vice versa, as
`
`necessary to bring within the scope of these topics any information or documents and things that
`
`might otherwise be construed to be outside their scope.
`
`TOPICS
`
`The process by which Teva identified regorafenib as a candidate for a potential
`
`1.
`
`Abbreviated New Drug Application and which individuals and entities were involved in that
`
`process.
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`2.
`
`The decision to file ANDA No. 209728, the information considered in reaching
`
`that decision, and the individuals and entities involved in that decision.
`
`3.
`
`Why Teva chose to file an ANDA for a generic regorafenib product in addition to
`
`an ANDA for a generic sorafenib product.
`
`4.
`
`All patent certifications in connection with ANDA No. 209728, any amendments
`
`or supplements thereto, which individuals were involved in the patent certifications, and what
`
`information was considered.
`
`5.
`
`The contents of the proposed labeling for Teva’s ANDA Product, the decision-
`
`making as to the contents of the proposed label for Teva’s ANDA Product, which individuals
`
`3
`
`
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`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 6 of 8 PageID #: 623
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`
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`and entities were involved in the decision-making, and the contents of any discussions related in
`
`any way to the decision-making.
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`6.
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`7.
`
`8.
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`9.
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`10.
`
`11.
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`Product.
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`12.
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`13.
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`The projected sales and market share of Teva’s ANDA Product.
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`The indications for Teva’s ANDA Product.
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`Teva’s pricing practices as they pertain to Teva’s ANDA Product.
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`Teva’s anticipated profits and/or losses from sale of Teva’s ANDA Product.
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`Teva’s marketing or planned marketing of Teva’s ANDA Product.
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`Any actual, potential, or anticipated commercial launch of Teva’s ANDA
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`The preparation and contents of Teva’s Notice Letter.
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`All manufactured batches of Teva’s ANDA Product, including the batch size,
`
`batch number, or other identifying notation, and dates of manufacture and delivery.
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`14.
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`Any novelty, patentability, validity, due diligence, or freedom-to-operate search,
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`evaluation, or investigation conducted by or on behalf of Teva relating to the subject matter of
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`any of the Patents-in-Suit.
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`15.
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`The polymorphic form of regorafenib in Teva’s ANDA Product and any analyses
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`of the polymorphic form of regorafenib in Teva’s ANDA Product.
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`16.
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`Any metabolites generated by the use of Teva’s ANDA Product in accordance
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`with
`
`its
`
`labeling,
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`including
`
`the
`
`identification
`
`thereof and
`
`their contribution
`
`to
`
`the
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`pharmacological properties of Teva’s ANDA Product.
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`17.
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`Any anilinic impurities contained in Teva’s ANDA Product, including the
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`identification thereof and any analyses to determine the quantity of anilinic impurities in Teva’s
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`ANDA Product.
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`4
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`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 7 of 8 PageID #: 624
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`
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`18.
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`Any anilinic impurities contained in the regorafenib used to make Teva’s ANDA
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`Product, including the identification thereof and any analyses to determine the quantity of
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`anilinic impurities in said regorafenib.
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`19.
`
`The impurity specifications/limits (including for any anilinic impurity) for Teva’s
`
`ANDA Product, including what they are, how they were determined, and who was involved in
`
`determining those specifications.
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`20.
`
`The impurity specifications/limits (including for any anilinic impurity) for the
`
`regorafenib used to make Teva’s ANDA Product, including what they are, how they were
`
`determined, and who was involved in determining those specifications/limits.
`
`21.
`
`The process for synthesizing the regorafenib used to make Teva’s ANDA
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`Product, including identity of the starting materials, reagents, intermediates, and side products.
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`22.
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`The assays used to measure any anilinic impurities in Teva’s ANDA Product and
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`the development thereof.
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`23.
`
`The assays used to measure any anilinic impurities in regorafenib used for Teva’s
`
`ANDA Product and the development thereof.
`
`24.
`
`Any agreements between Teva and Apotex related to regorafenib, Stivarga®, a
`
`generic version of Stivarga®, Teva’s ANDA Product, or this litigation.
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`25.
`
`All communications between Teva and Apotex relating to regorafenib, Stivarga®,
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`a generic version of Stivarga®, Teva’s ANDA Product, or this litigation.
`
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`5
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`Case 1:16-cv-01221-LPS Document 66 Filed 07/12/18 Page 8 of 8 PageID #: 625
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`CERTIFICATE OF SERVICE
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`I hereby certify that on July 12, 2018, I caused the foregoing to be electronically filed
`
`with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
`
`registered participants.
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`
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`I further certify that I caused copies of the foregoing document to be served on
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`July 12, 018, upon the following in the manner indicated:
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`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.
`
`Mark D. Schuman, Esquire
`Todd S. Werner, Esquire
`Samuel Lockner, Esquire
`Jennell C. Bilek, Esquire
`Shelleaha L. Jonas, 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.
`
`
`
`
`
`/s/ Anthony D. Raucci
`_____________________________________
`Anthony D. Raucci (#5948)
`
`
`
`
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