Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 1 of 8 PageID #: 610
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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
`
`Apotex Corp. and Apotex Inc. (collectively, “Apotex”) pursuant to Rule 30(b)(6) of the Federal
`
`Rules of Civil Procedure.
`
`At the time of the deposition, Apotex shall designate one or more of its directors, officers,
`
`managing agents, or other persons who will testify on behalf of Apotex as to all information
`
`known or reasonably available to Apotex 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
`
`Apotex Corp. and Apotex Inc. (collectively, “Apotex”) pursuant to Rule 30(b)(6) of the Federal
`
`Rules of Civil Procedure.
`
`At the time of the deposition, Apotex shall designate one or more of its directors, officers,
`
`managing agents, or other persons who will testify on behalf of Apotex as to all information
`
`known or reasonably available to Apotex 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 65 Filed 07/12/18 Page 2 of 8 PageID #: 611
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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
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`
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`Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 3 of 8 PageID #: 612
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`
`
`ATTACHMENT A
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`INSTRUCTIONS AND DEFINITIONS
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`As used herein, the terms “you,” “your,” “yours,” and “Apotex” mean jointly and
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`1.
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`severally defendants Apotex Corp., Apotex Inc., their officers, directors, employees, divisions,
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`parent companies, subsidiaries, affiliates, and predecessors or successors-in-interest, any joint
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`venture to which they may be a party, consultants, agents, and accountants, including any person
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`who served in any such capacity at any time.
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`2.
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`As used herein, “Teva” means
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`jointly and severally defendant Teva
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`Pharmaceuticals USA, Inc., its officers, directors, employees, divisions, parent companies,
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`subsidiaries, affiliates, and predecessors or successors-in-interest, any joint venture to which it
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`may be a party, consultants, agents, and accountants, including any person who served in any
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`such 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
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`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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`Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 4 of 8 PageID #: 613
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`7.
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`As used herein, “Apotex’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. 203085, as well
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`as the active pharmaceutical ingredient drug substance(s) identified therein, including but not
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`limited to any generic equivalent of Stivarga®.
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`8.
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`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®.
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`9.
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`As used herein, the term “FDA” means the United States Food and Drug
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`Administration, including without limitation its employees, scientists, technicians, agents,
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`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,
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`joint ventures, businesses, consortiums, clubs, associations, foundations, governmental agencies
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`or instrumentalities, societies, and orders.
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`11.
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`As used herein, “Apotex’s Notice Letters” means the Notice Letters sent from
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`Apotex to Bayer on or about November 8, 2016 and March 17, 2017.
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`2
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`Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 5 of 8 PageID #: 614
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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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`As used herein, the term “’553 patent” means United States Patent No. 8,637,553.
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`As used herein, the term “’107 patent” means United States Patent No. 9,458,107.
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`As used herein, the term “Patents-in-Suit” means the’553 and ’107 patents.
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`The use of the singular form of any word includes the plural and vice versa, as
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`necessary to bring within the scope of these topics any information or documents and things that
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`might otherwise be construed to be outside their scope.
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`
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`1.
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`The process by which Apotex identified regorafenib as a candidate for a potential
`
`TOPICS
`
`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. 203085, the information considered in reaching
`
`that decision, and the individuals and entities involved in that decision.
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`3.
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`All patent certifications in connection with ANDA No. 203085, any amendments
`
`or supplements thereto, which individuals were involved in the patent certifications, and what
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`information was considered.
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`4.
`
`The contents of the proposed labeling for Apotex’s ANDA Product, the decision-
`
`making as to the contents of the proposed label for Apotex’s ANDA Product, which individuals
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`and entities were involved in the decision-making, and the contents of any discussions related in
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`any way to the decision-making.
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`5.
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`6.
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`7.
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`8.
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`The projected sales and market share of Apotex’s ANDA Product.
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`The indications for Apotex’s ANDA Product.
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`Apotex’s pricing practices as they pertain to Apotex’s ANDA Product.
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`Apotex’s anticipated profits and/or losses from sale of Apotex’s ANDA Product.
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`3
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`
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`Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 6 of 8 PageID #: 615
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`
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`9.
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`10.
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`Product.
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`11.
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`12.
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`Apotex’s marketing or planned marketing of Apotex’s ANDA Product.
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`Any actual, potential, or anticipated commercial launch of Apotex’s ANDA
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`The preparation and contents of Apotex’s Notice Letters.
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`All manufactured batches of Apotex’s ANDA Product, including the batch size,
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`batch number, or other identifying notation, and dates of manufacture and delivery.
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`13.
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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 Apotex relating to the subject matter of
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`any of the Patents-in-Suit.
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`14.
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`The polymorphic form of regorafenib in Apotex’s ANDA Product and any
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`analyses of the polymorphic form of regorafenib in Apotex’s ANDA Product.
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`15.
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`Any metabolites generated by the use of Apotex’s ANDA Product in accordance
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`with
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`its
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`labeling,
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`including
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`the
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`identification
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`thereof and
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`their contribution
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`to
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`the
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`pharmacological properties of Apotex’s ANDA Product.
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`16.
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`Any anilinic impurities contained in Apotex’s ANDA Product, including the
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`identification thereof and any analyses to determine the quantity of anilinic impurities in
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`Apotex’s ANDA Product.
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`17.
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`Any anilinic impurities contained in the regorafenib used to make Apotex’s
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`ANDA Product, including the identification thereof and any analyses to determine the quantity
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`of anilinic impurities in said regorafenib.
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`18.
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`The impurity specifications/limits (including for any anilinic impurity) for
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`Apotex’s ANDA Product, including what they are, how they were determined, and who was
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`involved in determining those specifications/limits.
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`4
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`Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 7 of 8 PageID #: 616
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`19.
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`The impurity specifications/limits (including for any anilinic impurity) for the
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`regorafenib used to make Apotex’s ANDA Product, including what they are, how they were
`
`determined, and who was involved in determining those specifications/limits.
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`20.
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`The process for synthesizing the regorafenib used to make Apotex’s ANDA
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`Product, including identity of the starting materials, reagents, intermediates, and side products.
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`21.
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`The assays used to measure any anilinic impurities in Apotex’s ANDA Product
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`and the development thereof.
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`22.
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`The assays used to measure any anilinic impurities in regorafenib used for
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`Apotex’s ANDA Product and the development thereof.
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`23.
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`Any agreements between Apotex and Teva related to regorafenib, Stivarga®, a
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`generic version of Stivarga®, Apotex’s ANDA Product, or this litigation.
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`24.
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`All communications between Teva and Apotex relating to regorafenib, Stivarga®,
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`a generic version of Stivarga®, Apotex’s ANDA Product, or this litigation.
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`5
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`Case 1:16-cv-01221-LPS Document 65 Filed 07/12/18 Page 8 of 8 PageID #: 617
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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
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`with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
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`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, 2018, upon the following in the manner indicated:
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`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`/s/ Anthony D. Raucci
`_____________________________________
`Anthony D. Raucci (#5948)
`
`Kenneth L. Dorsney, Esquire
`Morris James LLP
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801-1494
`Attorneys for Defendants Apotex Inc.
`and Apotex Corp.
`
`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 Inc.
`and Apotex Corp.
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