Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 1 of 10 PageID #: 4146
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`PFIZER INC., WYETH LLC, PFIZER
`PHARMACEUTICALS LLC, PF PRISM
`C.V. and PFIZER MANUFACTURING
`HOLDINGS LLC,
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`NOTICE OF RULE 30(b)(6) DEPOSITION OF
`CFT PHARMACEUTICALS LLC
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`C.A. No. 14-781 (SLR)
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`Plaintiffs,
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`v.
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`Defendant.
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`CFT PHARMACEUTICALS LLC,
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
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`Attorneys for Plaintiffs
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`
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`OF COUNSEL:
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`Thomas H. L. Selby
`David I. Berl
`Stanley E. Fisher
`Adam D. Harber
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`September 2, 2015
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`REDACTED -
`PUBLIC VERSION
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`

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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 2 of 10 PageID #: 4147
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
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`PFIZER INC., WYETH LLC, PFIZER
`PHARMACEUTICALS LLC, PF PRISM
`C.V. and PFIZER MANUFACTURING
`HOLDINGS LLC,
`
`
`NOTICE OF RULE 30(b)(6) DEPOSITION OF
`CFT PHARMACEUTICALS LLC
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`PLEASE TAKE NOTICE that commencing on September 15, 2015, at the law offices of
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`C.A. No. 14-781 (SLR)
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`Plaintiffs,
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`v.
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`
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`Defendant.
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`CFT PHARMACEUTICALS LLC,
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`Williams & Connolly LLP, 725 Twelfth Street, NW, Washington, D.C. 20005, or at such other
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`time and place agreed upon by the parties, Plaintiffs Pfizer Inc., Wyeth LLC, Pfizer
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`Pharmaceuticals LLC, PF Prism C.V., and Pfizer Manufacturing Holdings LLC (collectively,
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`“Plaintiffs” or “Pfizer”), through their attorneys, will take the deposition of Defendant CFT
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`Pharmaceuticals LLC (“Defendant” or “CFT”), pursuant to Rule 30(b)(6) of the Federal Rules of
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`Civil Procedure.
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`At the time of the deposition, CFT shall designate one or more of its directors, officers,
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`managing agents, or other persons who will testify on behalf of CFT as to all information known
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`or reasonably available to CFT regarding the subject matters set forth in Attachment A.
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`The deposition will take place upon oral examination before a notary public or other
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`person authorized to administer oaths, will be recorded by stenographic and/or sound-and-video
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`means, and will continue from day to day until completed. You are invited to attend and
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`participate.
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`REDACTED -
`PUBLIC VERSION
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 3 of 10 PageID #: 4148
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Maryellen Noreika
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintiffs
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`
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`OF COUNSEL:
`
`Thomas H. L. Selby
`David I. Berl
`Stanley E. Fisher
`Adam D. Harber
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`September 2, 2015
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`2
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 4 of 10 PageID #: 4149
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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,” “Defendant,” “Defendant’s,”
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`1.
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`“CFT,” and “CFT’s” mean CFT Pharmaceuticals LLC and its officers, directors, employees,
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`divisions, parent companies, subsidiaries, affiliates, predecessors or successors-in-interest, any
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`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, and specifically including, but not limited
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`to, CFT Pharmaceuticals LLC,
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`.
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`2.
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`As used herein, the term “Plaintiffs” shall mean Plaintiffs Pfizer Inc., Wyeth LLC,
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`Pfizer Pharmaceuticals LLC, PF Prism C.V., and Pfizer Manufacturing Holdings LLC.
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`3.
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`As used herein, the terms “and” and “or” shall be construed either disjunctively or
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`conjunctively, and references shall be construed either as singular or plural, as necessary to bring
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`within the scope of these topics any information that might otherwise be construed to be outside
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`their scope.
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`4.
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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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`5.
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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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`6.
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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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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 5 of 10 PageID #: 4150
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`7.
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`As used herein, the term “communication” means any transmission of information
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`from one person to another, including, without limitation, by personal meeting, telephone,
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`facsimile, electronic transmission, including electronic mail, and teleconference.
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`8.
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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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`9.
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`As used herein, “tigecycline” shall mean the compound tigecycline, or any salt
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`form, solvate, polymorph (including but not limited to Form I) or any other form of the
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`compound tigecycline, 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 in Tygacil®.
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`10.
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`As used herein, the phrase “Tygacil®” shall mean any of Plaintiffs’ products that
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`include tigecycline as the active pharmaceutical ingredient.
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`11.
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`As used herein, the phrase “CFT’s ANDA Product” refers to any product
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`described in New Drug Application (“ANDA”) No. 205722, as well as the active pharmaceutical
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`ingredient drug substance(s) identified therein.
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`12.
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`As used herein, the phrase “CFT’s Notice Letter” shall mean the Notice Letter
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`sent from CFT to Plaintiffs on or about May 7, 2014, as well as any attachments thereto.
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`13.
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`As used herein, the phrase “CFT’s Tigecycline API” refers to the Tigecycline
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`Active Pharmaceutical Ingredient in CFT’s ANDA Product.
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`14.
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`As used herein, the phrase “FDA” shall mean the United States Food and Drug
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`Administration.
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`2
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 6 of 10 PageID #: 4151
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`15.
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`As used herein, the phrase “’828 patent” shall be construed to mean U.S. Patent
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`No. 7,879,828.
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`16.
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`As used herein, the phrase “’995 patent” shall be construed to mean U.S. Patent
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`No. 8,372,995.
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`17.
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`18.
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`of any kind.
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`19.
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`20.
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`As used herein, “IR” means infrared spectroscopic analysis of any kind.
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`As used herein, “NMR” means nuclear magnetic resonance spectroscopic analysis
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`As used herein, “XRD” means X-ray powder diffraction.
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`As used herein, “DSC” means differential scanning calorimetry.
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`3
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 7 of 10 PageID #: 4152
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`10.
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`TOPICS
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`The decision to develop CFT’s ANDA Product, including the process(es) by which CFT
`identified an injectable IV infusion containing tigecycline as a candidate for development
`as a generic product, the factors and information considered in that process, and which
`individuals and entities were involved in the decision-making process(es).
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`The decision to file ANDA No. 205722, including the process(es) by which CFT decided
`to file an ANDA for its tigecycline product, the factors and information considered in
`making that decision, including economic factors, and which individuals and entities
`were involved in the decision-making process.
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`ANDA No. 205722 (including any amendments or supplements thereto) and the contents
`thereof, including any patent certifications in connection with ANDA No. 205722 and the
`reasons and bases therefore, the drafting, preparation, and filing of ANDA No. 205722,
`and any communications to and from the FDA regarding ANDA No. 205722.
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`The synthesis, identification, characterization, and properties of each ingredient contained
`in CFT’s ANDA Product, including the active pharmaceutical ingredient, and the
`reason(s) CFT chose to use each ingredient in its formulation.
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`Testing by CFT, its agents, or parties contracting with CFT, of tigecycline or any product
`containing tigecycline, including but not limited to any comparison or comparative test of
`CFT’s tigecycline product with any other tigecycline-containing product.
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`The polymorphic and/or amorphous form(s) of CFT’s ANDA Product, CFT’s
`Tigecycline API, and/or any intermediate product or composition in the manufacturing
`process used to make CFT’s ANDA Product and CFT’s Tigecycline API, including all
`studies and test data assessing such form.
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`All XRD and melting point data regarding CFT’s ANDA Product, CFT’s Tigecycline
`API, and the tigecycline present in any intermediate product or composition in the
`manufacturing process used to make CFT’s ANDA Product and CFT’s Tigecycline API.
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`The stability or instability of, or changes over time in, the polymorphic and/or amorphous
`form(s) of CFT’s ANDA Product, CFT’s Tigecycline API, and the tigecycline present in
`any intermediate product or composition in the manufacturing process used to make
`CFT’s ANDA Product and CFT’s Tigecycline API.
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`All stability studies conducted on any batches of CFT’s ANDA Product and/or CFT’s
`Active Pharmaceutical Ingredient, including the purpose for and results of such studies.
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`The method or process by which CFT’s ANDA Product will be manufactured and
`produced, including the steps or elements comprising those manufacturing methods or
`processes, the development of those manufacturing methods or processes, and the
`individual(s) and/or entities involved in determining those methods or processes.
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 8 of 10 PageID #: 4153
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`The research and development of the process for synthesizing tigecycline API set forth in
`Drug Master File No.
`, including but not limited to all changes to the process
`during the research and development and the reasons therefore.
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`The method or process by which CFT’s Tigecycline API will be manufactured and
`produced, including the steps or elements comprising those manufacturing methods or
`processes, the development of those manufacturing methods or processes, and the
`individual(s) and/or entities involved in determining those methods or processes.
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`The conditions in which CFT’s ANDA Product, CFT’s Tigecycline API, and/or the
`intermediate products and compositions used in CFT’s ANDA Product or CFT’s
`Tigecycline API are created, maintained, and stored.
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`The research and development of CFT’s ANDA Product or any generic version of
`Tygacil®.
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`The pH of the bulk solution prior to lyophilization of CFT’s ANDA Product, including
`the research and development of the pH of the bulk solution prior to lyophilization and
`any and all testing regarding the pH of the bulk solution prior to lyophilization.
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`The pH of CFT’s ANDA Product after admixture and/or reconstitution, including the
`research and development of the pH of CFT’s ANDA Product after admixture and/or
`reconstitution and any and all testing regarding the pH of CFT’s ANDA Product after
`admixture and/or reconstitution.
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`The specifications for CFT’s ANDA product, including but not limited to the purpose and
`effect of the specifications, including but not limited to those contained in sections
`2.3.P.5 and 2.3.P.8.
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`CFT’s master batch records for the drug product, as described in Section 3.2.P.3.3.1 of
`CFT’s ANDA.
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`All revenue forecasts, market share projections, consumer analysis, identification of
`potential customers (individually and categorically) and/or other financial or market
`analysis regarding CFT’s ANDA Product, and the bases and assumptions underlying any
`such forecasts, analyses or projections.
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`CFT’s current or anticipated marketing and promotion of its ANDA Product.
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`CFT’s knowledge of, and reference to, DMF No.
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`, and the effect of such reference.
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`Communications between CFT and any supplier, or agent or affiliate thereof, regarding
`DMF No.
`, the tigecycline described by DMF No.
`, or the processes or
`intermediates used to prepare the tigecycline described by DMF No.
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`11.
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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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`17.
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`18.
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`19.
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`20.
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`21.
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`22.
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`2
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 9 of 10 PageID #: 4154
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`CFT’s Notice Letter and the contents and preparation thereof, including which
`individuals and entities were involved in that process.
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`Any novelty, patentability, validity, due diligence, or freedom-to-operate search,
`evaluation, or investigation conducted by or on behalf of CFT relating to the subject
`matter of the ’828 patent and/or ’995 patent.
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`CFT’s knowledge, the knowledge of CFT’s suppliers, or communications between CFT
`and its suppliers regarding the ’828 patent, U.S. Patent Application No. 11/374,330, U.S.
`Provisional Application No. 60/661,030, and/or U.S. Patent Publication 2006/0247187,
`and any review or analyses thereof conducted by CFT, including relating to the patent’s
`validity and/or potential infringement by CFT’s ANDA Product or CFT’s Tigecycline
`API.
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`CFT’s knowledge, the knowledge of CFT’s suppliers, or communications between CFT
`and its suppliers regarding the ’995 patent, U.S. Patent Application No. 11/440,032,
`and/or U.S. Provisional Application No. 60/684,995, and any review or analyses thereof
`conducted by CFT, including relating to the patent’s validity and/or potential
`infringement by CFT’s ANDA Product or CFT’s Tigecycline API.
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`The identity of persons with knowledge of each of the foregoing topics.
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`23.
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`24.
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`25.
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`26.
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`27.
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`3
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`Case 1:14-cv-00781-SLR Document 73 Filed 09/09/15 Page 10 of 10 PageID #: 4155
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`CERTIFICATE OF SERVICE
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`I hereby certify that on September 2, 2015, I caused the foregoing to be
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`electronically filed with the Clerk of the Court using CM/ECF, which will send notification of
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`such filing to all registered participants.
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`I further certify that I caused copies of the foregoing document to be served on
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`September 2, 2015, upon the following in the manner indicated:
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`James M. Lennon, Esquire
`Monté T. Squire, Esquire
`Samantha G. Wilson, Esquire
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`Attorneys for CFT Pharmaceuticals LLC
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`Jeffrey S. Ward, Esquire
`Wendy M. Ward, Esquire
`Edward J. Pardon, Esquire
`MERCHANT & GOULD, P.C.
`10 East Doty Street, Suite 600
`Madison, WI 53703
`Attorneys for CFT Pharmaceuticals LLC
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`Ian McFarland, Esquire
`MERCHANT & GOULD, P.C.
`9717 Cogdill Road, Suite 101
`Knoxville, TN 37932
`Attorneys for CFT Pharmaceuticals LLC
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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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`/s/ Maryellen Noreika
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`Maryellen Noreika (#3208)