Case 1:15-cv-00697-RGA Document 60 Filed 08/31/16 Page 1 of 9 PageID #: 897
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 15-697-RGA
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`HOSPIRA, INC.,
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`Plaintiff/Counterclaim
`Defendant,
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`v.
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`AMNEAL PHARMACEUTICALS LLC,
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`Defendant/Counterclaim
`Plaintiff.
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`AMNEAL'S NOTICE OF DEPOSITION OF HOSPIRA, INC.
`PURSUANT TO FED. R. CIV. P. 30(b)(6)
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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, Defendant Amneal Pharmaceuticals LLC ("Amneal") by its attorneys, will take the
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`deposition upon oral examination of Plaintiff Hospira, Inc. (“Hospira”), before a court reporter,
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`notary public, or other person authorized by law to administer oaths and take testimony. The
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`deposition will commence at 9:00 AM EST on September 14 2016, at the offices of Sughrue
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`Mion, PLLC, 2100 Pennsylvania Avenue, NW, Washington, DC 20037, or such other date, time,
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`and location as may be mutually agreed to by counsel. The deposition will be recorded by
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`stenographic means and will be videotaped. You are invited to attend and participate.
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`PLEASE TAKE FURTHER NOTE that, pursuant to Rule 30(b)(6), Hospira is required to
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`designate and produce one or more knowledgeable person to testify on its behalf with respect to
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`the matters set forth in Schedule A, attached hereto. The person(s) so designated shall be
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`required to testify as to those matters known or reasonably available to Hospira. Amneal
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`Case 1:15-cv-00697-RGA Document 60 Filed 08/31/16 Page 2 of 9 PageID #: 898
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`requests that Hospira identify in writing at least ten (10) business days in advance of the
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`deposition, the name(s) and title(s) of the person(s) who will testify on its behalf and the subject
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`matters on which each person will testify. You are invited to attend and cross-examine.
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`/s/ Kelly E. Farnan
`Kelly E. Farnan (#4395)
`Christine D. Haynes (#4697)
`Richards, Layton & Finger, P.A.
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`farnan@rlf.com
`haynes@rlf.com
`Attorneys for Defendant-Counterclaim Plaintiff
`Amneal Pharmaceuticals LLC
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`Of Counsel:
`Michael R. Dzwonczyk
`Azy S. Kokobi
`Grant S. Shackelford
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`(202) 293-7060
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`Dated: August 31, 2016
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`Case 1:15-cv-00697-RGA Document 60 Filed 08/31/16 Page 3 of 9 PageID #: 899
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`DEFINITIONS
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`1. “Plaintiff” and “Hospira” shall refer to Hospira, Inc., its officers, directors, employees,
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`agents, partners, corporate parents, subsidiaries, or affiliates.
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`2. “Defendant” and “Amneal” shall refer to Amneal Pharmaceuticals LLC.
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`3. "FDA" shall refer to the U.S. Food and Drug Administration, its officers and program
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`centers, employees, or agents.
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`4. "PTO" shall refer to the U.S. Patent and Trademark Office.
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`5. "NDA" shall refer to New Drug Application.
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`6. The “’158 Patent” shall mean U.S. Patent No. 8,242,158, entitled “Dexmedetomidine
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`premix formulation” and issued on August 14, 2012.
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`7. The “’470 Patent” shall mean U.S. Patent No. 8,338,470, entitled “Dexmedetomidine
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`premix formulation” and issued on December 25, 2012.
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`8. The “’527 Patent” shall mean U.S. Patent No. 8,445,527, entitled “Methods of treatment
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`using a dexmedetomidine premix formulation” and issued on June 4, 2013.
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`9. The “’106 Patent” shall mean U.S. Patent No. 8,648,106, entitled “Dexmedetomidine
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`premix formulation” and issued on February 11, 2014.
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`10. “The PrecedexTM Patents” or “Patents-in-suit” shall refer collectively to the ’158 Patent,
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`the ’470 Patent, the ’527 Patent, and the ’106 Patent.
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`11. “Inventors” shall mean the named inventors of the patents-in-suit.
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`12. “Current Litigation” shall mean the lawsuit entitled Hospira, Inc. v. Amneal
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`Pharmaceuticals LLC, Civil Action No. 15:697-RGA, pending in the United States District
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`Court for the District of Delaware.
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`13. “Dexmedetomidine” shall mean the S-enantiomer of medetomidine, as the free base or
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`pharmaceutically acceptable salt.
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`14. “PrecedexTM” shall mean any Dexmedetomidine product sold under the PRECEDEXTM
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`trademark, including PrecedexTM Concentrate and PrecedexTM Premix, marketed pursuant to
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`NDA No. 21038 and Supplemental NDA Nos. 21038/S-020 and 21038/S-024.
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`15. “Amneal’s Proposed ANDA product” shall mean the dexmedetomidine product
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`described in ANDA No. 207551 and for which Amneal seeks FDA approval.
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`16. “The ANDA” and “Amneal’s ANDA” shall refer to ANDA No. 207551 and any
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`supplements, amendments and/or correspondence with the FDA related thereto.
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`17. “The NDA” or “Hospira’s NDA” shall mean NDA No. 21-038.
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`18. “The Supplemental NDAs” shall mean, collectively, New Drug Application No. 21038
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`Pre-Approval Supplement S-016, New Drug Application No. 21038 Pre-Approval Supplement
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`S-020 and/or New Drug Application No. 21038 Pre-Approval Supplement S-024.
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`19. “The Certification” and “Amneal’s Certification” shall mean the certification submitted
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`to the FDA by Amneal and referred to in an notice letter and detailed statement dated June 26,
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`2015 addressed to Plaintiff.
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`20. “The Notice Letter” or “Amneal’s Notice Letter” shall mean the Notice of Certification
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`Under 21 U.S.C. § 355(j)(2)(B) dated June 26, 2015, from Amneal to Hospira, including the
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`detailed statement of the factual and legal bases for the opinions set forth therein.
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`21. “Prior Art” shall refer to those references that may be used to evaluate the novelty and
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`nonobviousness of claimed subject matter in a patent application or patent and includes all
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`things, patents, published applications, publications, disclosures, sales, offers for sale, prior uses
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`or other acts or occurrences included within the meaning of 35 U.S.C. §§ 102 and 103. “Prior
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`Art,” as that term is used herein, includes both documentary sources (patents and publications
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`from anywhere in the world) and non-documentary sources (things known, used or invented in
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`the United States).
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`22. “Concerning” shall refer to relating to, referring to, describing, evidencing or
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`constituting.
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`23. “Communication” shall refer to any information (in the form of facts, ideas, inquiries, or
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`otherwise) transmitted or transferred, whether oral or written.
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`24. The use of the singular form of any word includes the plural and vice versa.
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`SCHEDULE A
`DEPOSITION TOPICS
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`1. The conception and reduction to practice of the subject matter claimed in the Patents-in-
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`Suit, including all evidence corroborating such conception, reduction to practice, and diligence
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`and the identity of the person(s) who participated in such conception, reduction to practice, and
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`diligence.
`2. The formulation and manufacturing for PrecedexTM premix.
`3. Any studies, experiments, analyses, investigation or reports supported, conducted or
`authorized by Hospira, or any of the Inventors, concerning PrecedexTM concentrate and
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`PrecedexTM premix, including, but not limited to stability studies.
`4. The approved labels for PrecedexTM premix and concentrate formulations, including the
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`approved indications and disclosed methods of administration.
`5. Administration of PrecedexTM concentrate solution to patients.
`6. Any study or analysis concerning development of a premix formulation of
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`Dexmedetomidine.
`7. Hospira’s decision to pursue the PrecedexTM premix formulation, including, but not
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`limited to, any surveys, market research, competitive research, post-marketing studies, sales data,
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`experience or research conducted by, or on behalf of, Hospira.
`8. Any study or analysis concerning selection of a container or vessel for storing
`PrecedexTM concentrate and premix formulations conducted by or on behalf of Hospira,
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`including but not limited to stability and potency studies.
`9. Use of glass vials and glass ampules for storing parenteral pharmaceuticals, including,
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`but not limited to, medetomidine and Dexmedetomidine.
`10. Hospira’s factual basis for asserting that Amneal is or has been infringing, inducing
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`infringement, or contributorily infringing any particular claim of the Patents-in-Suit, including,
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`but not limited to, a comparison of each element of each claim in the Patents-in-Suit to the
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`product that Hospira accuses of infringing any particular claim of the Patents-in-Suit.
`11. Any methods, tests or experiments reported in the Patents-in-suit, including the
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`following:
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`a. any literature searches relevant to the methods, tests or experiments;
`b. information concerning the source and/or basis for developing these methods,
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`tests or experiments;
`c. preparation of the formulations described in the Examples; and
`d. laboratory notebooks or related research materials relating to these methods, tests
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`or experiments.
`12. The subject matter of the Patents-in-Suit, and any related counterpart patent applications
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`or patents, including, but not limited to the experimental work that corresponds to the Examples
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`in the Patents-in-suit; and Hospira’s understanding of the subject matter disclosed in connection
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`with the Examples in the Patents-in-suit.
`13. The selection of the concentration ranges of Dexmedetomidine as claimed in the Patents-
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`in-Suit.
`14. The selection of concentration ranges of sodium chloride as claimed in the Patents-in-
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`Suit.
`15. Sales and offers for sale of Hospira 0.9% Sodium Chloride Injection, Usp (Preservative-
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`Free) Size: 50 Ml, Description: Fliptop Vial - Plastic (SKU: ABT488850-BX Unit Box).
`16. The preparation, filing, and prosecution of the Patents-in-Suit, including identification of
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`persons and other entities involved during prosecution.
`17. Declarations and supporting evidence submitted during prosecution of the Patents-In-
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`Suit, including the Declaration of Huailiang Wu.
`18. The preparation, filing, and contents of any NDA or IND relating to dexmedetomidine
`hydrochloride and/or PrecedexTM.
`19. Any data, testing results, experiments or studies conducted in connection with NDA
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`NDA No. 21-038, whether or not submitted to FDA
`20. Any data, testing results, experiments or studies conducted in connection with the
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`Supplemental .NDA Nos. 21-038/S-020 and 21-038/S-024.
`21. The commercialization, promotion, marketing and sale of PrecedexTM concentrate and
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`premix, including but not limited to advertising, promotion, target markets, market penetration,
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`pricing, pricing policies, launch plans, business plans, marketing plans and strategies, sales and
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`profits, and the impact of such marketing and advertising efforts.
`22. Marketing studies relating to PrecedexTM concentrate and premix formulations conducted
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`by or on behalf of Hospira, including studies conducted by Decision Development Inc.
`23. Actual and projected sales, profits, losses, and costs for PrecedexTM premix and
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`concentrate formulations.
`24. Comparison of actual and projected sales, profits, losses, and costs for any product sold
`under the trade name PrecedexTM including both the premix and concentrate formulations.
`25. Sales of, and market share for, PrecedexTM, including:
`a. the first offer for sale and sale of PrecedexTM premix in the United States;
`b. gross and net sales, both by quarter and annually of PrecedexTM in the U.S.
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`market;
`c. profit and loss data, both by quarter and annually, for PrecedexTM from the date of
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`launch to the present;
`d. any growth or decline in sales of PrecedexTM and factors contributing to the same;
`e. actual market share data for PrecedexTM from the date of its launch to the present;
`f. any projections of sales, profits and/or market share of PrecedexTM, including any
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`projections taking into consideration entry of generic or authorized generic
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`products;
`g. any impact from the sale of PrecedexTM on other drug products, including any
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`other of Hospira’s drug products; and
`h. any assessments of the share of any other class of drugs of which PrecedexTM is a
`member or is considered a competitor that PrecedexTM
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` attained in the United
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`States, both by quarter and annually, since receipt of FDA approval.
`26. The identity of any products Hospira considers as competitors to PrecedexTM premix and
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`the basis for such position.
`27. Market research concerning PrecedexTM concentrate and premix and any competitor
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`products including but not limited to: IMS data; competitive analyses; market studies; patient
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`and doctor studies; and prescription studies.
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`28. The marketing, advertising or promotion of PrecedexTM, including:
`a. marketing, detailing and advertising efforts or campaigns (whether past, present
`or anticipated) by or on behalf of Hospira for PrecedexTM, including any
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`voucher/rebate programs or on-line initiatives;
`b. indications for which PrecedexTM
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`c. Hospira’s marketing, detailing or advertising expenditures both by quarter and
`annually, for PrecedexTM; and the target market for PrecedexTM.
`29. The factual basis for any and all information allegedly tending to refute or substantiate
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`any secondary consideration of nonobviousness of the subject matter claimed in the Patents-in-
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`Suit that Hospira intends to rely on, including without limitation, commercial success, long felt
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`need, prior failure, industry recognition, and copying, and the identification of data or other
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`evidence in Hospira’s possession supporting or contrary to the existence of such secondary
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`considerations.
`30. Any comparison prepared by or on behalf of Hospira or the Inventors of any property of
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`Dexmedetomidine products with any Prior Art compound.
`31. Any evaluation or knowledge of any Prior Art to the Patents-in-suit by or on behalf of
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`Hospira or the Inventors.
`32. Any and all Prior Art to the Patents-in-suit whether identified by or on behalf of Hospira
`or any defendants in any litigation involving PrecedexTM or the patents-in-suit, and any
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`assessment of the same by or on behalf of Hospira.
`33. Any communications with FDA concerning a generic version of PrecedexTM or any
`Dexmedetomidine products identifying PrecedexTM as a reference-listed drug, including any
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`communications concerning bioequivalence testing, product quality or labeling changes.
`34. The identification, and factual information concerning the subject matter, of any pending
`Citizen Petition concerning PrecedexTM or dexmedetomidine hydrochloride injection products.
`35. Any settlement or resolution of any dispute concerning the Patents-in-suit or PrecedexTM.
`36. Any documents or things supporting any information provided in response to the Topics
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`set forth above.
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