Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 1 of 12 PageID #: 1861
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-1453-LPS
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`Plaintiffs,
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`APOTEX INC. and APOTEX CORP.,
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`Defendants.
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`MEDA PHARMACEUTICALS INC. AND CIPLA LTD.’S NOTICE OF DEPOSITION
`OF APOTEX INC. AND APOTEX CORP.’S PURSUANT TO FED. R. CIV. P. 30(b)(6)
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`PLEASE TAKE NOTICE that Plaintiffs Meda Pharmaceuticals Inc. (“Meda”) and Cipla
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`Ltd. (“Cipla”) (collectively, “Plaintiffs”) by their counsel will take the testimony by deposition
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`upon oral examination of Defendants Apotex Inc. and Apotex Corp. (collectively, “Apotex” or
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`“Defendants”) pursuant to Rule 30(b)(6) of the Federal Rules of Civil Procedure.
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`The deposition will begin at 9:00 a.m. on January 29, 2016 at the offices of STERNE
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`KESSLER GOLDSTEIN & FOX P.L.L.C., 1100 New York Avenue, N.W., Washington, D.C. 20005,
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`or at such other time and place as may be agreed upon by counsel. The examination will be taken
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`before a Notary Public or other person authorized to administer oaths pursuant to Rule 28 of the
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`Federal Rules of Civil Procedure, and will continue from day to day until completed. The
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`testimony at the deposition will be recorded by videographic, stenographic, audio, audiovisual,
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`and/or real-time computer means.
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`Pursuant to Rule 30(b)(6), Defendants shall designate one or more officers, directors,
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`managing agents, or other persons who consent and are knowledgeable to testify on its behalf
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`with respect to each of the subject matters set forth in attached Schedule A. Defendants are
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 2 of 12 PageID #: 1862
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`requested to provide Plaintiffs’ counsel with written notice, at least ten (10) business days in
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`advance of the deposition, of the name and title of each witness who will testify on behalf of
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`Defendants and the particular topic(s) set forth in Schedule A as to which each such witness will
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`testify.
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`Pursuant to Rule 30(b)(2) of the Federal Rules of Civil Procedure, Defendants are hereby
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`requested to produce at or before the time of the deposition, any and all documents and things
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`that in any way refer to or concern any of the topics set forth in the attached Schedule A that
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`have not previously been produced to Plaintiffs in this action. Plaintiffs reserve the right to
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`continue this deposition should Defendants fail to produce such documents and things at or
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`before the time of the deposition.
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`If counsel for Defendants have any questions regarding this Notice, you are invited to
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`contact counsel for Plaintiffs to discuss the matter.
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`ASHBY & GEDDES
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`/s/ John G. Day
`_________________________________
`Steven J. Balick (#2114)
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`500 Delaware Ave., 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`jday@ashby-geddes.com
`amayo@ashby-geddes.com
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`Attorneys for Plaintiffs
`Meda Pharmaceuticals Inc. and Cipla Ltd.
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`Of Counsel:
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`H. Keeto Sabharwal
`Dennies Varughese
`Uma N. Everett
`Rami Bardenstein
`Dallin Glenn
`Josephine J. Kim
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
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`Dated: December 30, 2015
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 3 of 12 PageID #: 1863
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`SCHEDULE A
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`DEFINITIONS
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`The following definitions shall apply:
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`1.
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`The terms “Apotex,” “Defendants,” “you” and “your” mean Apotex Inc., any of
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`its predecessors, subsidiaries (including Apotex Corp.), domestic or foreign divisions,
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`departments, parents, affiliates, present or former officers, directors, employees, agents,
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`representatives, entities acting in concert, joint-venture, or partnership relationship with you, and
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`others acting on your behalf.
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`2.
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`The term “Meda” means Meda Pharmaceuticals Inc. and any of their
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`predecessors, domestic or foreign divisions, departments, subsidiaries, parents or affiliates.
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`3.
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`The term “Cipla” means Cipla Ltd. and any of their predecessors, domestic or
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`foreign divisions, departments, subsidiaries, parents or affiliates.
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`4.
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`The term “Plaintiffs” means Meda Pharmaceuticals Inc. and Cipla Ltd. and any of
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`their predecessors, domestic or foreign divisions, departments, subsidiaries, parents or affiliates.
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`5.
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`The term “present action,” “this action,” “this lawsuit,” or “this litigation” means
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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al., C.A. No. 14-cv-1453-LPS (D. Del.).
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`6.
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`The term “Patents-in-Suit” refers to U.S. Patent Nos. 8,163,723 and 8,168,620
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`and all applications that led to their issuance.
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`7.
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`The term “Asserted Claims” refers to the claims of the Patents-in-Suit identified
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`in Plaintiffs’ July 13, 2015 disclosure of asserted claims, including claims 1-4, 7, 8, 10-18, and
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`20-28 of the ’723 patent and claims 1-13, 15-18, 21, 22, 24-26, 28, 29, 31, 33, 35-47 of the ’620
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`patent.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 4 of 12 PageID #: 1864
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`8.
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`The terms “infringe” and “infringement” mean direct infringement, contributory
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`infringement, inducement of infringement, literal infringement, and infringement under the
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`doctrine of equivalents. See 35 U.S.C. § 271.
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`9.
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`“NDA” means “New Drug Application” as defined under 21 U.S.C. § 355(b) et
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`seq.
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`10.
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`“ANDA” means “Abbreviated New Drug Application,” as defined under 21
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`U.S.C. § 355(j) et seq.
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`11.
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`“Orange Book” means Approved Drug Products with Therapeutic Equivalence
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`Evaluations, which is published by the Secretary of the U.S. Department of Health and Human
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`Services pursuant to 21 U.S.C. §§ 355(b)(1) and (c)(2).
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`12.
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`“Paragraph IV Certification(s)” means a certification made by an ANDA filer that
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`it believes a patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or
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`sale of the generic drug for which the ANDA is submitted, made pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4).
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`13.
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`“Paragraph IV Notice(s)” means a notice sent pursuant to 21 U.S.C.
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`§ 355(j)(2)(B) and 21 C.F.R. § 314.95 to the named owner of the patents listed in the Orange
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`Book and/or the holder of the NDA for the reference listed drug, which provides the legal and
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`factual bases for the ANDA filer’s belief that the listed patents are invalid or not infringed by a
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`proposed generic product.
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`14.
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`“Dymista®” is the azelastine and fluticasone combination nasal spray product
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`described in NDA No. 202236.
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`15.
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`“Apotex’s Nasal Spray” means the products and formulation(s) described in
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`Apotex’s ANDA No. 207712 for which Apotex is seeking FDA approval for any indication.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 5 of 12 PageID #: 1865
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`16.
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`The term “Prior Art” means any subject matter encompassed by 35 U.S.C. § 103
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`and each and every subsection of 35 U.S.C. § 102.
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`17.
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`The term “person” means any individual, corporation, partnership, sole
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`proprietorship, firm, board, joint venture, association, agency, authority, commission, or other
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`entity.
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`18.
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`The term “document(s)” is defined broadly to be given the full scope of that term
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`contemplated by the Federal Rules of Civil Procedure, and the Federal Rules of Evidence, and
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`includes all non-identical copies of a document, all drafts of final documents, all other written,
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`typed, printed, recorded or graphically portrayed matter in any form or embodiment, and all
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`other data compilations from which information can be obtained and translated if necessary, that
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`are or have been in your actual or constructive custody or control, regardless of the medium on
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`which they are produced, reproduced, stored (including computer programs and files containing
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`any requested information), and any recording or writing, as these terms are defined in Federal
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`Rule of Evidence 1001. Any document bearing marks, including initials, stamped initials,
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`comments, or notations not part of the original text or photographic reproduction thereof, is a
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`separate document.
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`19.
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`The term “communication(s)” means all written, electronic, oral, telephonic, or
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`other inquiries, dialogues, conversations, interviews, correspondence, consultations, negotiations,
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`agreements, understandings, meetings, letters, notes, telegrams, advertisements, computer mail,
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`email, and all other documents evidencing any verbal or nonverbal interaction between persons
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`and entities.
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`20.
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`The term “thing(s)” shall be construed under the broadest possible construction
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`under the Federal Rules of Civil Procedure.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 6 of 12 PageID #: 1866
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`21.
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`The term “Proprietary Information” means and includes all information for which
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`dissemination has been restricted, whether publicly or privately, and/or for which measures have
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`ever been taken to protect against its public and/or private dissemination. Propriety Information
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`shall also mean all information not generally known to the public.
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`22.
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`The terms “include” and “including” mean include or including without
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`limitation.
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`23.
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`The terms “each” and “any” mean any and all.
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`24.
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`The terms “relate to,” “related to,” and “relating to” mean, in whole or in part,
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`constituting, containing, embodying, reflecting, describing, analyzing, identifying, mentioning,
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`stating, referring directly or indirectly to, dealing with, or in any way pertaining to.
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`25.
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`The term “describe,” when used in relation to an act, event, instance, occasion,
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`transaction, conversation, or communication, means: (1) to state the date and place thereof; (2) to
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`identify the individual participants; (3) to summarize separately for each individual participant
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`what that participant said or did; and (4) to identify each document used or prepared in
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`combination therewith or making any reference thereto.
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`26.
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`The term “identify,” when used with respect to a person, means to state, to the
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`extent known, the person’s full name, present or last known address, and when referring to a
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`natural person, additionally, the occupation or business in which the person is engaged, and the
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`person’s present or last employer and title or position.
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`27.
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`The term “identify,” when used with respect to a document, means to state, to the
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`extent known, the (i) type, (ii) subject matter, (iii) date, (iv) author(s), addressee(s), and
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`recipients(s), and (v) Bates number of the document.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 7 of 12 PageID #: 1867
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`28.
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`The term “identify” when used with respect to a communication, means to state,
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`to the extent known, the (i) means of communication (e.g. telephone call, meeting, etc.), (ii) date
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`of the communication, (iii) subject matter of the communication, and (iv) originator, recipient,
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`and any other party to the communication.
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`29.
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`The term “date” means the exact day, month, and year, if ascertainable, or, if not,
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`your best approximation thereof.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 8 of 12 PageID #: 1868
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`INSTRUCTIONS
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`1.
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`Defendants shall provide witness(es) prepared to testify in detail as required by
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`Rule 30(b)(6) of the Federal Rules of Civil Procedure concerning each topic enumerated below.
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`2.
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`The designated witness must be able to provide the identity and location of
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`documents concerning each of the topics in this Notice.
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`3.
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`The designated witness must be able to provide the identity and location of
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`person(s) most knowledgeable about each of the topics in this Notice.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 9 of 12 PageID #: 1869
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`TOPICS FOR EXAMINATION
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`1.
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`The facts, considerations, reasons, and analyses upon which Apotex decided to
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`develop and seek approval for Apotex’s Nasal Spray.
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`2.
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`All business or strategic plans, sales or other forecasts, marketing projections or
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`studies, valuations, pricing plans or other analyses or expectations concerning the possible
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`commercial launch of Apotex’s Nasal Spray, including, but not limited to: (i) Apotex’s
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`estimation of future sales (in units and dollars), cost of goods, and profits for Apotex’s Nasal
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`Spray after launch; (ii) any evaluation or analyses relating or referring to the impact that the
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`launch of Apotex’s Nasal Spray or other generic versions of Dymista® would have on the market
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`for Dymista®; (iii) the bases and methodology for its analyses, forecasts, and projections; and
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`(iv) the intended market for Apotex’s Nasal Spray and all anticipated preparation and/or
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`discussion of such documents or information.
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`3.
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`The identity of all Apotex employees involved in the decision to pursue
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`development of Apotex’s Nasal Spray.
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`4.
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`The identity of all Apotex employees involved in the research and development of
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`Apotex’s Nasal Spray.
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`5.
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`Any formulation development work undertaken or considered by Apotex during
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`the development of Apotex’s Nasal Spray, including (i) the identity of each ingredient in each
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`formulation
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`that Apotex considered when developing
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`its Nasal Spray
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`(“considered
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`formulation”); (ii) the amount of each ingredient in each considered formulation; (iii) the
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`function/purpose of each ingredient in each considered formulation; (iv) the reasons for the
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`selection and the amount of each ingredient in each considered formulation; and (v) the reasons
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`for the decision to change or otherwise abandon the considered formulation.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 10 of 12 PageID #: 1870
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`6.
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`The formulation of Apotex’s Nasal Spray, including but not limited to: (i) the
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`identity of each ingredient in Apotex’s Nasal Spray; (ii) the amount of each ingredient in
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`Apotex’s Nasal Spray; (iii) the function/purpose of each ingredient in Apotex’s Nasal Spray; (iv)
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`the reasons for the selection and the amount of each ingredient in Apotex’s Nasal Spray; and (v)
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`the identity of any other ingredients considered for use, but ultimately not used, in Apotex’s
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`Nasal Spray and the reasons for the decision not to use the ingredient.
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`7.
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`Any
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`research, design,
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`reverse engineering, development, scale-up, and
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`manufacture conducted by Apotex that resulted in, or that was considered but failed, or that was
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`abandoned or rejected, in arriving at the formulation of Apotex’s Nasal Spray, and the decision
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`to pursue such research, design, reverse engineering, development, scale-up, and manufacture
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`and any factor(s) considered in that decision.
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`8.
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`Any testing performed by Apotex on Apotex’s Nasal Spray or any formulation
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`considered during the development of Apotex’s Nasal Spray, including testing that was disclosed
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`in Apotex’s ANDA No. 207712 and testing that was not disclosed in Apotex’s ANDA No.
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`207712.
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`9.
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`Any opinion, evaluation, testing, or consideration regarding the infringement,
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`non-infringement, validity, invalidity, enforceability, unenforceability, or patentability of any
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`claim of the Patents-in-Suit and Apotex’s reliance thereon.
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`10.
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`The factual basis for any and all secondary considerations of nonobviousness of
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`the Asserted Claims, including but not limited to: any purported commercial success; any
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`purported long-felt and unsolved need; any purported unexpected results when compared to the
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`closest prior art; any purported failure of others; any purported evidence of industry acceptance;
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`any alleged skepticism by others; and any purported teaching away by others.
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 11 of 12 PageID #: 1871
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`11.
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`Any analysis of any related patent applications, including foreign applications, of
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`the Patents-in-Suit undertaken by Apotex or undertaken at Apotex’s direction.
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`12.
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`Apotex’s first awareness of the Patents-in-Suit.
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`13.
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`14.
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`Any attempts by Apotex to design around the Patents-in-Suit.
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`Apotex’s current organizational structure,
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`including but not
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`limited
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`to
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`departments, divisions, or groups, involved in research and development, sales, marketing,
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`regulatory, and business development.
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`15.
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`Apotex’s drafting, preparation, and filing of Apotex’s ANDA No. 207712,
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`including but not limited to all amendments and supplements thereto, communications with the
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`FDA, and meetings with the FDA regarding Apotex’s ANDA No. 207712.
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`16.
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`Any agreements Apotex has or has had with any entity related to the
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`development, supply, manufacture, sale, distribution, use or marketing of Apotex’s Nasal Spray.
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`17.
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`The preservation, custodianship, location, storage, filing, and collection of
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`documents and things responsive to any document request served on Apotex in this action,
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`including (1) any document retention, transfer, or destruction policies, (2) the destruction,
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`storage, scanning, or recycling of any documents or electronic storage devices such as but not
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`limited to tapes, by or on behalf of Apotex, and (3) any policies, practices, or standard operating
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`procedures regarding the storage and backup of electronic information, including but not limited
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`to documents, emails, and servers.
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`18.
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`All steps taken by each person designated to testify about any of the matters set
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`forth above to acquire information known or reasonably available to Apotex about each such
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`matter, including documents reviewed, discussed, or prepared in connection with or in
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`Case 1:14-cv-01453-LPS Document 69 Filed 12/30/15 Page 12 of 12 PageID #: 1872
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`anticipation of the testimony by each designated witness, and the identity of any individual(s)
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`consulted to obtain information about which testimony is provided or sought.
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