Mark S. Olinsky
`SILLS CUMMIS & GROSS P.C.
`One Riverfront Plaza
`Newark, New Jersey 07102-5400
`(973) 643-7000
`molinsky@sillscummis.com
`
`Stephen M. Klein
`SILLS CUMMIS & GROSS P.C.
`One Riverfront Plaza
`Newark, New Jersey 07102-5400
`(973) 643-7000
`sklein@sillscummis.com
`
`Attorneys for Defendant
`MSN LABORATORIES PRIVATE LTD.
`and MSN PHARMACEUTICALS INC.,
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`BAUSCH HEALTH IRELAND LIMITED
`and SALIX PHARMACEUTICALS, INC.,
`
`v.
`
`Plaintiffs,
`
`Civil Action No. 21-10057
`
`MSN LABORATORIES PRIVATE LTD.
`and MSN PHARMACEUTICALS INC.,
`
`Defendant.
`
`DEFENDANTS MSN LABORATORIES PRIVATE LTD. AND
`MSN PHARMACEUTICALS INC.’S FIRST SET OF REQUESTS FOR
`PRODUCTION TO PLAINTIFFS (Nos. 1-50)
`
`Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure, Defendants MSN
`
`Laboratories Private Ltd. and MSN Pharmaceuticals Inc. (“MSN” or “Defendants”) request that
`
`Plaintiffs Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. (collectively “Plaintiffs”)
`
`respond to each request set forth below and produce for inspection and copying the documents and
`
`Bausch Health Ireland Exhibit 2003, Page 1 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`SILLS CUMMIS & GROSS P.C.
`One Riverfront Plaza
`Newark, New Jersey 07102-5400
`(973) 643-7000
`molinsky@sillscummis.com
`
`Stephen M. Klein
`SILLS CUMMIS & GROSS P.C.
`One Riverfront Plaza
`Newark, New Jersey 07102-5400
`(973) 643-7000
`sklein@sillscummis.com
`
`Attorneys for Defendant
`MSN LABORATORIES PRIVATE LTD.
`and MSN PHARMACEUTICALS INC.,
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`BAUSCH HEALTH IRELAND LIMITED
`and SALIX PHARMACEUTICALS, INC.,
`
`v.
`
`Plaintiffs,
`
`Civil Action No. 21-10057
`
`MSN LABORATORIES PRIVATE LTD.
`and MSN PHARMACEUTICALS INC.,
`
`Defendant.
`
`DEFENDANTS MSN LABORATORIES PRIVATE LTD. AND
`MSN PHARMACEUTICALS INC.’S FIRST SET OF REQUESTS FOR
`PRODUCTION TO PLAINTIFFS (Nos. 1-50)
`
`Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure, Defendants MSN
`
`Laboratories Private Ltd. and MSN Pharmaceuticals Inc. (“MSN” or “Defendants”) request that
`
`Plaintiffs Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. (collectively “Plaintiffs”)
`
`respond to each request set forth below and produce for inspection and copying the documents and
`
`Bausch Health Ireland Exhibit 2003, Page 1 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`things described below, within thirty (30) days of service of these requests for production. The
`
`production shall be made at the offices of Defendants’ counsel, or at some other place to be agreed
`
`upon by the parties.
`
`
`
`To the extent that any answer to any of these requests may at any time be incomplete or
`
`incorrect due to information acquired by Plaintiffs subsequent to the service of each of their
`
`answers, Defendants request that Plaintiffs promptly serve and file supplemental answers
`
`reflecting the complete and correct information pursuant to Rule 26 of the Federal Rules of Civil
`
`Procedure.
`
`DEFINITIONS
`
`1.
`
`“Plaintiffs” and “You” means individually and collectively, Bausch Health Ireland
`
`Limited and Salix Pharmaceuticals, Inc. and current and former officers, directors, employees,
`
`consultants, attorneys, experts, agents, partners, corporate parents, subsidiaries, subdivisions,
`
`predecessors, affiliates, or entities acquired through merger or acquisition including but not limited
`
`to Synergy Pharmaceuticals Inc..
`
`Inc.
`
`2.
`
`3.
`
`“Defendants” means MSN Laboratories Private Ltd. and MSN Pharmaceuticals
`
`“Patents-in-Suit” refers to: United States Patent Nos. 7,041,786 (“the ’786 patent”),
`
`9,610,321 (“the ’321 patent”), 9,616,097 (“the ’097 patent”), 9,919,024 (“the ’024 patent”),
`
`9,925,231 (“the ’231 patent”) and 10,011,637 (“the ’637 patent”).
`
`4.
`
`5.
`
`6.
`
`“FDA” means the United States Food & Drug Administration.
`
`“NDA” means New Drug Application.
`
`“IND Application” means Investigational New Drug Application.
`
`
`
`2
`
`Bausch Health Ireland Exhibit 2003, Page 2 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`7.
`
`“Communication” means any transmission of information between two or more
`
`persons, including information transmitted by way of telephone conversations, letters, faxes,
`
`email, computer links, written memorandums or other documents, bulletin board posting, and face-
`
`to-face conversations.
`
`8.
`
`“Document” is defined to be synonymous in meaning and equal in scope to the
`
`usage of the term “documents or electronically stored information” in Federal Rule of Civil
`
`Procedure 34(a)(1)(A). A draft or non-identical copy is a separate document within the meaning
`
`of this term.
`
`9.
`
`The term “MSN ANDA” means the ANDA associated with MSN’s generic
`
`plecanatide tablets, ANDA No. 215780, produced to plaintiffs on June 18, 2021 with bates
`
`numbers MSN-PLE-000001 through MSN-PLE-008929.
`
`10.
`
`The term “MSN ANDA Products” means the generic plecanatide products that are
`
`the subject of the MSN ANDA.
`
`11.
`
`The term “The Comiskey Declaration” refers to the declaration of Stephen
`
`Comiskey signed on February 18, 2015 and filed with the United States Patent Office under 37
`
`C.F.R. § 1.132 during the prosecution of United States Patent Application No. 13/421,769, which
`
`issued as U.S. Patent No. 9,616,097.
`
`12.
`
`The term "The Second Comiskey Declaration" refers to the declaration of Stephen
`
`Comiskey signed on September 06, 2016 and filed with the United States Patent Office under 37
`
`C.F.R. § 1.132 during the prosecution of United States Patent Application No. 14/845,644, which
`
`issued as U.S. Patent No. 9,610,321.
`
`
`
`3
`
`Bausch Health Ireland Exhibit 2003, Page 3 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`13.
`
`“Avicel PH112” refers to a proprietary microcrystalline cellulose manufactured by
`
`Dupont and is an ingredient used in the studies that are the subject of both Comiskey Declarations
`
`identified as “a low-moisture carrier.”
`
`14.
`
`“Avicel PH102” refers to a proprietary microcrystalline cellulose manufactured by
`
`Dupont and is an ingredient used in the studies that are the subject of both Comiskey Declarations
`
`identified as “a regular grade carrier.”
`
`REQUESTS FOR PRODUCTION
`
`REQUEST NO. 1: A Complete, un-redacted copy of NDA 208745, including any IND
`
`applications in your possession that refer in any way to plecanatide.
`
`REQUEST NO. 2: Complete, un-redacted copies of all non-privileged documents that
`
`are in the possession or control of You that refer to, summarize, document, or include any
`
`communications between You and the FDA concerning NDA 208745, as well as any amendments
`
`or supplements to said NDA.
`
`REQUEST NO. 3: All non-privileged documents that relate to the Patents-in-Suit or
`
`Related Applications, including but not limited to, foreign search reports and testimony in
`
`litigations, disputes, oppositions, and related proceedings throughout the world involving
`
`plecanatide.
`
`REQUEST NO. 4: All agreements and draft agreements that relate to the manufacture,
`
`sale, marketing, or distribution in any way of any dosage form containing plecanatide, including
`
`all agreements and draft agreements between any entity (including but not limited to both corporate
`
`entities named as Plaintiffs in this case) concerning any product approved under NDA 208745.
`
`
`
`4
`
`Bausch Health Ireland Exhibit 2003, Page 4 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`REQUEST NO. 5: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments described in The Comiskey Declaration,
`
`including any and all experimental results not summarized or included in said declaration.
`
`REQUEST NO. 6: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments described in The Second Comiskey Declaration,
`
`including any and all experimental results not summarized or included in said declaration.
`
`REQUEST NO. 7: A complete and accurate printed copy of the complete document
`
`identified in footnote 1 to The Comiskey Declaration and The Second Comiskey Declaration.
`
`REQUEST NO. 8: All non-privileged documents that relate to, refer to, or consist of
`
`the “References Cited” section of the Patents-in-Suit or Related Applications, including but not
`
`limited to all U.S. Patent Documents, Foreign Patent Documents, and Other Publications listed
`
`therein.
`
`REQUEST NO. 9: All product specification sheets, or any document whatsoever, in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Avicel® trade name, including but not limited to any document identifying Avicel PH 102, 112,
`
`or 200 as reflected in U.S. Patent No. 9,610,321, Column 5, lines 25-30.
`
`REQUEST NO. 10: All product specification sheets, or any document whatsoever, in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Celphere® trade name, including but not limited to any document identifying Celphere SCP-
`
`100 as reflected in U.S. Patent No. 9,610,321, Column 5, line 27.
`
`
`
`5
`
`Bausch Health Ireland Exhibit 2003, Page 5 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`REQUEST NO. 11: All product specification sheets, or any document whatsoever, in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Advantose® trade name, including but not limited to any document identifying ADVANTOSE
`
`100, as reflected in U.S. Patent No. 9,610,321, Column 9, lines 33-36.
`
`REQUEST NO. 12: All product specification sheets, or any document whatsoever, in
`
`Your possession or control that is not privileged that refers in any way to the content,
`
`characteristics, ingredients or function in a pharmaceutical formulation of any material sold under
`
`the Prosolv® trade name, including but not limited to any document identifying Prosolv SMCC 90
`
`LM, as reflected in U.S. Patent No. 9,610,321, Column 16, 27-28, and lines 53-54; or PROSOLV
`
`LM90 as identified in Col. 88, line 57 of the same patent.
`
`REQUEST NO. 13: All non-privileged documents that relate to, refer to, or consist of
`
`any foreign search reports and testimony in litigations, disputes, oppositions, and related
`
`proceedings throughout the world involving plecanatide.
`
`REQUEST NO. 14: All non-privileged documents in your possession or control that
`
`relate to, refer to, or consist of any reference to the naturally occurring peptides uroguanylin and
`
`guanylin, including but not limited to human uroguanylin, rat uroguanylin and opossum
`
`uroguanylin, and human guanylin, rat guanylin and opossum guanylin, and the use of said
`
`compounds (alone or in combination) as guanylate cyclase receptor agonists, for the regulation of
`
`fluid and electrolyte transport in the huma GI tract by, e.g., serving as paracrine regulators of CFTR
`
`activity, and/or for the treatment of constipation.
`
`
`
`6
`
`Bausch Health Ireland Exhibit 2003, Page 6 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`REQUEST NO. 15: All non-privileged documents in your possession or control that
`
`relate to, refer to, or consist of any reference to human uroguanylin, and its use for controlling
`
`intestinal absorption and regulating intestinal fluid and electrolyte transport.
`
`REQUEST NO. 16: All non-privileged documents in your possession or control that
`
`relate to, refer to, or consist of any reference to human guanylin, and its use for controlling
`
`intestinal absorption and regulating intestinal fluid and electrolyte transport.
`
`REQUEST NO. 17: All non-privileged documents and communications referring to, or
`
`relating to U.S. Patent No. 5,140,102.
`
`REQUEST NO. 18: All non-privileged documents and communications referring to or
`
`relating to Forte et al., New Physiol. Sci, 1996, 11, 17-24.
`
`REQUEST NO. 19: All non-privileged documents and communications referring to or
`
`relating to Li et al., Regulatory Peptides, 1997, 68, 45-56.
`
`REQUEST NO. 20: All non-privileged documents and communications referring to or
`
`relating to Joo et al., Physiology, 1999, G633-G644.
`
`REQUEST NO. 21: All non-privileged documents and communications referring to or
`
`relating to Hamra et al., Endocrinology, 1996, 137(1).
`
`REQUEST NO. 22: All non-privileged documents and communications referring to or
`
`relating to Nakazato, J. Gastroenterol, 2001, 36, 219-225.
`
`REQUEST NO. 23: All non-privileged documents and communications referring to and
`
`relating to WO 01/25266.
`
`REQUEST NO. 24: All documents pertaining to your investigation, due diligence, and
`
`eventual acquisition of Synergy Pharmaceuticals Inc. in a bankruptcy court supervised auction and
`
`
`
`7
`
`Bausch Health Ireland Exhibit 2003, Page 7 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`sale, through which the worldwide rights to the Trulance (plecanitide) product were acquired by
`
`You.
`
`REQUEST NO. 25: All documents in your possession or control that refer to, relate to,
`
`or include any documents associated with the bankruptcy court supervised auction and sale,
`
`through which the worldwide rights to the Trulance (plecanitide) product were acquired by You.
`
`REQUEST NO. 26: The December 12, 2018 agreement to acquire certain assets of
`
`Synergy Pharmaceuticals, Inc., including all non-privileged documents preceding that agreement
`
`in which the assets that were the subject of the transaction were valued.
`
`REQUEST NO. 27: All documents in your possession or control that pre-date the
`
`December 12, 2018 agreement to acquire certain assets of Synergy Pharmaceuticals, Inc. and
`
`reference, in any way, any anticipated, expected, or possible generic competition for
`
`TRULANCE®, and/or the impact of such competition on the value of the worldwide rights to the
`
`Trulance (plecanitide) product.
`
`REQUEST NO. 28: All documents relating in any way to Your efforts to continue
`
`leveraging the comprehensive irritable bowel syndrome (IBS) portfolio held by Bausch, with
`
`TRULANCE® being a natural complement to XIFAXAN® (rifaximin) product, as stated by
`
`Joseph C. Papa in the letter to shareholders in the 2019 Bausch Health Annual Report.
`
`REQUEST NO. 29: All documents that describe, document, or relate in any way to the
`
`scale, depth and strength of Bausch’s sales footprint in gastroenterology and primary care,
`
`including but not limited to the “Salix team” which was said to “be able to offer physicians and
`
`patients multiple treatment options that span the types of IBS,” as stated by Joseph C. Papa in the
`
`letter to shareholders in the 2019 Bausch Health Annual Report.
`
`
`
`8
`
`Bausch Health Ireland Exhibit 2003, Page 8 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`REQUEST NO. 30: A copy of each and every agreement that You have, or have
`
`negotiated, with any entity that involves the manufacture, use, sale, or contemplated sale of a
`
`generic version of TRULANCE® in the United States at any time.
`
`REQUEST NO. 31: All documents concerning the experimental and factual support for
`
`all portions of the Patents-in-Suit and statements made to the PTO in the prosecution of the Patents-
`
`in-Suit, including in the prosecution of any application in the claimed priority applications of the
`
`Patents-in-Suit.
`
`REQUEST NO. 32: All agreements held between You and or your counsel concerning
`
`any consulting services provided to you regarding plecanatide by any named inventor of any patent
`
`in suit.
`
`REQUEST NO. 33: All documents concerning or related to the earliest priority date that
`
`You assert for each claim of the Patents-in-Suit.
`
`REQUEST NO. 34: Documents sufficient to identify the individuals who allegedly
`
`conceived of, and/or reduced to practice or assisted in the reduction to practice of, the alleged
`
`invention(s) or subject matter claimed in the Patents-in-Suit.
`
`REQUEST NO. 35: All documents written or reviewed by the inventors of the Patents-
`
`in-Suit pertaining to the subject matter of the Patents-in-Suit, including applications in the priority
`
`claim of the Patents-in- Suit.
`
`REQUEST NO. 36: All documents concerning Defendants’ alleged infringement of any
`
`claim of the Patents-in-Suit.
`
`REQUEST NO. 37: All documents relating to agreements with any company or
`
`companies for the development, sale, marketing, or promotion of plecanatide, or a pharmaceutical
`
`composition thereof, including, but not limited to, any agreements and drafts thereof.
`
`
`
`9
`
`Bausch Health Ireland Exhibit 2003, Page 9 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`REQUEST NO. 38: All documents prepared for and/or shared in any due diligence
`
`concerning any agreement, license, or negotiation related to plecanatide, or a pharmaceutical
`
`composition thereof, the Patents-in-Suit, the applications that issued as the Patents-in-Suit, and the
`
`applications in the claimed priority chain of the Patents-in-Suit.
`
`REQUEST NO. 39: Documents sufficient to show the costs associated with marketing,
`
`advertising, or promoting TRULANCE®, including the costs of the sales force, detailing, product
`
`sampling, and all other promotional costs associated with TRULANCE®.
`
`REQUEST NO. 40: Documents sufficient to show the marketing, advertising, or
`
`promotion for TRULANCE® including, without limitation, any press releases and publications,
`
`any marketing plans, advertising plans, promotional programs or strategies.
`
`REQUEST NO. 41: All documents relating to any market analysis by or on behalf of
`
`You concerning TRULANCE® or any pharmaceutical composition thereof.
`
`REQUEST NO. 42: Documents sufficient to show the sales, revenue, and/or profits for
`
`TRULANCE® since its first sale to the present.
`
`REQUEST NO. 43: Documents sufficient to show cost data (including unit costs), sales
`
`data, profit data, and market share data, including rebate, chargeback, and adjustment data, given
`
`on a monthly basis for TRULANCE® since its first sale to the present.
`
`REQUEST NO. 44: All documents relating to the forecast or projection for sales,
`
`revenue, and profit for TRULANCE®.
`
`REQUEST NO. 45: All documents concerning or referring to products that compete for
`
`sales or market share with TRULANCE® (either in Plaintiff’s estimation, or that of third parties
`
`such as IMS, IQVIA, and/or Wolters Kluwer).
`
`
`
`10
`
`Bausch Health Ireland Exhibit 2003, Page 10 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`REQUEST NO. 46: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the molecular modeling experiments and the Examples described
`
`in U.S. Patent No. 7,041,186 at cols. 7:22 to 13:15, and 15:25 to 17:5.
`
`REQUEST NO. 47: All documents, including laboratory notebooks and all available
`
`experimental data, pertaining to the experiments described in Examples 1 through 100 as identified
`
`in U.S. Patent No. 9,610,321 Cols. 85-100.
`
`REQUEST NO. 48: All non-privileged documents that relate to U.S. Patent Appln. No.
`
`17/397,796, filed on August 09, 2021 or Related Applications, including but not limited to, all
`
`communications with the United States Patent and Trademark Office, all communications with
`
`foreign patent offices, including but not limited to foreign search reports, involving U.S. Patent
`
`Appln. No. 17/397,796, filed on August 09, 2021.
`
`REQUEST NO. 49: All non-privileged documents that relate to U.S. Patent Appl. No.
`
`17/478,027, filed on August 17, 2021 or Related Applications, including but not limited to, all
`
`communications with the United States Patent and Trademark Office, all communications with
`
`foreign patent offices, including but not limited to foreign search reports, involving U.S. Patent
`
`Appln. No. 17/478,027, filed on August 17, 2021.
`
`REQUEST NO. 50: All non-privileged documents that relate to U.S. Patent Appl. No.
`
`16/870,942, filed on May 9, 2020 or Related Applications, including but not limited to, all
`
`communications with the United States Patent and Trademark Office, all communications with
`
`foreign patent offices, including but not limited to foreign search reports, and related proceedings
`
`throughout the world involving U.S. Patent Appl. No. 16/870,942, filed on May 9, 2020.
`
`
`
`
`
`
`
`11
`
`Bausch Health Ireland Exhibit 2003, Page 11 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
`
`/s/Mark S. Olinsky
`Mark S. Olinsky
`SILLS CUMMIS & GROSS P.C.
`One Riverfront Plaza
`Newark, New Jersey 07102-5400
`(973) 643-7000
`molinsky@sillscummis.com
`
`Stephen M. Klein
`SILLS CUMMIS & GROSS P.C.
`One Riverfront Plaza
`Newark, New Jersey 07102-5400
`(973) 643-7000
`sklein@sillscummis.com
`
`Dated: January 11, 2022
`
`OF COUNSEL:
`
`B. Jefferson Boggs
`MERCHANT & GOULD PC
`1900 Duke Street, Suite 600
`Alexandria, Virginia 22314
`(703) 684-2500
`jboggs@merchantgould.com
`
`Christopher J. Sorenson
`Karen Beckman
`MERCHANT & GOULD PC
`3200 IDS Center
`80 S. Eighth Street
`Minneapolis, Minnesota 55402
`(612) 332-5300
`csorenson@merchantgould.com
`kbeckman @merchantgould.com
`
`Attorneys for Defendants
`
`12
`
`Bausch Health Ireland Exhibit 2003, Page 12 of 12
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`
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