Case 1:23-cv-01219-RGA Document 28 Filed 10/16/24 Page 1 of 4 PageID #: 150
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: XARELTO (RIVAROXABAN) (’310)
`PATENT LITIGATION
`
`BAYER PHARMA AG, BAYER AG, and
`JANSSEN PHARMACEUTICALS, INC.
`
`Plaintiffs,
`
`v.
`
`TARO PHARMACEUTICAL INDUSTRIES
`LTD. and TARO PHARMACEUTICALS
`U.S.A., INC.
`
`BAYER PHARMA AG, BAYER AG, and
`JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LIMITED, et al.
`
`Defendants.
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`MDL NO. 21-MD-3017-RGA-LDH
`
`C.A. No. 23-1219-RGA
`
`C.A. No. 21-314-RGA-LDH
`(Consolidated)
`
`STIPULATION AND ORDER REGARDING CONSOLIDATION AND SCHEDULE
`
`WHEREAS, Plaintiffs Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals, Inc.
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`(collectively, “Plaintiffs”) filed C.A. No. 23-1219-RGA against Defendants Taro Pharmaceutical
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`Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. (“Taro”) in connection with Taro’s
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`submission of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: XARELTO (RIVAROXABAN) (’310)
`PATENT LITIGATION
`
`BAYER PHARMA AG, BAYER AG, and
`JANSSEN PHARMACEUTICALS, INC.
`
`Plaintiffs,
`
`v.
`
`TARO PHARMACEUTICAL INDUSTRIES
`LTD. and TARO PHARMACEUTICALS
`U.S.A., INC.
`
`BAYER PHARMA AG, BAYER AG, and
`JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LIMITED, et al.
`
`Defendants.
`
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`MDL NO. 21-MD-3017-RGA-LDH
`
`C.A. No. 23-1219-RGA
`
`C.A. No. 21-314-RGA-LDH
`(Consolidated)
`
`STIPULATION AND ORDER REGARDING CONSOLIDATION AND SCHEDULE
`
`WHEREAS, Plaintiffs Bayer Pharma AG, Bayer AG, and Janssen Pharmaceuticals, Inc.
`
`(collectively, “Plaintiffs”) filed C.A. No. 23-1219-RGA against Defendants Taro Pharmaceutical
`
`Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. (“Taro”) in connection with Taro’s
`
`submission of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug
`
`
`
`Case 1:23-cv-01219-RGA Document 28 Filed 10/16/24 Page 2 of 4 PageID #: 151
`
`Administration seeking, inter alia, approval for a generic version of Plaintiffs’ 2.5 mg Xarelto®
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`product prior to the expiration of U.S. Patent No. 10,828,310 (“the ’310 patent”); and
`
`WHEREAS, Plaintiffs are engaged in related litigations against Taro and a number of
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`defendants in connection with the ’310 patent, which are coordinated and consolidated under MDL
`
`No. 21-3017-RGA and C.A. No. 21-314-RGA-LDH (consolidated), which are currently stayed
`
`pending final resolution of the appeal of Mylan Pharmaceuticals Inc. et al. v. Bayer Pharma AG,
`
`IPR2022-00517 (PTAB), see Bayer Pharma Aktiengesellschaft v. Mylan Pharms. Inc., No. 2023-
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`2434 (Fed. Cir.); and
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`WHEREAS, the parties wish to streamline discovery and conserve their and the Court’s
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`resources;
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`NOW, THEREFORE, Plaintiffs and Taro hereby STIPULATE, and request that the Court
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`ORDER, as follows:
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`1.
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`C.A. No. 23-1219-RGA shall be consolidated with C.A. No. 21-314-RGA-LDH
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`(consolidated) for all purposes, including for trial. All papers shall be filed in C.A. No. 21-314-
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`RGA-LDH (consolidated).
`
`2.
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`The Court’s Orders staying the case in C.A. No. 21-314-RGA-LDH (“Stay Orders,”
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`D.I. 144, 153) shall apply to C.A. No. 23-1219-RGA.
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`3.
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`The Scheduling Order in C.A. No. 21-314-RGA-LDH (consolidated) (D.I. 22), as
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`modified by stipulation and Court Order, shall govern C.A. No. 23-1219-RGA;
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`4.
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`Taro shall adopt for all purposes of C.A. No. 23-1219-RGA all discovery requests
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`served by Taro or jointly by the defendants in C.A. No. 21-314-RGA-LDH (consolidated);
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`5.
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`All documents produced by Plaintiffs or by Taro in the consolidated case shall be
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`deemed produced in C.A. No. 23-1219-RGA;
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`2
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`Case 1:23-cv-01219-RGA Document 28 Filed 10/16/24 Page 3 of 4 PageID #: 152
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`
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`6.
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`Plaintiffs will deem served upon Taro all of Plaintiffs’ discovery responses and all
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`parties’ court filings in C.A. No. 21-314-RGA-LDH (consolidated), to the extent such materials
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`are already available to Taro in the consolidated case;
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`7.
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`Taro shall adopt in C.A. No. 23-1219-RGA the invalidity contentions made by Taro
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`in C.A. No. 21-314-RGA-LDH (consolidated) under Paragraph 4(d) of the Default Standard, and
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`the identification of references and combinations of references made by Taro in C.A. No. 21-314-
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`RGA-LDH (consolidated) under paragraph 4(g)(iv) of the Scheduling Order and Paragraph 4(d)
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`of the Default Standard;
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`8.
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`The Stipulation and Order regarding claim construction in C.A. NO. 21-314-RGA-
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`LDH (consolidated) (D.I. 72, 73) shall apply;
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`9.
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`The Stipulated Protective Order in C.A. No. 21-314-RGA-LDH (consolidated)
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`(D.I. 36, 37) shall apply; and
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`10.
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`The Stipulation and Order regarding infringement in C.A. No. 21-314-RGA-LDH
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`(consolidated) (D.I. 117, 119) shall apply.
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`3
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`
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`Case 1:23-cv-01219-RGA Document 28 Filed 10/16/24 Page 4 of 4 PageID #: 153
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`
`/s/ Derek J. Fahnestock
`
`Jack B. Blumenfeld (#1014)
`Rodger D. Smith (#3778)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`rsmith@morrisnichols.com
`dfahnestock@morrisnichols.com
`
`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH, Bayer Pharma AG, Bayer
`AG, and Janssen Pharmaceuticals, Inc.
`
`/s/ Robert M. Vrana
`____________________________________
`Anne Shea Gaza (#4093)
`Robert M. Vrana (#5666)
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`Phone: (302) 571-6600
`agaza@ycst.com
`rvrana@ycst.com
`
`Attorneys for Defendants Taro
`Pharmaceutical Industries Ltd. and Taro
`Pharmaceuticals U.S.A., Inc.
`
`16
`October
`SO ORDERED this ____ day of _________________, 2024.
`
`/s/ Richard G. Andrews
`UNITED STATES DISTRICT JUDGE
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`4
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