Case 1:24-cv-00336-RGA Document 24 Filed 11/21/24 Page 1 of 5 PageID #: 183
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: XARELTO (RIVAROXABAN) (’310)
`PATENT LITIGATION
`
`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER PHARMA AG, BAYER AG,
`and JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`PRINSTON PHARMACEUTICAL, INC.,
`
`Defendant.
`
`BAYER PHARMA AG, BAYER AG and
`JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LIMITED, et al.
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`MDL NO. 21-MD-3017-RGA-LDH
`
`C.A. No. 24-336-RGA
`
`C.A. No. 21-314-RGA-LDH
`(Consolidated)
`
`STIPULATION AND ORDER REGARDING CONSOLIDATION AND SCHEDULE
`
`WHEREAS, Plaintiffs Bayer Intellectual Property GmbH, Bayer Pharma AG, Bayer AG,
`
`and Janssen Pharmaceuticals, Inc. (collectively, “Plaintiffs”) filed C.A. No. 24-336-RGA against
`
`Defendant Prinston Pharmaceutical, Inc. (“Prinston”) in connection with Prinston’s submission of
`
`an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE: XARELTO (RIVAROXABAN) (’310)
`PATENT LITIGATION
`
`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER PHARMA AG, BAYER AG,
`and JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`PRINSTON PHARMACEUTICAL, INC.,
`
`Defendant.
`
`BAYER PHARMA AG, BAYER AG and
`JANSSEN PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LIMITED, et al.
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`MDL NO. 21-MD-3017-RGA-LDH
`
`C.A. No. 24-336-RGA
`
`C.A. No. 21-314-RGA-LDH
`(Consolidated)
`
`STIPULATION AND ORDER REGARDING CONSOLIDATION AND SCHEDULE
`
`WHEREAS, Plaintiffs Bayer Intellectual Property GmbH, Bayer Pharma AG, Bayer AG,
`
`and Janssen Pharmaceuticals, Inc. (collectively, “Plaintiffs”) filed C.A. No. 24-336-RGA against
`
`Defendant Prinston Pharmaceutical, Inc. (“Prinston”) in connection with Prinston’s submission of
`
`an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration
`
`
`
`Case 1:24-cv-00336-RGA Document 24 Filed 11/21/24 Page 2 of 5 PageID #: 184
`
`seeking, inter alia, approval for a generic version of Plaintiffs’ 2.5 mg Xarelto® product prior to
`
`the expiration of U.S. Patent No. 10,828,310 (“the ’310 patent”)1; and
`
`WHEREAS, Plaintiffs are engaged in related litigations against a number of 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 is 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. 2023-2434 (Fed.
`
`Cir.); and
`
`NOW, THEREFORE, Plaintiffs and Prinston hereby STIPULATE, and request that, with
`
`respect to all claims related to the ’310 patent, the Court ORDER, as follows:
`
`1.
`
`All claims related to the ’310 patent pending in C.A. No. 24-336-RGA shall be
`
`consolidated with C.A. No. 21-314-RGA-LDH (consolidated) for all purposes, including for trial.
`
`All papers concerning claims related to the ’310 patent shall be filed in C.A. No. 21-314-RGA-
`
`LDH (consolidated).
`
`2.
`
`The Court’s Orders staying the case in C.A. No. 21-314 (“Stay Orders,” D.I. 144,
`
`153) shall apply to all claims related to the ’310 patent in C.A. No. 24-336-RGA.
`
`3.
`
`The Scheduling Order in C.A. No. 21-314-RGA-LDH (consolidated) (D.I. 22), as
`
`modified by stipulation and Court Order, shall govern all claims related to the ’310 patent in C.A.
`
`No. 24-336-RGA, except that:
`
`1 Plaintiffs’ Complaint also alleges that Prinston’s ANDA No. 208459 seeks approval for generic
`versions of Plaintiffs’ 10 mg, 15 mg, and 20 mg Xarelto® tablets prior to the expiration of U.S.
`Patent No. 9,539,218 (“the ’218 patent”). The Parties do not wish to consolidate Plaintiffs’ claims
`related to the ’218 patent.
`
`2
`
`
`
`Case 1:24-cv-00336-RGA Document 24 Filed 11/21/24 Page 3 of 5 PageID #: 185
`
`a. Prinston Pharmaceutical, Inc. shall be considered a “Defendant Group”
`
`under the definition set forth in footnote 2 of paragraph 4(c);
`
`b. The dates and deadlines in paragraphs 2 and 3 related to Initial Disclosures
`
`and Joinder of Other Parties and Amendment of Pleadings shall not apply.
`
`Within five business days of the stay being lifted, Prinston and Plaintiffs
`
`shall meet and confer regarding revised dates for these deadlines;
`
`c. Prinston shall be considered to be a party to the Joint discovery served by
`
`the defendants in C.A. No. 21-314-RGA-LDH (i.e., Defendants' First Set of
`
`Joint Interrogatories to Plaintiffs (Nos. 1-9) and Defendants' First Set of
`
`Joint Requests for Production to Plaintiffs (Nos. 1-60) served concurrently
`
`April 18, 2022);
`
`d. Prinston shall not separately serve disclosures under Paragraph 4(d) of the
`
`Default Standard in connection with the ’310 patent. Prinston shall adopt
`
`the invalidity contentions made by the defendants in C.A. No. 21-314-
`
`RGA-LDH (consolidated) under Paragraph 4(d) of the Default Standard
`
`(i.e., Defendants' Joint Invalidity Contentions served February 28, 2022),
`
`and the identification of references and combinations of references made by
`
`the defendants in C.A. No. 21-314-RGA-LDH (consolidated) under
`
`paragraph 4(g)(iii) of the Scheduling Order and Paragraph 4(d) of the
`
`Default Standard (i.e.: (i) Defendants’ Prior Art Narrowing served on behalf
`
`of defendants Mylan and Teva on October 14, 2022; (ii) the email bearing
`
`the subject line “In re Xarelto (rivaroxaban) U.S. Patent No. 10,828,310
`
`Patent Litigation – Defendants’ references and combinations (Lupin, Taro,
`
`3
`
`
`
`Case 1:24-cv-00336-RGA Document 24 Filed 11/21/24 Page 4 of 5 PageID #: 186
`
`DRL”);2 and/or (iii) the grounds set forth in IPR2022-00517 (specifically,
`
`the Petition for Inter Partes Review of U.S. Patent No. 10,828,310; the
`
`Decision Granting Institution of Inter Partes Review; and the Final Written
`
`Decision Determining All Challenged Claims Unpatentable).
`
`e. All dates and deadlines held in abeyance as a result of the Stay Orders shall
`
`remain subject to the stay (C. A. No. 21-314-RGA-LDH, D.I. 144, 153) and
`
`shall be revised accordingly in the event that the stay is lifted; and
`
`f. Paragraphs 8–10 shall not apply. Plaintiffs and Prinston will not separately
`
`engage in Markman briefing in connection with the ’310 patent, and the
`
`Stipulation and Order regarding claim construction in C.A. No. 21-314-
`
`RGA-LDH (consolidated) (D.I. 72, 73) shall apply to all claims related to
`
`the ’310 patent.
`
`4.
`
`The Stipulated Protective Order in C.A. No. 21-314-RGA-LDH (consolidated)
`
`(D.I. 36, 37) shall apply.
`
`2 Prinston understands there are multiple groups of references and combinations of references
`disclosed by defendants in C.A. No. 21-314-RGA-LDH (consolidated), and Plaintiffs understand
`that Prinston may join either or both groups. Prinston further understands there is a dispute as to
`whether all defendants should have provided a single, joint identification of references and
`combinations of references under paragraph 4(g)(iii) of the Scheduling Order. Prinston’s adoption
`of the identification of references and combinations of references made by defendants is without
`prejudice to Plaintiffs’ ability to object to defendants’ disclosure of anything more than a single,
`joint identification of references and combinations of references that does not exceed the limit in
`paragraph 4(g)(iii) of the Scheduling Order.
`
`4
`
`
`
`Case 1:24-cv-00336-RGA Document 24 Filed 11/21/24 Page 5 of 5 PageID #: 187
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`HEYMAN ENERIO GATTUSO & HIRZEL, LLP
`
`/s/ Dominick T. Gattuso
`____________________________________
`Dominick T. Gattuso (#3630)
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`Phone: (302) 472-7300
`dgattuso@hegh.law
`
`Attorney for Defendant Prinston
`Pharmaceutical, Inc.
`
`/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.
`
`21st
`November
`SO ORDERED this ____ day of _________________, 2024.
`
`/s/ Richard G. Andrews
`UNITED STATES DISTRICT JUDGE
`
`5
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
