Case 1:24-cv-00336-RGA Document 23 Filed 11/21/24 Page 1 of 4 PageID #: 179
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`IN RE: XARELTO (RIVAROXABAN)
`(’310) PATENT LITIGATION
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`MDL No. 21-3017-RGA-LDH
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`BAYER INTELLECTUAL PROPERTY
`GMBH, BAYER PHARMA AG, BAYER
`AG and JANSSEN PHARMACEUTICALS,
`INC.,
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`Plaintiffs,
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`v.
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`C.A. No. 24-336-RGA
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`PRINSTON PHARMACEUTICAL, INC.,
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`Defendant.
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`STIPULATION AND ORDER REGARDING INFRINGEMENT
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`Plaintiffs Bayer Intellectual Property GmbH, Bayer Pharma AG, Bayer AG, and Janssen
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`Pharmaceuticals, Inc. (collectively, “Plaintiffs”) and Defendant Prinston Pharmaceutical, Inc.
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`(“Prinston”) hereby STIPULATE, and request that the Court ORDER, as follows:
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`1.
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`The use of the 2.5 mg rivaroxaban tablet product that is a subject of
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`Prinston’s ANDA No. 208549 (including any amendments or supplements thereto, which
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`specifically relate to the 2.5 mg strength) (“Prinston’s 2.5 mg ANDA Product”) in accordance with
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`its labeling infringes each of claims 1–4 of U.S. Patent No. 10,828,310 (“the ’310 patent”), but
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`only if the claim is asserted at trial and not proven invalid or unenforceable (in a proceeding before
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`(a) a United States district court or (b) the United States Patent and Trademark Office, in each case
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`(a) and (b) from which no appeal (other than by a petition to the United States Supreme Court for
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`a writ of certiorari) has been or can be taken).
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`Case 1:24-cv-00336-RGA Document 23 Filed 11/21/24 Page 2 of 4 PageID #: 180
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`2.
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`Prinston will induce infringement of each of claims 1–4 of the ’310 patent,
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`but only if the claim is asserted at trial and not proven invalid or unenforceable (in a proceeding
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`before (a) a United States district court or (b) the Unites States Patent and Trademark Office, in
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`each case (a) and (b) from which no appeal (other than by a petition to the United States Supreme
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`Court for a writ of certiorari) has been or can be taken), through the sale of Prinston’s 2.5 mg
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`ANDA Product.
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`3.
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`Prinston’s submission of ANDA No. 208549 with a Paragraph IV
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`certification to the ’310 patent was a technical act of infringement pursuant to 35 U.S.C.
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`§ 271(e)(2) of each of claims 1–4 of the ’310 patent, but only if the claim is asserted at trial and
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`not proven invalid or unenforceable (in a proceeding before (a) a United States district court or (b)
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`the Unites States Patent and Trademark Office, in each case (a) and (b) from which no appeal
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`(other than by a petition to the United States Supreme Court for a writ of certiorari) has been or
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`can be taken).
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`4.
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`As a result of the stipulations of infringement set forth herein, Plaintiffs
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`agree that they will not take any fact witness depositions of any Prinston employees, officers, or
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`directors in this action, unless Prinston or its experts relies or intend to rely on such witness
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`testimony. Plaintiffs further agree that Prinston does not need to produce further documents as
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`part of fact discovery in this action except for its submissions to FDA related to ANDA No. 208549
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`and correspondence with FDA related to ANDA No. 208549. The aforementioned restrictions on
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`discovery shall not apply in the event of a claim for damages by either party.
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`5.
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`If Plaintiffs remove the recommended doses of aspirin from the Xarelto
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`prescribing information and replace them with a new dose(s) of aspirin, and the replacement
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`dose(s) of aspirin does not fall within or overlap with 75–100 mg, then this stipulation will not
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`Case 1:24-cv-00336-RGA Document 23 Filed 11/21/24 Page 3 of 4 PageID #: 181
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`preclude Prinston from contesting infringement of any of claims 1–4 of the ’310 patent on the basis
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`of the changed aspirin dosing information. If Plaintiffs remove the recommended doses of aspirin
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`from the Xarelto prescribing information and replace them with a new dose(s) of aspirin, and the
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`replacement dose(s) of aspirin falls within or overlaps with 75–100 mg, then this stipulation will
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`not preclude Prinston from contesting infringement of any of claims 2–4 of the ’310 patent for
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`which the amount of aspirin recited in that claim is not encompassed by the new aspirin dose(s)
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`on the basis of the changed aspirin information.
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`6.
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`This stipulation is not intended to, and does not, limit or otherwise affect
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`Prinston’s ability to defend against Plaintiffs’ infringement claims on any other ground, including
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`asserting defenses of invalidity or unenforceability.
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`The parties make this stipulation without prejudice to or waiver of their rights on
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`any appeal of any judgment of this Court, except with respect to the matters of infringement as
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`stipulated herein.
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`Case 1:24-cv-00336-RGA Document 23 Filed 11/21/24 Page 4 of 4 PageID #: 182
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`HEYMAN ENERIO GATTUSO & HIRZEL, LLP
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`/s/ Dominick T. Gattuso
`____________________________________
`Dominick T. Gattuso (#3630)
`300 Delaware Ave., Suite 200
`Wilmington, DE 19801
`Phone: (302) 472-7300
`dgattuso@hegh.law
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`Attorney for Defendant Prinston
`Pharmaceutical, Inc.
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`/s/ Derek J. Fahnestock
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`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
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`Attorneys for Plaintiffs Bayer Intellectual
`Property GmbH, Bayer Pharma AG, Bayer
`AG and Janssen Pharmaceuticals, Inc.
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`21st
`November
`SO ORDERED this ____ day of _________________, 2024.
`
`/s/ Richard G. Andrews
`UNITED STATES DISTRICT JUDGE
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