Case 1:14-cv-00686-LPS Document 87 Filed 05/06/15 Page 1 of 5 PageID #: 3707
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`FOREST LABORATORIES, INC., FOREST
`LABORATORIES HOLDINGS, LTD. and
`ADAMAS PHARMACEUTICALS, INC.,
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`
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`C.A. No. 14-686 (LPS)
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`)))))))))))))
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` Plaintiffs,
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`v.
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`RANBAXY INC., RANBAXY
`LABORATORIES LIMITED and TEVA
`PHARMACEUTICALS USA, INC.,
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`
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` Defendants.
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`STIPULATION AND ORDER
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`The Court, upon the consent and request of Plaintiffs Forest Laboratories, Inc.,
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`Forest Laboratories Holdings, Ltd., and Adamas Pharmaceuticals, Inc. (collectively, “Plaintiffs”)
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`and Defendants Ranbaxy Inc. and Sun Pharmaceuticals Industries, Ltd. (formerly Ranbaxy
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`Laboratories Limited) (collectively, “Ranbaxy”), hereby acknowledges the following Stipulation
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`and issues the following Order.
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`STIPULATION
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`1.
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`This Court has subject matter jurisdiction over this patent infringement
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`action (the “Action”). Ranbaxy consents to personal jurisdiction in this Court for purposes of
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`this Stipulation and Order, and any proceedings relating thereto. Venue is proper in this Court as
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`to Plaintiffs and Ranbaxy for this action.
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`2.
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`In this Action, Plaintiffs have charged Ranbaxy with infringement of U.S.
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`Patent Nos. 8,168,209 (“the ‘209 Patent”); 8,173,708 (“the ‘708 Patent”); 8,283,379 (“the ‘379
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`Patent”); 8,329,752 (“the ‘752 Patent”); 8,362,085 (“the ‘085 Patent”); and 8,598,233 (“the ‘233
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`Patent”) in connection with Ranbaxy’s submission of Abbreviated New Drug Application
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`Adamas Exhibit 2007
`Ranbaxy Labs. Ltd. et al. (Petitioners) v. Adamas Pharms., Inc. (Patent Owner)
`Case IPR2015-00410
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`Page 1 of 5
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`Case 1:14-cv-00686-LPS Document 87 Filed 05/06/15 Page 2 of 5 PageID #: 3708
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`(“ANDA”) 205929 directed to generic extended release capsule products containing 7
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`milligrams, 14 milligrams, 21 milligrams, and 28 milligrams of memantine hydrochloride per
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`capsule to the U.S. Food and Drug Administration (“FDA”).
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`3.
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`In response to Plaintiffs’ charges of patent infringement, Ranbaxy has
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`alleged certain defenses and counterclaims, including that U.S. Patent No. 8,039,009 (“the ‘009
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`Patent”), the ‘209 Patent, the ‘708 Patent, the ‘379 Patent, the ‘752 Patent, the ‘085 Patent, and
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`the ‘233 Patent are invalid and/or not infringed by the filing of ANDA 205929 with the FDA
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`and/or any making, using, selling, or offering to sell within the United States, or importing into
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`the United States, of the generic extended release capsule products containing 7 milligrams, 14
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`milligrams, 21 milligrams, and 28 milligrams of memantine hydrochloride that are the subject of
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`ANDA 205929. To date, no decision has been obtained from this Court regarding Plaintiffs’
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`charges of infringement or Ranbaxy’s defenses and counterclaims.
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`4.
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`Ranbaxy admits that the submission of ANDA 205929 to the FDA for the
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`purpose of obtaining regulatory approval to engage in the commercial manufacture, use, and/or
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`sale of the generic extended release capsule products containing 7 milligrams, 14 milligrams, 21
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`milligrams, and 28 milligrams of memantine hydrochloride per capsule within the United States
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`before the expiration of the ‘209 Patent, the ‘708 Patent, the ‘379 Patent, the ‘752 Patent, the
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`‘085 Patent, and the ‘233 Patent was a technical act of infringement of each of those patents
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`under 35 U.S.C. § 271(e)(2)(A). This admission is without prejudice to Ranbaxy’s defenses and
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`counterclaims in the Action that the ‘009 Patent, the ‘209 Patent, the ‘708 Patent, the ‘379
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`Patent, the ‘752 Patent, the ‘085 Patent, and the ‘233 Patent are invalid and/or not infringed by
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`any making, using, selling, or offering to sell within the United States, or importing into the
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`United States, of the generic products described by ANDA 205929. This admission is further
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`Case 1:14-cv-00686-LPS Document 87 Filed 05/06/15 Page 3 of 5 PageID #: 3709
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`without prejudice to any claim, defense, or counterclaim in any possible future action between
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`Ranbaxy and any of the Plaintiffs regarding the ‘009 Patent, the ‘209 Patent, the ‘708 Patent, the
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`‘379 Patent, the ‘752 Patent, the ‘085 Patent, and/or the ‘233 Patent and a generic memantine
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`hydrochloride product other than the generic products that are the subject of ANDA 205929.
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`5.
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`Both parties agree that all other claims, defenses, and counterclaims set
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`forth in Plaintiffs’ and Ranbaxy’s pleadings against each other, including the allegations and
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`averments contained therein, should be dismissed, without prejudice.
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`ORDER
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`Accordingly, pursuant to the above Stipulation, and upon the consent and request
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`of Plaintiffs and Ranbaxy, IT IS HEREBY ORDERED, ADJUDGED AND DECREED
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`THAT:
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`1.
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`The filing of ANDA 205929 was a technical act of infringement of the
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`‘209 Patent, the ‘708 Patent, the ‘379 Patent, the ‘752 Patent, the ‘085 Patent, and the ‘233
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`Patent under 35 U.S.C. § 271(e)(2)(A). No decision of the Court has been obtained by either
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`party regarding the presumptive validity of the ‘209 Patent, the ‘708 Patent, the ‘379 Patent, the
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`‘752 Patent, the ‘085 Patent, and the ‘233 Patent and/or whether any making, using, selling, or
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`offering to sell within the United States, or importing into the United States, of the products
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`described by ANDA 205929 would infringe those patents.
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`2.
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`All other claims, defenses, and counterclaims set forth in Plaintiffs’ and
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`Ranbaxy’s pleadings against each other, including the allegations and averments contained
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`therein, are hereby dismissed, without prejudice.
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`3.
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`Ranbaxy, its officers, agents, servants, employees, and attorneys, and all
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`other persons in active concert or participation with any of them who receive actual notice of this
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`Order by personal service or otherwise, are hereby enjoined from manufacturing, using, offering
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`Case 1:14-cv-00686-LPS Document 87 Filed 05/06/15 Page 4 of 5 PageID #: 3710
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`to sell, or selling within the United States, or importing into the United States, the generic
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`extended release capsule products containing 7 milligrams, 14 milligrams, 21 milligrams, and 28
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`milligrams of memantine hydrochloride per capsule that are the subject of ANDA 205929 during
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`the life of the ‘209 Patent, the ‘708 Patent, the ‘379 Patent, the ‘752 Patent, the ‘085 Patent, and
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`the ‘233 Patent, including any extensions and pediatric exclusivities, absent a license agreement
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`or other authorization by Plaintiffs, unless all of the claims of the ‘209 Patent, the ‘708 Patent,
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`the ‘379 Patent, the ‘752 Patent, the ‘085 Patent, and the ‘233 Patent are found invalid or
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`unenforceable by a court decision from which no appeal has been or can be taken, other than a
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`petition for a writ of certiorari to the U.S. Supreme Court.
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`4.
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`Plaintiffs and Ranbaxy each expressly waive any right to appeal or
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`otherwise move for relief from this Stipulation And Order.
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`5.
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`This Court retains jurisdiction over Plaintiffs and Ranbaxy for purposes of
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`enforcing this Stipulation And Order.
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`6.
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`This Stipulation And Order shall finally resolve this Action between
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`Plaintiffs and Ranbaxy.
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`7.
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`This Stipulation And Order is without prejudice to any claim, defense, or
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`counterclaim in any possible future action between Ranbaxy and any of the Plaintiffs regarding
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`the ‘209 Patent, the ‘708 Patent, the ‘379 Patent, the ‘752 Patent, the ‘085 Patent, and/or the ‘233
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`Patent and a product other than the generic extended release capsule products containing 7
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`milligrams, 14 milligrams, 21 milligrams, and 28 milligrams of memantine hydrochloride per
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`capsule that are the subject of ANDA 205929.
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`8.
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`The Clerk of the Court is directed to enter this Stipulation And Order
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`forthwith.
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`Case 1:14-cv-00686-LPS Document 87 Filed 05/06/15 Page 5 of 5 PageID #: 3711
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`RICHARDS, LAYTON & FINGER, P.A.
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`/s/ Travis S. Hunter
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`Chad M. Shandler (#3796)
`Travis S. Hunter (#5350)
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`shandler@rlf.com
`hunter@rlf.com
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`Attorneys for Ranbaxy Inc. and Ranbaxy
`Laboratories Limited
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Maryellen Noreika
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`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
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`Attorneys for Plaintiffs
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`SO ORDERED this ______ day of May 2015
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`HONORABLE LEONARD P. STARK
`UNITED STATES DISTRICT JUDGE
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`Page 5 of 5