`DISTRICT OF NEW JERSEY
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO AL TO LLC,
`
`Plaintiffs,
`
`v.
`
`TEVA PHARMACEUTICALS USA,
`INC. and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.,
`
`Defendants.
`
`Civil Action No. 11-3962 (MLC) (DEA)
`(Consolidated)
`
`Hon. Mary L. Cooper, U.S.D.J.
`Hon. Douglas E. Arpert, U.S.M.J.
`
`FINAL JUDGMENT
`
`WHEREAS, Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC
`
`(collectively, "Plaintiffs") asserted that the submission to the United States Food
`
`and Drug Administration ("FDA") of Abbreviated New Drug Application
`
`("ANDA") No. 090713 by Defendants Teva Pharmaceuticals USA, Inc. and Teva
`
`Pharmaceutical Industries, Ltd. (collectively, "Teva") for its generic palonosetron
`
`hydrochloride int~avenous solution products (0.25 mg I 5 mL and 0.075 mg I l .5
`
`mL) ("Teva's ANDA Products") infringed U.S. Patent Nos. 7,947,724 ("the '724
`
`patent"), 7 ,94 7, 725 ("the '725 patent"), 7 ,960,424 ("the '424 patent"), and
`
`8,598,219 ("the '219 patent");
`
`RECEIVED
`NOV 1 6 2015
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`M
`AT 8:30
`·
`Helsinn Healthcare S.A., et al.
`WILLIAM l WALSH CLERK
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1040
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`HELSINN HEALTHCARE S.A. and
`ROCHE PALO AL TO LLC,
`
`Plaintiffs,
`
`v.
`
`TEVA PHARMACEUTICALS USA,
`INC. and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.,
`
`Defendants.
`
`Civil Action No. 11-3962 (MLC) (DEA)
`(Consolidated)
`
`Hon. Mary L. Cooper, U.S.D.J.
`Hon. Douglas E. Arpert, U.S.M.J.
`
`FINAL JUDGMENT
`
`WHEREAS, Plaintiffs Helsinn Healthcare S.A. and Roche Palo Alto LLC
`
`(collectively, "Plaintiffs") asserted that the submission to the United States Food
`
`and Drug Administration ("FDA") of Abbreviated New Drug Application
`
`("ANDA") No. 090713 by Defendants Teva Pharmaceuticals USA, Inc. and Teva
`
`Pharmaceutical Industries, Ltd. (collectively, "Teva") for its generic palonosetron
`
`hydrochloride int~avenous solution products (0.25 mg I 5 mL and 0.075 mg I l .5
`
`mL) ("Teva's ANDA Products") infringed U.S. Patent Nos. 7,947,724 ("the '724
`
`patent"), 7 ,94 7, 725 ("the '725 patent"), 7 ,960,424 ("the '424 patent"), and
`
`8,598,219 ("the '219 patent");
`
`RECEIVED
`NOV 1 6 2015
`M
`AT 8:30
`·
`WILLIAM l WALSH CLERK
`
`Exh. 1040
`
`
`
`WHEREAS, Plaintiffs further asserted that the commercial manufacture,
`
`use, offer to sell, sale, or importation ofTeva's ANDA Products, if approved by
`
`the FDA prior to the expiration of the '724, '725, '424, and '219 patents, including
`
`any pediatric exclusivity, would infringe the '724, '725, '424, and '219 patents;
`
`WHEREAS, Plaintiffs asserted claims 2 and 9 of the '724 patent, claim 2 of
`
`the '725 patent, claim 6 of the '424 patent, and claims 1, 2, and 6 of the '219 patent
`
`("the asserted claims") against Teva.
`
`WHEREAS, this action was tried before the Court on June 2-5, 8-12, 15-16,
`
`2015, and August 12, 2015;
`
`NOW THEREFORE, IT IS ORDERED AND ADJUDGED that for the
`
`reasons set forth in the November 13, 2015 Memorandum Opinion, and any further
`
`opinion that the Court will issue:
`
`1.
`
`Judgment is entered as follows:
`
`a.
`
`The asserted claims of the '724, '725, and '424 patents are valid
`
`and are infringed by both ofTeva's proposed 0.25 mg I 5 mL and 0.075mg/1.5
`
`mL generic products.
`
`b.
`
`The asserted claims of the '219 patent are valid and are
`
`infringed by Teva's proposed 0.25 mg I 5 mL generic product.
`
`c.
`
`The asserted claims of the '219 patent are valid and are not
`
`infringed by Teva's proposed 0.075 I l .5 mL mg generic product.
`
`2
`
`Exh. 1040
`
`
`
`2.
`
`Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any final
`
`approval of ANDA No. 090713 by the FDA shall be no earlier than July 30, 2024,
`
`the expiration of the '724, '725, '424, and '219 patents, including pediatric
`
`exclusivity. If Plaintiffs become entitled to any other exclusivities that are not
`
`referenced herein, Plaintiffs may apply to the Court for further relief as may be
`
`appropriate.
`
`3.
`
`Pursuant to 35 U.S.C. § 271(e)(4)(B), Teva and its officers, agents,
`
`servants, employees, and attorneys, and other persons who are in active concert or
`
`participation with Teva, its officers, agents, servants, employees, and attorneys, are
`
`hereby enjoined until the expiration of the '724, '725, '424, and '219 patents,
`
`including any applicable exclusivity, from the commercial manufacture, use, offer
`
`to sell, or sale within the United States, or importation into the United States, of
`
`any palonosetron hydrochloride intravenous solution product that is the subject of
`
`ANDA No. 090713.
`so ORDERED this /kif. day of A/py~ , 2015.
`
`le Mary L. ooper
`The Honor
`United ates District Judge
`
`3
`
`Exh. 1040
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