Amarin Pharma, Inc. et al v. Roxane Laboratories, Inc. et.al,

Filing 128

CONSENT JUDGMENT pursuant to ECF No. 127 Stipulation. Signed by Judge Miranda M. Du on 5/25/2018. (Copies have been distributed pursuant to the NEF - LH) Modified on 5/25/2018 to correct doc title(LH).

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD. 10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135 Tel.: (702) 948-8771 / Fax: (702) 948-8773 E-mail: nsantoro@santoronevada.com, jsmith@santoronevada.com Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice) Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice) Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice) COVINGTON & BURLING LLP One CityCenter, 850 Tenth Street, NW Washington, DC 20001 Tel.: (202) 662-6000 / Fax: (202) 662-6291 E-mail: csipes@cov.com, estole@cov.com, mkennedy@cov.com, mkeane@cov.com, esonnenschein@cov.com, awhitt@cov.com Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited 15 UNITED STATES DISTRICT COURT DISTRICT OF NEVADA 16 17 18 AMARIN PHARMA, INC. and AMARIN PHARMACEUTICALS IRELAND LIMITED, Plaintiffs, 19 20 TEVA PHARMACEUTICALS USA, INC. (Consolidated with 2:16-cv-02562-MMD-NJK, 2:16-cv-02658-MMD-NJK, and 2:17-cv-02641MMD-NJK) v. 21 Case No.: 2:16-cv-02525-MMD-NJK 22 CONSENT JUDGMENT Defendant. 23 24 Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (hereinafter collectively 25 “Amarin”), and Teva Pharmaceuticals USA, Inc. (hereinafter “Teva”), the parties in the above- 26 captioned actions, have agreed to terms and conditions representing a negotiated settlement of the 27 actions and have set forth those terms and conditions in a Settlement Agreement (the “Settlement 28 1 Agreement”). Now the parties, by their respective undersigned attorneys, hereby stipulate and 2 consent to entry of judgment and an injunction in the actions, as follows: 3 ORDERED, ADJUDGED AND DECREED as follows: 4 This District Court has jurisdiction over the subject matter of the above actions and has 5 personal jurisdiction over the parties. 6 As used in this Consent Judgment, the terms “Teva Product,” “Approved Vacepa Product,” 7 “Generic Icosapent Ethyl Product,” “Licensed Patents,” and “Affiliate” shall have the meanings 8 assigned to them in the Settlement Agreement. 9 Teva admits that the Teva Product infringes the Licensed Patents and that the Licensed 10 Patents and all the claims contained therein are each valid and enforceable in all respects. This 11 admission is without prejudice to any claim, defense or counterclaim (including non-infringement, 12 invalidity, unenforceability and unpatentability) in any future action regarding both (a) the Licensed 13 Patents and (b) a product other than a Generic Icosapent Ethyl product and other than the Teva 14 Product. 15 Unless otherwise specifically authorized pursuant to the Settlement Agreement, Teva, 16 including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed 17 Patents, on its own part or through any Affiliate, by making, having made, using, selling, offering to 18 sell, importing or distributing of the Teva Product. 19 Unless otherwise specifically authorized pursuant to the Settlement Agreement, Teva is 20 hereby enjoined and estopped during the term of each of the Licensed Patents from making any 21 challenge to the validity or enforceability of the Licensed Patents and from asserting that the Teva 22 Product does not infringe any of the Licensed Patents. Amarin acknowledges that Teva is entitled 23 to maintain its Paragraph IV certification to the Licensed Patents with respect to the Teva Product 24 pursuant to 21 C.F.R. § 314.94(a)(12)(v). 25 26 This Consent Judgment does not impact the U.S. Food and Drug Administration’s ability to grant final approval of the Teva Product at any time. 27 28 -2- 1 2 3 4 5 6 Compliance with this Consent Judgment may be enforced by Amarin and its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. This District Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and the Settlement Agreement. All claims, counterclaims, affirmative defenses and demands in these actions are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. 7 IT IS SO ORDERED: 8 _______________________________________ UNITED STATES DISTICT JUDGE 9 May 25, 2018 Dated:_________________________________ 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 We hereby consent to the form and entry of this Order: /s/Jason D. Smith Nicholas J. Santoro (Nev. Bar No. 532) Jason D. Smith (Nev. Bar No. 9691) SANTORO WHITMIRE, LTD. 10100 W. Charleston Blvd., Suite 250 Las Vegas, NV 89135 Tel.: (702) 948-8771 / Fax: (702) 948-8773 Email: nsantoro@santoronevada.com, jsmith@santoronevada.com /s/ John P. Desmond John P. Desmond (Nev. Bar No. 5618) Brian R. Irvine (Nev. Bar No. 7758) DICKINSON WRIGHT PLLC 100 West Liberty St., Suite 940 Reno, NV 89501 Tel: (775) 343-7500 / Fax: (775) 786-0131 E-mail: jdesmond@dickinsonwright.com, birvine@dickinsonwright.com Christopher N. Sipes (admitted pro hac vice) Einar Stole (admitted pro hac vice) Michael N. Kennedy (admitted pro hac vice) Megan P. Keane (admitted pro hac vice) Eric R. Sonnenschein (admitted pro hac vice) Alaina M. Whitt (admitted pro hac vice) COVINGTON & BURLING LLP One CityCenter, 850 Tenth Street, NW Washington, DC 20001 Tel.: (202) 662-6000 / Fax: (202) 662-6291 Email: csipes@cov.com, estole@cov.com, mkennedy@cov.com, mkeane@cov.com, esonnenschein@cov.com, awhitt@cov.com J.C. Rozendaal (admitted pro hac vice) Michael E. Joffre (admitted pro hac vice) Chandrika Vira (admitted pro hac vice) STERNE KESSLER, GOLDSTEIN & FOX PLLC 1100 New York Ave., NW, Suite 600 Washington, DC 20005 Tel: (202) 371-2600 / Fax: (202) 371-2540 E-mail: jcrozendaal@skgf.com, joffre@skgf.com, cvira@skgf.com Attorneys for Defendant Teva Pharmaceuticals USA, Inc. Attorneys for Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited 27 28 -3-

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