Case 2:10-cv-05954-WHW-CLW Document 804 Filed 03/26/14 Page 1 of 5 PageID: 47723 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY JANSSEN PRODUCTS, L.P. et al., Plaintiffs, : C.A. No. 1 0-5954-WHW-CLW V. LUPIN LIMITED et al., Defendants. CONSENT JUDGMENT AND ORDER This action for patent infringement having been brought by Plaintiffs Janssen Products, L.P. and Janssen R&D Ireland (collectively, Janssen ) against Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively, Teva ) for infringement of United States Patent Nos. 5,843,946, 6,248,775, RE42,889, RE43,596, 7,700,645, 7,126,015, and 7,595,408 ( the 946 Patent, the 775 Patent, the 889 Patent, the 596 Patent, the 645 Patent, the 015 Patent, and the 408 Patent, respectively); Teva and Plaintiffs have entered into a Settlement Agreement to settle this action (the Settlement Agreement ) and a License Agreement (the License Agreement ) under which Janssen has granted Teva a license to the Janssen Patents, as defined below (the License ), pursuant to the terms and conditions in the Settlement Agreement and License Agreement; Janssen currently markets in the United States pursuant to New Drug Application No. 21-976 tablets containing darunavir ethanolate for the treatment of HIV- 1 infection, all
Case 2:10-cv-05954-WHW-CLW Document 804 Filed 03/26/14 Page 2 of 5 PageID: 47724 strengths of which Janssen currently sells under the trade name PREZISTA (the Prezista Product ); Teva filed or caused to be filed Abbreviated New Drug Application ( ANDA ) No. 202-118 ( Teva s ANDA ) containing a paragraph IV certification with respect to the 645 Patent and seeking FDA approval to make, sell, offer for sale, use and/or import in or for the United States a product under or described in Teva s ANDA (the Teva Product ); Teva submitted or caused to be submitted paragraph III certifications with respect to the 946 Patent, the 775 Patent, the 889 Patent, the 596 Patent and United States Patent No. RE43,802 ( the 802 Patent ), which paragraph III certifications provide that Teva does not seek FDA approval of Teva s ANDA until after the expiration of such Patents and their associated exclusivities (the 946 Patent, the 775 Patent, the 889 Patent, the 596 Patent, the 802 Patent, the 645 Patent, the 01 5 Patent, and the 408 Patent collectively the Janssen Patents ). Teva acknowledges that (i) claims of each of the 946 Patent, the 775 Patent, the 889 Patent, the 596 Patent, and the 802 Patent, and (ii) the currently asserted claims of the 645 Patent, the 015 Patent, and the 408 Patent, are valid and enforceable solely with respect to the Teva Product in the United States; The Parties have agreed to terminate the pending litigation by the entry of this Judgment and Order; and Plaintiffs and Teva now consent to this Judgment and Order. IT IS HEREBY ORDERED, ADJUDGED AND DECREED: 1. This Court has jurisdiction over the parties and subject matter of this action. 2. Teva admits that (i) claims of each of the 946 Patent, the 775 Patent, the 889 Patent, the 596 Patent, and the 802 Patent, and (ii) the currently asserted claims of the 645 2
Case 2:10-cv-05954-WHW-CLW Document 804 Filed 03/26/14 Page 3 of 5 PageID: 47725 Patent, the 01 5 Patent, and the 408 Patent, are valid and enforceable solely with respect to the manufacture, use, sale, offer for sale, and importation of Teva Product in the United States. 3. All affirmative defenses, claims and counterclaims, which have been or could have been raised by Plaintiffs against Teva and its affiliates, or by Teva and its affiliates against Plaintiffs, in this action solely with respect to the Teva Product and the Janssen Patents are hereby dismissed with prejudice. 4. Teva admits that absent a license from Plaintiffs, the manufacture, sale, offer for sale, use or import of the Teva Product in the United States would constitute infringement of (i) claims of each of the 946 Patent, the 775 Patent, the 889 Patent, the 596 Patent, and the 802 Patent, and (ii) the currently asserted claims of the 645 Patent, the 015 Patent, and the 408 Patent. 5. Neither this Judgment and Order nor the entry of this Judgment and Order may be asserted by Plaintiffs against Teva or any of its affiliates, and shall have no preclusive effect whatsoever, in any cause of action, litigation or proceeding with respect to any product other than the Teva Product in the United States and with respect to any patent other than the Janssen Patents. 6. Teva and its affiliates are hereby enjoined from manufacturing, using, offering for sale, selling in the United States, or importing into the United States the Teva Product during the life of the Janssen Patents until the occurrence of the Start Date under the License Agreement, or as otherwise permitted under the License Agreement. 7. The parties waive all right to appeal from this Judgment and Order. 8. This Court shall retain jurisdiction of this action and over the parties for purposes of enforcement of the provisions of this Judgment and Order. 3
Case 2:10-cv-05954-WHW-CLW Document 804 Filed 03/26/14 Page 4 of 5 PageID: 47726 9. Each party is to bear its own costs and attorneys fees. / IT IS SO ORDERED this day 9/ _/ nitedstates District Judge /s/ John E. Flaherty John E. Flaherty MCCARTER & ENGLISH, LLP 100 Mulberry Street Four Gateway Center Newark, New Jersey 07102 Tel: (973) 639-7903 Fax: (973) 297-3971 Of Counsel Gregory L. Diskant (gldiskant@pbwt.com) Eugene M. Gelernter (emgelerntner@pbwt.com) frena Royzman (iroyzman@pbwt.com) PATTERSON BELKNAP WEBB & TYLER LLP 1133 Avenue of the Americas New York, New York 10036 Tel.: (212) 336-2000 Fax: (212) 336-2222 /s/ Michael E. Patunas LITE DEPALMA GREENBERG, LLC Michael E. Patunas Mayra V. Tarantino Two Gateway Center, Suite 1201 Newark, NJ 07102 (973) 623-3000 (973) 623-0858 (fax) mpatunas@litedepalma.com mtarantino@litedepalma. corn Of Counsel: GOODWIN PROCTER LLP David M. Hashmall Joseph B. Crystal The New York Times Building 620 Eighth Avenue New York, NY 10018 (212) 813-8800 (212) 355-3333 (fax) dhashmall@goodwinprocter.com jcrystal@goodwinprocter.com Attorneys for Janssen Products, LP., Janssen R&D Ireland 4
Case 2:10-cv-05954-WHW-CLW Document 804 Filed 03/26/14 Page 5 of 5 PageID: 47727 GOODWIN PROCTER LLP James C. Rehnquist Elaine Herrmann Blais Emily L. Rapalino Exchange Place 53 State Street Boston, MA 02109 (617) 570-1000 (617) 523-1231 (fax) jrehnquist@goodwinprocter.com eblais@goodwinprocter. corn erapalino@goodwinprocter. corn Attorneys for Defendants Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd. 5