From the record · verbatim
"NOW THEREFORE, IT IS HEREBY ORDERED, ADJUDGED, AND DECREED THAT: 1. This Court has jurisdiction over Plaintiffs Merck Sharp & Dohme B.V. and Merck Sharp & Dohme LLC (collectively, “Merck”), Defendants1 , and subject matter of this action. 2. In accordance with the Court’s June 13, 2023 Opinion and Order (ECF Nos. 418 and 419), pursuant to Federal Rule of Civil Procedure 58, Final Judgment is entered in favor of Merck and against Defendants with respect to RE44,733 (“the ’733 patent”). Defendants’ ANDA Products that are the subject of ANDA Nos. 214307 (Aurobindo), 213915 (Mylan), 214276 (USV), 214236 (DRL), 214364 (Gland), 214230 (Mankind), 214311 (Sandoz), 214319 (Sun), 213868 (Fresenius), and 214126 (Teva) (collectively, “Defendants’ ANDAs”) infringe claims 4, 12, and 21 of the ’733 patent. 3. There is no finding of invalidity as to the ’733 patent. 1 Aurobindo Pharma USA, Inc., Aurobindo Pharma Ltd., and Eugia Pharma Specialties Ltd. (collectively, “Aurobindo”); Mylan API US LLC, Mylan Pharmaceuticals Inc., and Mylan Inc. (collectively, “Mylan”); USV Private Ltd. (“USV”); Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “DRL”); Gland Pharma Ltd. (“Gland”); Sandoz Inc. and Lek Pharmaceuticals d.d. (collectively, “Sandoz”); Mankind Pharma Ltd. and Lifestar Pharma LLC (collectively, “Mankind”); Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries Ltd (collectively, “Sun”); Fresenius Kabi USA, LLC (“Fresenius”); and Teva Pharmaceuticals USA, Inc. (“Teva”) (Aurobindo, Mylan, USV, DRL, Gland, Sandoz, Mankind, Sun, Fresenius, and Teva are collectively referred to herein as “Defendants”). Case 2:20-cv-02576-CCC-LDW Document 423 Filed 06/29/23 Page 1 of 8 PageID: 9444 2 4. The portion of the patent term extension for the ’733 patent after December 14, 2022 is not invalid. 5. The ’733 patent does not expire until January 27, 2026. 6. Pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval by FDA of Defendants’ ANDAs shall be no earlier than the expiration date of the ’733 patent, except to the extent subsequently (a) agreed between any Defendant(s) and Merck or (b) ordered by this Court. 7. Pursuant to 35 U.S.C. § 271(e)(4)(B), Defendants and their officers, agents, servants, employees, and attorneys, and other persons in active concert or participation with any of them, are hereby enjoined from commercially manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the products that are the subject of Defendants’ ANDAs until January 27, 2026, except to the extent subsequently (a) agreed between any Defendant(s) and Merck or (b) ordered by this Court. 8. All pending motions and other outstanding requests for relief not specifically addressed herein are DENIED. SO ORDERED this ___ day of June 2023"
Case 2:20-cv-02576 · D.N.J. · closed 29 June 2023