From the record · verbatim
"Plaintiff Jazz Pharmaceuticals Ireland Limited (“Jazz”) and Defendant Granules India Limited (“Granules”), the parties in the above-captioned action, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this 26th day of March, 2026: ORDERED, ADJUDGED, AND DECREED as follows: 1. This Court has jurisdiction over the subject matter of the above action andhas personal jurisdiction over the parties for purposes of this action only, including as set forth below in Paragraph 6 of this Consent Judgment. Case 2:25-cv-14606-SRC-JSA Document 23 Filed 03/26/26 Page 1 of 4 PageID: 592 - 2 - 2. As used in this Consent Judgment, the term “Granules ANDA Product” shall mean a drug product manufactured, imported, sold, offered for sale, marketed, or distributed pursuant to Abbreviated New Drug Application No. 220725 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico. 3. As used in this Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 8,591,922; 8,772,306; 8,901,173; 9,050,302; 9,132,107; 9,486,426; 10,195,168; 10,213,400; 10,675,258; 10,864,181; 11,253,494; 11,426,373; 11,554,102; and 11,986,446. 4. Until expiration of the Patents-in-Suit, Granules, including any of its successors and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third party on its behalf, by making, having made, using, selling, offering to sell, importing, or distributing of the Granules ANDA Product in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico, unless and to the extent otherwise specifically authorized by Jazz, and is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the Patents-in-Suit by any such third parties in connection with making, having made, using, selling, offering to sell, importing, or distributing of any calcium, magnesium, potassium, and sodium oxybates oral solutioncontaining drug product that references NDA 212690 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico, unless and to the extent otherwise specifically authorized by Jazz. 5. Compliance with this Consent Judgment may be enforced by Jazz and its respective successors in interest or assigns. 6. This Court retains jurisdiction to enforce the terms of this Consent Judgment and to enforce and resolve any disputes related thereto. Case 2:25-cv-14606-SRC-JSA Document 23 Filed 03/26/26 Page 2 of 4 PageID: 593 - 3 - 7. All claims, counterclaims, affirmative defenses and demands pertaining tothe Patents-in-Suit are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. 8. Nothing herein prohibits or is intended to prohibit Granules frommaintaining any “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to the Patents-in-Suit. 9. Nothing herein prohibits or is intended to prohibit Granules from engagingin any activity permitted under 35 U.S.C. § 271(e)(1). 10. Nothing herein restricts or is intended to restrict the U.S. Food and DrugAdministration from approving Abbreviated New Drug Application No. 220725 or the Granules ANDA Product."
Case 2:25-cv-14606 · D.N.J. · closed 26 March 2026
