“This matter is before the Court on the unopposed motion of Plaintiffs Amicus Therapeutics US, LLC and Amicus Therapeutics, Inc. (collectively “Amicus”) and Defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively “Lupin”). WHEREAS, Amicus owns U.S. Patent Nos. 11,633,388; 11,833,164; and 12,042,490 (“the Asserted Patents”); Case 1:23-cv-00964-CJB Document 24 Filed 12/22/25 Page 1 of 5 PageID #: 678 2 WHEREAS, Lupin submitted Abbreviated New Drug Application No. 217793 (“Lupin’s ANDA”) to the FDA under 21 U.S.C. § 355(j) seeking to obtain approval to commercially manufacture and sell generic migalastat for treatment of Fabry disease; WHEREAS, in this Action, Amicus alleges that Lupin infringed one or more claims of the Asserted Patents under 35 U.S.C. § 271(e)(2) by virtue of Lupin’s submission of Lupin’s ANDA to the FDA and has sought an injunction for such infringement, and Lupin has denied such allegations; WHEREAS, Amicus and Lupin have reached an agreement to finally settle the Litigation as set forth in this Consent Judgment as to Lupin and a separate License Agreement (“License Agreement”) which is contemporaneously and separately being executed; WHEREAS, final settlement of this Action will help Amicus and Lupin avoid the substantial uncertainty and risks involved with prolonged litigation; WHEREAS, final settlement of this Action will permit Amicus and Lupin to save litigation costs, as well as adhere to the judicially recognized mandate that encourages the settlement of litigation whenever possible; WHEREAS, final settlement of the Action serves the public interest by saving judicial resources and avoiding the risks to each of Amicus and Lupin associated with infringement; and WHEREAS, Amicus and Lupin each consent to personal jurisdiction in Delaware for purposes of enforcing the License Agreement; IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows: 1. The Court has jurisdiction over Amicus and Lupin and the subject matter of this litigation. 2. Lupin acknowledges that it has infringed the Asserted Patents under 35 U.S.C. § 271(e)(2) and that Amicus did not authorize the manufacture, use, sale, offer for sale, importation Case 1:23-cv-00964-CJB Document 24 Filed 12/22/25 Page 2 of 5 PageID #: 679 3 and distribution of the product described in Lupin’s ANDA 3. Lupin and its successors, assigns, and affiliates, and partners or joint-venturers with are enjoined as of the date hereof from infringing the Asserted Patents by the commercial manufacture, use, offer to sell, sale, importation, or distribution of any generic migalastat products that are the subject of Lupin’s ANDA that is not pursuant to a license granted by Amicus or otherwise exempt from infringement under 35 U.S.C. § 271(e)(1), and from inducing others to infringe or contributing to the infringement of the asserted patents by inducing others to manufacture, use, offer to sell, sale, import, or distribute or contributing to others’ manufacture, use, offer for sale, sale, importation, or distribution of any generic migalastat products that are the subject of Lupin’s ANDA that is not pursuant to a license granted by Amicus or otherwise exempt from infringement under 35 U.S.C. § 271(e)(1). 4. All claims in this Action are hereby dismissed without prejudice. 5. Each party shall bear its own costs and attorneys’ fees. 6. This Court shall retain jurisdiction over Lupin and Amicus for the purpose of enforcing the terms of this Consent Judgment and over any matters related to or arising from the interpretation or enforcement of the License Agreement or any legal or equitable claim concerning the License Agreement by any third party. 7. This Consent Judgment constitutes a “consent decree” pursuant to 21 U.S.C. § 355(j)(5)(B)(iii)(I)(bb), such that Final Approval of Lupin’s Abbreviated New Drug Application No. 217793 under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) may be granted on the date that this Consent Judgment is entered.”