Bausch & Lomb Incorporated, Bausch + Lomb Ireland Limited, and Eye Therapies, LLC v. Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd., No. 3:26-cv-14597 (D.N.J.), is a Hatch-Waxman patent complaint filed November 11, 2026. The complaint says Bausch & Lomb Incorporated is a New York corporation with a place of business in Rochester, New York, and is the registered holder of approved New Drug Application No. 218424 for Lumify Preservative Free ophthalmic solution/drops (brimonidine tartrate, 0.025%). It says Bausch + Lomb Ireland Limited is an Irish company based in Dublin and exclusively licenses the asserted patents, and that Eye Therapies, LLC is a Delaware limited liability company based in Dana Point, California, and is the owner of the asserted patents. The complaint alleges, upon information and belief, that Dr. Reddy's Laboratories, Inc. is a New Jersey corporation based in Princeton, New Jersey; that Dr. Reddy's Laboratories, Ltd. is a public limited company organized under the laws of India and based in Hyderabad; and that Dr. Reddy's Laboratories, Ltd. is the ultimate parent of Dr. Reddy's Laboratories, Inc. The complaint alleges, upon information and belief, that venue is proper under 28 U.S.C. §§ 1391(c) and (d) and 1400(b).
The patents and the ANDA
The complaint asserts two patents, each titled Vasoconstriction Compositions and Methods of Use: U.S. Patent 12,311,050, issued May 27, 2025, and U.S. Patent 12,514,857, issued January 6, 2026. The complaint says both patents are listed in the FDA's Orange Book in conjunction with NDA No. 218424 for Lumify Preservative Free, which it says FDA approved on April 19, 2024, and that the Orange Book entry for Lumify Preservative Free shows an expiration date of July 27, 2029, for each asserted patent. The complaint asserts at least one claim of each patent, including, for example, claim 1. Claim 1 of the '050 patent covers a method for reducing eye redness in a human subject having ocular hyperemia, consisting of topically administering to an eye of that person, who is in need of that reduction of eye redness, a composition in the form of an ocular drop consisting of 0.025% weight by volume brimonidine as the sole active ingredient, and one or more non-therapeutic components that do not include a preservative, wherein the ocular drop has a pH between 5.5 to 6.5, and wherein the ocular hyperemia is reduced. Claim 1 of the '857 patent covers a method selected from the group consisting of reversing rebound hyperemia, reducing eye redness, increasing eye whiteness and a combination thereof, comprising topically administering to a subject in need thereof a composition comprising from about 0.01% to about 0.025% w/v brimonidine or a pharmaceutically acceptable salt thereof, wherein w/v denotes weight by total volume of the composition.
The complaint alleges, upon information and belief, that the defendants filed or caused to be filed ANDA No. 221730 under section 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j), seeking approval to manufacture, use, and sell in the United States a generic version of Lumify Preservative Free. It says the plaintiffs received a letter from the defendants dated August 21, 2026, purporting to be a Notice of Paragraph IV Certification regarding that ANDA, addressed to Bausch & Lomb Incorporated and Eye Therapies, and that the letter is directed to U.S. Patents 8,293,742, 11,596,600, and 9,259,425, which are not asserted in this action. The complaint says the defendants have not certified under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the '050 or '857 patents and have not provided the plaintiffs notice with respect to either asserted patent. It alleges that the notice letter, the ANDA submission, and applicable regulatory requirements demonstrate that the defendants intend to commercialize the ANDA product before the asserted patents expire, including because, according to the notice letter, the defendants seek approval to engage in the commercial manufacture, use, or sale of the product before the July 27, 2029 expiration of the '600 patent, which the complaint says is the same expiration date as the asserted patents.
The counts and the prayer
Count I alleges infringement of the '050 patent under 35 U.S.C. § 271(e)(2) by submitting the ANDA, and alleges, upon information and belief, that if the ANDA product is approved and marketed it will be used according to its labeling in a manner that infringes at least claim 1, and that the defendants will induce infringement under § 271(b) and contributorily infringe under § 271(c). Count II seeks a declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that commercial manufacture, use, offer for sale, sale, or importation of the ANDA product will infringe the '050 patent. Counts III and IV plead the same theories for the '857 patent. The prayer asks for judgment that the claims of each asserted patent are not invalid and not unenforceable and that the defendants have infringed at least one claim of each under § 271(e)(2); an order under § 271(e)(4) that the effective date of any FDA approval of the ANDA product be not earlier than the expiration of the asserted patents, or such later date as the court may determine; injunctions against commercial manufacture, use, import, offer for sale, and sale of the ANDA product, and against seeking, obtaining, or maintaining approval of the ANDA, until those patents expire; a declaration that the case is exceptional under 35 U.S.C. §§ 285 and 271(e)(4), with costs, expenses, and reasonable attorney's fees; and further relief the court deems just and proper.
What to watch next
Watch for the defendants' answer, a Rule 12 motion, or a scheduling order.