Adverio, Bayer and Merck Sue Torrent Over Generic VERQUVO (Vericiguat) Tablets on Six Patents.

Adverio Pharma GmbH, Bayer AG, MSD Pharma GmbH, and Merck Sharp & Dohme LLC v. Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc., No. 1:26-cv-01434 (D. Del.), is a Hatch-Waxman patent complaint filed November 6, 2026. The complaint says Adverio Pharma GmbH and Bayer AG are German corporations based in Leverkusen, Germany; that Adverio is the assignee of each asserted patent; that MSD Pharma GmbH, a German corporation based in Munich, is an exclusive licensee under each asserted patent; and that Merck Sharp & Dohme LLC, a New Jersey limited liability company based in Rahway, New Jersey, holds NDA No. 214377 for VERQUVO (vericiguat). It alleges, on information and belief, that Torrent Pharmaceuticals Ltd. is an Indian corporation based in Ahmedabad, India, and that Torrent Pharma Inc. is a Delaware corporation based in Basking Ridge, New Jersey, and a wholly owned subsidiary of the Indian company. Subject matter jurisdiction is pleaded under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202, and venue, on information and belief, under 28 U.S.C. §§ 1400(b) and 1391(c)(3).

The drug and the ANDA

The complaint describes VERQUVO as a soluble guanylate cyclase stimulator indicated to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic heart failure and ejection fraction less than 45%, sold as 2.5 mg, 5 mg, and 10 mg tablets, and says each asserted patent is listed in the Orange Book in connection with VERQUVO. The FDA Orange Book lists NDA 214377 for VERQUVO with an approval date of January 19, 2021. The complaint says that by a letter dated September 25, 2026, Torrent notified the plaintiffs that it had submitted ANDA No. 220221, with an amendment, seeking approval to sell 5 mg and 10 mg vericiguat tablets, and that the amendment included a Paragraph IV certification as to the asserted patents. It alleges, on information and belief, that ANDA No. 220221 was also prepared and submitted for Torrent's 2.5 mg vericiguat tablets, and that the vericiguat in the 5 mg and 10 mg products is in crystalline form of Polymorph I. It says this action was filed within 45 days of receipt of the notice letter.

The patents

Four of the patents are titled Substituted 5-fluoro-1H-pyrazolopyridines and their use: U.S. Patent 8,420,656, issued April 16, 2013; U.S. Patent 8,921,377, issued December 30, 2014; U.S. Patent 10,736,896, issued August 11, 2020; and U.S. Patent 11,439,642, issued September 13, 2022. U.S. Patent 9,993,476, issued June 12, 2018, carries the printed title Substituted 5-flouro-1H-pyrazolopyridines and their use. U.S. Patent 9,604,948, issued March 28, 2017, is titled Process for preparing substituted 5-fluoro-1H-pyrazolopyridines. The complaint alleges, on information and belief, that Torrent's products will infringe at least claim 7 of the '656 patent, claim 8 of the '377 patent, claim 1 of the '948 patent, claim 4 of the '476 patent, claim 4 of the '896 patent, and claim 1 of the '642 patent.

Claim 7 of the '656 patent claims a compound of a drawn chemical formula, or a salt thereof. Claim 4 of the '377 patent claims a method of treatment of heart failure by administering to a human or animal an effective amount of a pharmaceutical composition comprising a compound of formula (I) and an inert, non-toxic, pharmaceutically suitable excipient, and claim 8 depends from claim 4 and specifies the compound of formula (I) as a drawn structure. Claim 1 of the '948 patent claims a compound of formula (I) in crystalline form of polymorph I whose x-ray diffractogram shows peak maxima of the 2 theta angle at 5.9, 6.9, and 22.7. Claim 1 of the '476 patent claims a method of treating or preventing one or more of coronary heart disease, systolic or diastolic heart failure, angina pectoris, ischaemias, peripheral and cardiac vascular disorders, kidney failure, renal insufficiency, and increased microalbuminurea by administering a therapeutically effective amount of a compound of formula (I), or an N-oxide, salt, or salt of an N-oxide thereof, to a human or animal in need thereof, and claim 4 depends from claim 1 and specifies the compound of formula (I) as a drawn structure. Claim 4 of the '896 patent claims a pharmaceutical formulation comprising the compound of formula (I-A) or a salt thereof and an inert, non-toxic, pharmaceutically suitable excipient. Claim 1 of the '642 patent claims a method of treating or preventing one or more of coronary heart disease, systolic or diastolic heart failure, angina pectoris, ischaemias, peripheral and cardiac vascular disorders, kidney failure, renal insufficiency, and increased microalbuminurea by administering a therapeutically effective amount of a compound of formula (I-A) or a salt thereof to a human or animal in need thereof. The complaint says the claims of the '656 and '896 patents cover vericiguat (the '896 patent also pharmaceutical formulations of it), that the '948 patent claims cover vericiguat in crystalline form of polymorph I, that the '377 patent claims cover methods of treating heart failure with vericiguat or a composition comprising it, and that the '476 and '642 patent claims cover methods of treating or preventing the listed conditions by administering vericiguat.

The counts and relief

For each patent, the complaint pleads one count of infringement under 35 U.S.C. § 271(e)(2) through the ANDA submission and one count for a declaration under 28 U.S.C. §§ 2201 and 2202 that commercial manufacture, use, sale, offer for sale, or importation of the 5 mg and 10 mg products will infringe, induce infringement of, and/or contribute to infringement under 35 U.S.C. § 271(a), (b), and/or (c): Counts 1 and 2 for the '656 patent, 3 and 4 for the '377 patent, 5 and 6 for the '948 patent, 7 and 8 for the '476 patent, 9 and 10 for the '896 patent, and 11 and 12 for the '642 patent. The prayer asks for a judgment of infringement; an order that the effective date of any FDA approval be no earlier than the latest expiration date of the relevant asserted patents, inclusive of any extensions and additional exclusivity periods; preliminary and permanent injunctions; a declaratory judgment of infringement; a declaration that the case is exceptional and attorneys' fees under 35 U.S.C. § 285; costs and expenses; and other relief.

Docket

The docket shows the complaint, magistrate consent forms, the ANDA form, the patent and trademark report to the Commissioner, two Rule 7.1 disclosure statements, and summons issued. Watch for a judge assignment, service on the Torrent companies, and their answer, counterclaims, or a Rule 12 motion. The case can end at any time, including by settlement or voluntary dismissal.