Merck Sharp & Dohme Corp, a subsidiary of Merck & Co has fileda petition in a US court against Aurobindo Pharma Limited alleging the Indian drugmaker is planning to come out with generic versions of its blockbuster drug Janumet before expiration of patent. Merck filed the possible patent infringement petition against Aurobidno in the United States District Court for the District of Delaware on four counts last week.
Janumet (metformin hydrochloride and sitagliptin Phosphate) which is indicated to control high blood sugar in people with type 2 diabetes clocked over USD two billion revenues globally including USD 589 million in the USA in 2019, according to Merck's 2019 annual report. Patents of Janumet will expire in July 2022 for theUSA withsix-month pediatric exclusivity, Merck said in theannual report.
Merck in its petition, said that Aurobindo Pharma had submitted ANDAs (abbreviated new drug application)to the USFood and Drug Administration (FDA) seeking approval from thehealth regulator to engage in the commercial manufacture,sale, and/or importation of the intended generic drugs priorto the expiration of the "708" patent. Merck sought the court, among others, apreliminaryand permanentinjunction enjoining Aurobindo, and allpersonsacting in concert with it, from the commercialmanufacture, use, sale, offer for sale, orimportation intothe United States of the Indian drug maker's ANDA Products, orany other drug productcovered by or whose use is covered bythe "708" patent, prior to the expiration.
In June, Merck dragged Dr Reddy's Laboratories to a UScourt over similar patent issues on Janumet and Januvia. UnderParagraph IVPatentCertifications, a companycan seek FDA approval to market a generic drug before theexpiration ofpatentsrelated to the branded medicine thatthe pharma company seeks to copy.
Acity-based pharmaceutical company senior official said patent litigation cases are not uncommon for generic drug makers in the USAand thelawsuit will not have anyimplications on the performance of the company.