Merck Sharp & Dohme Corp has moved a US court against Dr Reddy's Laboratories, alleging that the Indian drug maker was planning to come out with generic versions of its multi-billion dollar drugs, Januvia and Janumet, before expiration of its patent.
Merck has filed the possible patent infringement petition against Dr Reddy's in the United States District Court for the District of Delaware on four counts.
Januvia (sitagliptin phosphate) and Janumet (metformin hydrochloride and sitagliptin Phosphate), which are indicated to control high blood sugar in people with type 2 diabetes clocked over $5.5 billion revenues globally including $2.3 billion in USA in 2019.
Patents of Januvia and Janumet will expire in July 2022 for the US with six-month pediatric exclusivity, Merck said in its 2019 annual report.
Merck in its petition filed on June 23, said Dr Reddys had submitted ANDAs (abbreviated new drug application) to the US FDA seeking approval from the health regulator to engage in commercial manufacture,sale and or importation of intended generic drugs prior to expiration of the 708 patent.
Merck sought the court, among others, a preliminary and permanent injunction enjoining Dr Reddy's and all persons acting in concert with it, from the commercial manufacture, use, sale, or importation into the US the Indian drug makers ANDA Products or any other drug product covered by the patent.
Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded medicine that the pharma company seeks to copy.
Acity-based pharmaceutical company senior official said patent infringement cases are not uncommon for generic drug makers in the USA and the lawsuit will not have any implications on the performance of the company.
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