Aurobindo Pharma in legal battle with Merck over Janumet

US pharma giant Merck & Co’s (NYSE: MRK) Indian subsidiary, which trades under the name Merck Sharp & Dohme, has sued an Indian company seeking to block it from ploughing ahead with its planned generic that Merck alleges would infringe its patent.

Merck filed a petition in a US court against Aurobindo Pharma (BSE: 524804),P alleging the Indian drug maker is planning to come out with a generic version of its blockbuster diabetes drug Janumet (metformin hydrochloride and sitagliptin phosphate) before expiration of patent.

Merck filed the patent infringement petition against Aurobindo in the United States District Court for the District of Delaware on four counts.

Janumet is indicated for the control of high blood sugar in people with type 2 diabetes reported over $2 billion revenues globally including $589 million in the USA in 2019.

Patents of Janumet will expire in July 2022 for the USA with a six-month pediatric exclusivity, Merck said in its annual report.

Merck in its petition, said Aurobindo Pharma had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration seeking approval to engage in the commercial manufacture, sale, and/or importation of the intended generic drugs prior to the expiration of the '708' patent.

Also suing Dr Reddy’s

In June, Merck had dragged Dr Reddy's Laboratories (BSE: 500124) to a US court over similar patent issues on Janumet and Januvia (sitagliptin phosphate).

Januvia and Janumet generated over $5.5 billion revenues globally including $2.3 billion in USA in 2019. Patents on Januvia are also to expire in July 2022.

Merck sought from the court, among others, a preliminary and permanent injunction enjoining Dr Reddy's and all persons acting in concert with it.

Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiry of a patent related to the branded medicine that the pharma company seeks to copy.