New Delhi: Glenmark Pharmaceuticals Ltd cannot make or sell the anti-diabetes drug sitagliptin, the Delhi high court ordered on Friday after hearing US-based Merck Sharp and Dohme Corp.’s plea on patent infringement.

Justices S. Ravindra Bhat and Najmi Waziri, however, allowed Glenmark to sell inventory held by distributors and retailers. The firm sells the medicine under the brand names Zita and Zita-met.

The temporary restraint will hold till another judge of the high court decides on the lawsuit filed by the US drug maker. The bench on Friday also directed Merck to file an undertaking that it will compensate Glenmark for damages in case it loses the patent suit. Glenmark has been directed to furnish an undertaking to comply with the injunction within two weeks and submit a detailed account of its earnings from the products from the date of the filing of suit.

Merck has established a case of patent infringement since Glenmark uses sitagliptin as the active component in its chemical formulation, the court said.

However, “given the size of the diabetes drug market in India and the sheer number of patients from all economic strata of society, the demand for low-priced medicines will remain, rather than any distortion of demand due to brand loyalty or a first mover’s advantage to Merck", the judges said.

Balancing the interests of the litigants, the court said its interim direction ensures that Glenmark will, if successful, be able to return to the market without any handicap and be compensated at market value for the period for which it was excluded.

Merck, which manufactures sitagliptin under the brand names Januvia and Janumet, had approached the high court in April 2013 to restrain Glenmark from manufacturing the drug used for the treatment of type II diabetes. In a 5 April 2013 order, justice Rajiv Sahai Endlaw had refused to grant an injunction.

“The company is seeking legal advice on the next steps and will take appropriate action," a Glenmark spokesperson said.

Welcoming the court’s directions, Merck’s India spokesperson said, “Merck is pleased with the injunction granted by the Delhi high court against Glenmark for patent violation of our diabetes medicines Januvia and Janumet. We believe our patents for both the drugs are valid and enforceable and will continue to defend them."

Another Indian generic drug maker, Sun Pharmaceutical Industries Ltd, which sells sitagliptin in India under the brand name Istavel and the sitagliptin-metformin combination under the brand name Istamet with a permit from Merck, has also sued Glenmark in this case.

The matter will come up for hearing before the single judge on 10 April.

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