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New Delhi:

The Supreme Court on Friday restrained Glenmark Pharmaceuticals Ltd from manufacturing sitagliptin, a key active molecule of the company’s anti-diabetes drug, over which the generic drug maker is embroiled in a patent dispute with US-based Merck Sharp and Dohme Corp., a unit of Merck and Co. Inc.

Merck Sharp and Dohme in 2013 moved the Delhi high court against Glenmark, alleging patent infringement. Judge Rajiv Sahai Endlaw refused to grant an injunction against Glenmark, but a two-judge bench of the high court reversed this position, finding merit in Merck’s plea.

Glenmark then approached the apex court, where at a preliminary stage, the court stayed the Delhi high court’s ruling.

“Going by the prima facie (on the face of it) satisfaction of the high court, we’re of the view that unfinished manufacture of sitagliptin phosphate monohydrate (SPM)... will not be undertaken for the present," the order said.

SPM is the main component of Glenmark’s drug which, according to Merck, cannot be made without manufacturing the active molecule sitagliptin, patented by the US drug maker.

The court, however, allowed Glenmark to sell its stock, valued at 85 crore, in the market. Glenmark told the court these stocks would last for five-six months, or till October-November.

If five months of stock is worth just 42 crore, it will not make a dent in a big company like Glenmark even if the amount is annualized, said Sarabjit Kour Nangra, pharmaceutical analyst at Angel Broking Pvt. Ltd.

A bench comprising justices Ranjan Gogoi and N.V. Ramana asked the trial judge of the Delhi high court to hear the patent dispute on a day-to-day basis starting from 6 July. Before this date, a local commissioner appointed by the high court is required to complete recording the evidence in the case by 30 June, starting on 20 May.

The court is looking to balance the interests of three drug makers, while keeping in mind the larger public interest, it said in its order.

Glenmark declined to comment.

The court also set a timeline for the patent trial to conclude. The arguments in the case are set to start on 6 July, before which all the evidence in the case has to be recorded.

Noting that the court had taken an “unusual and extraordinary course of action" in setting a time schedule for the trial to be completed, the apex court said this was “prompted" by the court’s wish to ensure that “highly contested commercial cases" (like this one) requiring “immediate attention in national interest" could be dealt with.

Merck sells the medicine to control type-II diabetes under the brands of Januvia and Janumet. It also licenses the use of its patent to Sun Pharmaceutical Industries Ltd, which markets the product under the brand names Istavel and Istamet.

Anti-diabetes drugs are the top-selling therapy area in India, where about 65 million people live with the disease and that number is expected to reach 100 million by 2030.

A month’s dose of Merck’s drugs costs about 1,300 ($20) and 1,900 ($30), respectively. Merck has licensed the drugs to Sun Pharmaceutical Industries Ltd for sale in India.

Glenmark sells the medicines under the brand names Zita and Zita-met at a nearly 30% discount to Merck’s price.

Shreya Punj and Reuters contributed to this story.

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