The Supreme Court on Friday restrained Glenmark Pharmaceuticals from the manufacture and institutional sales of branded generic versions of anti-diabetes drug, Sitagliptin, till July 22 even as it allowed it to continue selling existing stocks, asking the trial judge to decide expeditiously on the company’s dispute with US-based Merck, which holds a patent on the drug.
Merck’s India subsidiary had dragged Glenmark to court in 2013, seeking to halt the sale of generic versions of the type II diabetes drug, sold by the Indian company at much lower prices than the patented version. Last year, Glenmark sold its drugs, branded Zita and Zita-Met, 30% cheaper than Merck’s Januvia and Janumet, enabling patients to save up to Rs 5,000 a year.
Another Indian firm, Sun Pharmaceutical, is Merck’s licensee for making sitagliptin in India. It sells the drug in the country under the brand name Istavel and the sitagliptin-metformin combination under the brand name Istamet. Sun Pharme also sued Glenmark in this case.
An SC bench headed by Justice Ranjan Gogoi, without going into the merits of the Delhi High Court’s March 20 decision restraining Glenmark from manufacturing and selling sitagliptin, said its “primary concern would be to balance equities between parties while maintaining public interest, which will be best served if the existing stock of Zita and Zita-Met is allowed to be sold in the market, which, according to the petitioner (Glenmark), itself can take care of the current demand in the market by November 2015.” The court added: “…we are of the view that the unfinished formulations of sitagliptin phosphate monohydrate (SPM), which is to be processed in the petitioner’s factory, will not be undertaken …until the next date of heraring” on July 22.
The apex court also gave the Registrar General of the HC the liberty to approach the Chief justice for “necessary remedial action” if any difficulties arise during recording of the evidence. To ensure that the matter does not drag on further, the bench directed the local commissioner to record evidence on a day-to-day basis commencing from May 28 and complete the same on or before June 30. While warning both Merck and Glenmark against any non-cooperation during the trial, it asked the trial judge to commence arguments on or from July 6.
Glenmark’s counsel AM Singhvi told the court that the firm had stocks to the tune of Rs 42 crore of Zita and Rs 43 crore of Zita-Met available in various channels of the market. Glenmark said it had nil stock of both the drugs in its godown, and “1,770 kg of unfinished formulation of SPM being processed towards of preparation of tablets was lying in the factory and it would take 2-3 months for complete conversion into finished product.” Kapil Sibal appeared for Merck.
Earlier, the apex court had stayed the Delhi HC March 20 decision restraining Glenmark from manufacturing and selling sitagliptin. While the US firm says it had invented sitagliptin, used in its anti-diabetes drugs, and has patent over the molecule, Glenmark has contended it has used sitagliptin phosphate in its anti-diabetes drugs-Zita and Zita-Met-and the US firm has no patent right over this salt.