HC blocks Glenmark from selling US firm’s diabetes drug

The Delhi High Court today restrained Indian firm Glenmark Pharmaceuticals from manufacturing, marketing or selling its anti-diabetes drugs Zita and Zita-Met, saying it has "prima facie" infringed the patent of US drug maker Merck Sharp and Dohme (MSD).

A bench of Justices S Ravindra Bhat and Najmi Waziri, while granting the interim injunction, said MSD "has established a prima facie case of patent infringement" by Glenmark.

It directed Glenmark to give an undertaking that it will comply with the order.

The court also set aside its earlier single-judge order of 5 April 2013 refusing to restrain Glenmark from manufacturing and selling its medicines meant for treatment of Type-2 diabetes.

The bench, however, on Glenmark's oral plea to allow it to sell its goods already in the market, clarified that it "may sell such of the products which are already in the market, ie, in possession of its distributors and retailers".

"It shall be in compliance of injunction, not further sell or distribute or place in the market the drugs in question," the court said and added if any stocks of such goods are in its factory awaiting distribution, "true and correct accounts thereof be given".

It also allowed representatives of MSD to inspect the gate passes of the manufacturing facility of Glenmark to ascertain for themselves as to how much stock has already been distributed prior to the order and what remains in factory.

It directed MSD to give an undertaking that in the event it loses in patent infringement suit, it will compensate the Indian firm for the losses suffered by it.

MSD in its plea challenging the earlier order as well as seeking an interim injunction against Glenmark had alleged that the Indian pharma company had violated its IPR over its anti-diabetes medicines, Januvia and Janumet, by coming out with their own drugs containing the same salts.

The US firm had said it had invented 'Sitagliptin' salt used in its anti-diabetes drugs and has patent over the molecule.

Glenmark, on the other hand, had contended that 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. .

Glenmark had said that Sitagliptin Phosphate has been a distinct product from Sitagliptin and due to this, MSD had obtained separate patent for Sitagliptin Phosphate in the US.

MSD first applied for a separate patent for Sitagliptin Phosphate in India and later abandoned it, Glenmark had said.

On its part, the US drug firm had said its anti-diabetes drug Januvia is not costly at Rs43 a pill which is roughly one-fith h of its price in the US.

Welcoming the court's directions, an MSD India spokesperson said, "MSD 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."