Glenmark loses anti-diabetes drugs' patent battle to Merck

However while granting the injunction, the high court did not say anything about sale of existing stock

In a relief for US drug major Merck Sharp and Dohme (MSD), Delhi High Court on Wednesday restrained Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs Zita and Zita-Met, saying it has infringed patent of the American company.

"Injunction allowed," Justice A K Pathak said and added that MSD shall be entitled to actual cost of the proceedings. "In view of the finding returned on the above referred issues defendant is restrained by decree of permanent injunction from making using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone or in combination with any other drug thereby infringing patent of plaintiff (MSD)," the court said.

CASE STUDY

• High court restrained Glenmark from manufacturing and selling its anti-diabetes drugs Zita and Zita-Met
• It said the firm has infringed patent of the US company
• Justice A K Pathak said MSD shall be entitled to actual cost of the proceedings
• Glenmark says it was evaluating legal options at this point in time  
• The bench, however, said it might sell its products already in the market
• MSD had sought injunction against Glenmark alleging the firm violated its IPR over its anti-diabetes drugs

"We accept the honourable high court's decision. We are evaluating our legal options at this point in time."  Glenmark said in a statement.

Earlier, in an interim order, a division bench of the high Court had restrained Glenmark from making or selling its drug, used for treatment of Type-2 diabetes.

The bench had, 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 i.e in possession of its distributors and retailers". However, while granting the injunction on Wednesday, the high court did not say anything about sale of existing stock.

MSD in its plea had sought injunction against Glenmark alleging that the Indian pharma company had violated its intelectual property right (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 molecule.

Glenmark, on the other hand, had contended that it has used 'Sitagliptin Phosphate' in its anti-diabetes drugs, Zita and Zita-Met, and 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 Rs 43 a pill which is roughly 1/5th of its price in the US. According to market sources, Glenmark's version costs around 30 per cent less.