Express Pharma

Delhi HC upholds MSD’s Sitagliptin patent

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Glenmark accepts decision, evaluating legal options

Ruling in favour of US drug major Merck Sharp and Dohme (MSD), Delhi High Court has restrained Mumbai-based Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs, Zita and Zita-Met, saying it has infringed the former’s patent on the main ingredient, Sitagliptin.

‘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. 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-II 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, the HC did not say anything about sale of existing stock.

MSD in its plea had sought injunction against Glenmark alleging that the latter had violated its IPR over its anti-diabetes medicines, Januvia and Janumet, by launching drugs containing the same salts.

The US firm had said it had invented ‘Sitagliptin’ salt used in its anti-diabetes drugs and has a 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 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.

MSD has welcomed the decision of the Delhi HC. While accepting the decision, Glenmark’s statement said it was ‘evaluating legal options.’

PTI

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