Providing a major sigh of relief to the US drug major Merck Sharp and Dohme (MSD), the High Court has ruled a decision in its favour, protecting its IPR subjected interest for an anti-diabetic drug; against the generic version manufactured by Glenmark.
As a result, Glenmark has been directed by the High Court not to manufacture, market or distribute its anti- diabetic drug Zita and Zita-met, in lieu of the infringement of the rights of the American company.
As a part of the landmark judgment, MSD is also entitled to the actual cost of the proceeding on the case.
This decision comes after the high court had earlier, in an interim order, directed Glenmark to stop manufacturing its drugs, which is used to treat type-2 diabetes. However, it had allowed the company to sell its existing stock in the market.
“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.
However while granting the injunction today, 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 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.