The Delhi High Court has restrained Glenmark from making and marketing generic versions of Merck Sharp & Dohme (MSD)'s popular antidiabetic drug Januvia (sitagliptin) and Janumet (combination of sitagliptin and metformin) in its latest order dated October 7, 2015.
The Delhi High Court has restrained Glenmark by decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in SPM on the basis of findings related to infringement of the patents of Merck's sitagliptin products.
MSD expressed its happiness with the injunction granted against Glenmark’s patent violation of its diabetes drugs. In an email reply the company stated, “MSD is pleased that the Hon’ble High Court of Delhi has found Glenmark to have infringed the patents of our sitagliptin products Januvia and Janumet and have restrained Glenmark by decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in sitagliptin phosphate monohydrate (SPM) or any other salt of sitagliptin in any form, alone or in combination with one or more drugs.”
In April 2013, Glenmark launched the generic version of Merck’s popular antidiabetic drug Januvia and Janumet. Subsequently Merck filed a suit against Glenmark seeking interim relief. The Delhi HC denied interim relief to Merck. After denial of interim relief, Merck was also briefly engaged in mediation with Glenmark over the Januvia patent. Aggrieved by the denial of interim relief Merck also filed an appeal, seeking injunction. The Delhi High court division bench granted the interim injunction.
As per the Delhi HC Order on the patent infringement of Merck's SPM, "In view of the findings returned on the above referred issues defendant (Glenmark) is restrained by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in sitagliptin phosphate monohydrate (SPM) or any other salt of sitagliptin in any form, alone or in combination with one or more other drugs thereby infringing the suit patent no. 209816 of the plaintiffs (MSD).
Molecule sitagliptin was patented in various countries including India vide Indian Patent No. 209816.
Application was filed in India on January 6, 2004; whereas international application was filed in USA with priority date July 6, 2001. Patent in India was granted on September 6, 2007 under the title beta - amino tetrahydroimidazo (1,2- a) pyrazines and tetrahydrotrioazolo (4, 3 - a) pyrazines as dipeptidyl peptidase inhibitors for the treatment of diabetes.
Grant of patent was not opposed by any member of the public or interested party in India at any stage, despite extensive publicity given by the plaintiffs to its commercial products sold under the brand name Januvia and Janumet. The drug is used for treatment of type II diabetes. Sitagliptin was approved for sale in USA in October, 2006 and in Indian market on March 28, 2008.