The Hon’ble High Court of Delhi rejects Merck Sharp and Dohme Corporation (MSD) suit for injunction restraining infringement of patent and seeking interim relief restraining the Glenmark Pharmaceuticals Ltd. from making, use, selling, distributing, advertising, offering for sale and in any other manner dealing of drug Zita and Zita-Met containing Sitagliptin and Sitagliptin - Metformin combination respectively.
MSD holds patent on Sitagliptin, sold product under the brand name “JANUVIA” and “JANUMET”. MSD has also granted a license to Sun Pharmaceutical Industries Limited which sells Sitagliptin Phosphate under the brand name “ISTAVEL” and Sitagliptin - Metformin combination under the brand name “ISTAMET”. In the argument MSD drawn an attention to the documents evidencing the process patent obtained by the Glenmark in US for preparation of R-Sitagliptin and its pharmaceutically acceptable salts to contend that the Glenmark therein has admitted the Merck’s US patent in Sitagliptin.
Glenmark has elaborated that the product of the Merck which injunction is claimed comprises of three parts namely “S”, “PD” and “DC” and Merck in USA has separate patents, for each of the three parts. Merck in India is holding the patent for the part “S” i.e. Sitagliptin only and though had applied for separate patents for the parts “PD” and “DC” but which were declined and subsequently affirmatively abandoned. Hence, Merck is having patent for Sitagliptin Hydrochloride only and not for Sitagliptin Phosphate.
The Hon’ble High Court found that the plaint proceeds on the premise that Sitagliptin Phosphate is the same as Sitagliptin but which is not found to be the case of Merck in its own application for grant of Sitagliptin Phosphate and which was abandoned. On the contrary it has emerged that Merck itself has in USA taken an independent patent for Sitagliptin Phosphate and similarly applied in India and which has been rejected and while applying for independent patent in Sitagliptin Phosphate in USA, India and Europe having claimed it to be a new invention and a different product than Sitagliptin.
Merck failed to demonstrate the circumstances in which a separate patent for Sitagliptin Phosphate was made. In the decision the Hon’ble court has mentioned “….the plaintiff certainly cannot be granted interim relief on a case not pleaded and in the face of its admission of Sitagliptin Phosphate being a new invention worthy of patent.”
If you wish to refer whole order you may click here....