Merck wins injunction in sitagliptin patent row

Pharmaceutical company Merck has secured a preliminary injunction against Indian drug company Aprica after it tried to market generic versions of the branded diabetes drug Januvia.

The High Court of Delhi ruled on June 17 that prima facie Aprica’s generic medicine contained a salt identical to sitagliptin, the patented molecule found in Merck’s Januvia, as well as sitagliptin’s derivative salt.

Merck, which owns patents covering sitagliptin in 102 countries, sued Aprica in June 2013 for patent infringement. Its drug Januvia is used to lower blood glucose levels among people with type 2 diabetes.

The court found that Merck would suffer “irreparable loss and injury” if Aprica was allowed to sell its products.

“Huge investment has been made in the invention of the said molecule and the sales in India alone are in crores,” the order said.

Pravin Anand, managing partner at Indian law firm Anand and Anand who is representing Merck in the litigation, said the injunction was “of course most important” for his client.

He noted, however, that the injunction is only ex-parte – or preliminary – which means it could be revoked.

“Once the injunction application is argued, the injunction may be confirmed or (theoretically) set aside. It is our belief that the injunction would be confirmed as we have a very strong case.”

Aprica has until August 13 to respond to the order. To have the injunction removed, Aprica would have to show it is not infringing the patent or that the patent is invalid.

In a separate case earlier this year, Merck failed to win an injunction against Indian generic drug-maker Glenmark, which is marketing generic versions of Januvia. The court said Merck failed to show that the sitagliptin in its drugs produced different results to Glenmark’s. The case is pending.

Aprica did not respond to a request for comment.