Delhi High Court blocks Glenmark diabetes drugs

The Delhi High Court has granted pharmaceutical company Merck an injunction that prevents Glenmark Pharmaceuticals from making and selling its diabetes drugs Zita (sitagliptin) and Zitamet (sitagliptin/metformin).

The court ruled that Glenmark’s products had infringed a patent owned by Merck, known outside of the US and Canada as Merck Sharp and Dohme (MSD).

It added that Glenmark may continue to sell Zita and Zitamet products that are already on the market, but may not take any further steps toward placing more drugs on the market.

The ruling on Friday (March 20) set aside a previous decision by the court that dismissed MSD’s application.

The case centred on MSD’s drug sitagliptin, which lowers blood sugar levels in patients with type 2 diabetes.

In India, MSD markets sitagliptin phosphate monohydrate salt under the brand name Januvia, and a sitagliptin/metformin combination as Janumet. It licenses Sun Pharmaceutical Industries to market and distribute the drugs under the names Istavel and Istamet.

MSD launched the case in 2013, arguing that Glenmark’s products infringed its sitagliptin patent. It asked the court for a permanent injunction against Glenmark.

Glenmark argued in a counterclaim that MSD’s patent should be revoked. It said that in India, MSD holds a patent covering sitagliptin, but had abandoned patent applications to protect sitagliptin phosphate.

MSD argued that the phosphate is claimed in the patent.

Judges S Ravindra Bhat and Najmi Waziri threw out the court’s prior decision and granted the injunction against Glenmark.

A spokesperson for MSD told LSIPRit was pleased with the decision.

“We believe our patents for Januvia and Janumet are valid and enforceable and will continue to defend them,” the spokesperson added.

In a statement, Glenmark said it was “seeking legal advice” on the next steps and will take appropriate action.