Bajaj Healthcare Files Compulsory License with Indian Patent Office for Baricitinib

Recently, drug manufacturer, Bajaj Healthcare Limited issued a press release stating that they have filed a compulsory license application with the Indian Patent Office seeking permission to manufacture both active pharmaceutical ingredients (raw materials) and formulation of Baricitinib under the Indian Patents Act.

Baricitinib is essentially a drug approved in the US and European Union, for the treatment of rheumatoid arthritis. under certain regulated conditions, Baricitinib has been shown to prevent oxygen breathlessness in patients and has been approved for emergency use, including in India. Currently, the drug Baricitinib is licensed to US pharma giant Eli Lilly & Company, by its originator company INCYTE, providing them the rights for marketing it across the globe.

The request for the compulsory license has been filed with respect to Indian Patent 270765 granted on January 18, 2016, on Baricitinib. The application comes after another pharmaceutical company, Natco Pharma filed a similar request earlier last month which was later withdrawn after Eli Lilly and Natco agreed to a voluntary licensing deal.

Bajaj Healthcare filed the compulsory license application with the Patent Office after Eli Lilly declined its request for the grant of a voluntary license on Baricitinib on two occasions citing the reason that it is really challenging for them to sign voluntary licensing agreements with all the Indian companies who have requested for the same. Eli Lilly and Company has already inked voluntary licensing agreements with Indian pharma majors. One can find out more about this here.

In its application, Bajaj Healthcare has stated that the price of Baricitinib sold by Eli Lilly in India is not affordable to the public and that it can manufacture the same drug at an estimated price of Rs 14 (for 1mg), Rs 18 (2 mg), and Rs 28 (4 mg) tablet as opposed to Eli Lilly’s drug, the entire course of which, costs about Rs 45,220 per patient.