Natco files for Compulsory Licensing for drug Baricitinib

Natco files for Compulsory Licensing for drug Baricitinib

Natco recently has filed for Compulsory Licensing under Section 92 of the Patents Act for the drug Baricitinib, approaching the Controller of Patents. The drug Baricitinib has been approved in the EU and India in 2017 and 2018 as per the application and is used for the treatment of diseases such as rheumatoid arthritis.

The drug Baricitinib is owned by Incyte Holdings Corporation and has provided the license to Eli Lilly, who markets it under the name of Olumiant. Natco has previously received a Compulsory License for Bayer's Nexavar, going through the Section 84 route.

Stating the treatment of Covid-19, the application also quotes the study of taking the combination of Baricitinib with Remdesivir which proves to be more effective than that of delivering Remdesivir alone. This combination contains its reference to the Emergency Use Authorization for taking Baricitinib and Remdesivir in combination, taking 1 tablet up to 14 days.

Section 92 requires that if the Central Government is satisfied, in respect of any patent in force in circumstances of national emergency or circumstances of extreme urgency or case of public non-commercial use, that compulsory licenses must be granted at any time after the sealing thereof to work the invention, it may make a declaration to that effect.

Going through the Section 92 route is a strategic move since there is an ongoing emergency and Natco will not want to fight with the patent owner.

Form 27 data, on which Natco too relies, states that the drug Olumiant is not manufactured in India with hardly 9000 drug imported in 2019 and 2020. With more than 30 lakh patients, the supply would not meet the demand. Moreover, Natco also relied upon the recent judgment of the Delhi High Court where the court emphasized the consideration for CLs for Baricitinib.

Natco also states that they have received the emergency use authorization from DGCI stating the unmet medical need. Moreover, they even have submitted bioequivalence studies for showing bioequivalence to Olumiant. More surprisingly, Natco states that they will be willing to make the tablets available at price between Rs. 15 to 30 per tablet. Moreover, Natco also claims to prefer patients with economically weaker sections and government welfare schemes.