On May 03, 2021, Natco pharma filed application for Compulsory Licence (CL) for Baricitinib under Section 92 before the Controller of Patents.

 

Natco filed this CL application with respect to Indian Patent No. IN270765, which cover baricitinib compound. This CL application was filed under Section 92 & not under Section 84. Section 92 relates to “Special provision for compulsory licences on notifications by Central Government”. Section 92 deals with issuing of CL in specific situations such as national emergency or in circumstances of extreme urgency or in case of public non-commercial use. Natco based its application on prevailing Covid-19 situation in India.

 

Baricitinib was approved in few countries including India for rheumatoid arthritis. With respect to scientific basis for use of baricitinib in Covid-19, Natco cites few publication where use of baricitinib in reducing viral load was mentioned. It also cites that USFDA has granted Emergency Use Authorisation of baricitinib in combination with remdesivir for the treatment of COVID-19 on Nov. 19, 2020.

 

With respect to special provisions for compulsory licences, CL application mentions that there is national public health emergency. This Covid-19 situation has been declared as a pandemic. Central Drugs Standard Control Organisation (CDSCO) also issued notification that Emergency Use Authorisation through a Special Regulatory Pathway could be given during this pandemic as there is an unmet medical need. Hon’ble Supreme court & High court also took cognizance about lack of availability or lack of affordability of essential medicines during pandemic. Therefore, the first requirement, namely the recognition by the Central Government of the existence of a national emergency due to public health concerns as well as extreme urgency is satisfied. For unmet need, CL application cites lack of supply as well as lack of affordability of baricitinib. It states that only 8870 & 8385 tablets were imported in India during 2019 & 2020 respectively, as per Form-27 & average cost per tablet is of INR 3230. Whereas, the total number of Covid-19 patients currently undergoing treatment is over 34 lakhs, and the numbers are only increasing on a daily basis. Natco would be offering tablet at a price of INR 30 (4mg), INR 20 (2mg) & INR 15 (1mg). It says that actual prices may vary due to some factors. Moreover, Natco has also received Emergency Use Authorisation for baricitinib on Apr. 19, 2021.

 

Natco, thus on these facts requested issuance of CL & agreed to pay 7% royalty on net profits.  However, one thing is missing here is that the Central Government has not issued notification in the Official Gazette which is required under Section 92. Natco has filed this CL application before the issuance of the notification. It would be interesting to see, what could be next course of action by the Controller or Central Government. As a counter measure, Eli Lilly (Innovator) is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements (See link here).

 

Stay tuned for the new developments!