NATCO seeking Compulsory License application for Baricitinib in India
On 3 rd May 2021, NATCO Pharma Limited has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib in combination with Remdesivir, is used for treatment of COVID-19 positive patients. Summary: In light of the grave and life threatening public health emergency, NATCO Pharma moved before the Controller of Patents for Compulsory License of Drug Baricitinib in India. NATCO seeking the Compulsory License under Section 92(1) with Section 92(3) of The Patents Act, 1970. Facts & Targeted Approach: PATENT: IN270765 (INCYTE/Lilly: Expiry Date: Mar 10, 2029) Patent Covers: Baricitinib Compound & its phosphoric acid salt. CDSCO Approvals: · May 07, 2018: For the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more d...