Eli Lilly buckles under pressure, offers voluntary licence to Natco Pharma

On Monday US drug maker Eli Lilly said that it will issue voluntary licence to Hyderbad based , ending the legal battle that was brimming over compulsory license for the drug in less than a month. “Natco will be collaborating with Lilly to further accelerate and expand the availability of baricitinib in India during this pandemic, improving the local treatment options available to positively impact the lives of people who are currently battling COVID-19 in India”, the company said in a statement. Adding that the company continues to engage in active dialogue with the regulatory authorities and government in India to deliver baricitinib donations through the humanitarian aid organization, Direct Relief and to donate Lilly’s anti-COVID-19 treatments, including Lilly’s neutralizing antibodies.

Lily has issued voluntary licenses for Barcitinib to six Indian drug makers besides Natco, these include-

, , Dr Reddy’s, , Torrent Pharma and MSN Labs. Barcitinib, in combination with Remdesivir, received emergency approval last year from the USFDA for treatment of hospitalized Covid19 patients who are not on ventilator. Barcitinib is normally used to treat arthiritis. India’s drug regulator granted an emergency approval to the Lily and Natco pharma last week.

Lily’s was pushed to issue the VL to Natco after the government of India intervened in an attempt to put an end to the legal dispute over the drug. ET had reported on May 10 that multinational pharma companies such as Lily have resorting to giving VL to experimental covid drugs that might potentially help them stave of demands for compulsory license from activists and questions from courts.

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Hyderabad based Natco pharma and a couple of health activist groups had filed petitions in the Supreme Court in April this year asking it to direct the Indian government to issue CL under section 92 of the Indian Patent Act that allows this in order to expanding manufacturing of a critical drug during a national emergency.

It is not clear that at what price Natco will be selling the drug now that it has received a VL. But in its applications to the Supreme Court Natco has said that as an applicant it “ it will be making its Baricitinib formulation available at a cost of INR 30.00 per tablet”. The company has said that the total cost for the treatment of 14 days usng the drug will be Rs 420.00 for a patient. It had appealed for the CL on the grounds that Lily’s brand was costing Rs 42287, for a 14 day regimen.

“The Applicant has not sought for a stand-alone non- Covid-19 approval and instead has consciously limited its request to the DCGI for Covid-19 treatment alone following the EU Authorization granted by the USFDA”, said the petition from Natco. Natco’s company spokesperson did not respond to a text by ET asking the company whether it still continues to sell the drug at the price it had mentioned to court.

In early May, US drug maker MSD also issued voluntary licences to Indian drug makers —Cipla, Sun, Emcure, Hetero and Dr Reddy’s— for its anti viral drug Molnupiravir. MSD said that it will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs. “MSD is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses”, the company said in a statement.

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