India’s BDR Pharmaceuticals attempt to launch generic version of remdesivir looks difficult, says GlobalData

Following the news that India-based BDR Pharmaceuticals has sought the Drug Controller General of India (DCGI)’s approval to manufacture and sell the generic version of remdesivir without entering into a licensing pact with Gilead Sciences;

Prashant Khadayate, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“This endeavor is not new for BDR Pharmaceuticals as it had earlier unsuccessfully attempted to launch a generic version of a patented drug in India. In Bristol-Myers Squib Sprycel’s case in 2013, BDR application under the compulsory licensing application to make a generic version of patented Sprycel was rejected because it failed to obtain a voluntary license for the drug from Bristol-Myers Squib.

“BDR Pharmaceuticals’ application to launch the first generic looks difficult as Gilead has entered into a non-exclusive license with Cipla, Jubilant Life Sciences, Hetero and Mylan in India to manufacture and distribute generic remdesivir in 127 countries and expected to provide technology transfer for the manufacturing of active pharmaceutical ingredient (API) as well as finished formulation of remdesivir. Earlier, Gilead followed the similar deals with Indian companies for generic hepatitis C drugs before to thwart losing their patent.

“Gilead is likely to apply to India’s Central Drugs Standard Control Organisation (CDSCO) soon seeking marketing authorisation. Gilead’s patents on remdesivir in India is valid until 2035 and allows it to exclusively make and sell the drug in the country unless it licenses those rights to another company.

“According to GlobalData’s COVID-19 dashboard, as of 28 May 2020, India has 158,613 confirmed cases and the dashboard forecasts 572,636 confirmed cases in India in a low transmission risk scenario by 09 June 2020.

“During this challenging time, there is no doubt that it is the responsibility of the regulatory bodies and judiciary to protect the interests of the Indian citizens. However, India is committed to protect the intellectual property rights within the country as part of the Trade Related Intellectual Property Rights (TRIPs) agreement of World Trade Organisation (WTO).

“Even if generic remdesivir is approved by the Indian regulatory body and launched in India by BDR Pharmaceuticals, in such a scenario, Gilead has all the rights to file patent infringement case against BDR Pharmaceuticals and this could further delay the launch. Also, BDR Pharmaceuticals needs to show that the public requirement didn’t meet in the absence of a generic version and that it has sought a regular licence from the innovator and failed. However, this COVID-19 situation is unprecedented and it is hard to predict the winning party in the court of law.”

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