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Plea in Apex Court for Authorisation for Use of Remdesivir, Favipiravir and Tocilizumab for Govt. Purposes and Granting Compulsory Licenses for Their Patent

An Application has been filed in the suo motu matter before the Supreme Court pertaining to the COVID-19 crisis in the country seeking directions to issue authorization for using the patents for government purpose and/or notifying grant of Compulsory Licenses under Patents Act for patent covering drugs Remdesivir, Favipiravir and Tocilizumab.

By: Gurleen Kaur Anand, Amity University, Mumbai

The Application seeks for directions by the Supreme Court to issue authorization for using the patents for government purpose under Section 100 of the Patents Act and notify grant of Compulsory Licenses under Section 92 of the Patents Act for patents covering the drugs Remdesivir, Favipiravir and Tocilizumab.

This Application sets out three drugs enlisted for the treatment: Remdesivir, a drug developed in 2009 to treat Hepatitis C, which is a patented drug in India and whose patent is held by Gilead Sciences, Inc.

It is submitted that ordinarily, one chemical compound should have only one patent, but in the case of this drug, three patents have been granted, thereby resulting in market monopoly for Gilead till 2035.

It is also stated that while Remdesivir is provided by the licensees between a price range of INR 899 to 3490, the same is being sold in the black market at a price as high as INR 30,000 per vial due to limited stocks and shortages, which has been recognized by the CDSCO which has attempted to put into place a monitoring mechanism to ensure availability of this drug.

The application said “The Central Government is empowered under Section 100 of the Patents Act to authorize any person to use a patented invention for the purposes of the government. In the case of Remdesivir, Favirpiravir and Tocilizumab, this power may also be exercised to authorize entities to produce these patented drugs. Additionally, Section 92 explicitly empowers the Central Government to notify compulsory licenses for a patent in circumstances of national emergency, extreme urgency or public non-commercial use.”

Further, the Application prays for compulsory licenses under Section 92 to be issued and for directions to the Centre to undertake forecasting of the courses required to treat the virus which has affected people across the country.

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