Use Clause 92 of the Indian Patent Act, break Remdesivir monopoly, issue Compulsory License

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Joseph P Chacko
Joseph P Chacko
Joseph P. Chacko is the publisher of Frontier India. He holds an M.B.A in International Business. Books: Author: Foxtrot to Arihant: The Story of Indian Navy's Submarine Arm; Co Author : Warring Navies - India and Pakistan. *views are Personal

Gilead Sciences’ anti-viral drug Remdesivir is the first drug to have displayed efficacy in treating Covid-19 patients. In a press release on 29 June, US Department of Health and Human Services announced an agreement with Gilead Sciences’ to purchase large supplies of Remdesivir for the United States. As per the release, “HHS has secured more than 500,000 treatment courses of the drug and it represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production in August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials. A treatment course of Remdesivir is, on average, 6.25 vials.” The price of Remdesivir in the United States is $3,000 (Rs. 2.25 lakhs in Indian currency), for a 5-day course. This also means that Remdesivir will not be available for the rest of the world for the next three months.

Gilead had applied to the Indian Drug Regulatory Agency CDSCO for import and marketing of Remdesivir on 29th May 2020 and was permitted under Emergency Use Authorization on 1st June 2020. Gilead has announced non-exclusive voluntary licensing agreements with Indian pharmaceutical companies including Cipla, Hetero, Dr Reddy’s Laboratories and others. The agreements allow these companies to manufacture remdesivir for distribution in 127 countries.

After manufacturing in India, Remdesivir will be sold at a ‘concessional’ price of $400 or about Rs. 30,000-35,000 for a 5-day course. The cost of manufacturing Remdesivir for a full course as worked out by experts is less than $10 or Rs 750 in the US and around Rs. 100 in India. Gilead, by virtue of its patent monopoly, commands an asking price that appears ridiculous.

Under Clause 92 of India’s Patent Act, India has the right to issue a compulsory license to manufacture the drug in India. Indian generic drug manufacturers have the ability to manufacture the generic version of Remdesivir. Under Clause 92A of the Patent Act, a compulsory license can even be issued for export to countries that may require the drug and not have the capability to manufacture it.

But it depends on the will of Narendra Modi government to invoke both the clauses to make it happen. Given the past experiences of Modi Government standing up to the US government, this seems to be a tall task. The latest example is Modi government’s U-Turn in allowing limited exports of anti-malaria drug hydroxychloroquine after the U.S. president warned that India could face retaliation for restricting the drug’s supply. On April 5, Judd Deere, deputy White House press secretary took to twitter to announce “Today, @realDonaldTrump spoke with Prime Minister Narendra Modi of India to discuss how the two countries can work together to combat the coronavirus pandemic. The two leaders agreed to remain in touch on the issue of global supply chains for critical pharmaceuticals and medical supplies and to ensure they continue to function as smoothly as possible during the global health crisis.” It will be interesting to see if Modi government is able to use the ‘critical pharmaceuticals and medical supplies’ argument back to the US president.

India is one of the largest generic drug manufacturers in the world and there should be no reason why Remdesivir and other COVID-19 drugs cannot be made available rapidly and at affordable prices to India and the world.


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