Argentinian health groups oppose monopoly patents on remdesivir drug for coronavirus treatment

July 9, 2020: US pharmaceutical giant Gilead has filed five patent applications for a 20-year monopoly on the manufacture and commercialisation of the drug remdesivir in Argentina. Remdesivir is the first drug approved globally to treat people infected with COVID-19. If the National Institute of Industrial Property (INPI) rejects the patent, it would be a significant step toward Argentina being able to manufacture remdesivir locally at a reduced price.

Fundación GEP has opposed Gilead’s patent applications While clinical trials are being developed globally for other drugs to treat COVID-19, remdesivir already has the approval, for emergency use, of the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has approved its commercialization.

The monopoly rights granted by patents would allow the company to set excessively high prices, as it has already done with sofosbuvir, a drug that cures hepatitis C. Patent rights are reinforced in many trade agreements.

“We had access to the patent applications and were able to confirm that they do not meet the patentability requirements in force in Argentina, so they should be rejected by INPI,” said Lorena Di Giano, Executive Director of Fundación GEP. She argues that Gilead’s application fails to demonstrate any inventive step, and it uses combinations of existing active ingredients.

Gilead set a price of US$390 for each application of the drug for the US and other developed countries. This is almost 400 times higher than its manufacturing cost, which, according to a study by the University of Liverpool, is less than one dollar per unit.

A month ago Gilead signed voluntary licensing agreements for remdesivir with pharmaceutical manufacturers based in India and Pakistan. According to estimates from the Institute of Clinical and Economic Review (ICER), the price for the generic versions from the two producers in India authorized by Gilead - Hetero Labs and Cipla - that will be available to the 127 Lower Middle Income Countries, would not exceed US$80 a dose.

“Even we see $80 dollars a dose is extremely expensive. Gilead deliberately leaves out many countries, as is the case with most of countries in South America. Clearly, it is in the excluded countries where Gilead intends to get the biggest profit. Argentina is one of them, so we must pay special attention to the patent applications filed as part of this strategy”, warned Di Giano.

Hedge funds are the main shareholders in companies like Gilead, and they are interested in high profits, not in saving lives. Public health, other community groups and some governments are supporting the WHO C-TAP process for exemptions from patent rules and trade rules so that all COVID-related medicines and vaccines can be made available at affordable prices for all. The pandemic has exposed the need for essential medicines to be made available as public goods, not for private profit.