Fundación GEP has filed a new opposition against a patent application that Gilead has filed 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, Argentina will give a step forward toward the access to this drug, because it would be possible to manufacture it locally at a reduced price.
Fundación GEP has filed a new Pre- grant patent opposition against a patent application that Gilead has filed in order to be granted the right over the drug in Argentina. Remdesivir is the first drug approved globally to treat people infected with COVID-19. As clinical trials are being developed globally, remdesivir already has the approval, for emergency use, of the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has approved its commercialization.
In Argentina, Gilead has filed at least five patent applications before National Institute of Industrial Property (INPI), with the intention of having a monopoly over the manufacture and commercialization of the drug in Argentina. The exclusive rights granted by patents would allow the company to establish excessively high prices, as they have already done with other products like sofosbuvir, a drug that cures hepatitis C.
By filing these oppositions, Fundación GEP claims it is necessary to conduct a thorough revision of the content of the patent applications filed by Gilead in Argentina. “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 Di Giano.
“We have submitted before the patent office information proving that Gilead’s patent applications on remdesivir do not meet the legal conditions of novelty or inventive step, because they claim treating methods, pharmaceutical salts and compositions that are not new and which are obvious, as well as it tries to claim combinations of already existing active ingredients. And what is more, they lack the descriptive information required by the National Patent Law”, exemplifies Di Giano.
Gilead set a price for that drug: $ 390 each application for the government of the United States and developed countries. A value almost 400 times higher than its manufacturing cost, which, according to a study by the University of Liverpool, does not exceed one dollar per unit. Even the price for private health insurance in the United States could be even higher, at $ 520 per dose.
Patents allow companies to set exorbitant prices, remotely different from their manufacturing cost. It goes without saying that prices become more affordable when there is diversity of production and there is price competition in the market. Particularly in the case of remdesivir, a month ago Gilead has signed voluntary licensing agreements 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 that are already being developed by two producers in India authorized by Gilead – Hetero Labs and Cipla – and will be accessible by the 127 LMIC, would not exceed $ 80 a dose.
“By signing voluntary licensing agreements, Gilead provides technology for the generic manufacturing of remdesivir, but controls which countries can buy these more affordable versions. 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”, warns Lorena Di Giano, Executive Director of Fundación GEP.
“Life is a supreme value is an incontestable truth, but, ¿what happens when a big pharma company is the absolute owner of a life-saving treatment? Hedge funds are the main shareholders in these companies, and they are not interested in saving lives; they only seek profit and, in any case, that countries be forced to pay extortive prices so they can gain exorbitant profit. COVID-19 has proved what a fatal mistake it was to make health an object of market, and medicines a merchandise, instead of considering them social goods. It might be the opportunity to transform the system and set medical technologies free from the market”, was the thought of José María Di Bello, president of Fundación GEP.
INPI has to urgently examine and reject Gilead’s patent applications on remdesivir. Absence of monopoly on this drug or others that prove their efficacy in treating COVID-19 will guarantee local manufacturing and universal access to affordable generic versions for all the people that might need them.