Our campaign partner, Fundación GEP, has filed a second patent opposition against one of Gilead’s numerous patent applications for the drug remdesivir, used in the treatment of COVID-19.
Last month Fundación GEP filed the first opposition on this drug.
Gilead has submitted five patent applications on the same drug in Argentina alone.
The applications have been submitted by Gilead to the National Institute of Industrial Property (INPI), which if approved would grant Gilead a monopoly in Argentina, on a drug which could be a breakthrough in the COVID-19 pandemic. If the company gained exclusive rights it would be able to establish excessively high prices, as they have already done with other products, such as sofosbuvir, a drug that cures hepatitis C.
“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” says Lorena Di Giano, Executive Director of Fundación GEP.
“We have submitted information before the patent office, 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”, says Di Giano.
If INPI rejects the patent, Argentina would be a step closer to making the drug accessible, as it would be possible to manufacture it locally at a reduced price.
Patents allow companies to set exorbitant prices, which are vastly different to their manufacturing cost. Gilead is charging the USA and other developed countries $390 per vial.
“Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient,” says the Gilead statement. According to a study by the University of Liverpool, remdesivir can be produced, with a profit, for around a dollar per day.
A month ago Gilead has signed voluntary licensing agreements for remdesivir for mainly low- and lower-middle income countries, 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 being developed by two producers in India authorized by Gilead (Hetero Labs and Cipla), would not exceed $80 per vial.
“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 $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 Di Giano.
“What happens when a big pharma company is the absolute owner of a life-saving treatment? Hedgefunds 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”, says José María Di Bello, president of Fundación GEP.
INPI has to urgently examine and reject Gilead’s patent applications on remdesivir.
Monopolies must be prevented on remdesivir and any other drugs that price effective in treating COVID-19. As absence of monopolies will guarantee local manufacturing and universal access to affordable generic versions for all the people that might need them.
- Argentina: Fundación GEP opposes Gilead’s patent application on remdesivir
- All COVID-19 drugs can be made for around $1 per day