Break Gilead’s patent since US has bought all stock of Remdesivir

Trump is trying to improve his waning electoral chances by reserving all of Gilead’s stock of Remdesivir to cover up his disastrous handling of the Covid-19 epidemic so far

July 05, 2020 by Prabir Purkayastha

The US has bought up the entire stock of Remdesivir from Gilead, making it near impossible for this drug to be available anywhere else in the world. After making America sick again, Trump is trying to compensate for his administration’s failure by buying Gilead’s production for the next three months for the US, leaving nothing for the rest of the world. This makes it all the more urgent that we break Gilead’s patent and issue compulsory license to Indian companies to manufacture the drug. The Indian Patent Act, 2005 in which the Left played a very important role, has clear provisions for compulsory licensing during a health emergency or an epidemic. COVID-19 is obviously both.

With its huge number of cases and deaths, the US is the global leader on how not to fight the pandemic. Brazil and India are leaders on this front too.

Remdesivir is the only drug that in trials has shown some benefit in fighting the virus infection. Remdesivir works by reducing the replication of the virus in the human body, and this helps in shortening the hospital stay of the patient by about 15-20%. If the patient progresses to a more serious stage, needing oxygen support or ventilation, Remdesivir is of little help. Here, drugs like dexamethasone, which are anti-inflammatory, become important. Dexamethasone, which has also shown efficacy in clinical trials, reduces lung inflammation arising out of the infection, and not the infection itself. Dexamethasone is off-patents and widely available at low costs.

But even if Remdesivir cuts down the infectious period, apart from the benefit to the patients, it is also useful for society. By reducing the patient’s infectious period, it lowers the rate of virus transmission.

Next big battle

We have been arguing in these columns that after the battle for access to cheap AIDS drugs , the next big battle would be f ought over COVID-19 medicines and vaccines. In the World Health Assembly, the US was the only country that opposed the resolution that all medicines and vaccines should be put in a common patent pool, and be accessible to all countries at reasonable costs. We now know the reason for the US opposition. It wants control over medicines and vaccines for the fight against the epidemic. One reason is to make the US citizens feel that Trump is looking after them by providing medicines, even if his administration has failed miserably in the fight against the COVID-19 epidemic. Secondly, by controlling the medicine for the rest of the world, Trump can bargain with them and try to regain the global hegemon status that the US has lost.

With this step, the US has also made clear its intention regarding vaccines as well. The US has backed a set five companies with a 13-billion dollar purse, as a part of its Warp Speed program to support vaccine development. One of the five is Moderna, a US biotech company, and one of the front-runners in the current vaccine trials. The other four backed by the US are: Astra Zenca-Oxford University, Johnson & Johnson; Merck; and Pfizer with BioNTech. If any of these vaccines succeed and others do not, be ready for a similar situation for vaccines as well. Fortunately for the world, there are a total of 17 such vaccines in the WHO’s list of ongoing clinical trials , and another 132 in the pipeline.

Apart from the US buying up the entire stock of Remdesivir, the other issue is the price at which Gilead is selling this drug. For the US patients, the cost is $,3,000 (in Indian rupees, two and a half lakh rupees) for a 5-day course. For India, Gilead had licensed Cipla, Hetero and Jubilant, three Indian drug manufacturers to sell this drug at Rs. 30,000 (or $400) for a full course. The Indian drug companies would essentially use the Gilead supplied API, the key pharmaceutical ingredient and convert it to injectable form for sale in India.

Cost of Remdesivir

What is the actual cost of a course of Remdesivir? According to industry sources, the active ingredient for a course should not cost more than Rs. 100. If we add to that the cost of making it into a course of 5 injections, the total cost should not be more than Rs.300; or less than $5 in India. Calculations by two authors from Institute for Clinical and Economic Review in the US, show that the price of Remdesivir for a full course of treatment in the US to be less than $10.

Why should a full course costing less than $10, be priced at $3,000, or 300 times its cost of production? At the “concessional” price of $400 for India, it is still 40 times the cost of its production! Gilead’s argument is that its medicines saves hospital bills of around $12,000 and by charging only one-fourth of that, even if its is 300 times its cost of production, it is doing the customers a big favor.

As we know from the results of the clinical trials, Remdesivir does not save lives. Otherwise, Gilead’s price would have factored a lifetime earnings saved by Remdesivir, and its price would probably have been even 10 times higher!

It is not clear that after the US has bought the entire stock of Gilead, it will have any APIs left for the rest of the world. Even if it does, the amounts are going to be completely insufficient for other countries.

Long Battle Ahead

So what can the rest of the world do? Fight a long battle as we did during the AIDS epidemic against the US and its drug cartel allies like Switzerland, France, UK and Germany? When the AIDS drugs were priced around $10,000-15,000 for an annual course in the US and Europe, and a concessional price of $4,000 for poor countries?

This battle was fought for 10 years, before it could be one won in the WTO’s Doha Round in 2001. The Doha Declaration finally accepted that in the case of a health emergency or an epidemic, any country had the right to issue a compulsory license for producing such drugs. And such a license to produce the drug could be issued even to a company outside the country’s borders. Indian generic drug manufacturer Cipla could then supply the AIDS drugs at $350 for a year’s course to a number of countries, which would otherwise have been completely bankrupted; or seen their AIDS patients die in large numbers without medicines.

We have already won the battle over AIDS drugs and created a precedent. COVID-19 has already killed an estimated half a million and infected over 10 million. No one can dispute that is both a health emergency and a pandemic. So the remedy of using a compulsory license already exists in our Patent Act and in the Doha Declaration.

Remdesivir is a small chemical molecule and easy to manufacture. An earlier version, which was also patented by Gilead but never manufactured, is known to be effective in cat coronavirus infections. Since Gilead never manufactured it, it is available only from fly by night operators , producing it in basements or garage workshops. This shows how easy it is to produce Remdesivir, as it is only a minor tweak of the earlier patent. Any country with a minimal chemical infrastructure can produce this drug.

So why are other countries then not starting the manufacture of Remdesivir? Are they hoping that Gilead and the US would behave better than they did earlier during the AIDS epidemic? Or are they afraid of the US? Trade sanctions under USTR 301 is a threat that the US holds over many countries including India. India figures prominently each year in the US Super 301 list for its Patent Act not being in conformity with the US laws, and after 2012 for daring to issue a compulsory license to Natco for Nexavar, a cancer drug. Bayer was selling Nexavar at a price of $65,000 for a year’s course, which Natco started selling at less than 3% of the Bayer price.

PM Modi buckled under Trump’s threat and exported hydroxychloroquine to the US even though it was under an export ban at that time. Will he be willing to stand up to the US on Remdesivir? After India issued the compulsory license on Nexavar, Marjan Dekker, the CEO of Bayer had said   “We did not develop this medicine for Indians…We developed it for western patients who can afford it.” Will Modi agree with Trump that Remdesivir should be reserved for only US patients? Even if we have the capacity to produce it for our people? Or does his trade war with China demand surrendering to the US on the COVID-19 front?