Russia's Supreme Court has rejected a lawsuit by U.S. biotech company Gilead Sciences that challenged the right of a Russian government decree to allow a domestic pharmaceutical company to produce a generic version of Gilead’s antiviral drug remdesivir without consent.
The Supreme Court said on May 27 that the government decision to grant Russian drugmaker Pharmasyntez permission to produce and sell the anti-COVID-19 treatment without the consent of the patent holder was valid due to the emergency conditions created during the coronavirus pandemic.
Remdesivir, originally developed to treat hepatitis C, has been approved in the United States and dozens of countries to help treat COVID-19.
Last December, Russia granted Pharmasyntez a compulsory license, which gives a company permission to produce and sell a patented product without the consent of the patent owner for one year.
The decree stipulates that Pharmasyntez must pay Gilead an unspecified amount in compensation, which to date has not been paid.
Pharmasyntez produces remdesivir under the name Remdeform. Earlier this week, Russia shipped Remdeform to India as part of its humanitarian aid contributions to the South Asian country, which is fighting a surge in COVID-19 cases.
Gilead argued in court that it repeatedly expressed its ability to supply the drug to Russia and that the government decree was issued only to save money.
Pharmasyntez has registered Remdeform for a maximum price of 7,400 rubles ($100), while Gilead had offered a rate of 28,000 rubles ($380).
The government contested in court that it had no option but to issue the compulsory license to expedite COVID-19 treatment and that at the time Gilead had not sent an application to reduce the cost of the drug in line with laws on the maximum selling prices for vital and essential medicines.
“Proceeding from this, a critical situation developed when, from January 1, not a single drug could be in the territory of the Russian Federation. At the same time, as of January 1, 2021, there were 7,092 patients who were on artificial lung ventilation. This is a severe form of a disease that required serious treatment. Therefore, under these conditions, the government is taking the decision to grant the right to use several patents for the production of the drug remdesivir, "said the deputy head of the Federal Anti-Monopoly Service, Sergei Puzyrevsky.
The Federal Anti-Monopoly Service also argued that Gilead discriminated against Russia by allowed its drug to be produced by seven manufacturers in other countries at sale prices of less than $100.
Before asking for permission from the government, Pharmasyntez had asked Gilead for permission to produce the drug but was denied.
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