The Russian government has extended a decree to allow a domestic pharmaceutical company to produce a generic version of a U.S. biotech company’s COVID-19 drug without consent.
The government on December 30 approved the extension for one year of a decree originally issued last year to grant Russian drugmaker Pharmasyntez permission to produce and sell the antiviral drug remdesivir, citing the need to protect its citizens.
Pharmasyntez asked the Kremlin to allow it to produce a generic version of remdesivir in November 2020 without consent from Gilead Sciences, which holds the patent. Russia granted the license a month later. The U.S. company filed suit challenging the decision, but the Russia's Supreme Court in May rejected its claim.
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The governmental decree published on December 30 also said Pharmasyntez must pay compensation to the drug's patent holder but did not specify an amount.
Gilead Sciences did not respond to an e-mail from RFE/RL requesting comment on the decision.
Remdesivir, originally developed to treat hepatitis C, has been approved in the United States and dozens of countries to help treat COVID-19.
A World Health Organization (WHO) panel in November 2020, however, advised against using it. The WHO cited a study showing that it “appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.”
Gilead argued in court that it had 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 nearly four times higher.
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.
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, Pharmasynthez had asked Gilead for permission to produce the drug but was denied.