Russian Firm Seeks Compulsory License to Manufacture Generic Remdesivir

A Russian drugmaker has asked the Kremlin for a compulsory license allowing it to manufacture a generic of Gilead Sciences’ antiviral drug remdesivir.

In a letter to the Russian government, Pharmasyntez President Vikram Punia said he reached out to Gilead in July to discuss a patent licensing agreement but did not hear back. He noted that other generic manufacturers have secured royalty-free licenses from Gilead to supply remdesivir in 127 countries.

It’s unclear whether the Russian government, even if it decided to approve Pharmasyntez’s request for a compulsory license for remdesivir, has the legal authority to override Gilead’s patent. There is a precedent for a government to override a company’s patent; for example, Canada passed a law earlier this year giving the government the authority to override drug patents during the pandemic.

In May and June, Gilead granted nonexclusive licenses for remdesivir to Dr. Reddy's Laboratories, Syngene, Zydus Cadila Healthcare, Eva Pharma, Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan. Those licenses are royalty-free until the World Health Organization declares an end to the pandemic or until a drug other than remdesivir or a vaccine is approved to treat or prevent COVID-19 (DID, June 16).

Last month, India and South Africa petitioned the World Trade Organization (WTO) to allow countries to choose whether to “grant or enforce any patents and other intellectual property (IP) related to COVID-19 drugs, vaccines and diagnostics for the duration of the pandemic.” If the WTO approved the petition — which seems unlikely because of strong opposition from the U.S., the European Union and other prominent WTO members — generic companies could start manufacturing cheaper versions of remdesivir without having to wait years or decades for drug patents to expire.

Gilead Sciences did not respond to a request for comment on the Russian company’s request. — Jason Scott