- Humanitarian Action with technical support from ITPCru has opposed Gilead’s patent in Russia for the combination of two antiretroviral drugs, tenofovir and emtricitabine, brand name Truvada.
- The prices charged under Gilead’s monopoly prohibit access to HIV treatment and PrEP.
- Russia pays around 40x the amount charged for generic versions. If the Russian court revokes the patent it will save money and save lives.
Tenofovir/emtricitabine (TDF/FTC), both the generic and branded version, is used to treat HIV in combination with other drugs. It is also recommended as a pre-exposure prophylaxis (PrEP).
Humanitarian Action submitted the patent opposition in February 2020, on the grounds of lack of novelty and industrial applicability.
The first hearing was postponed, from 22 April to 17 June, at the request of the patent holder, due to the COVID-19 pandemic. At the initial hearing, Gilead submitted its reply to the opposition. A second hearing on 14 July 2020 also dealt with procedural matters only, and the next hearing is not due until 9 September 2020.
YEARS OF MONOPOLY PRICES
The Eurasian patent (#015145) was granted in 2011 in the Eurasian Patent Convention (EAPC) territory, which includes Russia, and is valid until 13 January 2024.
It allows the the possibility of extension for a maximum of 5 years. The period has been extended in several EAPC countries, however, there has been no extension in Russia, and it is no longer legally possible.
If the patent is successfully revoked this year, this will reduce the monopoly period and overpricing by around three years. This would allow the state and patients to save significant amounts of money by purchasing quality-assured generic versions of TDF/FTC.
PROHIBITIVE PRICE BLOCKS ACCESS
The current price of TDF/FTC in the Russian Federation is approximately $200 (USD) per month, compared to $5 per month for generics.
TDF/FTC is scarcely available in Russian state programs, the prohibitive pricing being a key contributing factor. TDF/FTC is part of the main regimen recommended, both by the World Health Organization (WHO) and Russian specialists, for people starting antiretroviral therapy (ART) as well as being approved for PrEP.
Yet, due to price, it is yet to be included in Russia’s official list of essential medicines. In 2019 only a few hundred people out of the 535,000 receiving HIV treatment were accessing Truvada.
If the patent is cancelled generic manufacturers will be able to enter the market and supply tenofovir/emtricitabine at much lower prices, enabling Russia to treat more people for less money.