US government sues Gilead for patent infringement over HIV drugs
The US government is suing Gilead for patent infringement, claiming that the pharmaceutical company has been piggybacking on public research to earn billions from its HIV drugs.
Gilead has come under increasing pressure in recent months over the price of Truvada (emtricitabine/tenofovir), which if taken daily can reduce the risk of contracting HIV by up to 99%.
In 2005, the US Food and Drug Administration approved the drug for treating patients diagnosed with HIV.
But Truvada has made headlines mostly as a form of pre-exposure prophylaxis (PrEP), designed to prevent contraction of the disease in the first place.
The Centers for Disease Control and Prevention (CDC), a US government agency, registered four patents for PrEP after a series of publicly funded clinical trials.
Gilead has managed to maintain market exclusivity on all uses of Truvada until now. A generic version of the drug is expected to hit the market next year, following a settlement with Teva.
But while Gilead holds a monopoly on the drug, it has faced staunch criticism for overpricing the treatment, which critics say could be the key to fighting HIV.
The US government has also come in for criticism over its perceived failure to rein in Gilead and protect the fruits of public research.
In May, Democratic congresswoman Alexandra Ocasio-Cortez wrote to health secretary Alex Azar demanding answers on the CDC’s efforts to enforce its PrEP patents.
Yesterday, the government sued Gilead for infringing its PrEP patents through the sale of Truvada and another drug Descovy “for use as the PrEP regimens that the Department of Health and Human Services (HSS) has patented”.
Yesterday, the government sued Gilead for infringing its PrEP patents and the patent of another drug, Descovy, which Gilead uses as the PrEP regimens “that [the US Department of Health and Human Services (HSS)] has patented”.
Commenting on the suit, Azar said: “Gilead must respect the US patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”
“The complaint filed today seeks to ensure that they do.”
According to the HSS, Gilead has “repeatedly refused” to obtain licenses for the government patents.
The move comes after Gilead took its own steps to ward off the government’s patent claims.
In August, the company sought inter partes review of the patents at the Patent Trial and Appeal Board.
Gilead claimed that the patents are invalid as the use of Truvada as PrEP was already widely known.
The government maintains that it was CDC scientists who discovered the use of the drug as PrEP through publicly funded research.
Two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed licences with HHS, the department said.
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