The Trump administration has sued pharma company Gilead Sciences, manufacturer of the HIV prevention drug. Truvada that costs about $20,000 a year. For earnings billions from research funded with taxpayer’s money but not paying back taxpayers. The company sells two anti-HIV drugs, Truvada and Descovy, both pre-exposure prophylaxis drugs (PrEP) that patients can take once daily. The government accuses Gilead of ignoring government patients repeatedly as the company keeps infringing on the patents owned by HHS or the Department of Health and Human Services. The government alleges that the company refused attempts by HHS to license its patent and earn royalties.
A highly effective drug
Truvada is highly effective in preventing the spread of HIV through sexual encounters with a failure rate of only 1%. Since the first approval of the drug in 2004, Gilead Sciences has earned billions of dollars from sales while helping the nation to stop the spread of the menacing virus.
Hindering the efforts of the government
In February, the government announced its goal to reduce new HIV infections by 75%. In 5 years with a target of wiping out the epidemic of HIV in America by 2030. Wider access to PrEP drugs is critical to attaining the goal. According to the critics, the exorbitant price of Truvada has kept it out of bounds. For people belonging to low-income groups who are at high risk and are hindering the government’s effort.
Flouting the patent norms
The Centre for Disease Control or CDC has done groundbreaking research. Together with the contributions from taxpayers played a significant role in the development of these drugs. And the government wants Gilead to respect the US patent system. To acknowledge the contributions of the stakeholders in the discovery of the drug. The complaint filed against the company seeks to ensure that the company does what the government expects from them in matters of legal compliance.
Chronology of Patents and drug approvals
According to a March report from the Washington Post, funded by about $50 million of taxpayer money. The researchers at CDC spent many years working with Truvada. Which is donated by Gilead to establish a treatment regimen to prevent the spread of HIV. The drug approval for treating people already infected with HIV came in 2004. Around the same time, CDC continued with its research to find if the drug could be useful to prevent infection. Filed its patent in 2006 after the drug showed to work as prophylactic in primates. In 2012, Truvada received approval for use in humans as PrEP, and in 2015 the government was given patents for the treatment regimens developed by the scientists at CDC.
Gilead has worked with CDC for years in the fight against HIV and even provided free drugs for government experiments besides assisting in the efforts to expand the treatment of Hepatitis c. The lawsuit filed on behalf of the CDC claims how, since 2015, Gilead has repeatedly refused to recognize CDC patent for Truvada. The company had previously said that the government’s claims of the patent are invalid because others had conceived the concept of PrEP before the government.