Gilead Sciences is challenging U.S. government patents, saying the government’s claim that it invented the use of Truvada as HIV prevention is invalid, the Washington Post reported. The pharmaceutical company filed a petition with the U.S. Patent and Trademark Office on Wednesday, Aug. 21 asking for a reexamination of those patents.
The HIV drug Truvada was approved in 2004 to treat people already infected with the disease. In 2006, the U.S. Centers for Disease Control and Prevention filed a patent claim for the use of Truvada as prevention of HIV. The CDC won its patents for Truvada for PrEP in 2015.
Gilead is now challenging those patent claims, saying it was already public knowledge that Truvada could be used as prevention of HIV before the government filed in 2006.
“That was already known in the public domain, and you can’t take that back,’’ Gilead patent lawyer Patricia Thayer said in an interview, as reported by the Washington Post.
Since being awarded the patents in 2015, the government has not enforced them in court. The government has not collected royalties from Gilead, despite the taxpayer-funded research that went into proving Truvada could be used for the prevention of HIV.
The CDC has reportedly said government scientists in government labs, working with government primates, showed Truvada worked for prevention. Researchers later proved the drug could work in humans using tens of millions of dollars in federal and private foundation grants, reported the Post.
Some HIV/AIDS activists have said Gilead’s new challenge is a sign the company is worried the government will take action to enforce the patents.
Those same activists have lambasted Gilead for the $20,000 per year price tag on Truvada for PrEP. Members of Congress say the cost is a prime example of a drug company profiting on a medical therapy developed with taxpayer dollars.
Gilead has defended its actions and reportedly said the patent fight is distracting from the efforts to reduce stigma and distribute Truvada for PrEP to more people.
The company has agreed to provide free Truvada to help the government’s efforts to eradicate HIV/AIDS by 2030—an initiative adopted by President Trump. The company said, however, the offer is not related to the patent dispute.
Gilead Sciences is facing more legal challenges in court from people who say they developed severe health complications after taking the HIV medications manufactured by the company.
Individuals are filing lawsuits against Gilead, alleging the HIV drugs Truvada, Viread, Complera, Stribild, and Atripla caused complications like chronic kidney disease, kidney failure, and bone density issues. All of these drugs are manufactured by Gilead and contain the powerful active ingredient tenofovir.
The lawsuits also claim that Gilead was developing another HIV drug at the same time as its tenofovir drugs, which it knew to be safer and just as effective. The company chose not to seek approval from the U.S. Food and Drug Administration, the lawsuits claim, until its exclusivity rights on Truvada were set to run out.