In a rare and dramatic move, federal government officials last week sued Gilead Sciences on the grounds that the drug maker infringed on government patents for two drugs prescribed for pre-exposure prophylaxis (PrEP).
In a prepared statement, the secretary of the U.S. Department of Health and Human Services (HHS), Alex M. Azar II, noted the role played by government-funded research in the first drug's approval for use as PrEP in 2012 and accused Gilead of "baselessly denying" the validity of federal patents and exaggerating its role in the development of PrEP. "Gilead must respect the U.S. patent system, the groundbreaking work by researchers with the Centers for Disease Control and Prevention [CDC], and the substantial taxpayer contributions to the development of these drugs," Azar wrote. The lawsuit brief describes the company's behavior as "malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith."
The lawsuit, filed by the Justice Department on behalf of HHS, did not specify an amount in damages.
The move by Azar was surprising, not just for the scathing language, but because he had praised the company earlier this year for agreeing to donate enough Truvada (emtricitabine/tenofovir disoproxil fumarate) to cover up to 200,000 patients for up to 11 years. And it was surprising because the U.S. government rarely sues over patent infringement.
According to Christopher Morten, a staff attorney and research scholar in law at the Collaboration for Research Integrity and Transparency at Yale Law School, the federal government could sue over patent infringement more often.
"The CDC and federal agencies don't do a good job of explaining to the public what they're spending taxpayer money on and how they're licensing patents," Morten said.
The road to the HHS lawsuit started earlier this year, when Morten and fellow Yale researcher Amy Kapczynski were approached by HIV prevention activists in the PrEP4All Collaboration with a tip that the government patents exist for PrEP and probably aren't being enforced.
When researching the issue, the Yale team determined that Gilead had contributed to the development of PrEP, but only in providing the main drug in in Truvada, tenofovir, free of charge, and that once CDC researchers discovered, in the mid-2000s, that the drug could be used for HIV prevention, HHS consequently applied for four patents covering the PrEP prevention regimens using Truvada and Descovy (emtricitabine/tenofovir alafenamide).
In the suit filed last week, Azar used this analysis, saying the patents entitle the department "to license CDC's PrEP regimens and receive a reasonable royalty for their use." Furthermore, the government says Gilead also relied on CDC experiments in its application to the Food and Drug Administration (FDA) for approval to use Truvada and emtricitabine -- which was developed by Emory University using funds from the National Institutes of Health (NIH) -- for PrEP. Robert M. Grant, M.D., M.P.H., of the University of California, San Francisco, conducted a crucial 2010 study called iPrEx that proved Truvada was not only effective in treating HIV but also in preventing it. That study was funded by the National Institutes of Health and the Bill and Melinda Gates Foundation, not by Gilead.
Once analysis by Morten and Kapczynski confirmed that the government had been holding valuable patents for years -- while Gilead had been collecting billions in sales from the medication -- they informed PrEP4All, which informed other advocates to sound the alarm. PrEP4All and others in the coalition also alerted the House Committee on Oversight and Reform as well as Sen. Debbie Stabenow (D-MI).
Rep. Elijah Cummings (D-MD), who chaired the House Oversight Committee until his death in October, asked the Government Accountability Office to open an investigation as to why the federal government had not enforced its patents.
In May, Cummings called Gilead's CEO Daniel O'Day to testify, and in an opening statement, Cummings told him, "This lifesaving treatment would not exist but for the research funded by the CDC and NIH." Later in the hearing, Grant testified that Gilead "did not provide leadership, innovation, or funding for PrEP research." O'Day fought back, insisting that Gilead developed the two drugs that are combined in Truvada, invented the combination that allowed these drugs to be taken as a single pill, and invented the drugs as used to treat HIV in combination with other antiviral drugs.
Morten said a $3 billion judgment is possible for past infringement of Truvada alone -- and even more for the time Gilead will continue to sell Truvada and Descovy as PrEP.
In August, Gilead asked the U.S. Patent and Trademark Office to cancel the government's patents, arguing, as O'Day did, that other researchers conceived of the idea of using the drugs for PrEP first. Last week the company vowed to ask the court to stay the government's lawsuit until the patent office reaches a decision.
The company also has sued companies that tried to enter the market with generics and settled out of court in each case. Truvada's wholesale price has doubled since FDA approved the drug for PrEP seven years ago, and it generates billions of dollars in annual revenue for Gilead.
Gilead maintains that almost no patient pays the list price for Truvada, or for Descovy, which was approved for PrEP in October, and that many qualify for assistance for both. But activists say that there's no reason for a list price -- $20,000 per year for Truvada -- to be so high, and that in other countries, generic versions of the drugs are available for as little as $60 a year without insurance and bureaucratic hurdles.
HIV prevention advocates point out that until generics are available in the U.S. (Truvada goes off patent next year, and Descovy goes off patent in 2022), Gilead will continue to have a monopoly on the drugs needed to end the HIV/AIDS epidemic. And they say the Trump administration's goal of ending new HIV transmissions by 2030 can't be accomplished if drugs are not made more affordable.
The CDC estimates that a million Americans are at high risk of getting HIV and would benefit from PrEP. But just over a quarter of those people are currently on PrEP.
Peter Maybarduk, director of the advocacy nonprofit Public Citizen, said there is a lot of flexibility for both the government and Gilead to structure a settlement. "The government has the power to demand access terms," he said. "Even better than a government windfall of cash would be requiring Gilead to lower its prices or license its patents for generic use immediately. The cost of PrEP could be vastly less expensive than it has been."
James Krellenstein, a co-founder of the PrEP4All Collaboration, said if the government prevails in its suit, HIV activists must demand that the settlement be spent to improve access to PrEP in the most impacted communities, including removing systemic barriers such as lack of transportation to doctor appointments. "What Gilead has collected in profit [from PrEP] is more than four times the CDC's entire HIV budget for research and development. We could cover every one of the one million people who need PrEP and have a half billion left over."
The Government Accountability Office has not indicated when it will release its report analyzing why it took so long for HHS to take action against Gilead. Morten and other advocates say it strains credibility to say that the government didn't know about the alleged patent infringement until this year.