A recent Truvada lawsuit filed by the Trump administration claims that Gilead Sciences infringed on CDC patents with their HIV drugs.

The Department of Justice (DOJ) filed the Truvada patent lawsuit against Gilead Sciences Inc. on Nov. 6, 2019. According to the HIV drug lawsuit, in 2006 the Centers for Disease Control and Prevention (CDC) allegedly did monkey studies on the medication as eligible for the pre-exposure prophylaxis (PrEP) program.

PrEP for HIV works to reduce the risk of HIV transmission by dosing at risk individuals with HIV medications preemptively.

Researchers from the CDC reportedly obtained four patents in relation to their results. However Gilead, in creating their Truvada medications, allegedly used this information without paying the fees associated with using patented results, and in turn the company reaped billions of dollars from sales of this drug.

“Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens,” claims the Trump administration. The federal government also argues that the patent infringement was intentional, calling the conduct “malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith.”

Truvada

Gilead’s other treatment drug, Descovy, is their more expensive option. Both drugs are cheaper outside of the U.S., but Gilead owns the U.S. anti-HIV market. In this country, Truvada has become a cash cow for Gilead, earning the program billions of dollars through sales.

The DOJ argues that the federal government is owed a portion of these profits due to the taxpayer dollars and researcher effort that went into the patented results.

“Gilead has profited from research funded by hundreds of millions of taxpayer dollars […] but has not paid any royalties to CDC,” the DOJ argues.

Gilead has rejected the claims, saying that the CDC’s patents are invalid. Because the CDC’s work was obvious and proposed by other scientists, Gilead argues that it cannot claim ownership over PrEP as a HIV prevention system. These arguments were reportedly made in petition with the U.S. Patent and Trademark Office (USPTO) earlier in 2019.

If the patents are invalid, the DOJ will no longer have standing. The validity of the CDC’s patents will have to be determined by a judge while the Truvada lawsuit is litigated.

Truvada Lawsuit Claims

Truvada is the only drug listed by the CDC as “safe” and able “to help block HIV infection,” despite Truvada’s side effects. Through PrEP, at-risk people can reportedly take Truvada daily to reduce their risk of contracting HIV from sex by 99 percent. For people who are at risk for HIV from injecting drugs, Truvada can reportedly decrease the HIV risk by 74 percent when taken daily.

The government notes that it is not downplaying the incredible impact that Truvada has had through the PrEP program. Instead, authorities urge Gilead to comply with patent regulations and have taken a firm stance by filing the Truvada lawsuit.

“HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” said the U.S. Department of Health & Human Services (HHS) Secretary Alex M. Azar II. “However, Gilead must respect the U.S. 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.”