Gilead’s Truvada Donation Raises Suspicions of Patent Ploy

Published on July 8, 2019 by Sandy Liebhard

Gilead Sciences recently made news by promising to donate 2.5 million of bottles Truvada, one of the company’s blockbuster TDF-based HIV medications, to government efforts aimed at eradicating HIV and AIDS.

While the Truvada donation would improve access among those unable to afford the pricey medication, some are concerned that the move is merely a ploy by Gilead to protect the lucrative drug patents that help pad its bottom line.

Gilead and CDC Truvada Patents

Gilead received U.S. Food & Drug Administration (FDA) approval to market Truvada as an HIV treatment in 2004. The FDA would go on to approve Truvada for pre-exposure prophylaxis (PrEp) in 2012.

About $50 million in federal grants went into Truvada’s development. The U.S. Centers for Disease Control (CDC) also conducted early experiments that ultimately contributed to Gilead’s efforts.

Before it was approved for PrEp, the company provided Truvada to CDC researchers investigating whether the medication could be used to prevent HIV.

While Gilead holds patents on the Truvada coformulation and the two drugs it contains, the CDC was actually granted its own patent on Truvada for PrEp in 2015.

Few Can Afford Truvada for PrEp

The Washington Post reported in March that the federal government had never enforced its Truvada patent.  Later that month, Gilead’s CEO was called before the U.S. House Oversight Committee and insisted the government’s patent was invalid.

During the same contentious hearing, an expert testified that Truvada is often far less expensive overseas. For example, a one-month supply can be had for just $8 per month in Australia, but costs nearly $2,000 in the United States. As a result, just 10% of Americans who would benefit from Truvada for PrEp are actually able to access the expenisive medication.

Patient advocates are now urging the federal government to leverage its Truvada patents in a bid to lower prices in the United States, perhaps by demanding royalties from Gilead.

Is Truvada Donation a Quid Pro-Quo?

Gilead announced its Truvada donation in May.

In a letter sent to Gilead just weeks later, Rep. Elijah E. Cummings, D-MD, chair of the House Oversight Committee, demanded information on any related negotiations with the U.S. Department on Health and Human Services. Specifically, Cummings and the three other Democrats who signed on to the June 26^th letter want to know if Gilead agreed to the Truvada donation in return for patent protection.

They also asked the company to explain its Truvada pricing strategy, noting that the wholesale cost of the HIV drug has increased some 63% since 2012.

Cummings, along with Sen. Debbie Stabenow, D-Mich., had asked the Government Accountability Office to investigate reports that Gilead was infringing on the CDC’s Truvada for PrEp patent just a week earlier.

“If true, this would mean that a private entity has generated billions of dollars in revenue over several years while infringing on government-owned intellectual property, and that the government either failed to detect the infringement or was aware but failed to prevent it,” the June 18^th letter states.

Reports indicate that the U.S. Justice Department is also looking into the matter.

Gilead HIV Drug Lawsuits

This isn’t the first time Gilead had faced questions over its HIV drug patents.

In fact, a growing number of lawsuits claim the company intentionally delayed development of a safer HIV medication called TAF merely to protect the profits derived from its patents for Truvada and other TDF-based drugs.

According to the complaints, Gilead suspended TAF development in 2004, asserting that the new medication was too similar to TDF to justify continuation. The company resumed TAF development just in time to launch Genvoya, the first of the new franchise, in 2015. At that point, Gilead began hyping Genvoya’s superior safety profile so doctors and patients would switch treatments before the patents on its TDF HIV begin to expire in 2021.

The alleged delay tactics allowed Gilead to “reap outsized profits” from the high costs of its TDF HIV-AIDS medication franchise, while limiting “patient access either through exorbitant out-of-pocket costs or co-pays, limitations in existing insurance, and rationing of these high-priced pills.”