AIDS Healthcare Foundation has filed a lawsuit against Gilead Sciences, accusing the drugmaker of manipulating the patent system to extend the patents on its HIV drug tenofovir, which is sold under the brand name Viread and included in the combination treatments Truvada, Stribild and Genvoya. The lawsuit focuses on Gilead’s new version of the drug, tenofovir alafenamide, or TAF. Genvoya, which the FDA recently approved, is Gilead’s only combination treatment to include TAF.

According to an AHF press release, the lawsuit alleges:

In a relentless effort to maximize its profits, Gilead manipulated the patent system and engaged in anticompetitive practices to prevent economical access to TAF – an antiviral agent used in the treatment of HIV. TAF is not a new compound. TAF is a prodrug of the compound Tenofovir, which was first synthesized over thirty years ago in the Czech Republic. Nor was TAF the first prodrug of Tenofovir. Several years before Gilead obtained a patent on TAF, Gilead had patented a similar prodrug called Tenofovir Disoproxil (“TDF”). Despite similarities between TAF and TDF and the weakness of the patents covering TAF, Gilead illegally seeks to extend the period of patent exclusivity for drugs incorporating Tenofovir by decades.

Gilead’s attempt to extend the period of patent exclusivity for drugs incorporating Tenofovir arises from Gilead manipulating the patent system…. Gilead’s actions have directly harmed AHF, which in 2015 alone purchased millions of dollars of antiviral drugs from Gilead.

“In 2013, Gilead unsuccessfully petitioned the FDA for a patent extension from three to five years on Stribild—which at $28,500 per patient, per year when it was introduced in January 2013 was the most expensive fixed-dose first-line combination HIV/AIDS therapy on the market,” said Michael Weinstein, AHF president, in the press release. “In November 2015, after the FDA approved Gilead’s Genvoya, we said the updated combination, with admittedly fewer potential side effects, was also developed as a means to extend prior patent protections. We believed then—as now—that Gilead is trying to monopolize the market by price gouging on its HIV/AIDS treatments, actions that severely diminish access to these lifesaving medications and serve as catalyst for our legal action today.”

AHF has a long history of battling Gilead, notably over the FDA-approved use of Truvada as pre-exposure prophylaxis (PrEP). Earlier in January, AHF sent a letter of complaint to the FDA, alleging that Gilead was promoting an off-label use of Truvada.

In a separate AHF press release, its complaint points to the Time2PrEP video campaign, specifically the spot titled “I Like to Party” (posted below). AHF claims that Gilead is promoting situational use of PrEP—that is, using it only when there is a high risk, as opposed to taking the pill daily. (The FDA has approved Truvada as PrEP only for daily use).

What’s more, AHF claims that Gilead is promoting Truvada under the radar by funding groups that then create ads for Truvada as PrEP. For example, the nonprofit group Public Health Solutions, which created the Time2PrEP campaigns and receives funding from Gilead.

For more about Genvoya, read the POZ article “FDA OKs Gilead’s Genvoya, First HIV Combo Pill With New Tenofovir.”


In a letter of complaint that is separate from the Gilead lawsuit, AHF claims this ad promotes situational use of Truvada as PrEP. Others disagree.