Statement: USPTO Director Andrei Iancu Rewards Gilead Billions for Intentionally Delaying Safer Drug
In December, we outlined how Gilead delayed access to a safer HIV drug in order to maximize their profits. Now, the USPTO has rewarded them billions of dollars for this exact behavior.
The cornerstone of Gilead’s HIV product line is tenofovir – a molecule that is present in the drugs that make up more than 99% of the company’s HIV revenue. Tenofovir itself cannot be taken by mouth, so the company markets two versions of the molecule that are both prodrugs of tenofovir: tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide fumarate (TAF). Once ingested and absorbed, the TDF and TAF prodrugs are converted back into tenofovir by the body. Although TDF and TAF ultimately are converted by the body to the same molecule, tenofovir, TAF is more efficiently absorbed than TDF. This allows TAF to be dosed at less than one tenth the dose of TDF, while having equivalent anti-HIV efficacy. Gilead claims that TAF is safer than TDF for the bones and kidneys because TAF can be used at a dramatically lower dose than TDF.
Gilead began developing TAF in 2001. In 2004, however, the company announced that it would discontinue the development of TAF following an “internal business review. In 2010, however, the company restarted development of TAF, and in 2015, a decade and a half after the development of TAF began, the company’s first drug containing TAF, Genvoya, would be FDA approved. Gilead then initiated a large-scale marketing push to transition all patients on TDF to TAF to avoid competition from generic TDF in December 2017.
In 2011, when investors asked then Chief Operating Officer (and future CEO) of Gilead Sciences, John Milligan, why the development of TAF was stopped and then started again, he admitted it was an intentional strategy to avoid cannibalizing TDF revenues. The company anticipated that TAF would be safer than TDF, especially for HIV treatment, and wanted to maximize revenues on TDF drugs before introducing newer, safer TAF drugs.
In essence, Gilead intentionally delayed access to drugs they claim are “safer” in order to maximize their profit at the expense of people’s health. A study commissioned and funded by Gilead estimated that forcing people to use TDF containing regimens instead of TAF containing regimens would result in more than 16,000 deaths and over 150,000 injuries in just over 9 years. Thus, according to their own estimations, hundreds of thousands of individuals have been adversely affected by Gilead’s decision to delay access to TAF containing drugs.
On December 14, 2015, Gilead filed an application with the FDA for a patent term extension (PTE) on the patents that protect TAF. The FDA recommended that the U.S. Patent and Trademark Office (USPTO) add over three years to the patent life on the patents protecting TAF. This PTE would be worth over $30 billion to Gilead Sciences. But had Gilead not intentionally delayed the development of the drug, there would be no need for patent term extension. This is because the drug would have been approved before the patent for TAF ever issued.
In December 2019, we filed a petition with the U.S. Patent and Trademark Office urging them to reject Gilead’s request for patent term extension on TAF because of this abuse of patent law. Today, however, the USPTO granted Gilead’s request for Patent Term Extension. This represents a disturbing precedent – the FDA and the USPTO are essentially rewarding a company to the tune of tens of billions dollars for intentionally delaying the development of a drug it believes is safer.