NYTimes: Years Ago, PrEP4All Correctly Called Out Gilead’s Intentional Delay In Developing Potentially Safer HIV Treatment to US Patent and Trademark Office
On Saturday July 22, a New York Times front-page investigation published “smoking gun” documents that confirm PrEP4All’s longstanding analysis of Gilead Pharmaceuticals’ unethical decision to stop development of a potentially safer version of a key HIV medication, tenofovir, in order to extend patent monopolies for HIV treatment and pre-exposure prophylaxis (PrEP). In 2019 and 2020, PrEP4All unsuccessfully fought Gilead’s unethical and illegitimate patent term extension on the medication, also known as tenofovir alafenamide or TAF.
In December 2019, PrEP4All filed a petition with the US Patent and Trademark Office (USPTO) that brought to USPTO’s attention much of the unethical conduct documented by the Times and urged USPTO to deny Gilead’s extensions or hold a hearing to gather further evidence. In February 2020, USPTO denied PrEP4All’s petition and granted Gilead’s extension.
The Times coverage, which uses documents obtained as part of a recent “pay-for-delay” case against the pharma juggernaut, demonstrates the accuracy of PrEP4All’s 2019 analysis that Gilead should not have been rewarded by USPTO for intentionally delaying research into TAF and then hiding that fact from the USPTO and Food & Drug Administration. The new documents clearly show that Gilead executives decided as early as 2003 to halt research of TAF in order to maximize profits, through what Gilead itself called a “patent extension strategy.”
Being proven right by these smoking gun documents is a hollow victory, however. PrEP4All’s December 2019 petition included over 200 pages of evidence of Gilead’s unethical patent extension strategy and received multiple letters of support from Members of Congress. PrEP4All’s petition also brought to USPTO’s and the broader public’s attention the fact that a study funded by Gilead estimated in 2018 that the company’s decision to delay development of TAF resulted in 16,200 additional deaths and over 150,000 additional injuries among people living with HIV over a nine year period. Despite all this, the USPTO denied PrEP4All’s petition—apparently without ever considering the evidence of Gilead’s unethical conduct, including its lies and omissions of material facts in statements to the USPTO. A few days after denying PrEP4All’s petition, the USPTO granted Gilead’s patent term extension, extending a key patent from 2022 to 2025. The USPTO’s decision rewarded Gilead to the tune of billions of dollars for unethical business decisions and unnecessary harm to people living with HIV.
“If I were Daniel O’Day or another C-suite exec at Gilead I’d probably be feeling pretty smug about my ability to game the government and get rewarded for delaying access to safer medications for people living with HIV.” says PrEP4All Executive Director Jeremiah Johnson. “The many ways in which Gilead has been able to outsmart the governmental systems that should protect those of us living with or vulnerable to HIV is actually quite brilliant in a diabolical way.”
“We have to ask ourselves what kinds of drug development and business decisions we want our government to reward,” says Amy Killelea, a Senior Policy Advisor for PrEP4All. “Right now the USPTO has sent a clear signal that companies are allowed to withhold medications they have found to be potentially safer in order to milk every dollar they can out of the American public.”
While advocates hope that a leading NYTimes story on Gilead’s abuses will lead to more visibility and accountability for a company that dominates both HIV treatment and PrEP prescriptions in the US, at present things stand to get much worse for people living with and vulnerable to HIV as the US House of Representatives has recommended to slash over $600M in funding as part of FY24 appropriations and gut potential funding for a National PrEP Program.
“We’ve been left completely unprotected from predators like Gilead, and now our government seems intent on throwing out decades of bipartisan support for HIV and PrEP funding” says PrEP4All Communications and Mobilization Manager, Michael Chancley. “Advocates have sent thousands of letters to Congress in the past week as part of our #PrEPSaves campaign, but I fear the many failures of our federal government will continue to create conditions for the HIV epidemic to rage on in Black and Brown communities.”