A USPTO legal adviser is off controversial Gilead HIV case after activists allege tweets show bias
Last week, a top legal adviser in the US Patent and Trademark Office working on the high-profile Gilead HIV PrEP case tweeted at Sen Bernie Sanders (I-VT) “What proof????” and then at activists “Do facts even matter to you?”
Now, STAT reports, she’s off of the case.
Activists in the coalition PrEP4All filed a petition to the USPTO on December 9 asking longtime senior legal advisor Mary Till be removed from the Gilead case, saying her tweets showed a bias toward Gilead. PrEP4All requested earlier this month the agency reject Gilead’s three-year patent extension for TAF (tenofovir alafenamide), a component of one of the HIV prevention regimens often referred to as PrEP. They allege the pharma giant delayed developing the drug in order to “game” the system and hold off generics.
“That she tweeted on December 5, just one day after our petition was submitted, suggests that she somehow formed an opinion on the merits of the petition without thorough consideration and may have prejudged the outcome,” wrote their attorney, Christopher Morten. “That she wrote, directly to my client, ‘Do facts even matter to you?’ and ‘No, you can’t, by law,’ indicates she may be fundamentally biased against our arguments and does not intend to give them fair consideration.”
A spokesperson for the agency told STAT yesterday that Till is “no longer working on the matter.” Till has served as a USPTO legal adviser for 14 years.
Till’s departure from the case marks a strange twist in an already highly unusual situation. Such patent extensions are generally routine – third-party input in patent cases are only allowed in “extraordinary situations” – but Gilead has long faced criticism for how it’s handled patents and access for its HIV drugs. Last month, the Trump administration sued Gilead for unpaid royalties on two PrEP drugs, and after the activist complaint, 12 Democratic senators urged USPTO official Andrei Iancu to conduct a “thorough” review of the issue.
Sanders reacted to the activists’ complaint with withering remarks on Twitter. “What a disgrace,” he wrote of Gilead’s alleged actions.
A greedy drug company deprives Americans of lifesaving HIV medicine, lies about it, then has the audacity to ask for a monopoly to make billions more in profit. What a disgrace.
I applaud the grassroots activists opposing this obscene corporate giveaway. https://t.co/fzRpouOGa8
— Bernie Sanders (@SenSanders) December 5, 2019
“What proof????” Till responded in a since-deleted tweet.
In another since-deleted tweet, she responded to a PrEP4All tweet by questioning the factual basis of their case. “Do facts even matter to you?” she asked.
Here is the deleted tweet I replied to. pic.twitter.com/TRfwbweV2B
— Doug Murphy (@Douglas_Murphy) December 6, 2019
When Prep4All tweeted its followers “You can help. Please call the United States Patent Office and tell them to deny Gilead’s request,” Till wrote, “No, you can’t, by law no third party participantion (sic).”
Till later responded to Prep4All’s suggestion on Twitter for a new drug development system based in the federal government. She wrote, “No expertise, no sales force, no manufacturing facilities, etc. You think drugs are expensive now… The companies with experience get this job done spending millions sometimes to just see a drug product fail in clinical trials. Keep your comments to something you know!”
TAF is used in Descovy, which became the second approved PrEP drug earlier this year after first landing on the market as a HIV treatment in 2015. TAF is considered safer than tenofovir disoproxil fumarate, or TDF, the nucleoside reverse transcriptase inhibitors used in the older PrEP drug, Truvada. Seizing on public remarks by former Gilead executives in 2011, activists have alleged the company held up on developing TAF so it could continue profiting on its TDF monopoly.