Gilead has faced criticism and lawsuits over its development timeline for HIV medicines, and the topic resurfaced this week as advocates challenged the company’s effort to score patent extensions.
In a petition at the U.S. Patent & Trademark Office, HIV advocates said Gilead delayed development of new, safer meds to protect the market for older meds. Gilead has sought to extend patent protections for its newer drugs, but advocates say that would only reward the company’s move to shelve the drugs for years at the expense of patients.
The advocates behind the petition, a group called PrEP4All, say Gilead invented tenofovir alafenamide, or TAF, in 2000. The company stopped development on the compound in 2004 and restarted its work in 2010, according to PrEP4All. The move was designed to protect its older, less safe tenofovir disoproxil fumarate (TDF) drugs, the organization argues, as they still had years of patent protections and were garnering strong sales.
The group quotes Gilead’s former COO and CEO John Milligan as saying the company was “concerned” about developing the follow-up compound because it was busy launching Truvada. TAF meds eventually hit the market in 2015.
In the petition, PrEP4All says the strategy was "unfair, unjust and dangerous to public health and safety."
"To reward this behavior with additional years of patent term would be fundamentally inequitable and would incentivize future drug companies to copy Gilead’s unethical playbook," the group said.
A Gilead spokesman said the company "strongly believes" the petition lacks merit, and that the company will defer to the PTO's decision making process on the patent term.
"For more than three decades, Gilead has been committed to developing and improving upon therapies that address unmet needs for people living with HIV," he added. "Patient safety is of foremost importance to us and any implication that Gilead delayed the development of a drug known to be safer than TDF is false."
It’s far from the first time the allegations have surfaced. Last year, California residents Michael Lujano and Jonathan Gary filed a lawsuit levying similar allegations in state court. Before that, the AIDS Healthcare Foundation (AHF) challenged the company on anticompetitive grounds; Gilead prevailed in the case.
This year, a federal judge allowed a set of similar claims from 140 patients in 31 states to proceed.
Aside from the R&D timing issue, Gilead’s HIV business has been in the news quite a lot lately. The company and federal authorities just this week kicked off a national program to provide preventative HIV drugs for free to people who can benefit and who don’t have insurance. Gilead agreed to a major drug donation earlier this year, but critics questioned the company’s motives.
And on the patent front, Gilead and the federal government have been arguing over intellectual property rights on PrEP meds, which are approved to prevent HIV infection. HHS says it has tried to license its patents to Gilead but that Gilead has refused. The agency sued for patent infringement last month and Gilead said it “strongly” believed the government’s patents are invalid.