Drugmakers have often lambasted the U.S. Patent and Trademark Office’s (PTO's) inter partes review system, but now Gilead Sciences is hoping to use it to its advantage. The drugmaker is taking on the U.S. government, arguing the Department of Health and Human Services’ patents covering preventive uses of its HIV drug Truvada are invalid.
Gilead says it “strongly” believes HHS’ pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) patents for Truvada granted since 2015 are invalid. It's asking the PTO to review and invalidate them accordingly.
The company hasn't acted on that belief until now, but Gilead says that “well before” HHS claims to have invented PrEP and PEP, “others had conceived of using an antiretroviral therapy” such as Truvada for “both forms of prophylaxis.”
The company pointed to unspecified 2004 guidelines recommending combo antitretrovirals for “high risk” individuals before HIV exposure. Centers for Disease Control and Prevention guidelines in 2005 recommended Truvada for prophylaxis immediately after exposure, the company says.
Government patents covering Gilead’s Truvada have made the rounds in the press lately, and the company figures the ongoing debate is “a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP."
“Resolving the patent issues will refocus the public dialogue about PrEP on what matters most: the real-world obstacles that prevent people at risk for HIV from accessing effective prevention,” the drugmaker said in a statement.
But one note on the timing. Gilead’s move comes on the heels of a Financial Times report that the company didn’t seek patent protection for the drug to cover PrEP use in the U.S. As a result, the drugmaker could owe $1 billion or more in royalties and damages to the government, according to the newspaper. Gilead disagreed with that conclusion and argued its Truvada patents cover all uses for the drug, the FT reported.
In recent months, Gilead has faced criticism over the med’s price—which has nearly tripled over 15 years, according to Bloomberg—and over a donation the company agreed to make. In May, the drugmaker said it would donate 2.4 million bottles for uninsured Americans through 2030, prompting questions about motive.
Lawmakers wondered whether the donation came as a part of negotiations between HHS and Gilead over Truvada patents, and therefore Gilead's ability to price at will. Many, including those at The New York Times editorial board, pointed out that the donation would allow Gilead to file for a massive tax write-off.
Meanwhile, a Truvada generic is set to hit the U.S. next year under an agreement Gilead made with Teva. Gilead's working to advance its Truvada follow-up, Descovy, in the meantime.
Gilead’s use of the inter partes review system highlights a logical disconnect between the pharma industry, which has railed against the process for years, and the drugmakers within the industry who employ it to strike down rival patents. In 2017, FT highlighted dozens of cases where pharma companies have sought to invalidate patents through IPRs, even though industry lobby groups routinely criticize the process.