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Gilead delayed safer HIV drug to extend monopoly profits, advocates allege

Published: December 6, 2019
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In 2005, Gilead Sciences notified federal regulators that it was suspending development of a potentially safer, more potent HIV-fighting drug than the one on the market. The company did not restart its Food and Drug Administration application until 2010. Now the five-year delay of a promising drug is at the core of accusations by advocates that Gilead improperly exploited the patent system at the expense of patient health.

An HIV-prevention group called PrEP4All Collaboration filed a petition Wednesday with the U.S. Patent and Trademark Office contending Gilead knew its new, improved drug — approved in 2015 and now part of Gilead’s combination therapies Genvoya and Descovy — was safer. But it alleged Gilead postponed development so it could continue to gain monopoly profits from its older combination HIV drugs, including Viread and Truvada, for a longer period,before those drugs went off patent and faced generic competition.

Gilead used the delaying tactic even though the older drugs posed more risks to bone and kidney health, PrEP4All alleged.

The group is asking the Patent and Trademark Office to reject Gilead’s request for three extra years of patent life on the newer drug, called tenofovir alafenamide, or TAF. Odds of success are steep because the patent office will review such third-
party petitions only in “extraordinary’’ circumstances, according to its rules.

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Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks — the drug’s price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.

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