Dec. 5, 2019
The Washington Post – 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.
“Continue to gain monopoly profits”
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.
The group’s accusations mirror allegations in class-action civil lawsuits filed in a U.S. District Court in California against the company by patients who took Gilead’s medications and allege their health was compromised by the company’s actions.
Gilead has denied the allegations in the lawsuits … READ MORE