February 21, 2020 10:51 AM EST Jason Mast R&D G

February 21, 2020 10:51 AM EST Jason Mast R&D

Gilead los­es two more patent chal­lenges on HIV pill, set­ting up court­room fight in Delaware


Gilead sus­tained two more loss­es in their ef­forts to rid them­selves of an ac­tivist-backed patent law­suit from the US gov­ern­ment over a best-sell­ing HIV pill.

Urged on by ac­tivists seek­ing to di­vert a por­tion of Gilead’s rev­enue to clin­ics and pre­ven­tion pro­grams, the De­part­ment of Health and Hu­man Ser­vices made a claim to some of the patents for the best-sell­ing HIV pre­ven­tion drug, Tru­va­da, al­so known as PrEP. Gilead re­spond­ed by ar­gu­ing in court that HHS’s patents were in­valid.

To­day, the US Patent and Trade­mark Of­fice ruled that Gilead was like­ly to lose the last two of those chal­lenges as well. The USP­TO ruled against Gilead on the first two patents ear­li­er this month.

The rul­ing is a sig­nif­i­cant win for HHS and ac­tivists in their ef­forts to col­lect on Gilead’s rev­enue. It means that the case will now be de­cid­ed in fed­er­al court in Delaware where, three months ago, the HHS filed a suit against Gilead for in­fring­ing on its patents and re­fus­ing to sign a li­cens­ing deal.

It is high­ly un­usu­al for the fed­er­al gov­ern­ment to sue phar­ma com­pa­nies over in­tel­lec­tu­al prop­er­ty, al­though it rou­tine­ly li­cens­es out patents that came out of gov­ern­ment-backed re­search. HHS said they tried to work out such a deal with Gilead for over a year, but Gilead main­tained the gov­ern­ment didn’t have rights to the patent.

HHS has point­ed in part to the near­ly $50 mil­lion of fed­er­al grants that backed HIV pre­ven­tion work by San Fran­cis­co AIDS foun­da­tion re­searcher Robert Grant and CDC re­searcher Thomas Folks. Gilead said oth­ers had al­ready for­mu­lat­ed the idea of us­ing an HIV drug for pre-ex­po­sure pro­phy­lax­is, point­ing to guide­lines pub­lished in 2005 by the Cen­ter for HIV Iden­ti­fi­ca­tion, Pre­ven­tion, and Treat­ment Ser­vices and AIDS Part­ner­ship Cal­i­for­nia.

The fed­er­al gov­ern­ment’s un­usu­al pur­suit has been fu­eled in part by AIDS ac­tivists, who have crit­i­cized the $21,100 price tag Gilead placed on PrEP. They say gov­ern­ment roy­al­ties could be used to fund treat­ment and ed­u­ca­tion pro­grams that will ex­pand ac­cess to the drug.

The high price Gilead has charged, along with ed­u­ca­tion­al and oth­er bar­ri­ers, has helped lead to wide racial, ge­o­graph­ic and eco­nom­ic dis­par­i­ties in who has ac­cess to the drug and where the HIV epi­dem­ic still reach­es cri­sis lev­els.

Tru­va­da, a pill, is more than 90% ef­fec­tive in pre­vent­ing HIV if tak­en prop­er­ly. Gilead has raised the price by more than $10,000 since it was in­tro­duced in 2004, when they charged $650 per month, or $7,800 per year.

The com­pa­ny has not­ed that its as­sis­tance pro­grams curb costs for many pa­tients and last year it do­nat­ed enough of PrEP to cov­er 200,000 pa­tients for 11 years.