The US fed­er­al gov­ern­ment’s con­tri­bu­tions to re­search on Gilead’s Covid-19 an­tivi­ral drug remde­sivir did not re­sult in any patent rights be­cause the re­search did not cre­ate new in­ven­tions, the Gov­ern­ment Ac­count­abil­i­ty Of­fice said in a re­port on Wednes­day af­ter­noon.

The re­port set­tles a long­stand­ing dis­pute over whether the gov­ern­ment might be co-in­ven­tors of remde­sivir, which has lin­gered since be­fore for­mer Cal­i­for­nia at­tor­ney gen­er­al Xavier Be­cer­ra (who’s now Biden’s HHS sec­re­tary) led a group of oth­er AGs last sum­mer in call­ing on the gov­ern­ment to in­ter­vene and low­er the more than $3,000 price tag for remde­sivir be­cause of the gov­ern­ment’s sig­nif­i­cant con­tri­bu­tions to remde­sivir.

The GAO re­port ac­knowl­edges that be­tween 2013 and 2020, the gov­ern­ment pumped $162 mil­lion in­to the de­vel­op­ment of remde­sivir, with the Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC), the De­part­ment of De­fense (DOD), and the Na­tion­al In­sti­tutes of Health (NIH) con­duct­ing and fund­ing pre­clin­i­cal re­search. In ad­di­tion, NIH fund­ed three remde­sivir clin­i­cal tri­als, in­clud­ing the one show­ing that the an­tivi­ral short­ened the re­cov­ery time for hos­pi­tal­ized pa­tients with se­vere Covid-19.

Gilead, how­ev­er, al­so con­duct­ed its own re­search that led to the in­ven­tion of remde­sivir and the com­pa­ny said it in­vest­ed $786 mil­lion in remde­sivir R&D from 2000 through De­cem­ber 2020, GAO says. Gilead added in a state­ment that its in­vest­ment in remde­sivir ex­ceed­ed $1 bil­lion in 2020 alone and that cur­rent­ly about half of all hos­pi­tal­ized pa­tients with Covid-19 in the US are treat­ed with the drug.

DOD, NIH and oth­er sci­en­tists at Van­der­bilt and the Uni­ver­si­ty of North Car­oli­na at Chapel Hill ac­knowl­edged to GAO that their sci­en­tists were not co-in­ven­tors of patent­ed remde­sivir dis­cov­er­ies. For in­stance, NIH of­fi­cials told the GAO that Gilead be­gan patent­ing meth­ods of us­ing remde­sivir to treat coro­n­avirus in­fec­tions in 2015, while NIH sci­en­tists be­gan their remde­sivir re­search fo­cus­ing on coro­n­avirus­es in 2016.

“The prin­ci­pal in­ves­ti­ga­tors of NIH-fund­ed coro­n­avirus re­search projects told us that they did not con­sid­er fil­ing in­ven­tion dis­clo­sures be­cause their re­search did not in­volve mak­ing any mod­i­fi­ca­tions to remde­sivir or its par­ent com­pounds. The prin­ci­pal in­ves­ti­ga­tors stat­ed that they viewed such mod­i­fi­ca­tions as the thresh­old for fil­ing such dis­clo­sures,” GAO said.

And even if the gov­ern­ment had filed for a remde­sivir method-of-use patent, DOD and NIH of­fi­cials said that would be of low eco­nom­ic val­ue be­cause the fed­er­al gov­ern­ment did not own the com­pound patents and would have had to li­cense those patents from Gilead if it want­ed to com­mer­cial­ize the method of use or li­cense it to an­oth­er com­pa­ny.

Ac­cord­ing to CDC of­fi­cials, as of last month, they said it was “un­like­ly that CDC would con­duct an in­ven­tor­ship analy­sis or pur­sue in­tel­lec­tu­al prop­er­ty rights giv­en Gilead’s back­ground in­tel­lec­tu­al prop­er­ty and the lim­it­ed po­ten­tial for CDC to li­cense any such rights.”

Chris Morten, a lawyer who cur­rent­ly teach­es at New York Uni­ver­si­ty School of Law, not­ed that the re­port did not clar­i­fy if a CDC sci­en­tist, Michael Lo, co-in­vent­ed Gilead’s remde­sivir com­pound patents, and if so, “CDC would, un­der the de­fault rules of patent law, have a claim to co-own­er­ship. But CDC ap­pears un­in­ter­est­ed in pur­su­ing its le­gal rights.”

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”