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.”

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The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

Back in April 2019, Amgen quietly shut down a Phase I trial for a drug named AMG 986. There was no safety concern; the molecule just didn’t hit the mark on helping the small band of heart failure patients who received it.

A small biotech, though, believes it would stand a chance in the burgeoning anti-aging field.

BioAge Labs has licensed AMG 986 — now renamed BGE-105 — with plans to parlay the existing IND into a quick Phase I trial teasing out the pharmacodynamic effects and set the stage for mid-stage tests focused on acute muscle indications.