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Mod­er­na and NIH can't agree on who in­vent­ed the life­sav­ing Covid-19 vac­cine, and their feud is now pub­lic — re­port
Max Gelman

Editor


Mod­er­na’s on­go­ing feud with the NIH over Covid-19 vac­cine patents has spilled in­to the open.

In a new re­port from the New York Times pub­lished Tues­day af­ter­noon, Mod­er­na is as­sert­ing that three NIH sci­en­tists were not in­volved in in­vent­ing the key com­po­nent in the biotech’s vac­cine, to the sur­prise of the in­sti­tute. The claim comes from a Ju­ly fil­ing with the US Patent and Trade­mark Of­fice, which the NYT post­ed in full along with its re­port.

With­in the fil­ing, Mod­er­na said it had “reached the good-faith de­ter­mi­na­tion” that three NIH sci­en­tists — John Mas­co­la, Bar­ney Gra­ham and Kizzmekia Cor­bett — “did not co-in­vent” the se­quence that prompts the body’s im­mune re­sponse to the coro­n­avirus spike pro­tein. The NIH, mean­while, says the trio worked with Mod­er­na at the out­set of the pan­dem­ic to de­sign the com­po­nent in ques­tion.

In re­sponse to an End­points News re­quest for com­ment, a Mod­er­na spokesper­son said the com­pa­ny has “all along” rec­og­nized the role the NIH played in de­vel­op­ing the Covid-19 shot. But the spokesper­son in­sist­ed on­ly Mod­er­na sci­en­tists in­vent­ed mR­NA-1273 — the co­de­name for the com­pa­ny’s vac­cine.

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The spokesper­son al­so claimed that Mod­er­na wasn’t not al­lowed to “choose” who to list on the patent ap­pli­ca­tion, per US law. It’s not clear to which law or laws Mod­er­na is re­fer­ring to.

“Fol­low­ing those rules, as we must, Mod­er­na is re­quired to on­ly list Mod­er­na sci­en­tists as the in­ven­tors for the patent claims to mR­NA-1273,” the spokesper­son wrote in an email. “Mod­er­na’s con­clu­sion is dri­ven by noth­ing oth­er than our oblig­a­tion to com­ply with U.S. patent law.”

End­points has al­so reached out to the NIH and will up­date this sto­ry ac­cord­ing­ly.

The patent has not yet been is­sued, and the NIH is re­port­ed­ly in­sist­ing the three sci­en­tists be in­clud­ed on the ap­pli­ca­tion.

At the cen­ter of the de­bate is whether Mod­er­na’s Covid-19 vac­cine orig­i­nal­ly sprung from a col­lab­o­ra­tion be­tween the biotech and the in­sti­tute, as the pair had been re­search­ing oth­er coro­n­avirus­es for four years when SARS-CoV-2 first emerged. The NIH called the shot the “NIH-Mod­er­na vac­cine” in press re­leas­es last year at the Phase III read­out, though Mod­er­na CEO Stéphane Ban­cel pushed back on that de­scrip­tion in an in­ter­view with MIT Tech­nol­o­gy Re­view.

Should the PTO is­sue Mod­er­na a patent based on the cur­rent ap­pli­ca­tion, the gov­ern­ment would have to go to court to ob­tain a li­cense. It’s not clear when the PTO is ex­pect­ed to make its de­ci­sion.

Mod­er­na’s back-and-forth with the NIH has been on­go­ing for over a year now. The NYT re­ports that the agency would not need Mod­er­na’s per­mis­sion to li­cense the vac­cine tech­nol­o­gy to oth­er com­pa­nies, coun­tries or or­ga­ni­za­tions if the sci­en­tists are named on the patent. Such a move could, the­o­ret­i­cal­ly, help boost vac­cine sup­ply.

The biotech has said pre­vi­ous­ly it won’t en­force its patents dur­ing the pan­dem­ic, but the NIH back­ing would pro­vide the au­thor­i­ty of the US gov­ern­ment rather than just a pub­lic com­pa­ny state­ment. The NIH could al­so ben­e­fit fi­nan­cial­ly from its re­searchers be­ing list­ed, though it’s not clear how much, the NYT’s re­port says.

Tues­day’s re­port comes as Pres­i­dent Joe Biden’s ad­min­is­tra­tion has been ramp­ing up pres­sure and crit­i­cism on Mod­er­na for pri­mar­i­ly sell­ing vac­cines to wealth­i­er coun­tries, de­spite pulling in bil­lions of dol­lars in prof­its, and re­sist­ing calls to share its vac­cine IP. Last week, Pub­lic Cit­i­zen al­so called on Mod­er­na to “clar­i­fy” the NIH’s role in in­vent­ing the vac­cine tech in a let­ter to agency di­rec­tor Fran­cis Collins.

In the new book A Shot to Save the World out last month de­tail­ing the in­ven­tions of the mR­NA Covid-19 vac­cines, Wall Street Jour­nal re­porter Gre­go­ry Zuck­er­man wrote the three NIH sci­en­tists in ques­tion de­signed a se­quence for a vac­cine and sent it to Mod­er­na. The biotech then used it to con­firm their own de­signs and pro­duce that vac­cine.

Zuck­er­man wrote:

On Thurs­day, Jan­u­ary 23, Wang packed his ma­te­r­i­al in a con­tain­er, try­ing hard to en­sure it didn’t leak, and shipped it all to Kizzmekia Cor­bett, the gov­ern­ment sci­en­tist who was do­ing sim­i­lar work with oth­er’s in Gra­ham’s lab. Cor­bett, Gra­ham and John Mas­co­la chose an ide­al spike-pro­tein de­sign and sent it to Mod­er­na. The com­pa­ny’s sci­en­tists, re­ly­ing on McLel­lan and Wang’s ear­li­er work, had built their own spike-pro­tein de­sign. It matched the one from the gov­ern­ment sci­en­tists, con­firm­ing they made the right choice. Mod­er­na took their cho­sen se­quence, em­ployed some so­phis­ti­cat­ed com­put­er soft­ware, and built an mR­NA mol­e­cule ca­pa­ble of pro­duc­ing the sta­bi­lized spike pro­tein. This would be­come Mod­er­na’s vac­cine anti­gen.