On November 15, NIH reported that it has been engaging with Moderna in “good faith discussions” to settle months of disputes regarding the firm’s patent applications, as reported that day by Yahoo. Moderna has offered to share the patents on its COVID-19 vaccine with the US government, along with allowing the government to “license the patents as they see fit.” Moderna asserts that the “strict rules” of US patent law required it to list only its own researchers, “as the inventors on these claims.” Yet NIAID objects, noting that, “its own thorough review” found that their scientists Kizzmekia Corbett, Barney Graham, and John Mascola should also be listed as inventors. “Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to people who played a major role in the development of the vaccine that they are now making a fair amount of money off of,” NIH’s director Dr. Francis Collins told Reuters. “Omitting NIH inventors from the principal patent application deprives NIH of a co-ownership interest in that application and the patent that will eventually issue from it,” offered an NIAID spokesperson. TrialSite notes that Moderna has benefited from in the aggregate billions of dollars in a combination of research grants and Operation Warp Speed-related government taxpayer-based injections. Are Dr. Fauci and crew now working to ensure the public’s interests—based on public investments — are represented?
A Unilateral Offer?
Earlier this month, the government watchdog group Public Citizen wrote a letter to NIH imploring it, “to publicly reclaim the foundational role” it had in creating the Moderna vaccine. “The U.S. government has done so much for Moderna and yet asked for so little in return, consistently. There is an urgent need for the U.S. government to reassert more control over how this vaccine is priced and produced,” offered Zain Rizvi, who is Public Citizen’s research director. On a side note, the GAO estimates that NIH has garnered about $2 billion worth of royalties since 1991 from its licensing patents for pharmaceuticals. Moderna just announced that they earned $10.7 billion from COVID-19 vaccine sales during 2021 up through September. Early on in our pandemic, Operation Warp Speed promised up to $483 million in order to speed up the creation and manufacturing on this product. As reported by Yahoo, Rizvi noted that in addition to the money that the US government might earn from patent ownership, said government could also, “leverage a license with co-inventorship to allow developing countries to ramp up production of the shots and prepare for future pandemics without strings attached.” Public Citizen’s Rizvi also offered that, “Moderna says it offered to allow that NIH to be a co-owner on some of the patent applications. But it did not say what it demanded from the NIH, if anything, in return. Was this a unilateral offer?”
Sped Up Development?
Early on in 2020, the Vaccine Research Center for NIAID was led by Graham, and it had already been working with Moderna on other pre-COVID-19 vaccine diseases. The agency notes that it, “pivoted to ramping up research into a new virus that had been raising alarm overseas.” NIAID researchers had long worked with scientist Jason McLellan and team on research into viruses similar to SARS-CoV-2 at the University of Texas, Austin. UT notes that the NIH assistance sped up the development of gene sequences that, “could be delivered in mRNA vaccines, which train the body to spot and fend off a signature spike protein on SARS-CoV-2.”
According to Anthony Fauci at an April congressional hearing, “The work of Dr. Barney Graham and Kizzmekia Corbett and others stabilized the pre-fusion spike protein, which is used in virtually all, with few exceptions, of the vaccines that are now successful.” And NIAID’s spokesperson notes that Moderna utilizes its, “stabilized spike protein technology in its vaccine.” Scientists from Moderna and NIH are also listed on a May 2020 patent filing relating to “methods of use” on mRNA vaccines for COVID-19, and NIAID has called this a “minor patent application.”
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“Without Input of NIAID”
While initially recognizing the research by Graham and his team and referring to collaboration with NIAID, Moderna seeks to separate its vaccine from the NIH work. They note that the mRNA sequence for their vaccine, “was selected exclusively by Moderna scientists using Moderna’s technology, and without input of NIAID scientists.” The firm asserts that NIH was, “not even aware of the mRNA sequence” in the vaccine, “until after Moderna had filed its patent request, which dates to as early as late January [2021].” While Graham and McLellan declined to comment, but Corbett has reportedly said that she, “decided that it is not my place to really say anything.—-Patent disputes and all of those things, I like to say, I leave it to the institutions and the attorneys to really figure that out. I sleep at night knowing that lives have been saved and knowing that the science that I put blood, sweat, and tons of tears into is saving those lives.”