Public health campaigners applauded the National Institutes of Health on Wednesday for standing its ground in a patent fight with Moderna, which claimed in a recent filing that U.S. government scientists did not co-invent technology at the heart of the pharmaceutical giant's shot.
Dr. Francis Collins, the director of the NIH, toldReuters Wednesday that contrary to Moderna's assertion, government scientists "played a major role in the development of the vaccine" that the Massachusetts-based corporation is "now making a fair amount of money off of."
"Moderna has turned this people's vaccine into a rich people's vaccine."
Last week, Moderna reported $3.3 billion in third-quarter profits from its coronavirus vaccine, the company's only product on the market.
Collins said Wednesday that he believes Moderna "has made a serious mistake here in not providing the kind of co-inventorship credit" to a trio of NIH scientists who--according to the government agency--helped develop key spike-protein technology that triggers an immune response against Covid-19.
"Clearly this is something that legal authorities are going to have to figure out," Collins added, suggesting a potential court battle.
"It's not a good idea to file a patent when you leave out important inventors, and so this is going to get sorted as people look harder at this," he continued. "I did not expect that to be the outcome from what had been a very friendly, collaborative effort between scientists at NIH and Moderna over many years."
Peter Maybarduk, director of Public Citizen's Access to Medicine's program, praised the NIH for belatedly "showing a modicum of verve" and "suggesting it will not allow federal scientists' role in the invention of the NIH-Moderna vaccine to be erased."
"Recognition as the vaccine's joint inventor can help the U.S. government finally responsibly steward the vaccine's use, including by helping secure access for the billions of people still awaiting a safe path out of the pandemic," Maybarduk said in a statement Wednesday. "We, the people, paid for its development. Federal scientists pioneered the understanding of coronaviruses and then worked in partnership with Moderna."
"But Moderna has turned this people's vaccine into a rich people's vaccine, refusing to share technology with WHO or developing country manufacturers and sharing very few doses with COVAX while overcharging poor nations," he added. "More than 10 million people have died from the pandemic so far. Humanity cannot afford the U.S. government's passivity. It is past time to share NIH-Moderna with the world."
Collins' comments came a day after the New York Timesreported that Moderna--which received billions of dollars in U.S. taxpayer funding to develop its coronavirus vaccine--said in a July filing with the U.S. Patent and Trademark Office that the company "reached the good-faith determination that [NIH scientists] did not co-invent the mRNAs and mRNA compositions claimed in the present application."
The Times noted that "Moderna has sought a number of patents in the United States and overseas related to different aspects of its Covid vaccine technology," but "experts said the disputed patent was the most important one in Moderna's growing intellectual property portfolio."
"The dispute is about much more than scientific accolades or ego," the Times continued. "If the three agency scientists are named on the patent along with the Moderna employees, the federal government could have more of a say in which companies manufacture the vaccine, which in turn could influence which countries get access."
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For months, vaccine equity advocates, Democratic lawmakers, and one now-retired NIH scientist have publicly urged the Biden administration to use the federal government's role in the development of the Moderna vaccine as leverage to force the company to share its technology with low-income countries.
While the Biden administration has reportedly pressured Moderna behind the scenes, White House Press Secretary Jen Psaki said during a briefing last month that the federal government lacks "the ability to compel Moderna to take certain actions"--a narrative that experts have disputed.
Thus far, Moderna has sold most of its coronavirus vaccine supply to rich countries while charging lower-income nations a premium and resisting calls to take part in technology transfer initiatives such as the WHO's mRNA hub in Africa.
The People's Vaccine Alliance estimated earlier this year that Moderna's vaccine could be made for as little as $1.20 a dose, but the company has charged nations between four and 13 times that price.
"Although the African Union recently announced its intent to purchase 110 million doses of the company's Covid-19 vaccine, most low-income countries have yet to secure any doses and the company refuses to share information that would allow other manufacturers to produce its mRNA vaccine and help end this global pandemic," Carrie Teicher, director of programs at Doctors Without Borders USA, wrote in an op-ed for STAT last week.
On Wednesday afternoon, activists from Doctors Without Borders rallied outside the White House to demand that President Joe Biden act immediately to ramp up global vaccine production and equalize distribution.
According to Our World in Data, 7.36 billion coronavirus vaccine doses have been administered globally but just 4.4% of people in low-income countries have received at least one dose.
Avril Benoit, executive director of Doctors Without Borders USA, lamented Wednesday that "in the United States, we are talking about a return to normalcy while most of the world hasn't even received a single dose."
"There was an all-hands-on-deck approach to developing these vaccines," Benoit said. "The Biden administration needs to harness that same urgency to ensure that these vaccines are rolled out everywhere as soon as possible. That means taking bold action to share U.S. vaccine doses, and it means putting pressure on pharmaceutical corporations so that global Covid-19 access is finally a reality."