Moderna and US Agree on Vaccine Patent Rights


WASHINGTON — Moderna and the National Institutes of Health are in a bitter dispute over who deserves credit for inventing the central ingredient of the company’s powerful coronavirus vaccine, a conflict with far-reaching implications for billions of dollars in the vaccine’s long-term distribution and future profits.

The vaccine was born from a four-year collaboration between Moderna and the NIH, the government’s biomedical research agency—a partnership that was widely hailed when the vaccine was found to be highly effective. The government then called it the “NIH-Moderna Covid-19 vaccine”.

The agency said three scientists at the Vaccine Research Center – the director of the centre, Dr. John R. Mascola; The recently retired Dr. Barney S. Graham; and Dr., who is now at Harvard. Kizzmekia S. Corbett – worked with Moderna scientists to invent the process that allows the vaccine to produce an immune response, and her name should appear in the “master patent application.”

Moderna disagrees. In a filing with the United States Patent and Trademark Office in July, the company said it had “reached a good faith decision that these individuals did not co-invent” the component in question. The patent application, which has not yet been published, names several of its own employees as the sole inventors.

The NIH had been in talks with Moderna for over a year to resolve the dispute; The company’s filing in July surprised the agency, according to a government official familiar with the matter. It is unclear when the patent office will take action, but its role is simply to determine whether a patent is warranted. If the two parties can’t agree when a patent is granted, the government will have to decide whether to go to court – a battle that can be costly and messy.

Conflict is much more than scientific praise or ego. If three agency scientists are named in the patent, along with Moderna employees, the federal government may have more say in which companies produce the vaccine, which could affect which countries have access to it. It would also give the federal treasury a nearly unlimited right to license technology that could bring millions.

The fight comes amid growing frustration in the US government and elsewhere with Moderna’s limited efforts to get its vaccine to poorer countries. The company, which has never released a product before, has received nearly $10 billion in taxpayer funding to develop and test the vaccine and provide doses to the federal government. It has already arranged supply deals worth approximately $35 billion by the end of 2022.

Dr. Mascola, Graham and Corbett declined to comment. But in their statements to the New York Times, the NIH and Moderna confirmed the conflict that had been simmering behind closed doors for more than a year.

“The NIH disagrees with Moderna’s inventive determination,” said Kathy Stover, spokesperson for the National Institute of Allergy and Infectious Diseases, the institute’s arm that oversees vaccine research. “Removing the NIH inventors from the main patent application deprives the NIH of its common ownership interest in that application and the patent that will eventually be deducted from it.”

Moderna’s spokesperson, Colleen Hussey, said the company “recognised from the start the NIH’s important role in the development of Moderna’s Covid-19 vaccine.”

But he said the company had to legally exclude the agency from core practice because “only Moderna’s scientists designed the vaccine.”

Scientists familiar with the situation said they saw it as Moderna’s betrayal. 1.4 billion dollars another $8.1 billion to develop and test its vaccine and provide the country with half a billion doses. “These two institutions have been working together for four or five years,” said John P. Moore, professor of microbiology and immunology at Cornell University, describing it as a matter of “scientific fairness and morality.”

As is typical in the pharmaceutical industry, Moderna a number of patents It’s about different aspects of Covid vaccine technology in the United States and overseas. But experts said the controversial patent is the most important in Moderna’s growing intellectual property portfolio. He’s trying to patent the genetic sequence that instructs body cells to make a harmless version of the spike proteins that pierce the surface of the coronavirus. an immune response.

While the Biden administration has so far not openly acknowledged the dispute, it has expressed disappointment at Moderna’s failure to do more. provide the vaccine to poorer countries despite making huge gains.

Activists begged the government to force Moderna to share its vaccine formula and transfer its technology to manufacturers who could produce it at a lower cost for poorer countries. But management officials say disqualified asking the company to do this.

Last week, the Public Citizen advocacy group, director of the NIH, Dr. Francis S. Collins, “to make public the role of the NIH in the invention of the vaccine” and to explain what it intends to do. to ensure full recognition of the contributions of federal scientists. “There was no response from the group.

“It’s not just about bragging rights,” he said. Zain RizviA drug policy expert at Public Citizen researching Moderna’s patent applications. “It’s also about supply. Patents are development monopolies, and it is a terrible idea for a private company to have a monopoly on a piece of technology that saves lives in a pandemic.”

Patent law experts said that if NIH scientists are named co-inventors on the patent, the agency will generally not need Moderna’s permission to license it to other companies or organizations. In theory, this could help increase the supply of the Moderna vaccine.

Moderna has pledge failing to enforce Covid vaccine patents during the pandemic. However, experts said a license from the government would provide manufacturers with additional legal protection and allow them to continue producing vaccines after the pandemic.

“You have the force of law rather than a public statement,” said Ameet Sarpatwari, an expert in drug policy and law at Harvard Medical School, with a license from the U.S. government.

But even if they did have a license, manufacturers would lack crucial ingredients, including the prescription and the company’s know-how, to make Moderna’s vaccine quickly.

A patent license is “just one piece of an otherwise huge puzzle,” said Jacob S. Sherkow, a biotechnology patent law specialist at the University of Illinois School of Law. “Patent license does not build factories, supply raw materials, train workers.”

The NIH could benefit financially from licensing the patent. Several experts said it was difficult to know how much, but Mr Sarpatwari estimated that the agency could harvest tens of millions of dollars.

Christopher Morten helps support a narrative for the company that “Moderna is not only the lucky recipient of the unprecedented massive US government investments, but that Moderna has made unique and significant contributions in its own right.” Pharmaceutical patent law major at Columbia Law School.

This could help the company justify its prices and reject the pressure to offer its vaccine to poorer countries.

The story of public-private collaboration has been one of the few bright spots of the pandemic. Three government scientists—particularly Dr. Corbett – hailed as a hero.

A young company that had never launched a product before, Moderna became a household name almost overnight. On the way to bring the vaccine up to $18 billion Moderna’s revenue this year. The company has already made deals of up to $20 billion for next year. Sales of the vaccine, both this year and next, are likely to be among the highest in a single year for any medicinal product in history.

Prior to his retirement, assistant director of the Vaccine Research Center, Dr. Graham began his work on coronaviruses long before the pandemic. In 2017, figuring out how to use protein engineering to stabilize spike proteins on the coronavirus before they fuse with other cells, among them Dr. He led a research team that included Corbett.

This technology has been Patented by the NIH. and several academic collaborators underpin a number of coronavirus vaccines, including those made by both Moderna and its main competitor, Pfizer-BioNTech. But a senior management official said that while BioNTech and other companies pay to license the technology, Moderna does not – another sensitive spot between the company and the government. Moderna declined to comment on the matter.

Moderna and government researchers had been working together for four years on projects involving other coronaviruses when the new one emerged in China. Ms Stover said in January 2020 that the NIH and Moderna had “agreed to collaborate and jointly develop” a vaccine.

Dr. Graham said the Vaccine Research Center quickly reset the virus on the gene for the spike protein and sent the data in a Microsoft Word file to Moderna. in an interview last year At the time, scientists independently identified the same gene, Moderna said. The company’s CEO, Stéphane Bancel, said Moderna had connected the data to their computers and designed an mRNA vaccine.

“We had two teams working in parallel to increase the chances,” Bancel said. MIT Technology Review.

when modern announced When the NIH discovered a year ago that the vaccine was extraordinarily protective in a major trial, it called it “NIH-Moderna Covid-19 vaccine” in its newsletter. Overseeing the research in his role as director of the Institute for Allergy and Infectious Diseases, Dr. Anthony S. Fauci, said “The vaccine was originally developed at my institute’s vaccine research center by a team of scientists led by Dr. Barney Graham and close colleague Dr. Kizzmekia Corbett.”

Asked late last year about the comment, Mr. Bancel pushed back. “The vaccine technology was developed by Moderna,” he insisted.

Consumer advocacy groups and government watchers have long complained that the NIH isn’t aggressive enough in its work to protect and assert legal rights – to the detriment of taxpayers who often face high costs for drugs developed with government funding and research.

“This points to these broader issues with the NIH being primarily exploited by medicine,” said James Krellenstein, founder of PrEP4All, an AIDS advocacy group that has successfully spurred the Trump administration to sue. Gilead Sciencesaccuses the company of making billions by infringing on government patents for anti-HIV drugs. NS litigation continues in U.S. District Court in Delaware.

Ms Hussey, spokesperson for Moderna, said that “the NIH’s right to have rights under the patent application is not dependent on their being listed as co-inventors.” He refused to answer additional questions about the rights he mentioned.

Scientists from the agency got a small name Patent application does not grant licenses. Ms Stover, spokesperson for the National Institute of Allergy and Infectious Diseases, said that none of the agency’s collaboration agreements with Moderna “contain language that controls the licensing of inventions that may arise from this work.”

kitty bennett contributed to research.



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