Wednesday, December 8, 2021

Moderna and US disagree over vaccine patent rights

WASHINGTON – Moderna and the National Institutes of Health are in a fierce debate over who deserves credit for inventing the centerpiece of the company’s potent coronavirus vaccine, a conflict that has widespread implications for the vaccine’s long-term distribution and billions of dollars in future profits. …

The vaccine is the result of a four-year collaboration between Moderna and the NIH, the government’s biomedical research agency – a partnership that was widely acclaimed when the vaccine was recognized as highly effective. At the time, the government called it “the NIH-Moderna COVID-19 vaccine.”

The agency says there are three scientists at its Vaccine Research Center: Dr. John R. Maskola, director of the center; Dr. Barney S. Graham, recently retired; and Dr. Kizmekia S. Corbett, now at Harvard, worked with Moderna scientists to create the genetic sequence that prompts the vaccine to elicit an immune response and should be listed in the “main patent application.”

Moderna disagrees. In a July filing with the United States Patent and Trademark Office, the company said it “in good faith concluded that these people were not co-inventors” of the component in question. Its pending patent application lists several of its collaborators as sole inventors.

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The NIH has been in talks with Moderna for over a year trying to resolve the dispute; The company’s July documents took the agency by surprise, according to a government official familiar with the matter. It is unclear when the patent office will act, but its role is simply to determine if a patent is justified. If the two parties do not come to an agreement by the time the patent is granted, the government will have to decide whether to go to court – a battle that can be costly and frustrating.

The debate isn’t just about scientific praise or ego. If the three agency scientists are listed in the patent along with Moderna employees, the federal government can have more influence over which companies produce the vaccine, which in turn could influence which countries gain access. It would also provide an almost unlimited right to license the technology, which could bring millions to the federal coffers.

The struggle comes amid growing frustration within the US government and elsewhere over Moderna’s limited efforts to get the vaccine to poorer countries. The company, which has not previously brought the product to market, has received about $ 10 billion from taxpayers to develop the vaccine, test it, and provide doses to the federal government. It has already secured nearly $ 35 billion in supply deals by the end of 2022.

Maskola, Graham and Corbett declined to comment. But in statements to The New York Times, the NIH and Moderna confirmed the conflict has been smoldering behind closed doors for over a year.

“The NIH disagrees with Moderna’s decision to invent,” said Katie Stover, spokeswoman for the National Institute of Allergy and Infectious Diseases, a branch of the institutes that oversees vaccine research. “The exclusion of NIH inventors from the main patent application deprives the NIH of the co-ownership interest in that application and the patent that will ultimately be granted therefrom.”

Moderna spokeswoman Colleen Hussey said the company “recognized from the outset the significant role that the NIH played in the development of the Moderna COVID-19 vaccine.”

But she said the company was legally obligated to drop the agency from the main proposal because the vaccine “was only developed by Moderna scientists.”

Scientists familiar with the situation said they see it as a betrayal by Moderna, which received $ 1.4 billion to develop and test its vaccine and another $ 8.1 billion to supply the country with half a billion doses. John P. Moore, professor of microbiology and immunology at Cornell University, called it a matter of “fairness and morality at the scientific level,” adding, “The two institutes have been working together for four or five years.”

As is common in the pharmaceutical industry, Moderna has applied for a number of US and international patents related to various aspects of COVID vaccine technology. But experts said the contested patent was the most important in Moderna’s growing portfolio of intellectual property. He is trying to patent a genetic sequence that instructs the body’s cells to create a harmless version of spike proteins that probe the surface of the coronavirus, which triggers an immune response.

While the Biden administration has so far not publicly acknowledged the split, the Biden administration has expressed disappointment that Moderna has not done more to provide its vaccine to poorer countries, even though it generates huge profits.

Activists pleaded with 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 administration officials say they have no authority to require the company to do so.

Last week, advocacy group Public Citizen wrote to Dr. Francis S. Collins, director of the NIH, urging him to “publicly explain the role of the NIH in inventing the vaccine” and explain what he set out to do. ” to ensure full recognition of the contribution of federal scientists ”. The group received no response.

“It’s not just about showing off,” said Zayn Rizvi, a drug policy expert at Public Citizen who has studied Moderna’s patent applications. “We are also talking about supplies. Patents are monopolies on development, and in a pandemic, having a monopoly on life-saving technology is a terrible idea. ”

If the NIH scientists were named co-authors of the patent, the agency would generally not need Moderna’s permission to license other companies or organizations, according to patent law experts. In theory, this could help expand the supply of Moderna vaccine.

Moderna has pledged not to apply patents on COVID vaccines during the pandemic. But the government license will give manufacturers additional legal guarantees and allow them to continue producing the vaccine after the pandemic, experts say.

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Licensed by the US government, “you have the force of law, not just a public domain statement,” said Amit Sarpatvari, an expert on pharmaceutical policy and legislation at Harvard Medical School.

But even with a license, manufacturers would lack the essential ingredients to quickly make Moderna vaccine, including the recipe and the company’s technical know-how.

The patent license is “just one piece of a very big puzzle,” said Jacob S. Sherkov, a biotechnology patent law expert at the University of Illinois College of Law. “The patent license does not allow building factories, does not use raw materials, and does not train workers.”

The NIH can financially benefit from patent licensing. Several experts said it was difficult to determine exactly how much, but Sarpatvari estimated that the agency could have raised tens of millions of dollars.

For the company, having patents solely in its own name helps “support the story that Moderna was not just a successful recipient of an unprecedented large investment from the US government, but that Moderna itself has made a unique and important contribution,” said Christopher Morten, an expert on Pharmaceutical Patent Law of the Columbia Law School.

This could help the company justify its prices and fight back pressure to make the vaccine available to poorer countries.

“Moderna wants exclusive ownership and control of this patent,” Morten said. “They want to be the only organization that decides where mRNA-1273 is produced, how it is produced, who produces it, at what price it is sold. And joint ownership of this patent poses a threat to that control. “

The history of public-private cooperation has become one of the few bright spots of the pandemic. Three government scientists – most notably Corbett, who has become a role model for young black women in academia and has worked to tackle vaccine hesitancy in minority communities – have been hailed as heroes.

The name Moderna became a household name almost overnight. The vaccine is expected to generate $ 18 billion in revenue for Moderna this year. The company has already secured up to $ 20 billion in deals for the next year. Vaccine sales this year and next are likely to be among the highest in a year for any medical product in history.

Graham, who was deputy director of the Center for Vaccine Research before retiring, began his work with coronaviruses long before the pandemic. In 2017, he led a team of researchers, including Corbett, who figured out how to use protein engineering to stabilize coronavirus spike proteins before they fuse with other cells.

This technology, patented by the NIH and several academics, is at the heart of a number of coronavirus vaccines, including those produced by both Moderna and its main competitor, Pfizer-BioNTech. But while BioNTech and other companies paid for the technology license, Moderna – no – is another sore point between the company and the government, a senior administration official said. Moderna declined to comment on this.

Moderna and government researchers worked together for four years on projects related to other coronaviruses when a new one appeared in China. In January 2020, the NIH and Moderna “agreed to collaborate and jointly develop” a vaccine, Stover said.

The Vaccine Research Center quickly focused on the virus’s spike protein gene and sent the data to Moderna as a Microsoft Word file, Graham said in an interview last year. At the time, Moderna reported that her scientists had independently identified the same gene. The company’s CEO, Stefan Bansel, said Moderna connected data to its computers and designed an mRNA-based vaccine.

“We had two teams working in parallel to increase the odds,” Bansel said in an interview with MIT Technology Review.

When Moderna announced a year ago that key trials had found the vaccine to be impressively protective, the NIH called it “the NIH-Moderna COVID-19 vaccine” in its own press release. Dr. Anthony Fauci, who led the research as director of the Institute of Allergy and Infectious Diseases, said that “the vaccine was actually developed at my institute’s vaccine research center by a team of scientists led by Dr. Barney Graham and his family. colleague, Dr. Kizmekia Corbett. “

When asked about comment late last year, Bansel declined. “The vaccine technology was developed by Moderna,” he insisted.

Consumer advocacy groups and government observers have long complained that the NIH is not aggressive enough to defend and defend legal rights to its work – to the detriment of taxpayers, who often face high costs of drugs developed with government funding and research.

“This points to these broader issues that the NIH is facing as it primarily uses pharmaceuticals,” said James Krellenstein, founder of PrEP4All, an AIDS advocacy group that successfully called on the Trump administration to sue Gilead Sciences, accusing the company of earning billions of dollars. by infringing on government patents for HIV prevention drugs. The lawsuit is pending in the US District Court in Delaware.

Hussie, a spokesman for Moderna, said that “the NIH has rights under the patent application, regardless of whether it is included in the list of co-authors.” She refused to answer additional questions about the rights she spoke of.

Scientists from the agency are listed on a minor patent application that does not give licensing authority over the technology covered by the original patent application. Stover, a spokesman for the National Institute of Allergy and Infectious Diseases, said none of the agency’s collaboration agreements with Moderna “include language governing the licensing of inventions that may arise from this work.”

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