Washington — Moderna and the National Institutes of Health are in fierce debate over who is credible for inventing the core elements of the company’s powerful coronavirus vaccine. This conflict will affect the long-term distribution and future benefits of vaccines by billions of dollars. ..
The vaccine was born out of a four-year collaboration between Moderna and the government’s biomedical research institute, NIH. This partnership was widely welcomed when the shot turned out to be very effective. At that time, the government called it the “NIH-Moderna Covid-19 vaccine.”
The agency says three scientists at the Vaccine Research Center — Dr. John R. Mascola, director of the center. Dr. Bernie S. Graham, who recently retired. Kizzmekia S currently in Harvard. Dr. Corbett worked with Moderna scientists to invent the process of creating an immune response in a vaccine. This should be mentioned in the “Major Patent Applications”.
Moderna disagrees. When filed with the United States Patent and Trademark Office in July, the company stated that it “reached a sincere decision that these individuals did not co-invent” the component in question. Patent applications that have not yet been issued nominate some of their employees as the only inventor.
NIH has been in talks with Moderna for over a year trying to resolve the dispute. The company’s July filings surprised authorities, according to government officials familiar with the matter. It is unclear when the Patent Office will act, but its role is simply to determine if the patent is justified. If both parties do not reach an agreement by the time the patent is issued, the government must decide whether to go to court. This is expensive and can be a daunting battle.
Controversy is more than scientific praise and ego. If scientists from three institutions were named in the patent along with Moderna employees, the federal government could have more say about which companies manufacture vaccines, which is next: Can affect which countries are accessible to. It also secures an almost free right to license the technology, which could bring millions of people to the Federal Treasury.
The battle takes place in the growing frustration of the US government and elsewhere, with Modana’s limited efforts to deliver vaccines to poorer countries. The company, which has never brought the product to market before, received nearly $ 10 billion in taxpayer funding to develop, test, and provide federal doses of the vaccine. By the end of 2022, it had already traded supplies worth about $ 35 billion.
Dr. Mascola, Graham, and Corbett declined to comment. However, in a statement to the New York Times, NIH and Moderna confirmed a simmering conflict in a closed room for over a year.
“NIH disagrees with Moderna’s inventor’s decision,” said Kathy Stober, a spokeswoman for the National Institutes of Allergic Infectious Diseases, a branch of the Institute that oversees vaccine research. “Excluding the inventor of NIH from a major patent application deprives NIH of sharing rights to that application and ultimately to the patents issued from it.”
“We have always been aware of the important role NIH played in the development of Moderna’s Covid-19 vaccine,” said Colleen Hussey, a spokeswoman for Moderna.
However, she said the vaccine was “designed only by Moderna scientists” and that the company is legally required to exclude distributors from its core applications.
Scientists familiar with the situation said they regarded it as a betrayal by Moderna, who received $ 1.4 billion in vaccine development and testing and an additional $ 8.1 billion to provide the country with 500 million doses. .. John P. Moore, a professor of microbiology and immunology at Cornell University, called it the issue of “fairness and morality at the scientific level” and “these two institutions have worked together for four to five years. I added.
As is common in the pharmaceutical industry, Moderna has sought numerous patents in the United States and abroad in connection with various aspects of Covid vaccine technology. But experts said the pending patents are the most important of Moderna’s growing intellectual property portfolio. It seeks to patent a sequence of genes that directs cells of the body to make a harmless version of a surface-studded peplomer of the coronavirus that triggers an immune response.
Although not publicly acknowledging the cracks so far, the Biden administration has done nothing more to provide vaccines to poor countries, despite Modana’s enormous profits. I am expressing dissatisfaction.
Activists have urged the government to share vaccine prescriptions with Moderna and transfer technology to manufacturers that can manufacture at low cost for poor countries. However, government officials say they do not have the authority to require the company to do so.
Last week, Advocacy Group Public Citizen sent a letter to NIH director Dr. Francis S. Collins, “publicly revealing NIH’s role in the invention of vaccines” and explaining what he is trying to do. Prompted. To ensure that the contributions of federal scientists are fully recognized. The group is not responding.
“It’s not just about bragging about rights,” said Zain Rizvi, a drug policy expert at Public Citizen, who studied Moderna’s patent application. “It’s also about supply. Patents are a development monopoly, and in a pandemic it’s a terrible idea to have private companies monopolize some of their life-saving technologies.”
Patent law experts said that if NIH scientists were nominated as co-inventors of patents, institutions would not normally need Moderna’s permission to license other companies or organizations. .. In theory, it could help expand the supply of Moderna vaccines.
Moderna has promised not to enforce the Covid vaccine patent during the pandemic. However, government licenses will provide manufacturers with additional legal reassurance and allow them to continue producing vaccines after a pandemic, experts said.
Ameet Sarpatwari, a pharmaceutical policy and legal expert at Harvard Medical School, said that a license from the U.S. government “provides not only a statement in the public domain, but the power of law.” ..
However, even with a license, manufacturers lack key components such as recipes and company technical know-how to quickly produce Moderna vaccines.
Jacob S. Sharkow, a biotechnology patent law expert at the University of Illinois Law College, said the patent license is “just a small part of the otherwise very large jigsaw puzzle.” “Patent licenses do not build factories, procure raw materials, or train workers.”
NIH can benefit financially from licensing patents. Some experts said it was difficult to know some, but Sarpatwari estimated that the agency could make tens of millions of dollars.
For the company, patenting by its name alone tells the story that “Moderna is not only a lucky recipient of an unprecedented large investment by the U.S. government, but also Moderna’s own essential contribution. It helps to support, “says Christopher Morten. An expert in pharmaceutical patent law at Columbia Law School.
It could help the company justify its price and reject the pressure to make the vaccine available to poorer countries.
The story of public-private partnership is one of the few glorious spots in a pandemic. Dr. Corbett, who has emerged as a role model for three government scientists, especially young black women in science, and has been working to address the hesitation of minority vaccines …