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41 Biotechnology L. Rep. 1 (2022)

handle is hein.journals/bothnl41 and id is 1 raw text is: 41 Biotechnology Law Report 1 News Briefs Number 1, 2022 © Mary Ann Liebert, Inc. DOI: 10.1089/b1r.2022.29263.sjz I Open camera or QR reader and scan code to access this article . and other resources online. Selected Developments in Biotechnology Law and the Biotechnology Industry By STEVEN J. ZWEIG MODERNA VS. NATIONAL INSTITUTES OF HEALTH T HE U.S. NATIONAL INSTITUTES of Health (NIH), which is the U.S. government's biomedical research agency, collaborated with Moderna in developing Moderna's mRNA COVID-19 vaccine- that's undisputed. But how much did each entity contribute to developing the vaccine's genetic sequ- ence that prompts an immune response? That is very much in dispute. The NIH claims that three scientists as its Vac- cine Research Center worked with Moderna scien- tists on developing that critical component and therefore should be named as co-inventors on the patent application. Moderna disagrees, and its filing with the U.S. Patent and Trademark Office (PTO) states that it had reached a good-faith determina- tion that these individuals-the NIH scientists- did not co-invent that component. Consequently, Moderna named only its own employees as inventors. Much more than bragging rights are at stake. If NIH scientists co-invented that genetic sequence, then the NIH could readily license the patent to other entities or organizations, giving it the ability to potentially expand access to the vaccine' while also bringing millions of dollars into federal coffers-a partial offset against the $1.4 billion the U.S. government gave Moderna to develop and test its vaccine. On the other hand, if only Mod- erna scientists were the inventors, then Moderna retains 100% control over a vaccine that brought the company $18 billion in revenue in 2021, with (as of December 2021) another $20 billion in deals entered into for 2022. BIDEN ADMINISTRATION BLACKLISTS DOZENS OF CHINESE TECH FIRMS AND RESEARCH AGENCIES In mid-December, the U.S. government black- listed and sanctioned a great many-dozens-of mainland China's tech companies and research institutes, barring them from exports or transfers of U.S. technology. There are also restrictions on the blacklisted entities' access to the U.S. financial system. Among the blacklisted entities is China's Academy of Military Medical Science and its sub- sidiary research institutions. The reason for the blacklist and sanctions? The belief that the People's Republic of China (PRC) 'The expansion of access is potential, not a given: even with the right to use a patent, to manufacture an mRNA vaccine requires expensive infrastructure, a highly educated and trained staff, rigorous procedures, and the right raw materi- als. To analogize: having the recipe for the world's best cake doesn't help if you have no flour, no eggs, and no oven. 1 Steven J. Zweig is the Managing Editor of Biotechnology Law Report.

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