RETHINKING BAYH-DOLE’S BAD-DEAL FOR THE AMERICAN TAXPAYER THROUGH THE LENS OF THE NIH-MODERNA DISPUTE

May 8, 2022
NC-JOLT-Vol.-23.4_882-921_Perrone

Before 1980, the right to own the patent on any invention researched and developed under a federal funding agreement typically went to the federal agency that provided the funding. The Patent and Trademark Law Amendments Act of 1980, or Bayh-Dole Act, reorganized this framework by presumptively granting the ownership rights of any such patents to the entity that received the funding. To further promote the Act’s stated purpose of increasing the commercialization rate of inventions derived under federally funded research agreements, Congress also ceded all financial interests in any resulting invention.

The Bayh-Dole Act successfully increased the number of federally funded research agreements and the rate that inventions created under these agreements are commercialized. But the Act has become an increasingly unfair economic bargain for the American taxpayer because the Act treats the public as a donor instead of an investor in research and development. The National Institutes of Health’s (“NIH”) current feud over inventorship concerning Moderna, Inc.’s (“Moderna”) mRNA-1273 COVID-19 vaccine patent clearly illustrates this unfair bargain. The vaccine resulted from years of collaboration between the NIH and Moderna and was essentially funded in its entirety by the government. However, Moderna is seeking to exclude three NIH scientists from the patent on the vaccine’s main genetic sequence that produces an immune response. The NIH claims these scientists should be listed on the patent as co-inventors.

Having the NIH scientists listed on the patent as co-inventors would give the NIH equal ownership of the patent which is likely to be quite valuable. On the other hand, excluding the NIH scientists would limit the public’s rights in the vaccine to the provisions of the Bayh-Dole Act which, in practice, do little to vindicate any public interest in the vaccine, despite the significant investment made by the public to facilitate its development. Accordingly, the Bayh-Dole Act must be amended to adequately promote the public’s financial interests in profitable inventions whose development is financed by the federal government.

Author: Jake Perrone

PDF: http://ncjolt.org/wp-content/uploads/sites/4/2022/05/NC-JOLT-Vol.-23.4_882-921_Perrone.pdf

Volume 23, Issue 4