iBIO joined with other life sciences state associations in a letter to Department of Health and Human Services Secretary Alex Azar voicing our concern with proposals that would allow the federal government to exercise “march-in rights” on innovative therapeutics or vaccines developed partially with federal funding.
The Patent and Trademark Law Amendments Act of 1980, referenced as the “ Bayh-Dole Act”, in recognition of its cheif authors, former Senators Birch Bayh (D-Ind.) and Bob Dole (R-Kan.), established a new legal framework regarding patent rights, in which recipients of federal funding could elect to take title to inventions they create as part of a federally funded research grant, and to engage in the a commercialization process, such as licensing the invention to a company to try to develop it into a new product.
The Bayh-Dole Act is widely hailed as a policy that fostered the US leadership in the life sciences industry and spawned a whole generation of scientist-entrepreneurs.
Key goal of the Bayh-Dole act was to enable the development and commercialization of new treatments and cures emanating from discoveries made by research institutions. Illinois universities rely on licensing deals related to research as a source of revenue. Over the past five years, Illinois universities have reported more than $1.25 billion in revenue from these licensing deals.
Concerning proposals keep surfacing to undermine the Bayh-Dole act and missuse “the march-in” right provision in the law to take away innovator’s intellectual property rights and controls the prices of mediices. The march-in provisions of the Bayh-Dole act are intended to be used in very limited circumstances by federal funding agencies to endure that discoveries are turned into products.
These proposals purposely misread the intention of the Bayh-Dole act and introduces a stark disincentive to biomedical innovation at a time when the industry needs to predictability and reliable IP protections to fight a global pandemic.
The majority of the biomedical industry in the US is made up of small and venture capital backed companies who are developing products that have not been introduced to the market. Intellectual property is the most valuable, and in many cases, the only assets these companies posses. Undermining the Bayh-Dole act would create an unreliable patent system and undermine incentives for future research.