The Bayh-Dole Act of 1980, codified at 35 U.S.C. § 200 et seq., facilitates technology transfer from government research to public benefit. The Act does this by facilitating the transfer of patent rights for commercialization from federally funded innovation. It secures private patent rights from inventions from federal research, and is widely considered to be a tremendous success, and some consider this Act to be one of the finest pieces legislation in the last century. At the time it passed the United States was falling behind the world in innovation, but that trend then reversed in part due to this Act.
Simply put, this Act facilitates private investment in innovation from government-funded research, in a decentralized manner. The commercialization of the Honeycrisp (or Honeycrunch) apple, which was developed at the University of Minnesota, is cited as one (of many) examples of successes due to the Act.[1]
This Act uses patent rights to make the otherwise difficult transition between government-funded work and public benefit from private sale of products based on the research. Fewer than 5 percent of government patents were being used, and almost none in the biotech field, and there were 28,000 patents in the control of the government which were being wasted without utilization when this Act was passed. The use of innovation in biotech (35-40 billion dollars is spend each year in biomedical research, primarily at the NIH) was particularly enhanced by this Act.
The goal of the Act, which was enacted during the lame duck Congress after President Ronald Reagan's landslide election victory in 1980, was as follows:[2]
| “ | It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and nonprofit organizations, including universities .... | ” |
This Act emphasized that many of the benefits should be in the United States, and that royalties should go back into research. The entrepreneurship today at American universities is attributed primarily to this Act.
The Bayh-Dole Act has been enormously influential in allowing a university or other entity to use federal funding for research and then obtain patents on their inventions, rather than the government insisting on retaining all rights to patents developed with federal funds as it had prior to this law.
This Act was unusual in not creating a new bureaucracy or requiring new funding.
A few months before the Act passed the Supreme Court ruled that biological innovation could be patented.[3]
In recent years there has been a debate as to whether the Bayh-Dole Act is working well with biomedical patents, amid many conflicts of interest.
March in rights are a special power granted to the federal government to order a patent holder under the Bayh-Dole Act to grant rights in a patent to another party. This power has never been invoked but continues to be a topic of controversy:
35 U.S. Code § 203.March-in rights[4]
Private organizations have developed to facilitate the technology from universities in a decentralized manner. The Wisconsin Alumni Research Foundation (WARF) is an example of a private foundation that promotes the transfer of inventions from the University of Wisconsin to public benefit.[5] These private entities help license technology and attract start-up companies to the regions of the universities.
The Bayh-Dole Act does not have any safeguards against conflicts of interest by government policymakers having financial interests in a particular approach to a problem, such as coronavirus. There are, however, other general federal statutes relating to conflicts of interest. Universities tend to have their own policies, with rare enforcement, against conflicts of interest.