Bayh-Dole Act
The Bayh-Dole Act , also known as the Patent and Trademark Law Amendments Act or Bayh-Dole Act , is a law in the United States that gives federally funded research facilities the right to use research .
description
The law was passed by Congress on December 12, 1980 , at the instigation of Senators Birch Bayh ( Democratic Party ) and Bob Dole ( Republican Party ) . The Bayh – Dole Act aims to facilitate and promote the use of inventions made with the help of government funds. The law is laid down in Title 35 ( Patents ) of the United States Code (USC) in Sections 200 to 212, as well as in Title 37 ( Patents, Trademarks, and Copyrights ) of the Code of Federal Regulations in Part 401.
The law allows US universities, small businesses, or nonprofits to use their intellectual property (mostly in the form of patents) that they have acquired as a result of government funding. Before the law was passed, intellectual property rights went to the federal government . By then, it held over 28,000 patents, less than 5% of which were used through a commercial license. One goal of the Bayh-Dole Act was to increase this quota. As a result of the Bayh-Dole Act, between 1993 and 2000 US universities were granted around 20,000 patents. Since then, the universities have been able to record considerable license revenues. In addition, around 3000 new companies (startups) were founded.
March-in Right
The Bayh-Dole Act enables the state financier of a research project, in certain strictly regulated cases, to revoke the exclusivity of the licensing and to be able to grant licenses to other licensees bypassing the patent holder. This is known as the March-in Right . To do this, however, one of four criteria must be met. For example, if the licensee has failed to bring the invention to practical application, or the health and safety of the population is at risk, or the licensee cannot adequately meet the requirements for public use of the invention, which is regulated by state regulations.
In order to exercise march-in rights , the state financier can act on their own initiative or at the request of a third party. Several requests from third parties to march-in have been made so far , but in no case (as of December 2011) has this right been exercised. An example of this is the petition from US Fabry disease patients , which was rejected in December 2010 by the National Institutes of Health as a government sponsor (see Fabry disease # Competitive situation and production problems ).
Effects of the Bayh-Dole Law
Before the Bayh Dole Act came into effect, there was very little willingness to license patents owned by the United States. This led to the situation that of the more than 30 billion US dollars that the state invested in research and development every year, only a very small part flowed back into the economic cycle in the form of new products or services. The negotiations with the US authorities about licenses were very laborious and time-consuming. The know-how relevant for the invention was not with the licensor, but with the inventor.
The Bayh-Dole Act gave US universities in particular the opportunity to claim for themselves and directly exploit inventions made by their employees, which were made within the framework of government funding. Among other things, this led to a sharp increase in the number of patents registered by universities. While this number was 250 patents per year in the early 1970s, it rose to over 3,000 in the late 1990s under the Bayh-Dole Act. The share of university patents in patent revenue rose from 1% to 5% in the same period. At the same time, license income also increased. Technology transfer facilities have been set up at universities . In addition, the inventors at the universities were given the opportunity to set up companies with their idea. Many higher education institutions exchange the patent usage rights for shares in the company. As a result, the results of academic research were translated into products much faster. Over 2000 new companies were founded in this way by 2002. 260,000 new jobs were created in the process, which in 2002 contributed around 40 billion US dollars to the US economy.
Some authors refer to the Bayh-Dole Act as one of the most important pieces of legislation in the United States for the past 50 years and the “Viagra of University Innovation”.
The life sciences sector benefited most from the Bayh-Dole Act.
Individual evidence
- ^ A b Commission of the European Communities: The role of universities in the Europe of knowledge. (PDF) Communication from the Commission of 5 February 2003, COM (2003) 58, p. 18.
- ↑ § 200. Policy and objective. Legal Information Institute
- ↑ Supreme Court of The United States: PDF
- ^ LN Cutler, B. Bayh: Letter to DE Shalala . ( Memento of the original from January 27, 2006 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Department of Health and Human Services, March 3, 1999, p. 11.
- ↑ Use of scientific results. Patent exploitation and licensing by public research institutions. (PDF; 603 kB) OECD report , p. 2
- ↑ § 203. March-in rights. United States Code
- ↑ Original text: action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use;
- ↑ Original text: action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees;
- ↑ Original text: action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the contractor, assignee, or licensees; or
- ^ C. Leaf: The Law of Unintended Consequences. In: CNN Money. 19 September 2005
- ^ A b David Audretsch: Universities and regional economic growth. ( Page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. (PDF; 76 kB) Max Planck Institute of Economics
- ↑ T. Hoeren: On the patent culture at universities - on new paths to the goal. (PDF; 263 kB) pp. 131–156.
- ↑ Innovation's golden goose. In: The Economist. 12 December 2002
- ^ The Bayh-Dole Act - A Guide To The Law And Implementing Regulations. ( Memento of the original from September 15, 2011 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. University of California
