Bayh–Dole Act
The Bayh- Dole Act, including Patent and Trademark Law Amendments Act or Bayh- Dole Act referred to, is a law in the United States, the institutions in which research is carried out with the help of federal funds, the right to exploit the results of research grants.
Description
The law was at the instigation of the two senators Birch Bayh (Democratic Party) and Bob Dole ( Republican) passed by Congress on December 12, 1980. The Bayh- Dole Act to the use of inventions that were made with the help of government funds, shall be facilitated and encouraged. The law of the United States Code (USC ) in § § 200-212, as well as in the title 37 ( Patents, Trademarks, and Copyrights ) of the Code of Federal Regulations codified in Title 35 ( Patents ) in 401 sub-
The law allows U.S. universities, small or non-profit companies to use their intellectual property ( mainly in the form of patents ), they have acquired as a result of state funding. Before the decree law the rights were property rights to the federal government. This held until then more than 28,000 patents, of which less than 5% were used on a commercial license. One goal of the Bayh- Dole Act was to increase this quota. As a result of the Bayh -Dole Act, about 20,000 patents were granted only in the period between 1993 and 2000, U.S. universities. The universities are now able to record major licensing income to some extent. In addition, about 3,000 new companies were founded ( start-ups).
March - in right
The Bayh- Dole Act allows the government financier of a research project, in particular, strictly regulated cases, waive the exclusivity of licensing and can be awarded to the patent holders over licenses to other licensees. This is called march- in right. These, however, one must be satisfied by four criteria. For example, if the licensee has failed the invention to practical application to bring, or the health and safety of the public is at risk. or the licensee, may not sufficiently meet the requirements for public use of the invention, which is governed by state regulations.
To exercise of march- in rights the government funders on its own initiative or at the request of a third party may be active. Several submissions from third parties have been indeed found to march- in, but in no case (as of December 2011) has been made use of this right. One example is the petition of U.S. patients with Fabry patients, which was rejected by the National Institutes of Health as a national donors in December 2010 (see Fabry disease # competition, production problems and treatment costs).
Effects of the Bayh -Dole Act
Before the enactment of the Bayh -Dole Act was the willingness to license acquisition of patents that were in the possession of the United States, very low. This led to the situation that of the more than 30 billion U.S. dollars by the state flowed annually in research and development, only a very small part in the form of new products or services in the economic cycle flowed back. The negotiations with the U.S. authorities about licenses were very tedious and time consuming. The relevant to the invention know-how was also not the licensor, but on the side of the inventors.
Due to the Bayh- Dole Act was given specifically to U.S. universities the opportunity the inventions of their employees who have been made in the context of government funding, to claim for themselves and to utilize directly. This led among other things to a sharp increase in the number of registered patents from universities. This figure was the beginning of the 1970s nor at 250 patents per year, it rose after the Bayh- Dole Act to over 3,000 in the late 1990s. The share of university patents on patent volume increased during the same period from 1% to 5%. In parallel, also the royalties. At universities, institutions were formed to technology transfer. In addition, there was the inventors at universities allows her idea to start a business. However, many higher education institutions replace the patent rights of use for shares of the company. As a consequence the results of academic research were reacted significantly faster products. About 2,000 new companies were formed in this manner until 2002. Here, 260,000 new jobs were created, which contribute in 2002 about 40 billion U.S. dollars to the U.S. economy.
Some authors refer to the Bayh- Dole Act as one of the most important laws of the United States in the last 50 years and as a "Viagra of the university innovations ".
Most benefited the life sciences from the Bayh- Dole Act.