Clinical Research Resources
Article 1, Section 8 of the Constitution of the United States gives Congress the power to "promote the Progress of Science and useful arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respecting Writings and Discoveries." The U.S. patent statute, which established the mechanism to implement Article 1, Section 8, of the Constitution, is Title 35 of the United States Code (35 U.S.C.).
In an attempt to increase licensing and product development from government-owned patents and to enhance economic development, especially for small United States companies, Congress passed the Bayh-Dole Act (Public Law 96-517, the Patent and Trademark Law Amendments Act) in 1980. The Act, along with subsequent related policies were consolidated into 37 CRF 401. It allowed universities to hold title to the inventions made by faculty members, to apply for patents on the inventions, and to license the inventions to companies on an exclusive or non-exclusive basis. There are many details of the Bayh-Dole Act, including the rights of the government to practice the invention and the requirement that Universities share with the inventor(s) a portion of any revenue received from licensing the invention.
Documents relating to the NIH's implementation of the Bayh-Dole act include a notice in the Federal Register (59 FR 55673) on November 8, 1994, a question and answer document regarding invention reporting in the NIH Guide in 1995 (Volume 24, Number 33, September 22, 1995) and two policy statements in the NIH Guide (Volume 25, Number 16, May 17, 1996 and Volume 25, Number 29, August 30, 1996) intended to define the procedures necessary to comply with the requirements of the Bayh-Dole Act. In May 1999, NIH published proposed guidelines for grantees on obtaining and disseminating research resources (Notice for Public Comment, 64 FR 100, 28205-28209).
In October 1995 the NIH established the "Interagency Edison" system, a national database that allows universities to enter data on inventions, thus satisfying their reporting obligations to the NIH and other Federal agencies participating in the system. The Interagency Edison (iEdison) website contains valuable information on the Bayh-Dole Act, invention reporting, and frequently asked questions.
The General Accounting Office (GAO) is charged with periodically reviewing compliance with the Bayh-Dole Act and reporting to the Judiciary Committees of the House and Senate. It has issued several reports, including one on May 7, 1998 (GAO/RCED-98-126) in which it reviewed the implementation of the Bayh-Dole Act by research universities.
One of the key provisions of the Bayh-Dole Act is the requirement for investigators receiving NIH grants to disclose their inventions to NIH in a timely way. In addition, Rockefeller University and many other institutions require faculty members to report inventions made with University resources and/or facilities to the institution, regardless of the funding source. Faculty members are obligated to assign their rights in the invention to the university. Under special circumstances, both the university and the NIH may return the rights to the inventor. The rules governing this process are described in the iEdison website for the NIH's interest and the university's patent policy for the university's interest.
The Association of University Technology Managers (AUTM) is an organization of technology transfer officers of universities, research institutes, teaching hospitals, and related institutions. It produces a report each year summarizing the status of technology transfer, including data on patents, licenses, new companies, and royalty income. Its webpage (http://www.autm.net) contains additional information on technology transfer.
Reviews of the history and impact of the Bayh-Dole Act are available as a 1999 report of the Council on Governmental Relations entitled The Bayh-Dole Act: A Guide to the Law and Implementing Regulations (http://www.ucop.edu/ott/bayh.html) and as a printed version of an address by Mr. Howard W. Bremmer delivered on November 11, 2001 to the National Association of State Universities and Land-Grant Colleges entitled The First Two Decades of the Bayh-Dole Act as Public Policy.