Sponsored by the U.S. Department of Energy Human Genome Program
Human Genome News Archive Edition
Human Genome News, March 1991; 2(6)
The NIH Program Advisory Committee on the Human Genome (PACHG) met on December 3, 1990, in Bethesda, Maryland, with Norton Zinder presiding. The meeting included funding reports, a presentation on intellectual property rights, and scientific presentations on large-scale mapping projects. [For a list of PACHG members and their affiliations, see HGN 2(3), 7 (September 1990).]
Zinder, in commenting on the scientific presentations, said they were indicative of the high-quality science being conducted under the auspices of the NIH human genome program.
Elke Jordan [Deputy Director, National Center for Human Genome Research (NCHGR)] briefly reviewed budget information and lists of grants awarded since FY 1990. She indicated that a substantial amount of the budget increase granted in 1991 would be spent on the research centers program and that additional funds have been allocated for research project grants and other components.
Alice Martin-specialist in intellectual property rights at the law firm of Arnold, White, & Durkee, certified medical geneticist, and member of the American Bar Association-provided an overview of the intellectual property that will be generated by the project (e.g., DNA sequences, technological developments, and databases). She described the types of mechanisms available to protect intellectual property-patents, copyrights, trademarks, and trade secrets-and summarized protection extent, enforcements, and advantages and disadvantages associated with each of these mechanisms.
Martin also explored the philosophical issue of whether legal protections for intellectual properties generated by genomic research are against the public interest. She provided examples of different approaches by inventors of various biological products and techniques. Legally protected intellectual property affords advantages, such as royalties that can be used to fund additional research, and gives opportunities for inventors to retain some control over the use of their inventions.
Addressing the question of the patentability of life forms and DNA sequences, Martin indicated that the U.S. Patent and Trademark Office uses three criteria in deciding whether or not to issue a patent: the invention must be new; must be nonobvious based on the prior art (i.e., the body of knowledge accumulated in the inventor's field of expertise); and must be useful.
She added that, although life forms or products that occur in nature cannot be patented, modifications of these life forms or products (e.g., isolated or purified DNA segments, clones, or cDNAs) may be patentable. Martin anticipated that the major difficulty in patenting DNA sequences will be in proving that they are nonobvious when technology and methods for generating sequences become widely used.
Elaborating on U.S. patent law, Martin discussed the experimental-use exception to property rights, whereby an individual can make or use a patented item as long as commercial gain is not intended. She also delineated some of the differences between U.S. and European patent laws and noted that efforts to make the two systems more compatible are in progress.
Martin concluded by stating that no new laws will be needed to address intellectual property issues related to the Human Genome Project, but she emphasized that an understanding of intellectual property rights will be essential in avoiding potential legal problems among inventors, collaborators, and funding agencies. She remarked that it might be appropriate for PACHG and DOE to form a joint working group on intellectual property issues to ensure that the rights of all parties are clearly stated and to stay abreast of public opinion and congressional actions.
Five grantees delivered scientific presentations on major mapping projects supported by NCHGR:
The electronic form of the newsletter may be cited in the following style:
Human Genome Program, U.S. Department of Energy, Human Genome News (v2n6).
The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.
Published from 1989 until 2002, this newsletter facilitated HGP communication, helped prevent duplication of research effort, and informed persons interested in genome research.