stand the information in the genome and to use it to benefit human health and well-being.

One important factor in the realization of the potential benefits of the Human Genome Project (HGP) that requires careful scrutiny is the practice of protecting intellectual property in the fields of genomics and its offspring—proteomics—the study of the protein products of the genome. Patents are sought not only by private sector scientists but also by scientists in universities, research institutes, and government laboratories. Whether the patent claims a gene sequence, its protein product, or a method to detect, produce, study, or manipulate the gene or protein, the freedom of others to conduct research on the role and function of a given gene or protein and their ability to employ them in health care on a reasonable basis could be constrained by the prior existence of a patent, or, more likely, an exclusive license or other restrictive license on a patent.

At the same time, intellectual property protection is essential to biotechnology and pharmaceutical firms that must invest hundreds of millions of dollars in research and development over many years to bring their products to market. To enable firms to garner the sustained investments needed for diagnostic and drug development and testing, patents provide a period of exclusivity with respect to the manufacture, use, or sale of the product. Furthermore, many biotechnology firms have established a market niche between the fundamental research of academic and government laboratories and the more applied research and development activities of large pharmaceutical firms. To remain viable, these companies also rely on intellectual property rights to discoveries that often are made early in the research and development process (i.e., closer to the basic research end of the spectrum) (Eisenberg, 1997). The scale of the rush to protect the rights to new genes is reflected in the fact that by 2001, before the HGP was even completed, just two biotechnology companies alone had filed more than 25,000 DNA-based patent applications for both full-length genes and gene fragments (Service, 2001).

Research universities, too, were spurred by federal legislation enacted in the 1980s to promote the commercial application of fundamental discoveries by their faculties by protecting intellectual property that could be licensed to companies. In a few well-publicized instances, this practice has reaped substantial financial rewards for the universities and inventors, which in turn has motivated other universities to adopt aggressive technology transfer practices. Today, as a consequence of all these activities, some fear that the public good derived from providing incentives to inventors so that they can benefit from their discoveries and from ensuring that public investments in basic research lead to effective prevention and treatment of disease is at risk of being diminished significantly by the negative potential of “thickets” of patents inhibiting future scientific discovery and development.



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