(or disease susceptibilities) through positional cloning (Collins, 1995). These genetic discoveries had immediate value as diagnostic products. They also were useful as research tools in the development of therapeutic products, but the relationship between gene and therapeutic product typically was less straightforward than it had been for the first generation of biotechnology products. Patents on these discoveries, although similar in form to patents on genes encoding therapeutic proteins, played a different and less familiar role in the biomedical community, setting the stage for conflict between people and institutions that had barely taken note of the first generation of gene patents. Professional societies of doctors and clinical geneticists in particular have been outspoken critics of disease gene patents, especially when they are the subject of exclusive licenses to perform DNA diagnostic tests.7 They argue that patent-based restrictions regarding who may perform genetic tests interfere with the practice of medicine and prevent other laboratories from identifying and validating new mutations. These arguments are particularly compelling to doctors and geneticists working in academic medical centers that are equipped to administer “home brew” genetic diagnostic tests themselves in pursuit of a mixed mission of treatment and research.

The advent of high-throughput DNA sequencing marked another important turning point in the history of genomic patents. By generating large amounts of DNA sequence information in advance of understanding the functions or disease relevance of particular sequences, high-throughput sequencing raised the possibility of obtaining patents on “upstream” genetic discoveries that—although potentially possessing patentable utility—were still far removed from developed products. As discussed in Chapter 2, the announcement of the filing by NIH of patent applications on the first expressed sequence tags (ESTs) identified by Craig Venter in a National Institutes of Health (NIH) laboratory set off controversy in the scientific community (Dickson, 1993; Milstein, 1993), although research scientists previously had expressed little concern about the patenting of genes encoding therapeutic proteins.

If the DNA sequence discoveries that were claimed in the provocative NIH patent filings encoded therapeutic proteins or were relevant to particular diseases, no one could have known it at the time. The most obvious value of ESTs was not

7  

See, e.g., Association for Molecular Pathology, AMP Position on Patenting of Genetic Tests (Dec. 17, 1999), posted on the Internet at www.ampweb.org/patent.htm; American College of Medical Genetics, Position Statement on Gene Patents and Accessibility of Gene Testing (Aug. 2, 1999), posted on the Internet at www.faseb.org/genetics/acmg/pol-34.htm; American Medical Association, H-140.944 Patenting the Human Genome, posted on the Internet at www.ama-assn.org/apps/pf_online?fn=browse&doc=policyfiles/HOD/H-14C; Academy of Clinical Laboratory Physicians and Scientists, Resolution: Exclusive Licenses for Diagnostic Tests (approved by the ACLPS Executive Council June 3, 1999), posted on the Internet at depts.washington.edu/lmaclps/license.htm; College of American Pathologists, Gene Patents Detrimental to Care, Training, Research, posted on the Internet at www.cap.org/html/advocacy/issues/Issue_Genepat.html.



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