Genes and other sequences discovered through the Human Genome Project and large-scale sequencing efforts by private biotechnology companies are being rapidly patented by non-profit academic and for-profit institutions. This recent phenomenon raises important policy questions for both health care and basic biomedical research. Many gene sequences, including expressed sequence tags and single nucleotide polymorphisms are particularly useful for developing predictive or diagnostic tests and downstream therapies. Because many patented genetic tests may fall within the standard of medical care, it is very important to examine whether current patent law and licensing procedures are behaving as intended, to enhance the public's access to new beneficial technologies. It is also important to know how research and development is affected by patenting of the tests. Although the effects of these patents on clinical genetic testing and related research may be broad and substantial, virtually nothing is known about these effects. On the one hand, intellectual property practices in biotechnology may provide important incentives for research that leads to innovations in genetic tests and treatment. On the other hand, others have argued that intellectual property laws and their implementation are not necessarily well suited for genetic technologies, and could deter innovation and commercialization. The proposed project will use case studies and a survey, combining qualitative and quantitative approaches, to describe and analyze the effects of a particular class of patents (those that claim DNA sequences for use as a genetic test). We will examine the effects on (1) provision of DNA-based genetic testing services, and (2) research and development of other genetic tests or therapies based on disease-gene associations at academic and commercial institutions. We will use the theory of anticommons developed by Heller and Eisenberg as the basis for a theoretical framework for identifying circumstances under which patents act as incentives or disincentives to genetic testing research, commercialization, and clinical services. This research will build a model for explaining the impact of patenting on clinical practice, research and development. Our analysis will form inform public policy by indicating whether intellectual property policies or their implementation should be changed to encourage research and technology transfer, and if so, how.
| Cho, Mildred (2010) Patently unpatentable: implications of the Myriad court decision on genetic diagnostics. Trends Biotechnol 28:548-51 |
| Barton, John H (2006) Emerging patent issues in genomic diagnostics. Nat Biotechnol 24:939-41 |
| Merz, Jon F; Cho, Mildred K (2005) What are gene patents and why are people worried about them? Community Genet 8:203-8 |
| Merz, Jon F; Henry, Michelle R (2004) The prevalence of patent interferences in gene technology. Nat Biotechnol 22:153-4 |
| Cho, Mildred K; Illangasekare, Samantha; Weaver, Meredith A et al. (2003) Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn 5:3-8 |
| Henry, Michelle R; Cho, Mildred K; Weaver, Meredith A et al. (2003) A pilot survey on the licensing of DNA inventions. J Law Med Ethics 31:442-9 |
| Merz, Jon F; Kriss, Antigone G; Leonard, Debra G B et al. (2002) Diagnostic testing fails the test. Nature 415:577-9 |
| Henry, Michelle R; Cho, Mildred K; Weaver, Meredith A et al. (2002) Genetics. DNA patenting and licensing. Science 297:1279 |
| Merz, Jon F; Magnus, David; Cho, Mildred K et al. (2002) Protecting subjects' interests in genetics research. Am J Hum Genet 70:965-71 |
| Caulfield, T; Gold, E R; Cho, M K (2000) Patenting human genetic material: refocusing the debate. Nat Rev Genet 1:227-31 |
