Center faculty have been studying and writing about the effects of gene patenting for many years. Drs. Jon Merz and Mildred Cho of Stanford, working with Dr. Debra Leonard of Penn and others, have developed a body of empirical work looking primarily at the effects of patents claiming genetic diagnostic tests on the practice of medicine. For the last 3 years, they have had NIH/NHGRI/ELSI funding (HG02034 to Cho et al.) for a large interview-based case study examining the effects on clinical medicine and research of patented genes. A number of smaller studies have also been performed, including work examining licensing practices, and several studies that are currently in preparation looking more in depth at patenting, licensing, and interferences in biotechnology. A bibliography of their work follows.

 
 

> Testimony/Presentation
> Papers
> Books

  

Testimony and Presentations:
Merz, J.F. On the Exclusive Licensing of Disease Gene Patents. DHHS Secretary's Advisory Committee on Genetic Testing, Washington DC. June 7, 2000.

Merz, J.F. Statement to the Subcommittee on Courts and Intellectual Property, Committee on the Judiciary, U.S. House of Representatives; Oversight Hearing on Gene Patents and Other Genomic Inventions. July 13, 2000.

Merz, J.F. The Canavan Case: Bargaining for Benefit and the Financial Windfalls of Genetic Discovery. Decade of ELSI Research Conference, Bethesda, MD, January 16-18, 2001.

Merz, J.F. The Patenting and Licensing of Disease Genes: IPR Challenges to Medicine and Science. Panel presentation; Patenting, Science and the Public Interest. AAAS Annual Meeting, Boston, MA. February 18, 2002

Papers:
Caplan, A.J., Merz, J.F. Patenting gene sequences (Editorial). Br. Med. J., 312:926, 1996.

Cho, M.K., Merz, J.F. Patients and patents (Letter). Nature, 390:221, 1997.

Merz, J.F., Cho, M.K., Robertson, M.A., Leonard, D.G.B. Disease gene patenting is a bad innovation. Molecular Diagnosis, 2:299-304, 1997.

Merz, J.F., Cho, M.K. Disease genes are not patentable: a rebuttal of McGee. Cambridge Quarterly Healthcare Ethics 7:425-428, 1998.

Merz, J.F., Cho, M.K., Leonard, D.G.B. Testing for Alzheimer's (Letter). Science, 281: 1285, 1998.

Merz, J.F. Disease gene patents: overcoming unethical constraints on clinical laboratory medicine. Clin. Chemistry 45:324-330, 1999.

Merz, J.F., Silverman, L.M. Comment: Uncovering rare mutations: an unforeseen complication of routine genotyping of APOE. Clinical Chemistry, 45:1579-1581, 1999.

Schissel, A., Merz, J.F., Cho, M.K. Survey confirms fears about licensing of genetic tests. Nature 402:118, 1999.

Caulfield T, Gold ER, Cho MK. Patenting human genetic material: refocusing the debate. Nat Rev Genet. 1:227-231, 2000.

Merz, J.F., Kriss, A.G., Leonard, D.G.B., Cho, M.K. Diagnostic testing fails the test: the pitfalls of patenting are illustrated by the case of haemochromatosis. Nature, 415: 577-579, 2002.

Merz, J.F., Leonard, D.G.B., Kriss, A.G., Cho, M.K. Industry opposes genomic legislation (Letter). Nature Biotechnol., 20:657, 2002.

Leonard DGB. Medical practice and gene patents: a personal perspective. Acad Med 77:1388-1391, 2002.

Henry, M.R., Cho, M.K., Weaver, M.A., Merz, J.F. DNA patenting and licensing. Science, 297,1279, 2002.

Merz, J.F. Patents limit medical potential of sequencing (Letter). Nature, 419:878, 2002.

Cho, M.K., Illangasekare, S., Weaver, M.A., Leonard, D.G.B., Merz, J.F. Effects of patents and licenses on the provision of clinical genetic testing services. J. Molecular Diagnostics, 5:3-8, 2003.

Henry, M.R., Cho, M.K., Weaver, M.A., Merz, J.F. A pilot survey on the licensing of DNA inventions. J. Law Med. Ethics, 31:442-449, 2003.

Merz, J.F., Henry, M.R. The prevalence of patent interferences in gene technology. Nature Biotechnol 22:153-154, 2004.

Book/Encyclopedia Chapters:
Cho, M. Ethical and legal issues in the 21st Century. In Preparing for the Millenium: Laboratory Medicine in the 21st Century. 1998. Orlando: AACC Press.

Katz, D., Merz, J.F. Patents and licensing, policy, patenting of inventions developed with public funds. In M.J. Mehlman, T. Murray, eds. Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. New York: John Wiley & Sons, pp. 854, 2000.

Merz, J.F. Discoveries: are there limits on what may be patented? In D. Magnus, A. Caplan, G. McGee, eds., Who Owns Life? Amherst, New York: Prometheus Press, 2002.

Merz, J.F. On the intersection of privacy, consent, commerce and genetics research. In: B.M. Knoppers, ed., Populations and Genetics: Legal Socio-Ethical Perspectives. New York: Kluwer Legal Int'l,  2003.

Herbst, J.L., Merz, J.F. Ethical, social, and legal issues related to molecular genetic testing. In W.B. Coleman and G.J. Tsongalis, eds. Molecular Diagnostics for the Clinical Laboratorian, 2nd Ed. Totowa NJ: Humana Press, forthcoming, 2004.

Merz, J.F. Disease gene patents. In J. Fuchs, M. Podda, eds. Encyclopedia of Diagnostic Genomics and Proteomics. New York: Marcel Dekker, forthcoming, 2004.

In preparation:
Spina, B.J., Henry, M.R., Merz, J.F. The licensing of human genes.

Center for Bioethics