261284 Gene patents and genomic databases: The long-term consequences of exclusive rights to conduct genetic tests

Monday, October 29, 2012 : 11:30 AM - 11:50 AM

Robert Field, JD, MPH, PhD , Department of Health Management and Policy, Drexel University School of Public Health, Philadelphia, PA
Sean McElligott, MS , Department of Health Care Management and Economics, University of Pennsylvania, Philadelphia, PA
David Asch, MD, MBA , Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA
Susan Domchek, MD , Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA
Mirar Bristol-Demeter, MA , Division of General Internal Medicine, University of Pennsylvania, Philadelphia, PA
Policy debates over gene patents, as well as ongoing litigation, have focused on the appropriateness of ownership rights for genes, the effects of patents on research, and the protection of innovators' interests. Largely ignored has been another issue of perhaps greater clinical and economic significance: patent holders are able to accumulate large and valuable databases of test results over which they maintain exclusive control. This information is an increasingly crucial resource for research and clinical care. For example, patents for the BRCA1 and BRCA2 genes, which indicate risks for breast and ovarian cancer, are held by Myriad Genetics, which conducts all clinical testing concerning them. Its database includes findings not only on mutations known to indicate heightened cancer risk but also on thousands of other genetic variations whose clinical significance is not well characterized. Linking data on such “variants of uncertain significance” with information on family histories and clinical outcomes, which Myriad also collects, is the only effective way to determine these variants' clinical meaning. On one hand, the concentrating effect of the patents allowed this information to be collected. On the other hand, the company limits access by outside researchers and clinicians, allowing it to control and possibly stifle research on the BRCA genes long after its patents have expired and potentially to maintain a dominant market position indefinitely. If the Supreme Court ultimately upholds Myriad's patents as a result of ongoing litigation, legal reforms are needed to limit these possible adverse long-term effects.

Learning Areas:
Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
Explain the implications of gene patents for the creation of genomic databases. Differentiate the direct effects of gene patents on clinical care and research from the indirect effects in concentrating information on clinical outcomes. Assess the status of ongoing litigation concerning the patentability of human genes. Analyze possible legal reforms to address the potential long-term effects of gene patents.

Keywords: Health Law, Genetics

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have training in law, public health and psychology. I have written extensively about health care regulation, ethical issues in public health, and health law.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.