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August 10, 2010

Genetics, Gene Patenting the Cause of Myriad Legal and Ethical Complexities

Predictive genetic testing and gene patenting may sound like something from “A Brave New World,” but these seemingly science-fiction issues have become the basis for recent headlining litigation, Nanette R. Elster, director of the DePaul College of Law’s Health Law Institute, told audience members at an ABA Annual Meeting program in San Francisco.

During “Myriad Genetics: A New Roadmap to Patenting Genes?” expert Kayhan Parsi,  associate professor of Bioethics & Health Policy at the Neiswanger Institute for Bioethics and Health Policy, Loyola University, highlighted the innumerable benefits of gene testing for society, including informed family planning and early identification of medical conditions. Despite the benefits, there are downsides, and Myriad Genetics has taken gene testing a step further with gene patenting.

Prior to the March 2010 ruling, Myriad Genetics’ decade-old patent on BRCA-1 and BRCA-2—two genes closely associated with breast and ovarian cancer—that company was the only laboratory breast cancer patients could rely on for testing. For years, this monopoly kept cancer victims at a serious disadvantage.  A number of legal issues are raised by patenting: insurance discrimination, prevention of informed consent and employment discrimination—hiring, firing or conditioning employment based on genetic information.

As part of the panel discussion, Elster challenged the ethics of gene patenting, particularly when labs are discriminatory in the insurances they accept, preventing access to care for thousands. She posed the question: “If it’s possible to patent a gene and we’re all made up of genes, is it possible to patent an entire person? Shouldn’t those genes belong to all of us?”

Dr. Bernard Lo, a medical ethics expert, also weighed in on the dilemmas caused by gene patenting: “Patients are being forced to make life-altering decisions based on one opinion.”

Only 35 states had laws that protect employees from discrimination based on genetic information until the passing of the Genetic Information Non-Discrimination Act in May 2008, which prohibits insurance companies and employers from discriminating on the basis of information found through genetic testing.

The program closed with a quote from George Bernard Shaw: “Science never solves a problem without creating 10 more.” Overturning the patents that Myriad Genetics held on genes BRCA-1 and BRCA-2 eliminates at least one of those problems for science and technology lawyers.  However, that resolution is temporary.  United States District Court Judge Robert W. Sweet in New York ruled in the Myriad Genetics case earlier this year, but it is being appealed.  In addition, what the ruling means to future bioethics cases remains to be seen.

Learn More About:  Annual Meeting 2010Health Law