After 10 years as director of the Duke Center for Genome Ethics, Law and Policy, Dr. Robert Cook-Deegan has stepped aside to focus on research, policy engagement and teaching. He weighs in on the impending U.S. Supreme Court decision regarding patentable genetic matter (in which he co-authored several amicus curiae briefs), the privacy implications of mapped genomes and his role in the new Duke in D.C. program.
Recent events suggest the Supreme Court may reverse established practice in biotechnology patents, making DNA molecules whose sequences are found in living organisms ineligible to be patented. What are the implications of this decision?
This case is unusual because it does not pit two litigants in a fight over who gets patent rights. The suit was brought by the ACLU and the Public Patent Foundation in order to change the law, not to make money. The suit was filed against the US Patent and Trademark Office, Myriad Genetics and members of the board that oversees patents held by the University of Utah. Companies whose business plans are based on gene patents for DNA-based tests would have to devise a different patent strategy if the court rules against Myriad. That’s actually not very many companies.
However, the intellectual framework that comes out of the decision could have an impact on other patents—for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature. This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications.
What is your prediction?
I expect the Supreme Court to reverse lower court decisions at least in part. I expect the Supreme Court to say that genes are just not the sort of thing that can be patented. Exactly how they say that is just as important as whether that’s what they decide.
Implications of making one’s genetic information public have been in the news recently. Can personal privacy be protected while still meeting the needs of the research community?
Most of the time, yes, but some protections that we need are not yet in place. The idea that you can make your whole genome sequence publicly available and that nobody would know it is yours no longer appears to be plausible. So, in the age of DNA sequencing, what we mean by anonymity will change. The federal Genetic Information Nondiscrimination Act (GINA) prohibits discrimination in health insurance and employment, and many states have even stronger protections. Safeguards and penalties for misuse similar to those that govern financial data could be applied to genetic data. States and other countries are beginning to take this on. The federal government may also expand beyond GINA.
The Affordable Care Act protects individuals from being denied health insurance based on pre-existing conditions, including those discovered through genetic testing. Currently, there are no laws governing the use of genetic information by life insurance, long-term-care insurance and disability insurance companies. What does this mean for consumers? For insurers?
Insurers already use questionnaires and interviews to gauge the risk of, say, Alzheimer’s disease. Currently, there is nothing stopping insurers other than health insurers from denying coverage to consumers based on genetic information. Conversely, companies in the market need to protect against such risk or they could go bankrupt. Don Taylor has analyzed options for the long-term care insurance market in light of Alzheimer’s disease genetic testing. We could make long-term care insurance an entitlement, we could subside high-risk individuals, we could mandate coverage like automobile insurance, or we can allow the market to stratify into high-risk-high-price and low-risk-low-cost. It’s a policy debate we need to have.
What is your role in the Duke in D.C. program?
I’m teaching one of the courses for Duke in Washington this spring, the first time we’ve offered the program. It’s exactly the teaching I love. I believe in the synergy between doing policy research and teaching. It’s really fun for me and I hope also for the students.
In D.C., people are looking to solve policy problems. Duke students can get involved in that process. The program provides an opportunity for academic research layered on top of real-world engagement.