An ASU law professor explains a Supreme Court case challenging whether genes can be patented.
The Supreme Court is mulling whether genes can be patented. How would you like to see it rule?
My preference would be to prohibit new gene patents because they are products of nature, but to grandfather existing patents. It is unfair to retroactively take away the patents of companies that invested millions of dollars researching and commercializing genes in reliance on the government’s position announced over a decade ago that human genes can be patented. It is unlikely the Supreme Court could legally fashion such a compromise — I expect them to reject patents for genes.
The justices seemed to be OK with patenting the manipulation of genes. Would that be a workable compromise?
Yes, a workable compromise would be to prohibit patents on the genes themselves, but to grant patents for new diagnostic tests and other medical products that utilize genes.
As personalized medicine grows, will conflicts become common?
Personalized medicine is a “disruptive technology” that will bring enormous health benefits but in so doing will disrupt existing health-care practices, business models and regulatory programs. We will see more disputes and litigation not just in patents, but also in ownership of tissues, medical malpractice liability, informed consent, disclosure, privacy, discrimination and various contractual issues. Good for lawyers, maybe not for researchers, doctors and society.
How could the ruling affect the work being done in Phoenix by the TGen and other researchers?
TGen and other research institutes would benefit from a Goldilocks solution — one that is not too stringent, not too lenient, but just right. Patents on genes and other basic biological materials make it harder (and more expensive) for researchers to access critical raw materials needed for their research. Conversely, if there are no patents for the end products of the research in the form of diagnostic tests and new therapies, there will be inadequate incentive and investment to bring those innovations to the bedside to improve medical care for patients.
Will patients be less likely to get groundbreaking treatment if the court rules against Myriad Genetics?
Probably not. The Myriad patents are scheduled to expire next year, and there are few other “blockbuster” genes that all alone have the medical importance of the breast-cancer susceptibility genes patented by Myriad. Rather, most diseases are affected by many different genes (as well as the environment), and most medical benefits will come from new tests that simultaneously sample multiple genes and other factors to predict accurately the risk of disease, the best treatment for the disease, and the prognosis for the disease. An overly-broad Supreme Court decision that blocks patents for these innovative products could seriously jeopardize future health benefits.
Gene mapping has dropped drastically in price. Should healthy people have it done?
Many genetic tests will inform you about probabilities of future health risks, but in most cases there is nothing you can do about those risks. So it is a matter of personal preference whether you want to know about those predispositions. Genetic testing is most useful for people with disease (e.g., cancer) or a strong family history of inherited disease risks. It is starting to be used more for parents planning to have children, and patients prescribed certain drugs.