Prometheus v. Mayo -- how a supreme court ruling has freed biomarkers of the tyranny of private ownership. Now we await SCOTUS & The Myriad Case....
In recent decades, biomarkers have become essential in diagnosing disease and assessing patients’ responses to therapy. They are the language of desktop medicine. The increasing quantitative rigor and efficiency of these tests have led to the possibility of “personalized medicine.” Despite such progress, the way in which a physician uses biomarkers recapitulates an enduring practice of medicine: measure the patient, think about the result, and make a decision.
With these advancements, U.S. researchers and companies have also claimed patents on their biomarker discoveries. These patents have generated controversy over whether they hinder the practice of medicine and research by covering not just the actual test but also the use of the biomarker generally in making diagnoses and discovering new applications. This year, a lawsuit over one such patent reached the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories.
The Supreme Court settled the case of whether a patent on a biomarker test that invlved measuring the patient, thinking about the result according to a law of nature and then making a decision was in fact a valid patent. In short, can someone own a law of nature? Following a "hot bench" of oral arguments in December of 2011, the court issued a unanimous decision written by Justice Breyer. The court answered with a clear and resounding "no."
A patent that merely recites a law of nature and then claims a fee everytime a doctor applies that law to the care of their patients is simply out of bounds.
Patents on genes and the tests to diagnose and treat common diseases such as breast cancer and Alzheimers disease are now in jeopardy. The U.S. is now ready to truly engage a model of biomarker discovery and translation that can serve the public health.
To read more about this case and its substantial implications, read the essay in the New England Journal of Medicine and also this blog post and more discussion of biomarkers and personalized medicine in Knowledge@Wharton.
See also Danell J. Kevles' essay "Can they patent your genes?" in the March 2013 issue of The New York Review of Books. He provides a thoughtful summary of the Myriad case -- a company's claim to owenership of the BRCA genes that code for breast cancer -- that is now before the Supreme Court of the United States. I can't see Justice Bryer letting Mryiad get off easy. And will the Catholic justices tolerate a company owning God's creation?