Prometheus and Myriad -- how two supreme court rulings have freed biomarkers and genes from bondage

Prometheus and Myriad -- how two supreme court rulings have freed biomarkers and genes from bondage

In recent decades, biomarkers and genes 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. In 2012, a lawsuit over one such patent reached the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories.

In June 2013, with a unanimous ruling on the Myriad Genetics case that threw out patents on genes that explain risks of diseases, the court placed bookends on the law on patenting ways to measure genetic and biomarker risks. The ruling is a call for a reboot on the encroachment of big business owning medicine and medical science. The U.S. is now ready to truly engage a model of biomarker discovery and translation that can serve the public health.

Visit Science Progress for a just published essay that reflects the Myriad Genetics and Prometheus cases.

To read more about Prometheus and its substantial implications, read my essay co-authored with Aaron Kesselheim 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, a thoughtful summary of the events that led up to the Myriad case.