The U.S. Supreme Court is considering an issue with, AARP argues, tremendous ramifications for health policy. Allowing the lower court's ruling to stand would limit innovation, further increase health care costs and limit incentives for real innovations in medical care.
Patents reward inventors by providing a fixed period of exclusivity during which they can be compensated for their research, innovation and hard work by being the sole provider or licensor of the invention they have developed. However, not everything can be patented. While new tools for measurement or detection can be patented, laws of nature have been held not patentable. Science and engineering would grind to a halt if patents could be issued for "laws of nature" such as the type in this case. For example, if such observable occurrences could be patented, legal restrictions would prevent anyone from looking at the sun in order to figure out what time it is.
Mayo v. Prometheus presents a question of whether the discovery that certain drugs have specific correlations to medical conditions is patentable. In this case, the test involves measuring the level of a certain chemical in the body, whose presence can correlate to unhealthy conditions. This test is routinely used by doctors to evaluate and treat the cardiovascular health of people age 50 and over. If the patent is upheld, not only will these tests be more expensive, but medical testing and treatment could be delayed by perceived threats of patent violations when doctors simply use medical facts to diagnose and treat disease.
AARP's briefs in this and prior cases argue that it is outside of the letter and intent of patent law to allow patents for the scientific fact that there is a correlation between levels of a vitamin and levels of a chemical in the body. Patenting the linkage of a naturally occurring phenomenon would prevent doctors from merely thinking about medical facts necessary for sound medical treatment, and even consumers could be held liable for patent infringement when they think about medical correlations.
In the words of AARP's brief, "The patenting of medical correlations — which are nothing more than expressions of laws of nature — has led to severe restraint on the provision of medical care and a greatly increased cost and reduced availability of vital medical services, damaging the public health of the nation."
What's at Stake
As America's population ages, the demand for health services (including frequent medical testing and screening) will increase. Upholding patent claims such as those in this case will significantly stifle competition, increase costs and, most important, impede progress in the medical diagnosis industry — not just in this situation (which in and of itself affects a vast number of people), but in cases of other medical diagnoses.
Mayo Collaborative Services v. Prometheus Laboratories is before the U.S. Supreme Court.