IP Insights #1: Mayo and its Impact on Medicine

In Mayo v. Prometheus Labs, the Supreme Court invalidated a medical diagnosis patent because it was an unpatentable application of a law of nature. The patent was a method for determining the proper dosage level of a certain class of drugs administered to patients. The Court considered the patent to be merely reciting a natural law about the body’s physical chemistry and instructing doctors or researchers to apply that law to routine medical practice or research. The Court seemed to be concerned with diagnostic patents creating monopolies on medical research and practice, and thus inhibiting further discoveries.

Medical researchers and professionals have reacted favorably to the decision. They had feared that diagnostic patents would restrict medical research and experimentation, and that they would need to secure licenses in order to perform their routine work. In fact, doctors point out that the patent was covering something they do all the time: giving a patient different dosages of a drug, observing the results, and making a medical judgment about the proper dosage. Mayo and other academic hospitals will have more flexibility about conducting medical experiments with drugs without fear of infringing on someone else’s patents. 

What do you think about the Mayo v. Prometheus decision? Many have criticized the Court’s unsatisfactory reasoning; do you think it was rightly decided based on the Court’s patent law precedents? Most commentators have focused on the practical effect on doctors, medical researchers, and biotech companies. What do you think about the effect and how significant will Mayo be?

(To read the Mayo decision, click on the Supremecourt.gov link below. You can also read the PTO’s preliminary guidance in wake of Mayo at http://www.uspto.gov/patents/law/exam/mayo_prelim_guidance.pdf)