Patenting Diagnostic Tests: Mayo Collaborative Services v. Prometheus Laboratories, Inc.

In 2011, the case Mayo v. Prometheus was argued in front of the Supreme Court. The case concerned patented diagnostic technology that assessed the appropriate dosage of drug treatments for various gastrointestinal diseases such as Crohn's disease.

Prometheus laboratories sued Mayo Clinic, when Mayo attempted to use its own test, claiming patent infringement. A federal judge invalidated Prometheus Laboratories' patents on the grounds that patents cannot claim a body's reaction to drugs. This lower court decision was appealed toe the U.S. Court of Appeals of the Federal Circuit, which overturned the decision. This appellate decision was then appealed to the Supreme Court.

The Supreme Court decided in 9-0 decision to reverse the appellate decision, invalidating the Prometheus. In the majority opinion, the court emphasizes the patentability of applications of nature. The opinion denotes that though nature itself is unpatentable subject matter, applications of nature are indeed patentable subject matter. 

The opinion also discusses the novelty and obviousness of the patented invention - almost conflating obviousness and novelty (sections 102/103) with patentable subject matter (section 101). In this sense, the decision has been critiqued by many, declaring the decision as "killing industry". 


Share this:

, ,



  1. I really liked your introduction of the case! This particularly seems immoral to me, since we are talking about the health of humans. I wonder how often this happens to Mayo Clinic, though! - Probably very often, considering they have plenty of different diagnostic tests.