Mayo Collaborative Services V. Prometheus Laboratories, Inc.

Short Description

Supreme Court ruled that laws of nature cannot be patented unless there is an additional inventive concept.

Facts

Prometheus Laboratories held patents related to methods of determining the proper dosage of a drug used to treat autoimmune diseases. Mayo developed a competing test and was sued for infringement. Mayo argued that the patents were invalid because they claimed a natural law – the relationship between metabolite levels and drug effectiveness. The district court ruled in Mayo's favor, but the Federal Circuit reversed, holding the patents valid. The Supreme Court reviewed the case.

Issue / Question

Whether a process that applies a natural law is patentable when it lacks additional inventive steps beyond the law of nature itself.

Findings / Reasoning

The Supreme Court applied the two-step test: Step 1 – Identify whether the claims are directed to a law of nature. Step 2 – Determine whether the claim adds enough to transform it into a patent-eligible application. The Court found that Prometheus's claims merely recited a natural relationship and conventional steps, and thus were not patentable.

Suggestions / Implications

Patent applications in the medical and biotech fields must include innovative steps beyond discovering natural laws. This decision limits patents on diagnostic tests and personalized medicine.

Judgment / Date

March 20, 2012 – Supreme Court unanimously invalidated the patents.