Mayo Collaborative Services v. Prometheus Laboratories, Inc.

Mayo Collaborative Services v. Prometheus Laboratories, Inc. was a landmark United States Supreme Court case that addressed the issue of patent eligibility of medical diagnostic tests under the United States patent law. The case was decided on March 20, 2012, and is often cited in discussions about the patentability of biotechnological inventions, medical diagnostics, and the application of natural laws within the realm of patent law.

Background

The dispute centered around patents owned by Prometheus Laboratories that claimed methods for determining the optimal dosage of thiopurine drugs for gastrointestinal and non-gastrointestinal autoimmune diseases. The patents specifically involved measuring the levels of certain metabolites in the blood after the drug was administered, which would indicate how well the drug was being metabolized by the patient's body. Mayo Collaborative Services, operating Mayo Clinic laboratories, initially used these tests but later announced it would develop and use its own test with a similar methodology, leading Prometheus to file a lawsuit for patent infringement.

Supreme Court Decision

The Supreme Court, in a unanimous decision delivered by Justice Stephen Breyer, held that the patents in question effectively claimed natural laws - specifically, the relationship between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage would prove ineffective or cause harm. The Court reasoned that such natural laws are not patentable, and the methods claimed by Prometheus's patents did not transform these natural laws into patent-eligible applications because they merely instructed the user to "apply the law" by administering the drug and determining metabolite levels without providing any inventive concept beyond the natural law itself.

Implications

The decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. has had significant implications for the biotechnology and pharmaceutical industries, particularly in the area of personalized medicine and diagnostic testing. It set a precedent that has been used to challenge the validity of patents for other diagnostic methods that rely on natural laws or phenomena. The ruling emphasized the need for patent claims to do more than simply state a natural law and call for its application, requiring a demonstration of an inventive concept in the application of the law.

Criticism and Discussion

The decision has been both praised and criticized. Proponents argue that it prevents the monopolization of basic scientific tools that could hinder further innovation and research. Critics, however, contend that it creates uncertainty around the patentability of new diagnostic tests, potentially discouraging investment in biomedical research and development.

See Also

• Bilski v. Kappos
• Association for Molecular Pathology v. Myriad Genetics, Inc.
• Patentable subject matter
• United States patent law

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