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Washington Highlights

Supreme Court Invalidates Two Diagnostic Test Patents

March 23, 2012—In a unanimous decision, the Supreme Court March 20 ruled two “method patents” on diagnostic tests to be invalid because they embraced only naturally occurring relationships.  The Court ruled in favor of Mayo Collaborative Services, a unit of the Mayo Clinic, and against Prometheus Laboratories, Inc., which sought to enforce the patents for treatment of Crohns’ and other autoimmune diseases. 

Specifically, the patents claimed a method for administering a drug in a patient and measuring levels of blood metabolites to determine proper dosage.  Writing for the Court, Justice Stephen Breyer indicated that the patents identify only a correlation between drug dosage and metabolite levels and effectively claimed a “law of nature,” not a patentable invention. “We must determine whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws,” Breyer explained, concluding “that they have not done so and that therefore the processes are not patentable.”

In its decision, the court cited an amicus brief joined by the AAMC, the American College of Medical Genetics, and other medical and professional organizations on behalf of the Mayo Clinic.  The biotechnology industry and several academic organizations had supported Prometheus in concerns that such patent protection is needed to incentivize privately funded research on personalized medicine and diagnostic tests. 

The Court’s decision reaffirms that the patent system seeks to strike a balance between protecting open access to public information and exclusive rights to practice.  Breyer’s statements were very similar to his 2008 dissent in Labcorp v. Metabolite [see Washington Highlights, Nov. 14, 2008].


Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488


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