U.S. Supreme Court

Citing a Need to Encourage Scientific Discovery, Supreme Court Strikes Down Lab's Patents

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The U.S. Supreme Court has ruled for Mayo Clinic in its challenge to a competitor’s patents on blood test methods to determine correct drug dosages.

In a unanimous opinion (PDF), the court said the patents held by Prometheus Laboratories Inc. are invalid because they are based on laws of nature. Justice Stephen G. Breyer wrote the decision, emphasizing a concern that patent laws should not stand in the way of future innovation.

At issue are patents on a process for analyzing blood tests to measure the effects of varying dosages of thiopurine drugs, used to treat autoimmune diseases such as Crohn’s disease and ulcerative colitis. The patents “set forth laws of nature”—the relationship between concentrations of metabolites in the blood and the likelihood the thiopurine drugs will help or cause harm, Breyer said.

The steps in Prometheus’ patented processes involve conventional activity used by researchers, Breyer said, and don’t contain an “inventive concept” to make the patent valid. “Upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries,” he wrote.

Breyer explained the concept with a reference to Einstein and Newton. “Einstein could not patent his celebrated law that E=mc²; nor could Newton have patented the law of gravity,” Breyer said. “ Such discoveries are ‘manifestations of … nature, free to all men and reserved exclusively to none’ ” he wrote, citing prior precedent. If a law of nature is not patentable, neither is a process applying that law of nature, unless it has “additional features that provide practical assurance that the process is more than a drafting effort,” Breyer said.

He illustrated with an example. “Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa).”

The case is Mayo Collaborative Services v. Prometheus Laboratories Inc.

Prior coverage:

ABA Journal: “Patents and Patients: Personalized Medicine Is at the Heart of High Court Case”

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