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Saturday, March 24, 2012

Supreme Court: No Patent for Natural Process

MedPage Link


WASHINGTON -- The U.S. Supreme Court has unanimously invalidated two patents for thiopurine testing held by Promethius Laboratories, decreeing that the processes used in the test are natural and cannot be patented.
"The question before us is whether the [patent] claims do significantly more than simply describe ... natural relations," wrote Associate Justice Stephen Breyer for the court. "To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no."
Thiopurine, which is used to treat inflammatory bowel disease and other autoimmune diseases, is metabolized differently by each patient. As a result, it's often difficult to determine a correct dose for an individual patient, the court wrote in a syllabus explaining the case, known as Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al versus Prometheus Laboratories, Inc.
Prometheus' patents dealt with a process by which physicians can determine the correct dosage -- administering the drug to the patient, measuring its metabolite levels, and then using specific thresholds to determine whether to increase or decrease the dosage. The patents did not relate to any specific test to measure the thiopurine levels, but instead to the use of the test results.
The plaintiff in the case, the Mayo Clinic, had been using Prometheus' patented processes to determine thiopurine dosages but eventually decided it was going to market its own, slightly different, test. Prometheus sued Mayo, claiming patent infringement.
A federal district court agreed that Mayo had infringed the Prometheus patents but dismissed the case anyway, holding that the processes patented by Prometheus are really just natural laws or phenomena, and therefore aren't patentable. That decision was reversed on appeal, and Mayo eventually appealed to the Supreme Court.
"Because the laws of nature recited by Prometheus' patent claims -- the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm -- are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations," the court noted in the syllabus.
"This Court has repeatedly emphasized a concern that patent law not inhibit future discovery by improperly tying up the use of laws of nature and the like. Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are 'the basic tools of scientific and technological work,' there is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to 'apply the natural law,' or otherwise forecloses more future invention than the underlying discovery could reasonably justify," Justice Bryer wrote.
"... we conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid," he wrote in conclusion.

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