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Supreme Court to Hear Personal Medicine Patent Dispute

By | December 7, 2011

The Supreme Court hears arguments on Wednesday over whether Prometheus Laboratories may patent instructions for observing changes in a patient’s body to set drug dosages in a decision that could affect the future of “personal medicine.”

The case focuses on Nestle SA unit Prometheus’ patents for using synthetic thiopurine compounds to treat gastrointestinal disorders like Crohn’s disease.

Doctors are told to monitor patients taking the medication for certain metabolites in red blood cells, with the goal of hitting certain levels to assure patients the best treatment with the least side effects.

The Mayo Clinic, however, argues that the observations made to determine dosage are akin to a “natural phenomenon,” which by law may not be patented.

There are hundreds of similar patents with methods for helping doctors find which treatment is best for which individual patient, said Hans Sauer of the Biotechnology Industry Organization.

“Investment in personalized medicine could be at stake here. I think it’s very important that the Supreme Court get this right,” he said.

Consumer groups, like the AARP seniors’ advocacy group, disagree vehemently.

“Allowing patents on pure medical correlations… threatens doctors with claims of patent infringement should they discuss mere laws of nature with their patients, burdens the public with excessive health care costs and dulls incentives for real innovation in medical care,” the AARP and Public Patent Foundation wrote in a brief to the court.

Daniel Ravicher, head of the Public Patent Foundation, dismissed the notion that industry would be hurt if medical correlations were deemed unpatentable.

“My view is that it will help the pharmaceutical industry tremendously. They’re going to be just fine,” he said.

The fight began in 2004, when Mayo, a Prometheus customer, decided that it would bring out its own version of a $260 test. Prometheus sued, and Mayo’s test has never come to market.

Mayo won the first round, as a district court invalidated the patents. Prometheus appealed to the U.S. Court of Appeals for the Federal Circuit, which hears patent appeals. That court twice ruled that Mayo was wrong, saying that what Prometheus patented was a “transformation” and thus could be patented.

“Prometheus’ claims are drawn not to a law of nature, but to a particular application of naturally occurring correlations,” the appeals court said in its second opinion dated December 17, 2010.

Nestle bought San Diego-based Prometheus in July, making it part of Nestle Health Science.

The case is Mayo Collaborative Services et al v. Prometheus Laboratories, Inc. No. 10-1150.

(Reporting by Diane Bartz; Editing by Tim Dobbyn)

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