High court to review diagnostic test patent case

NEWS IN BRIEF — Posted July 18, 2011

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The U.S. Supreme Court agreed on June 20 to re-examine whether a test that measures patients' metabolite levels to determine drug dosages should be patentable.

Prometheus Laboratories sued Mayo Collaborative Services and Mayo Clinic Rochester in 2004, claiming that Mayo infringed on its test patents. Prometheus' diagnostic test measures metabolite levels in patients taking thiopurine drugs, then correlates those levels with the drugs' efficacy. Mayo developed its own test, which measured the same metabolites, but said its method used different levels to determine toxicity, according to court documents.

In 2008, a federal trial court ruled in favor of Mayo, but an appeals court reversed that decision in 2009. The Supreme Court vacated the appellate decision in 2010 in light of a similar case that changed how patent validity is measured. The case then was sent back to the lower court for reconsideration. In December 2010, the appellate court again ruled for Prometheus.

The high court will make a final determination on whether the tests can be patented. At this article's deadline, a date had not been scheduled for oral arguments.

Note: This item originally appeared at

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