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Supreme Court to Hear Natural Phenomena Patentability Case

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Supreme Court has agreed to hear a lawsuit between Mayo Collaborative Services and Prometheus Laboratories involving patented medical diagnostic technologies that could create legal limits on how far patents can go in covering natural phenomena, such as diagnostic and treatment-related chemical observations.

The court issued an order yesterday saying that it will hear the case in which Prometheus sued Mayo medical Laboratories and Mayo Clinic Rochester for infringing two patents related to tests for metabolite levels to control drug dosing for treating stomach disorders.

The Mayo v. Prometheus case involves alleged infringement of a medical test that Mayo had licensed from Prometheus and later offered on its own, but the core of the decision likely will focus on the patentability of natural phenomena under existing laws.

The patents at issue are US Patent Nos. 6,355,623 and 6,680,302, which involve the correlation between thiopurine drug metabolite levels and drug efficacy and toxicity, for which Prometheus holds exclusive licenses. The two parties had a licensing arrangement enabling Mayo to use the intellectual property, and Prometheus sued when Mayo began offering its own test based on statistical observations about this particular chemical-reaction relationship.

Of particular importance in this case will be how the court interprets these issues in the environment created by its decision in last year's Bilski v. Kappos, which established that business methods can be patented even if they do not pass the "machine or transformation" test, a determination of patentability based on whether a technology is tied to a particular apparatus or transforms an article into a different state.

Last year, the Supreme Court sent the Mayo v. Prometheus case back to the US Court of Appeals for the Federal Circuit for more consideration in light of the Bilski v Kappos decision.

Earlier, in 2008, a federal district court found that Prometheus' method claims were not patentable subject matter under 35 U.S.C. 101, but that decision was reversed at the federal circuit level last year on the basis that its testing methods were patentable under the machine-or-transformation test.

Now, Mayo is asking the Supreme Court to consider whether 35 U.S.C. 101 is satisfied by a claim that covers observed correlations between blood test results and patient health, even though such a patent could preempt natural phenomena, because it involves a 'transformation' of body chemistry.

A group of biomedical associations led by the American College of Medical Genetics and including the Association for Molecular Pathology, the College of American Pathologists, the American Medical Association, and others, has filed an amicus brief supporting Mayo. The ACMG-led group argues that health care policy is best served by established limits on the patentability of subject matter, including claims to observations about natural phenomena, that such patents raise ethical concerns, and that they can erode physicians' ability to provide quality care.

"The claims at issue here seek to patent the statistical observation that some doses of thiopurine drugs tend to be too high for some patients and some tend to be too low," ACMG argued. "These claims run afoul of time-honored prohibitions on patenting 'laws of nature.'"

The ACMG brief also stated that exclusive rights to information about scientific correlations could create patent thickets and could "raise the cost of medical care prohibitively," and that "patients are served best by the free and broad dissemination of scientific information that is relevant to providing better and more personalized care treatments."

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