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The Supreme Court Holds That Prometheus’s Diagnostic Method Claims Are Unpatentable Under 35 U.S.C. § 101

March 21, 2012

The United States Supreme Court issued a significant, unanimous decision yesterday in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (2012), holding that certain diagnostic patent claims were invalid for failure to recite patent-eligible subject matter under 35 U.S.C. § 101. The Court determined that the "steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field," and noted that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries." In so holding, the Supreme Court reversed a Federal Circuit decision that the method claims were patent-eligible under the machine-or-transformation test, and do not impermissibly claim natural phenomena.

The Supreme Court's opinion is of interest to pharmaceutical and biotechnology companies because the decision leaves a large number of therapeutic and diagnostic patent claims vulnerable to challenge, especially those that concern correlations resulting from natural body processes. The Supreme Court's decision states, however, that new drugs and new methods of using existing drugs remain patentable subject matter. And the decision suggests that certain patents covering diagnostic tests directed at the measurement of new or previously unknown analytes would withstand challenge under § 101.

To read the memo, click here.

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