Supreme Court Decision on Scope of Patent Protection: Supreme Court Holds Pharmaceutical Treatment Method Without “Inventive” Insight Unpatentable as a Law of Nature

Sullivan & Cromwell LLP - March 22, 2012

In a decision that is likely to have significant implications across the healthcare spectrum, including biotech, diagnostics and medical devices, on March 20, 2012, the U.S. Supreme Court held that two patents claiming methods for optimizing the therapeutic efficacy of drugs by monitoring metabolized byproducts in a patient’s bloodstream are ineligible for patent protection under 35 U.S.C. § 101 because they seek to claim fundamental laws of nature. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. ___ (2012).

In a unanimous decision, the Court continued the trend from its decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010), spurning the “machine-or-transformation test,” which was the pre-Bilski standard for determining patentability under § 101 and which the Federal Circuit had applied in Mayo both before and after the Bilski decision. Instead, the Supreme Court instructed that “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’” The Court held that a patentable process incorporating a natural law must also claim “an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Although the Court did not clearly articulate any new test in addition to the machine-or-transformation test, which it still declared “useful,” it concluded that the patents at issue overreached by claiming fundamental laws of nature and virtually any application of those laws, and that whatever the patents claimed beyond those fundamental laws was not sufficiently inventive to qualify them as eligible subject matter under § 101.