Supreme Court Overturns Court of Appeals: Invalidates Patents Directed to Optimizing Medical Therapy
In Mayo Collaborative Services v. Prometheus Laboratories, the U.S. Supreme Court overturned two issued patents on the grounds that they “disproportionately [tie] up the use of … underlying natural laws.” The patents at issue relate to diagnostic testing by monitoring patients who are given synthetic compounds for optimal treatment of medical conditions. The issue in the case was whether the patents cover an application of natural laws, which is patentable, or merely the laws themselves, which is not patentable. The Supreme Court held that the patents “involve well-understood, routine, conventional activity” and that the patents did not cover patentable subject matter that applies natural laws.
The case regards the exclusive licensee of the patents, Prometheus Laboratories, Inc. (“Prometheus”), that sued departments of the Mayo Clinic (“Mayo”) for refusing to pay Prometheus for a testing kit covered by the patents and for threatening to build its own testing kit. At the district court level, the patents were held invalid on the grounds that the patents claimed natural laws or natural phenomena, which are per se unpatentable. The Court of Appeals for the Federal Circuit (“CAFC”), however, reversed that holding on the grounds that the claims satisfied the “machine-or-transformation” step, and went beyond merely claiming laws of nature. The CAFC reasoned that the steps of administering a drug to a patient and determining an appropriate level is a transformation of the human body, and therefore is directed to patentable subject matter under 35 U.S.C. §101. The Supreme Court disagreed and reversed the CAFC.
This case highlights uncertainty currently in U.S. patent law relating to subject matter that may be eligible for patent protection and has been watched closely, particularly by those in the biotech industry and those affiliated with the American Medical Association. On one hand, some fear that the Court’s ruling could render thousands of issued patents invalid, and that expensive and extensive medical research may be left unprotected. On the other hand, some applaud the Decision for precluding laws of nature from being exclusively protected. Beyond those parties having a direct interest in the case, some have expressed concern of far-reaching effects of this Decision as it relates to other methods, such as business methods and computer applications.
The impact of this Decision may not be felt or understood for some time to come. The Decision closely tracts the claimed features, and thus may not broadly impact the Court’s previous decisions, nor the scope of 35 U.S.C. §101, more generally. Patent practitioners and applicants are cautioned by the Decision, however, to include features in patent claims to ensure that natural laws are applied and not merely recited, to avoid claiming the natural laws, themselves.
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