In a significant decision that could particularly impact the field of personalized medicine, the U.S. Supreme Court invalidated patent claims to a blood test used in the treatment of autoimmune diseases. In the March 20, 2012 opinion, the Court unanimously found that the patent claims merely recited a law of nature, making them patent ineligible. Mayo Collaborative Services v. Prometheus Laboratories, Inc., U.S., No. 10-1150, 3/20/2012. The implications of Mayo extend from inventions based on life sciences and biotechnology developments, such as diagnostic methods, to other processes and compositions of matter which were previously thought to be patent eligible.
Under U.S. law it has long been recognized that a law of nature cannot be patented, but application of a law of nature could enjoy patent protection. In the Mayo case, the Supreme Court applied this concept to a method of optimizing therapeutic efficacy in treating autoimmune diseases covered by Prometheus Laboratories’ U.S. Patent Nos. 6,680,302 and 6,355,632. The Court reasoned that Prometheus’ claims were not patent-eligible because the “claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.” Mayo, 566 U.S. ___ (2012), at 4, Slip Opinion.
After Mayo, when considering patentability or validity of a patent claim, one would ask:
(1) Does the claim involve a “natural law”?; and
(2) Do the additional features of the claim “do significantly more” than describe the natural law?
What qualifies as a “natural law”? Einstein’s theory of relativity (E=mc2) is the often-provided example of a law of nature. Indeed, the Supreme Court gives a nod to this famous law, stating, “Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced.” Mayo, 566 U.S. ___ (2012), at 9, Slip Opinion. As applied to the Prometheus claims, the Court found that “the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage…of drug will prove ineffective ...” is a law of nature.
Courts could extend this logic to a variety of discoveries, for example, to up- or down-regulation of biomarkers in certain disease states, or to the existence of single nucleotide polymorphisms (SNPs) in connection with certain disease states. As such, approaches to personalized medicine are certainly implicated.
But what does this mean for patent protection in the context of new life sciences and biotechnology discoveries? Assuming a “natural law” is involved, the question becomes, what “additional features” will be necessary to produce a patent-eligible invention. While the approach to pursuing protection will change, and the breadth of protection for certain inventions will change, skillful practitioners will continue to craft applications to protect innovation in the field of personalized medicine.
The effects of Mayo also extend not only to patentability of new discoveries, but to the value and validity of existing patent portfolios. We can expect to see challenges to existing patents in view of the decision. Companies and research institutions having portfolios that could be impacted by the Mayo decision should consult with counsel to develop strategies to manage value of the existing assets, with consideration to the use of U.S. continuation practice and use of different claiming strategies in applications that remain pending. Moving forward, the Mayo decision will also impact whether and how companies and research institutions will invest in and pursue protection for new life sciences and biotechnology developments. Patent counsel should be consulted for assessment and protection of new innovation.
Because of the broad implications of the Mayo decision, the community will be watching to see whether the Supreme Court remands the Myriad case (the “gene patent case” styled Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office) to the Federal Circuit for reconsideration in view of the Mayo holding.
Those interested in further information can contact Mandy Wilson Decker at firstname.lastname@example.org.