Don't Throw Out Fetal-Diagnostic Innovation with the Bathwater: Why Ariosa v. Sequenom Is an Ideal Vehicle for Constructing a Sound Patent-Eligibility Framework

Abstract

Over the past five years, the U.S. Supreme Court has reinvigorated patentable subject-matter limitations, issuing four significant decisions after nearly three dormant decades. These decisions reflect justifiable concerns about the patenting of abstract business methods and laws of nature. Just as importantly, they reveal internal inconsistencies and confusion about the scope of patentable subject matter and tension with the centuries-old fabric of patent-eligibility jurisprudence. As Justice Breyer remarked at the oral argument in Alice Corp. v. CLS Bank Int’l (2014), the Mayo (2012) decision did no more than “sketch an outer shell of the content” of the patent-eligibility test, leaving much of the substance to be developed by the patent bar in conjunction with the Federal Circuit.The Federal Circuit’s recent decision in Ariosa v. Sequenom uncritically accepts an expansive reading of Mayo that conflicts with insights from Myriad and Alice, thereby jeopardizing patent protection for diagnostic testing and other vital fields of biomedical research and possibly others. This amicus brief urges the Federal Circuit to grant en banc review in Ariosa v. Sequenom to ventilate critical issues left unanswered by the Supreme Court’s patent-eligibility decisions. Although some language in Mayo could be interpreted to set forth unconventional or inventive application as a possible test for patent-eligibility, Mayo suggests two other possibilities for an “inventive concept”: non-preemptive application; and non-generic application – that is, more than a statement of a natural law coupled with an instruction to apply it. While the panel was correct to perceive that Mayo describes preemption as the underlying justification for the patent-eligibility doctrine, not the operative test, we believe that the panel was incorrect to conclude that Mayo dictates unconventional or inventive application.