PERA increases certainty and confidence in patentability and promote innovation in diagnostics

The “patent eligibility” requirement of § 101 was not an issue life sciences clients typically faced before the Supreme Court 2012 and 2013 decisions in Mayo3 and Myriad.4 For example, until the Myriad decision, inventors who had discovered, isolated, identified, characterized, and determined the usefulness of a product “found in nature” could obtain a patent on an isolated or purified form of the product. The Supreme Court’s Myriad decision invalidated thousands of granted patents, and has made it difficult to obtain patents on products that are derived from nature, even if considerable ingenuity and effort is required to identify and characterize the product and its usefulness. Judges applying Myriad expansively often cite the Supreme Court’s unfortunate statement that “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”5 Restoring the patent eligibility of such discoveries as long as they have a specific and practical utility (as I understand PERA would) would restore U.S. patent eligibility to a more predictable state, which would permit innovators to answer the question “can I patent this?” with more certainty, and thus invest in their innovations with more confidence.

The Supreme Court took care in Myriad to state that its decision did not implicate the ability to patent “new applications of knowledge” about naturally-occurring products,6 but any comfort innovators took in that guidance was eviscerated when the Court refused to review the Federal Circuit decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc..7 The method at issue in Sequenom permitted diagnosis of certain fetal characteristics via maternal blood tests instead of invasive and dangerous amniocentesis procedures, but the court held that because the method “begins and ends with a natural phenomenon” (the presence of paternal DNA in maternal serum), it was not eligible for patenting.8 That decision has come to stand for the principle that many diagnostic methods cannot be patented because they pertain to so-called “natural phenomenon.”9 Thus, even when a diagnostic method reflects a “new application of knowledge,” it may be found ineligible for a U.S. patent. In the wake of Mayo and Sequenom, many clients no longer pursue U.S. patents on their diagnostic discoveries, and some have decided to focus their research and development resources in other countries where such technologies still can be patented.

Judge Lourie of the U.S. Court of Appeals for the Federal Circuit has written several concurring opinions expressing his frustration with the state of the law pertaining to diagnostic methods under Mayo that I commend to your attention.10 Judge Lourie stated that if he “could write on a clean slate,” the only exception to patent eligibility pertaining to “natural laws” would be “claims directed to the natural law itself, e.g. , E=mc2, F=ma, Boyle's Law, Maxwell's Equations, etc.”11 He “would not exclude uses or detection of natural laws.”12 As I understand it, PERA would be consistent with Judge Lourie’s proposal, and would restore patent eligibility of most diagnostic methods. I think that would encourage U.S. investment in this space, and ultimately promote development of new groundbreaking and innovative diagnostic methods.