Summary
The “prognosis” for patentability of medical diagnostic claims remains uncertain after an order of the Federal Circuit Court of Appeals (“Court”) denying a petition for an en banc rehearing of its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., (“Ariosa”). However, the opinions of the Court’s judges clearly reflect a growing concern over the danger of the U.S. Supreme Court’s opinion in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Mayo”) having a chilling effect on innovation and development of diagnostic methods. Notably, medical diagnostic claims remain patentable in many countries outside the United States. For strategies to protect inventions in the medical diagnostics and therapeutics field in the wake of Mayo and Ariosa, parties are urged to consult with qualified counsel.
In Ariosa, Nos. 2014-1139, 2014-1144 (Fed. Cir. June 12, 2015), the Court affirmed a district court’s holding that the claims at issue were not directed to patent eligible subject matter under 35 U.S.C. § 101. The claims recited a method of detecting a paternally-inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female. The method comprised amplifying a paternally-inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally-inherited nucleic acid of fetal origin in the sample.
Although the Court acknowledged that the claimed invention was a “breakthrough” invention, the Court issued an order denying a petition for an en banc rehearing of its decision. In opinions accompanying the denial order issued on December 2, 2015, the majority of the Court found that Mayo bound the Court to hold that the claims at issue were not patent eligible under § 101. However, several Federal Circuit judges expressed concern that current patent eligibility law under Mayo threatens to discourage development of new diagnostic or therapeutic methods in the life sciences.
To determine patent eligibility of the claims at issue in Ariosa, the Court applied the two-step framework from Mayo, 132 S. Ct. 1289 (2012): (1) determine “whether the claims were directed (to) a patent ineligible concept” (e.g., law of nature, natural phenomenon, or abstract idea), and (2) if the claims were directed to such subject matter, determine whether additional elements transformed the claim into an “inventive” application of the concept, thus making the claimed invention patent eligible.
Although the majority of judges found that the holding in Ariosa was correct under Mayo, several Federal Circuit judges expressed, in opinions accompanying the denial order, concern over Mayo’s restrictive patent eligibility rule for medical diagnostic claims. In particular, several judges criticized the second step of Mayo’s framework, recognizing that Mayo’s approach failed to account for “inventiveness” of diagnostic claims that could derive from discovery of the law itself, and not only from application of the law.
According to Judge Timothy B. Dyk, “there is a problem with Mayo insofar as it concludes that an inventive concept cannot come from discovering something new in nature – e.g., identification of a previously unknown natural relationship or property… Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself.” Judge Dyk added that “a too restrictive test for patent eligibility under 35 U.S.C. § 101 with respect to laws of nature (reflected in some of the language in Mayo) may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena.”
Judge Alan D. Lourie and Judge Kimberly A. Moore similarly expressed criticism on the “unsound” approach of analyzing the “inventiveness” of a diagnostic claim by analyzing inventiveness of additional steps divorced from the natural phenomenon. To address these concerns, the judges proposed alternative frameworks for analyzing patentability of diagnostic claims. Judge Lourie and Judge Moore suggested that the claims should be reviewed for patentability under § 112, instead of the “less-defined” § 101 eligibility rules. According to Judge Dyk, such an approach would “promote fundamental policies underlying § 101” by allowing the inventor exclusive right to what he invented, but not “foreclos[ing] more future invention than the underlying discovery could reasonably justify.”
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