Courts won’t follow and it increases uncertainty

At the outset, I disagree with Mr. Jones’s position that the U.S. Patent Office and courts are applying the “judicial exceptions” to Section 101 in a predictable manner. The only predictability in the life sciences space is that diagnostic methods as such are not eligible for patenting, but certainty in what cannot be patented does not incentivize innovation. The contrasts provided by the formulation and device cases cited above are just two examples of ongoing, problematic uncertainty.

I also disagree that any consistency in how the U.S. Patent Office applies Section 101 should weigh against the need for legislative reform. The U.S. Patent Office has issued guidelines for examiners to follow, but those guidelines are not binding on (or followed by) the courts, and always lag behind the most recent court decisions. As I noted in my written testimony, the U.S. Patent Office 2016 Patent Eligibility Guidance was inconsistent with the Federal Circuit’s 2015 decision in Sequenom, because it took until later in 2016 for the Federal Circuit decision to become final (e.g., the Supreme Court did not deny certiorari in Sequenom until June 2016, after the USPTO’s May 2016 guidance was promulgated). The years that pass between a district court’s expansive application of a “judicial exception” and a final determination of whether that holding will stand represent years of uncertainty not only for the parties to the litigation, but to all innovators and competitors potentially impacted by a similar decision.