Hon. Paul R. Michel

Confusion and misunderstanding among some independent inventors might slow or stall progress of the excellent eligibility reform bill recently introduced by Senators Chris Coons (D-DE) and Thom Tillis (R-NC). Titled the Patent Eligibility Restoration Act (PERA), the legislation would overturn Supreme Court and Federal Circuit decisions that scrambled settled law, excluding many worthy classes of inventions, such as medical diagnostic methods and advanced computer applications.

Anyone reading this by now knows of the current situation with Judge Pauline Newman and the investigation initiated by Chief Judge Moore. As a former chief judge of the Court of Appeals for the Federal Circuit, I understand the challenges of overseeing smart, independent, and strong-willed judges, and I’ve gained a somewhat unique perspective on the ongoing saga, albeit as an outsider.

Last week, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) launched the long-awaited legislative campaign to revive the faltering U.S. innovation system, jointly introducing one bill to restore patent eligibility and another to boost patent reliability at the Patent Trial and Appeal Board (PTAB).  As the chair and ranking member of the Senate subcommittee on Intellectual Property, they are well-positioned to move these bipartisan bills forward. They got assists from Senators Dick Durbin (D-IL) and Mazie Hirono (D-HI), who joined as original co-sponsors on the PREVAIL Act. While Coons and Tillis are well-placed, Durbin is even more so as he chairs the Judiciary Committee and serves as the number two leader of the majority party.

The patent world is trained on the upcoming Supreme Court Amgen v. Sanofi case. That case is the first time in over 75 years that the Supreme Court is evaluating the meaning and scope of the enablement requirement of 35 U.S.C. § 112. The case offers the Court an opportunity to correct a negative trend in enablement law that has made it more difficult to protect groundbreaking, pioneering inventions. Waiting in the wings, however, is an equally important Section 112 case: . There, the petitioner sought review on whether “the ‘written description of the invention’ [is] to be measured by the statutory standard of ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same.’” As is apparent, Juno’s written description issue is highly intertwined with the Section 112 enablement issue in Amgen v. Sanofi.

The current unreliability of patent-eligibility law, documented thus far here, here and here, has also created undue burdens on litigants and the courts. In this final installment, we detail how the current unreliability burdens litigants and the courts and how it is a fundamental threat to U.S. competitiveness and national security. Patent infringers now routinely raise Section 101 as a defense, often merely as a strategy to complicate and prolong the litigation, rather than as a good-faith defense with a likelihood of success. For example, one analysis found that, from 2012 to 2014 (when Alice was decided), Section 101 was raised in just two Rule 12(b)(6) motions across the country each year. In the year after Alice, that number rose to 36 motions, and by 2019, accused infringers were filing over 100 such motions each year.

Systemic-level studies and data regarding impact on investment and innovation, as detailed in Part II of this series, are not the only way to demonstrate the substantial harm that the current state of patent eligibility has inflicted on the U.S. innovation ecosystem. Other robust evidence shows that current Section 101 law has harmed innovation by removing the incentives to develop and commercialize particular inventions of public importance. As another form of harm, the vagueness and breadth of the Alice/Mayo framework have also enabled accused infringers to transmogrify Section 101 into a litigation weapon in inappropriate cases that has created unnecessary burdens and costs on innovators and the courts.

The muddled state of patent eligibility law has direct and significant negative consequences for U.S. R&D investment, and for innovation in key fields of medical, economic, and strategic importance to the United States and its citizens. Uncertainty reduces R&D investment, as has been well-documented, and reliable patent protection mitigates uncertainty and generates increased R&D investment. As we explained in Part I of this series, the experts overwhelmingly agree on these points.

Patent eligibility law in the United States is in a state of disarray that has led to inconsistent case decisions, deep uncertainty in the innovative, investment and legal communities, and unpredictable outcomes in patent prosecution and litigation. These facts have been extensively documented in multiple sources, including: the statements of all 12 active judges of the nation’s only patent court, the U.S. Court of Appeals for the Federal Circuit (confirmed prior to October 2021); the findings and reports of the Executive branch across all recent Administrations; the bi-partisan conclusions of Congressional committees; a robust body of academic studies; and at least forty separate witness statements at the 2019 hearings on this issue before the Senate Committee on the Judiciary Subcommittee on IP, including statements from advocates that oppose Section 101 reforms.