Hon. Paul R. Michel

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.

The only president ever to obtain one, Abraham Lincoln knew the essential role patents have played in the scientific and technological innovations that have driven American growth and prosperity since the founding of the republic. Lincoln listed the development of patent laws—along with the invention of writing and the discovery of America—among the most important events in world history. Patents have “peculiar value…in facilitating all other inventions and discoveries,” he said in a speech in 1858. Giving inventors exclusive use of their inventions for a limited time, “added the fuel of interest to the fire of genius in the discovery and production of new and useful things.” What was true a century and a half ago remains true today. But a recent ruling by the U.S. Court of Appeals for the Federal Circuit is threatening to bank the fire and limit the inventions of the future. Last August, a three-judge Circuit Court panel invalidated Sloan Kettering’s patent for its CAR T-cell cancer immunotherapy and overturned the $1.2 billion awarded Sloan Kettering and its partner and exclusive licensee, Juno Therapeutics, after a jury trial found Kite Pharma had infringed upon the patent. The court, en banc, refused to reconsider the ruling.

The Court of Appeals for the Federal Circuit, the nation’s patent court, is at a crossroad. Today, unlike in earlier decades, nearly all its cases are patent-related, yet, to my eye, barely half its members can be considered lifetime patent lawyers. And although any diligent lawyer can learn “black letter” patent law on the job (as I myself did), that is no longer sufficient, because judges also need a deep understanding of how inventors and investors, including corporate CEOs, rely on patents in making difficult and fateful decisions about whether to fund new R&D and manufacture new products, or not. Such decision-makers crave predictability of outcome and stability of legal requirements. Because uncertainty generates excess risk, when in doubt, they usually opt against going forward…. To me, this all suggests that the nominee to fill the vacancy on the CAFC expected in May should be a seasoned patent litigator.

On Monday,, March 2, an Amici Curiae Brief in Support of the Petition by American Axle was filed by Senator Thom Tillis, Honorable Paul Michel and Honorable David Kappos. The three amici conclude that they are “all convinced that section 101 is gravely damaging our country’s ability to succeed in the race for global innovation leadership, and all convinced that the solution to the dilemma lies with the Court taking up the American Axle case.”