Opinions and Editorials

Dec. 15, 2019

IP Watchdog: Five Years Later, the U.S. Patent System is Still Turning Gold to Lead by Kevin Madigan and Adam Mossoff

Five years after the last of the four decisions in patent eligibility doctrine by the Supreme Court—creating what is now referred to as the Alice-Mayo framework—the impact of this upheaval in the patent system has become even more clear. Ongoing court decisions and new data confirm that the Alice-Mayo framework has wrought an unsettling revolution and sowed uncertainty in what former U.S. Patent and Trademark Office (USPTO) Director David Kappos has referred to as the “the greatest innovation engine the world has ever known.” As policy debates on subject matter eligibility ramped up this past year, it is time to return back to the original dataset created by Robert Sachs and David Kappos that we presented in Turning Gold to Lead and provide an update.

The Continuing Legal and Policy Quagmire in Patent Eligibility Doctrine

Under the Alice-Mayo framework, courts continue to invalidate patents securing the fruits of inventive labors in medical diagnostic tests, medical treatment methods, medical devices, and in high-tech inventions. They continue to invalidate these patents without rhyme or reason. Contrary to long-settled rules on how to interpret patents, courts are disintegrating claims into their individual elements, focusing on only a single unpatentable element comprising a law of nature or abstract idea, finding easily no inventive step in this individual element, and concluding that the invention as a whole is ineligible for patent protection.

This pattern of decision-making is exhibited in so many court decisions, it’s impossible to detail them all. In Athena Diagnostics v. Mayo Collaborative Services (Fed. Cir. Feb. 6, 2019), for example, the Federal Circuit invalidated another innovative diagnostic medical treatment patent. On July 3, 2019, the Federal Circuit denied the en banc petition in Athena Diagnostics in a highly fractured decision with four dissenting opinions and another four separate concurrences. The recently filed cert petition by Athena Diagnostics is supported by several amici, including Chief Judge Paul Michel (ret.), and the case is now set to go to conference on January 10. This is just one illustrative example. As reported at the Senate hearings last June on the need for reform of patent eligibility doctrine, diagnostics, medical devices, and other cutting-edge innovations in healthcare are suffering greatly under the Alice-Mayo framework.