Patent subject matter eligibility is determined by section 101 of the Patent Act. The Supreme Court, in its “Alice-Mayo” cases created judicial exceptions to subject matter eligibility. These create uncertainty and unpredictability in patent approvals

As I have stated in past scholarship, testimony before Congress, amicus briefs, and agency comments, the U.S. patent system has been under an extensive amount of stress from all branches of the federal government for over fifteen years. The Supreme Court has been deciding patent cases at a rate not seen for almost a hundred years,2 changing the law in all aspects of the patent system. Among these numerous changes were four decisions between 2010 and 2014 on patent eligibility doctrine under § 101.3 These decisions severely restricted the inventions and discoveries that have long been considered patentable for over two centuries in the U.S. patent system.

These four decisions culminated in the “Alice-Mayo inquiry”—a two-factor legal framework that courts and the U.S. Patent & Trademark Office (USPTO) have applied since 2014 in assessing whether an invention or discovery is patentable subject matter under § 101.4 The Alice-Mayo inquiry has created a tremendous amount of uncertainty for innovators and severely restricted the patent eligibility of high-tech and biopharmaceutical innovations. It has had a negative impact on both inventors and the companies working in the innovation industries that invest millions of dollars in creating the new products and services that drive economic growth, job creation and higher standards of living. Thus, it is undermining the longstanding comparative advantage by the U.S. in the world in securing reliable and effective patent rights for all innovators.

The Alice-Mayo inquiry is one of many recent changes to the U.S. patent system that has called into question the longstanding U.S. claim to a “gold standard” patent system as compared to the rest of the world.5 As a result of the Alice-Mayo inquiry, the USPTO has denied patent applications or courts have invalidated issued patents in cutting-edge discoveries in medical care, such as treatments for breast cancer, diabetes, and strokes, among others.6 The USPTO appears to have corrected course in adopting its 2019 patent eligibility guidelines,7 but these patent examination guidelines are not a panacea. These regulatory guidelines can be easily repealed by a future USPTO director, and they have had no sway with the courts in reviewing the patents issued by the USPTO. Courts continue to apply the Alice-Mayo inquiry to invalidate patents on classic industrial technologies, such as an invention on a new method of manufacturing automobile axles,8 and, in another notorious case, the courts applied the Alice-Mayo inquiry to conclude that the invention of a new remote-controlled garage door opener is an unpatentable abstract idea.9

This is an alarming shift from the historical approach of the U.S. in securing reliable and effective patent rights in new innovations, which has been a key driver of economic growth in the U.S.10 It is even more concerning given the rise of a modern global competitor like China that seeks to compete technologically and economically by developing its own innovation economy, not just defeat the U.S. through military conflicts. Historically, the U.S. became the home to innovators and the R&D financing that drove technological and economic revolutions from the Industrial Revolution to today’s mobile revolution.11 Even with period upheavals in U.S. patent policy over the past two centuries, the U.S. forged ahead when other countries hesitated in securing patents in new discoveries and inventions, such as in biotechnology and computer software in the 1980s.12 Today, China and European countries are now the ones forging ahead and securing reliable and effective patents in innovation that the U.S. no longer reliably or effectively protects due in part to the closing of the doors to its patent system by the Alice-Mayo inquiry.13