On August 2, 2022, Bill S. 4734, titled the Patent Eligibility Restoration Act of 2022, was first introduced to the U.S. Senate by Senator Thomas Tillis (R-NC). Later, on September 28, 2022, Senator Chris Coons (D-DE) announced that he had joined as a co-sponsor. The bill, if passed, will significantly impact patent subject matter eligibility by amending 35 U.S.C. § 101.

The objective of the bill is to remove the uncertainty caused by the inconsistent application of the exceptions created by the Supreme Court decisions on patentability of abstract ideas, laws of nature, and natural phenomena. The Federal Circuit has previously noted that it was “at a loss as to how to uniformly apply § 101” and have urged the Supreme Court to provide guidance. Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, 977 F.3d 1379, 1382 (Fed. Cir. 2020).

The bill, inter alia, will expressly exclude judicial exceptions to patentable subject matter previously created under the Supreme Court decisions of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), and its progeny. The amended § 101 would exclude the following specific subject matter:

• Mathematical formula, apart from useful invention or discovery;
•  Unmodified human gene, as that gene exists in the human body;
• Unmodified natural material, as that material exists in nature.

The amended § 101 would also exclude the following processes:

• Non-technological economic, financial, business, social, cultural, or artistic processes;
• Mental processes performed solely in the human mind; and
• Those processes that occurs in nature wholly independent of, and prior to, any human activity.

A subsection of the proposal to amend § 101 also contains a requirement that patent eligibility determinations consider the claimed invention as a whole; without discounting or disregarding any claim element.

Medical diagnostic tests and software inventions have suffered the most from patent eligibility challenges. The uncertainty in U.S. patent law has caused many patent applications that address lifesaving drugs and other medical treatments to be denied by the USPTO while the same applications issue as patents in Europe and China. The lack of harmony in patentability has had a negative impact on society. For example, some have argued that drug companies’ objections to patenting Covid-19 vaccines and related drugs created a territorial environment and that, if such a bill as the Patent Eligibility Restoration Act of 2022 had been in place, it would have facilitated a swifter response to the coronavirus outbreak. On the one hand, biopharmaceutical companies would have a more direct path to maintain exclusive rights over inventions. The C4IP, Council for Innovation Promotion, which includes bipartisan intellectual property leaders, believes the bill would increase investment in critically important diagnostics research and development – an industry that had decreased in $9.3 billion dollars in investments in the four years following the Mayo decision. On the other hand, the bill would encourage companies to monopolize information needed for further innovative developments and impede access to lifesaving medicine. The ACLU, American Civil Liberties Union, which represented plaintiffs in key patent cases like Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 566 U.S. 902 (2012), takes the view that companies would take advantage of patent eligibility and harm efforts to treat health conditions.

Other uncertainties and mixed interpretation can result from the Patent Eligibility Restoration Act of 2022 passing. For example, the new bill begs the question as what it means for something to be “technological.” The term encompasses many things and is difficult to define. Consequently, courts will be forced to interpret: whether a particular economic, financial, business, social, cultural, or artistic process is technological or non-technological. And, of course, court intervention may lead to more uncertainty than we have today in applying the Mayo decision. The USPTO would also have to consider and set out new rules to apply the standards contained in the bill. The bi-partisan bill is being monitored by intellectual property professionals as it seeks to finally resolve the limits of patentable subject matter.