On August 2, 2022, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022 (S. 4734) (“PERA”). Senator Tillis characterized the bill to “restore patent eligibility to important inventions across many fields.” The “fields” were said to include “medical diagnostics, biotechnology, personalized medicine, artificial intelligence, 5G, and blockchain.”
The bill calls for the amendment of Sections 100 and 101 of the Patent Statute (35 U.S.C. § 100-101). Section 100 would be amended to change the present subparagraph (b) phrase “includes a new use of a known process” to read “includes a use, application, or method of manufacture of a known or naturally-occurring process.” The PERA also would add a new subparagraph (k) which reads as follows:
(k) The term ‘useful’ means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.
As for Section 101, the PERA replaces it completely. Although the first subparagraph of the PERA Section 101 retains much of the present statutory language, it adds two new subparagraphs directed to eligibility exclusions and eligibility determinations. Specifically, “a person may not obtain a patent for any of the following, if claimed as such:”
a mathematical formula, apart from a useful invention or discovery;
a process that (i) is a non-technological economic, financial, business, social, cultural, or artistic process; (ii) is a mental process performed solely in the human mind; or (iii) occurs in nature wholly independent of, and prior to, any human activity;
an unmodified human gene, as that gene exists in the human body; and
an unmodified natural material, as that material exists in nature.
Additional provisions, labeled “Conditions,” specify how excluded items may nonetheless be eligible for patent protection. Specifically, a mathematical formula can be eligible if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing. Also, a human gene or natural material will not be considered “unmodified” if it is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery.
The eligibility determinations portion specifies how eligibility determinations are to be made. Eligibility is to be determined as follows:
considering the claimed invention as a whole and without discounting or disregarding any claim element; and
without regard to (i) the manner in which the claimed invention was made; (ii) whether a claim element is known, conventional, routine, or naturally occurring; (iii) the state of the applicable art, as of the date on which the claimed invention is invented; or (iv) any other consideration in section 102, 103, or 112.
While the patent community has clamored for greater clarity as to what is patent eligible in the wake of the Supreme Court’s Alice v. CLS Bank decision, it is unclear whether the PERA provides that clarity. While the PERA identifies specific categories of subject matter that are not eligible for patenting—namely non-technological economic, financial, business, social, cultural, or artistic processes—it does not define what is covered by these categories. Such determinations would likely need to be made by a court, which would lead to more litigation. Related disputes could also arise regarding whether subject matter that falls into one of the excluded categories nevertheless satisfies one of the PERA’s conditions of patent eligibility. For example, the question of whether a computer-implemented process is merely using the computer for storing and executing the steps of the process also will need to be litigated. Finally, the PERA alters the current framework for determining eligibility, such as by removing considerations of whether a claim element is known, routine, or conventional. But the PERA does not provide a framework for determining patent eligibility by considering the claimed invention as a whole. It will take time to clarify such issues, either through additional legislation, the courts, or otherwise. In sum, while the PERA attempts to restore patent eligibility for many categories of inventions, it may not restore clarity in the law.