For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent to and often intertwined with medical devices. Congress is trying to help.
On May 1, 2025, the Patent Eligibility Restoration Act (PERA) was introduced in both the U.S. Senate and the U.S. House of Representatives, sponsored by Senators Thom Tillis (R-NC) and Chris Coons (D-DE) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA). PERA is a proposed amendment to the statute 35 U.S.C. 101 (Section 101), which governs patent eligibility. The goals and intended balance of this proposed legislation were summarized in a press release from Senator Tillis: “This bipartisan, bicameral legislation maintains the existing statutory categories of eligible subject matter, which have worked well for over two centuries, while addressing inappropriate judicially created eligibility limitations by creating clear rules for what is eligible.”
Why Reform Patent Eligibility Laws?
In the early 2010s, the U.S. Supreme Court issued a series of decisions providing the Alice/Mayo framework that relies on so-called “judicial exceptions” to the default under Section 101 of the patent laws that man-made concepts are eligible subject matter for patents. Those “exceptions”–areas not eligible for patenting–included: abstract ideas, laws of nature, and natural phenomena (including products of nature). PERA states that the judicially created Alice/Mayo framework and exceptions “have led to extensive confusion and a lack of consistency” and that Section 101 “is extremely confusing and difficult to discern and apply with any confidence.” See PERA at § 2(3)-(4). Moreover, PERA recites that the judicially created exceptions have led to “an increasing number of inventions [being] ineligible for patent protection.” See id. at § 2(2).
Members of Congress view this as an opportunity to clarify the laws of patent eligibility by amending 35 U.S.C. Section 101, the relevant patent statute.
What Is in the Proposed PERA?
PERA seeks to clarify patent eligibility law by expressly eliminating and replacing “all judicial exceptions to patent eligibility.” See id. at § 2(5)(A),(D). Specifically, the proposed language of Section 101 would recite that otherwise eligible subject matter would be “subject only to the exclusions in subsection (b),” which recites five express exceptions to patent eligibility. See PERA at Proposed Statutory Amendment §101(a)-(b).
PERA’s exceptions to patent eligibility are these:
- “A mathematical formula that is not part of a claimed invention….” See id. at (b)(1)(A). PERA further clarifies that such a claimed invention “shall not be excluded from eligibility for a patent if the invention cannot practically be performed without the use of a machine or manufacture.” See id. at (b)(2)(A).
- “A process that is substantially economic, financial, business, social, cultural, or artistic, even though at least 1 step in the process refers to a machine or manufacture.” See id. at (b)(1)(B). As above, PERA clarifies that such a claimed invention “shall not be excluded from eligibility for a patent if the invention cannot practically be performed without the use of a machine or manufacture.” See id. at (b)(2)(A).
- “A process that (i) is a mental process performed solely in the human mind; or (ii) occurs in nature wholly independent of, and prior to, any human activity.” See id. at (b)(1)(C).
- “An unmodified human gene, as that gene exists in the human body.” See id. at (b)(1)(D). PERA clarifies that “a human gene shall not be considered to be unmodified if that human gene is (i) purified, enriched, or otherwise altered by human activity; or (ii) otherwise employed in a useful invention or discovery.” See id. at (b)(2)(B).
- “An unmodified natural material, as that material exists in nature.” See id. at (b)(1)(E). PERA clarifies that “a natural material shall not be considered to be unmodified if that natural material is (i) isolated, purified, enriched, or otherwise altered by human activity; or (ii) otherwise employed in a useful invention or discovery.” See id. at (b)(2)(C).
Additionally, PERA forbids judges from implementing currently-used eligibility tests that have been criticized as extending beyond the realm of eligibility into other patent doctrines, such as novelty and obviousness. Specifically, PERA states that “[patent] eligibility shall be determined … without regard to” the following:
- “whether a claim element is known, conventional, routine, or naturally occurring;
- “the state of the applicable art, as of the date on which the claimed invention is invented; or
- “any other consideration in sections 102 [novelty], 103 [obviousness], or 112 [written description and enablement].”
See id. at (c)(1)(B)(ii)-(iv).
While this proposed legislation has merely been introduced and is not the law at this time, it is still helpful to understand the ongoing dialogue between the federal courts and Congress regarding patent law.
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congress, Medical Devices, patent eligibility, patent law in congress, Patents
