II 119th CONGRESS 1st Session S. 1546 IN THE SENATE OF THE UNITED STATES May 1, 2025 Mr. Tillis (for himself and Mr. Coons ) introduced the following bill; which was read twice and referred to the Committee on Judiciary A BILL To amend title 35, United States Code, to address matters relating to patent subject matter eligibility, and for other purposes.

1. Short title This Act may be cited as the Patent Eligibility Restoration Act of 2025 . 2. Findings Congress finds the following: (1) As of the day before the date of enactment of this Act, patent eligibility jurisprudence interpreting section 101 of title 35, United States Code, requires significant modification and clarification. (2) For many years after the original enactment of section 101 of title 35, United States Code, the Supreme Court of the United States and other courts created judicial exceptions to the wording of that section, thereby rendering an increasing number of inventions ineligible for patent protection. (3) Efforts by judges of district courts and courts of appeals of the United States to apply the exceptions described in paragraph (2) to specific circumstances have led to extensive confusion and a lack of consistency— (A) throughout the judicial branch of the Federal Government and Federal agencies; and (B) among patent practitioners. (4) Many judges of the United States Court of Appeals for the Federal Circuit and of various district courts of the United States have explicitly expressed the need for more guidance with respect to the meaning of section 101 of title 35, United States Code, and many patent owners, and persons that engage with patent owners, complain that the interpretation of that section is extremely confusing and difficult to discern and apply with any confidence. (5) Under this Act, and the amendments made by this Act, the state of the law shall be as follows: (A) All judicial exceptions to patent eligibility are eliminated. (B) Any invention or discovery that can be claimed as a useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, is eligible for patent protection, except as explicitly provided in section 101 of title 35, United States Code, as amended by this Act, as described in subparagraphs (D) and (E) of this paragraph. (C) Sections 102, 103, and 112 of title 35, United States Code, will continue to prescribe the requirements for obtaining a patent, but no such requirement will be used in determining patent eligibility. (D) The following inventions shall not be eligible for patent protection: (i) A mathematical formula that is not part of an invention that is in a category described in subparagraph (B). (ii) A mental process performed solely in the mind of a human being. (iii) An unmodified human gene, as that gene exists in the human body. (iv) An unmodified human gene that is isolated from the human body, but otherwise the same as that gene exists in the human body. (v) An unmodified natural material, as that material exists in nature. (vi) A process that is substantially economic, financial, business, social, cultural, or artistic. (E) Under the exception described in subparagraph (D)(vi)— (i) process claims drawn solely to the steps undertaken by human beings in methods of doing business, performing dance moves, offering marriage proposals, and the like shall not be eligible for patent coverage, and adding a non-essential reference to a computer by merely stating, for example, do it on a computer shall not establish such eligibility; and (ii) any process that cannot be practically performed without the use of a machine (including a computer) or manufacture shall be eligible for patent coverage. 3. Patent eligibility (a) In general Chapter 10 of title 35, United States Code, is amended— (1) in section 100— (A) in subsection (b), by striking includes a new use of a known process and inserting includes a use, application, or method of manufacture of a known or naturally-occurring process ; and (B) by adding at the end the following: (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. ; and (2) by amending section 101 to read as follows: 101. Patent eligibility (a) In general Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in subsection (b) and to the further conditions and requirements of this title. (b) Eligibility exclusions (1) In general Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such: (A) A mathematical formula that is not part of a claimed invention in a category described in subsection (a). (B) 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. (C) 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. (D) An unmodified human gene, as that gene exists in the human body. (E) An unmodified natural material, as that material exists in nature. (2) Conditions For the purposes of— (A) subparagraphs (A) and (B) of paragraph (1), the 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; (B) paragraph (1)(D), 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; and (C) paragraph (1)(E), 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. (c) Eligibility (1) In general In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined— (A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and (B) 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. (2) Infringement action (A) In general In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact. (B) Limited discovery With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph. . (b) Technical and conforming amendment The table of sections for chapter 10 of title 35, United States Code, is amended by striking the item relating to section 101 and inserting the following: 101. Patent eligibility. . 4. Rules of construction (a) Obviousness-Type double patenting Nothing in this Act, or any amendment made by this Act, may be construed to affect or alter the judicially-created doctrine of obviousness-type double patenting. (b) Insignificant extra-Solution activity With respect to the exclusions to patent eligibility described in subparagraphs (A) and (B) of section 101(b)(1) of title 35, United States Code, as added by section 3 of this Act, the inclusion of pre- or post-solution activity by a computer (or other machine or manufacture) in claim language shall not be sufficient to confer patent eligibility on the claim if that computer (or other machine or manufacture) is not necessary to practically perform the invention.