On June 22, Senator Thom Tillis (R – NC) and Senator Chris Coons (D – DE) introduced the Patent Eligibility Restoration Act of 2023, which seeks to eliminate all judicial exceptions to patent eligibility.[1] The bill proposes that “[a]ny invention or discovery that can be claimed as a useful process, machine, manufacture, or composition of matter, or any useful improvement thereof” should be eligible for patent protection, with the following exceptions:

• A mathematical formula that is not part of an invention that is in a category described in subparagraph (B).
• A mental process performed solely in the mind of a human being.
• An unmodified human gene, as that gene exists in the human body.
• An unmodified natural material, as that material exists in nature.
• A process that is substantially economic, financial, business, social, cultural, or artistic.

Regarding unmodified human genes and natural materials, the bill states that “[a] human gene or natural material shall not be considered to be unmodified if the gene or material, as applicable, is ‘(A) isolated, purified, enriched, or otherwise altered by human activity’ or ‘(B) otherwise employed in a useful invention or discovery.’” According to the bill, eligibility should be determined without regard to, among other things, the manner in which the invention was made or whether a claim element is known, conventional, routine, or naturally occurring.

The introduction of the bill comes just weeks after the Supreme Court requested that the respondents respond to CareDx’s petition for writ of certiorari in the CareDx, Inc. v. Natera, Inc. case. This bill is welcome news for those seeking clarity on what is and what isn’t patent-eligible subject matter.

[1] https://www.tillis.senate.gov/services/files/4B41CBF2-57AB-4E8E-9E93-7D714A7AAB40

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