You may have missed it, but it's election season in the United States. Yet even with the seemingly unbridgeable gulf between the two major political parties, there is at least one thing that unites many in the political world: patentable subject matter eligibility.
I know it sounds like a joke, but if you look at the trio of US Supreme Court decisions that defined current US patent eligibility law (Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012); Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013); and Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014)), all were unanimous decisions by a Court that is more often than not split along political lines.
Now, more than ten years after Mayo, a similarly bipartisan effort is underway, but this time in the US congress and in the form of a proposed law that if passed, will remedy much of the harm to IP stakeholders that resulted from the Supreme Court's decisions.
The proposed-law, the "Patent Eligibility Restoration Act," or PERA, was originally introduced in the Senate in June 2023 by Republican Senator Tom Tillis and Democratic Senator Chis Coons. An identical version of the proposed law was introduced on September 6, 2024 into the House of Representatives by Republican Representative Kevin Kiley and Democratic Representative Scott Peters. PERA will not be voted on or become a law before the upcoming US election. However, the introduction of both bills represents a significant positive step forward in addressing the confusion in the US patent system and damage to patent applicants caused by the current, Court-instituted legal standard, and I think is a sign of what's to come for the availability of patent protection for effected technologies in the US.
The recently introduced version of PERA begins by recognizing the problem: that despite the broad language of the US patent statute, many courts, including the US Supreme Court have "created judicial exceptions . . . thereby rendering an increasing number of inventions ineligible for patent protection." The proposed law addresses this issue directly, and states unequivocally: "Under 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 the existing law or] as described in subparagraphs (D) and (E) of this paragraph."
The PERA thus eliminates all judicial exceptions to patent eligibility. As noted, PERA is not a complete free-for-all, and does include several exceptions to patent eligibility. However, these exceptions are clearly defined: (i) mathematical formulae disconnected from any of the defined types of patent eligible subject matter; (ii) mental processes that are performed solely in the mind of a human being; (iii) an unmodified human gene, as it exists in the human body; (iv) an unmodified natural material, as that material exists in nature; and (v) a process that is substantially economic, financial, business, social, cultural, or artistic.
Importantly, the PERA clarifies several of these statutory exceptions to patentability. With respect to human genes and natural products, the proposed law notes that material that is "isolated, purified, enriched, or otherwise altered by human activity; or otherwise employed in a useful invention or discovery" is patent-eligible. These exceptions to the exceptions are significant correctives to the existing law under Mayo and Myriad Genetics, and reharmonizes US law with that of most other jurisdictions.
Similarly, with respect to mental processes and business methods, the PERA clarifies that "The process . . . shall not be excluded from eligibility for a patent if the process cannot practically be performed without the use of a machine or manufacture." Again, this requirement for technology to carry out the process is reharmonizes US law with that of many jurisdictions.
Lastly, the PERA disentangles the court-created fusion of patent eligibility and non-obviousness (i.e., the requirement that a claimed invention possess an "inventive concept" to avoid patent ineligibility). It does this by clearly stating that "eligibility shall be determined . . . without regard to . . . the state of the applicable art . . . or any other consideration [in the patent law]." This final component is quite significant, and unequivocally restates what should have been obvious to the Supreme Court: patent eligibility is only the first step in determining patentability of an invention. US patent law has the legal means to prevent old or obvious inventions from wrongly becoming a patent.
A couple of years ago, I reflected on the state of diagnostic methods patenting ten years after the Mayo decision. At the time, the legislative momentum was only just beginning. As the PERA is not yet law, and is unlikely to become law in the near future (though we can hold out hope for 2025!), my conclusions two years ago for what a patent applicant in the "judicial exception" technology space should be doing remain applicable today: "best practice, as in so many things, is to be flexible! Patent applications should include a variety of possibilities . . . to enable a variety of claims, and so that when the legislation moves forward (and it will), we will be ready for it."
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