By Dallas Nguyen '26
On March 11, 2024, a coalition of businesses, technology companies, and think tanks released a letter to the Chairman and Ranking Member of the Senate Judiciary Committee, urging them not to move forward with the proposed Patent Eligibility Restoration Act (PERA), S. 2140. The act, introduced by Senators Tillis and Coons on June 22, 2023, aims to provide clarity by changing the language for patent subject matter eligibility.
Currently, inventions must fall into one of four categories of subject matter – process, machine, manufacture, and composition of matter – to be eligible for patenting under Section 101 of the Patent Act (Section 101). However, the U.S. Supreme Court has noted three “judicial exceptions” – laws of nature, natural phenomena, and abstract ideas – that require further scrutiny for patent eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). PERA attempts to replace these exceptions with a more specific list of ineligible subject matter, such as certain mathematical formulas, substantial economic processes, and unmodified human genes. Notably, these categories themselves have exceptions. This means specific inventions within the proposed list of ineligible subject matter may still qualify for patents. For example, a substantial process can be patent-eligible if it “cannot practically be performed without the use of a machine (including a computer) or manufacture.” Likewise, a human gene or other natural material can be patented if it is “isolated, purified, enriched, or otherwise altered by human activity” or “otherwise employed in a useful invention or discovery.”
Since the act’s introduction, PERA opponents have cited two common arguments against it. First, it would disrupt two centuries of established U.S. patent law and make eligibility requirements even more confusing with its specificity, defeating the main purpose of the act. Second, and perhaps more contentious, PERA would allow the patenting of several ideas that would previously have been ineligible, leading to an expansion that some consider extreme. For instance, the March letter, signed off on by organizations from Amazon and Google to Domino’s and Berkshire Hathaway, claimed that many areas of daily modern life that require computers or similar technology, like business methods or data-storing devices, would suddenly become patentable under PERA.
In January, a separate opposition letter to the Senate from a coalition of public interest groups, including the ACLU, echoed concerns about the impact of gene patenting under PERA. The letter warned that PERA could allow patents on isolated genes linked to diseases like Alzheimer’s or even pathogens like Covid-19. More importantly, the groups argued, PERA could grant companies ownership over how this genetic information is used and shared. This could lead to exclusive rights to diagnose and treat diseases based on these genes, potentially limiting access to these life-saving tools. The letter pointed to the successful, rapid development of the Covid vaccine, hinged on the free sharing of information about the virus’s genetic variations among researchers and biotech companies, that would not have happened had PERA been in effect; a single company could have patented the entire viral genome, potentially delaying further research and development.
But PERA also has its share of proponents, who see the bill as a catalyst for innovation. Six of the eight witnesses who testified during a Senate Judiciary Committee hearing on the act were largely in support of passing it. One of them, Courtenay Brinckerhoff of Foley & Lardner, swung on the opposite end of the public interest groups’ concerns, seeing the ‘isolated’ provision as one that would encourage scientific development. PERA would not only open the door to progress for medications and chemicals isolated from plants and bacteria but also align the American patent system to other international jurisdictions that are already permitting ownership over these natural products. Professor Adam Mossoff of the Antonin Scalia Law School added weight to this argument, citing data showing that nearly 1,700 US-rejected patent applications between 2014 and 2019 were granted patents in China and the EU. PERA would thus boost American innovation and competitiveness, while also providing investor confidence through clearer patent eligibility rules. Other patent limitations also still exist to prevent overly broad patent protection. For example, AI or Machine Learning-based inventions are still subject to laws outside Section 101 that require significant contribution by a real person as the inventor.
PERA remains stuck in legislative limbo, even as additional groups, like the EFF, join the debate. For the foreseeable future, both sides will likely continue their efforts to sway the Senate, as the course of American innovation potentially hangs in the balance.