What Happened
Patent eligibility under 35 U.S.C. § 101 is back on the Senate Judiciary Committee's agenda. The Patent Eligibility Restoration Act (PERA) would rewrite Section 101 to eliminate the judge-made exceptions for "abstract ideas," "laws of nature," and "natural phenomena" that have governed eligibility since the Supreme Court's 2012 Mayo and 2014 Alice decisions. Committee members have been debating how to draft an exclusion for human genes and other narrow carve-outs without reopening the door to the kind of overbroad claiming the Court's precedent was meant to curb.
This isn't a new fight. Versions of eligibility reform have circulated in Congress since at least 2019, and the Federal Circuit has spent the intervening years applying Alice's two-step framework with results that even judges on the court have called unpredictable. Meanwhile, the Supreme Court has declined every invitation to revisit Section 101 itself, leaving Congress as the only realistic path to a fix.
Why It Matters
Eligibility remains the single biggest source of uncertainty in software, diagnostics, and life-sciences patenting. A claim that would clearly qualify as patentable subject matter in Europe or most of Asia can be invalidated in the U.S. as directed to an "abstract idea," often with little consistency between examiners, PTAB panels, and district courts applying the same test to similar claims.
For diagnostic method patents in particular, courts have struggled to distinguish patent-eligible applications of a natural correlation from ineligible claims on the correlation itself. That uncertainty has pushed some companies toward trade secret protection instead of patents for diagnostic innovations, even though trade secrets offer no protection against independent discovery or reverse engineering.
If PERA or similar legislation eventually passes, it would be the most significant statutory change to patent eligibility since the America Invents Act of 2011. But committee hearings are a long way from a floor vote, and past eligibility bills have stalled at exactly this stage.
What You Should Know
Don't wait for legislation. Whatever Congress eventually does, it won't retroactively rescue a poorly drafted application filed today. Claims should be drafted defensively under current law, with fallback positions that survive an eligibility challenge regardless of how the statute reads next year.
For software and diagnostics clients, that usually means anchoring claims in specific technical improvements rather than results, and building a robust specification that ties claimed features to concrete problems solved in the prior art.
Watch this space, but plan around the law as it exists. Eligibility reform has been "close" before and gone nowhere. Build a portfolio that works under Alice as it stands, and treat any statutory fix as a bonus rather than a strategy.