The Perils of the Patent Eligibility Restoration Act of 2025: A Threat to Patients, Small Businesses, and American Innovation

Alex Moss | May 2, 2025

The Patent Eligibility Restoration Act of 2025 (PERA), introduced in the U.S. Senate, claims to “restore” clarity to patent law. However, its sweeping changes risk monopolizing access to life-saving medical innovations and stifling competition across critical economic sectors. Below, we break down how PERA undermines patients, small businesses, and the principles of fair innovation.

1. Monopolizing Genetic Information and Medical Tests

PERA’s Section 101(b)(1) carves out narrow exclusions for patents on “unmodified” human genes and natural materials. However, the bill allows patents on modified genes or materials, even if the “modification” is trivial (e.g., isolating or purifying a gene—a necessary step in any genetic test). This creates a loophole for companies to patent naturally occurring genetic information by claiming minor alterations.

Example: Under PERA, a company could patent a breast cancer risk test by isolating the BRCA1 gene—a tactic already attempted (and rejected) thanks to the Supreme Court’s decisions in Myriad and Alice. Similarly, using conventional methods to detect a new virus (e.g., PCR tests to detect COVID-19) could become patentable, despite the virus itself being a product of nature.

Impact on Patients:

• Higher costs: Monopolies on genetic tests or treatments would let companies charge exorbitant prices.

• Delayed diagnoses: Competing labs could be barred from offering cheaper alternatives.

2. Resurrecting Abusive E-Commerce Patents

PERA revives the patenting of abstract ideas by allowing claims on “processes” that are “substantially economic, financial, or business-related” if tied to a machine (Section 101(b)(1)(B). This reinforces the worst of pre-Alice case law, where courts allowed patents on basic concepts implemented with off-the-shelf computer hardware and software.

Examples: Under PERA, a company could get a patent on the abstract idea of “verifying a credit card transaction using a computer” and “online shopping carts” on a standard website or app.

Section 4(b) attempts to block patents that add “insignificant” computer steps. However, it fails to stop claims where the computer is necessary but the core idea remains abstract. For example, a patent on “adjusting prices based on supply and demand using an algorithm” could easily slip through, harming small businesses that rely on conventional and ubiquitous e-commerce tools.

Impact on Small Businesses:

• Litigation risks: Patent trolls could sue startups for using standard online practices.

• Stifled innovation: Fear of lawsuits may deter entrepreneurs from investing in start-ups, entering tech markets, and developing new and improved consumer products of all kinds.

3. Double Patenting: Extending Monopolies Indefinitely

PERA explicitly preserves “obviousness-type” double patenting (Section 4(a)) but abolishes all other “judicially created” exceptions. Courts have historically blocked companies from patenting the same invention twice (non-obviousness-type double patenting) under Section 101. By erasing this safeguard, PERA lets corporations secure multiple patents on a single invention.

Example: A drug company could separately patent a medication and method of administering it to patients, extending its monopoly and delaying generic competitors.

Impact:

• Higher drug prices: Extended monopolies mean longer waits for affordable generics.

• Reduced competition: Startups and prospective competitors would face prohibitive barriers to market entry.

4. Post-Solution Activity: A Paper Shield Against Abuse

Section 4(b) claims to prevent patents that tack on generic computer steps to abstract ideas. However, this replicates flawed pre-Alice logic, where courts allowed patents on utterly non-inventive ideas like “diagnosing a disease by analyzing gene data on a computer,” and “booking a hotel room online.”

If a computer is deemed “necessary” to perform a claimed invention (even if the purported innovation is non-technical), PERA’s language offers no protection. This opens the door to patents on basic medical algorithms and business methods, undermining the progress of truly novel inventions like mRNA vaccines.

Conclusion: A Step Backward for Innovation

Supporters argue PERA clarifies patent law, but its vague language and considerable loopholes prioritize corporate monopolies over public health and fair competition. By enabling patents on natural genes, abstract business methods, and the same invention multiple times, the bill risks:

• Jeopardizing patient access to affordable genetic tests and treatments.

• Crushing small businesses under frivolous patent lawsuits.

• Rewarding gatekeepers, not innovators.

Congress must reject PERA and pursue reforms that protect both innovation and the public good.

Call to Action: Contact your representatives and urge them to oppose the Patent Eligibility Restoration Act of 2025. Innovation should serve everyone—not just patent holders.