S. 2140 – PERA Act

The Patent Eligibility Restoration Act (PERA) of 2023, put forward by Senators Thom Tillis and Chris Coons, is designed to clear up the confusion caused by recent court rulings on what can be patented under section 101 of the U.S. Code. The Act aims to eliminate all judicial exceptions to patent eligibility, maintaining the current categories of what can be patented while adding specific exclusions. Importantly, it clarifies that sections 102, 103, and 112 will still dictate the requirements for getting a patent, but these requirements won’t affect the initial eligibility decision. This change is meant to make things more straightforward for everyone involved in the patent process, from inventors to judges to patent officials.

A key feature of the PERA is its clear list of exclusions. Under the Act, patents cannot be granted for things like pure mathematical formulas, business methods, mental processes that can be done in the human mind, and naturally occurring processes or materials. However, if human intervention has significantly altered a gene or material, then it could be eligible for a patent. The legislation insists that patent eligibility should be assessed based on the invention as a whole, without considering how it was made or its state of the art at the time. This ensures that the focus remains on the practical utility and innovation of the invention itself.

The Act also addresses several common misconceptions. For example, it explicitly forbids patents on naturally occurring genes and materials unless they’ve been significantly modified by human action. This counters the myth that the Act would allow patents on natural genes. It also rebuts the idea that restoring patent eligibility for isolated genes and diagnostic methods would stifle innovation; in fact, history shows that such patent protections have previously driven significant investment and progress in these fields. Additionally, the Act clarifies that it won’t lead to higher prices for diagnostics or drugs. Instead, it aims to restore incentives for developing new technologies that can actually help lower healthcare costs. By providing clear rules and exclusions, the PERA aims to reduce uncertainty and encourage innovation in the U.S., helping the country maintain its edge in technology and biotech.

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