Intelectual Property (IP)

USPTO Wants Input on Scope of Possible Statutory Experimental Use Exception

“While the RFC is interested in how the experimental use exception applies to all technology areas, it provided the example of agriculture as one area that could benefit from greater clarity on experimental use.”

The U.S. Patent and Trademark Office (USPTO) issued a draft Request for Comments (RFC) today seeking public feedback “on the current state of the experimental use exception jurisprudence and whether legislative action should be considered to enact a statutory experimental use exception.”

The experimental use defense to patent infringement arises out of jurisprudence dating back to 1813 that allows some non-commercial experimentation with patented subject matter for limited purposes. According to the RFC, since the U.S. Court of Appeals for the Federal Circuit’s 2002 decision in Madey v. Duke University, which clarified the court’s view that the experimental use defense should be “very narrow and strictly limited,” many have weighed in on whether or not the exception should be expanded. While the RFC notes that the questions it is posing for comment “should not be interpreted as an indication that the USPTO has taken a position on or is predisposed to any particular views,” it spends some time detailing how other countries have approached experimental use, particularly that seven European countries have statutory exceptions that are broader than the U.S. common law exception.

It also notes that many jurisdictions in Asia, Canada and Latin America have codified experimental use exceptions.

While the RFC is interested in how the experimental use exception applies to all technology areas, it provided the example of agriculture as one area that could benefit from greater clarity on experimental use. It cited the U.S. Department of Agriculture’s 2023 report, More and Better Choices for Farmers: Promotion Fair Competition and Innovation in Seeds and Other Agricultural Inputs, which implied that the narrow exception may be a hindrance in this field. The report said:

“The patent system does not provide a breeding exemption and allows a research exception that encompasses only ‘very narrow’ experimental uses ‘solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.’ It does not include uses that have the ‘slightest commercial implication’ and has been interpreted to exclude academic research.”

The report was prepared in consultation with the USPTO, and the two agencies “committed to evaluating ‘new proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the addition of research or breeders’ exemptions for U.S. utility patents,’” said the RFC. The report was also directed by President Biden’s 2021 Executive Order on Promoting Competition in the American Economy.

The RFC poses eight questions for commenters, including:

1) how the exception impacts technologies such as (a) quantum computing; (b) artificial intelligence; (c) other computer-related inventions; (d) agriculture; (e) life sciences (including prescription drugs and medical devices); and (f) climate-mitigation technologies in particular;

2) whether there are any technologies that are negatively impacted by the narrow nature of the U.S. common law exception;

How a statutory exception would impact “the innovation and commercialization of new technologies”;

4) how the current state of the law on experimental use has impacted business decisions to pursue or maintain patent applications or to purchase, license or sell patents;

5) whether a statutory exception should be adopted;

6) how such a statutory exception should be defined;

7) public policy reasons for either maintaining the status quo or changing the exception; and

8) any additional general recommendations.

 “Clarifying the contours of the USPTO’s experimental use exception, especially in view of researchers’ needs today, will help us continue to address emerging challenges and unlock new opportunities in key technology sectors,” USPTO Director Kathi Vidal said in a press release about the RFC. “This RFC will help the USPTO better understand what additional clarity, if any, researchers and other innovators need.”

Comments are due by September 26, 2024.

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Eileen McDermott
Eileen McDermott is the Editor-in-Chief of IPWatchdog.com. Eileen is a veteran IP and legal journalist, and no stranger to the intellectual property world, having held editorial and managerial positions at […see more]

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