The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is interested in commentary across all technological fields, mentioning the agricultural industry as an area of special interest. This follows a March 2023 report from the U.S. Department of Agriculture, prepared with input from the USPTO, on “promoting fair competition and innovation in regards to seeds and other agricultural inputs.”

The common law experimental use defense to patent infringement dates back to an early 19th Century decision, Whittemore v. Cutter. The Notice further summarizes experimental use jurisprudence, ending with the Federal Circuit’s 2004 decision in Madey v. Duke University, which narrowed and “strictly limited” the experimental use defense, and remains the guiding decision to the common law defense in 2024.

According to the Notice, legislation aimed at codifying the experimental use defense has been largely unsuccessful; for example, the Genomic Research and Diagnostic Accessibility Act of 2002 proposed an allowance for “noninfringing uses of patents on genetic sequence information for purposes of research and genetic diagnostic testing, and to require public disclosure of such information in certain patent applications.” It was never enacted though.

Nonetheless, Article 30 of the TRIPS Agreement, to which the United States is a signatory, permits the enactment of an experimental use exception, so long as it does not “unreasonably conflict with a normal exploitation of the patent and do[es] not unreasonably prejudice the legitimate interest of the patent owner, taking account of the legitimate interests of third parties.” Accordingly, many countries around the world have codified an experimental use exception, such as the UK, Germany, Switzerland, Japan, China, Korea, India, and Brazil.

The experimental use defense has made its way into some U.S. legislation so far, however; notably with the Hatch-Waxman Act of 1984 and the Plant Variety Protection Act of 1970. The former codified a safe harbor provision (35 U.S.C. § 271(e)(1)) allowing for the experimental use of patented inventions as needed to seek regulatory approval for generic drugs and medical devices; the latter contains exemptions permitting the use of patented plant varieties for research (7 U.S.C. § 2544).

Consideration of the further codification of experimental use exceptions is prompted by, and consistent with, recent attempts to promote competition in the American economy, per President Biden’s 2021 Executive Order. On one hand, greater statutory protections for experimental use may encourage and foster innovation, yet conversely, its benefit to the economy may be limited. As the Federal Circuit explained in Madey, the experimental use exception does not immunize acts that are “in any way commercial in nature” or “in keeping with the alleged infringer’s legitimate business.” On the FDA safe harbor provision codified in the Hatch-Waxman Act, the Federal Circuit similarly concluded in Momenta II that allowing the commercial use of a patented method to fall under the experimental use safe harbor “would result in manifest injustice.” Therefore, the clear distinction between experimental uses and commercial activities would seemingly limit the economic benefit.

Comments are requested by September 26, 2024.