The United States Patent and Trademark Office (USPTO) today published a notice in the Federal Register (“the Notice”) seeking public comments and input on the current status of the Experimental Use Exemption. The USPTO is interested in comments from all technology sectors and identifies agriculture as an area of particular 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 with respect to seeds and other agricultural inputs.”
The common law defense of experimental use in patent infringement dates back to a decision in the early 19th century. Whittemore vs. CutterThe notice further summarizes the case law on experimental use and ends with the Federal Circuit’s 2004 decision in Madey vs Duke Universitywhich narrowed and “severely limited” the experimental use defense and remains the guiding decision for 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 to “allow patents on genetic sequence information for research and genetic diagnostic purposes without patent infringement and to require public disclosure of such information in certain patent applications.” However, the law was never enacted.
Nevertheless, Article 30 of the TRIPS Agreement, to which the United States is a signatory, allows the introduction of an experimental use exception as long as it does not “unreasonably conflict with a normal use of the patent and does not unreasonably prejudice the legitimate interests of the patentee, taking into account the legitimate interests of third parties.” Accordingly, many countries around the world have codified an experimental use exception, including the United Kingdom, Germany, Switzerland, Japan, China, Korea, India and Brazil.
However, the defense of experimental use has so far found its way into some U.S. laws, notably 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 experimental use of patented inventions when necessary for regulatory approval of generic drugs and medical devices; the latter contains exceptions allowing the use of patented plant varieties for research purposes (7 U.S.C. § 2544).
Consideration of further codification of experimental use exemptions is prompted by and consistent with recent attempts to promote competition in the American economy under President Biden’s 2021 Executive Order. On the one hand, stronger statutory protections for experimental uses can encourage and support innovation, but on the other hand, their utility to the economy may be limited. As the Federal Circuit in Madeythe experimental use exception does not immunize acts that are “in any way commercial in nature” or “consistent with the legitimate business of the alleged infringer.” With respect to the FDA’s safe harbor provision codified in the Hatch-Waxman Act, the Federal Circuit similarly concluded that the experimental use exception does not immunize acts… Moments II that it would be “manifestly unfair to place the commercial use of a patented method under the experimental use safe harbor.” Therefore, the clear distinction between experimental use and commercial activity would appear to limit the economic benefit.
Comments are requested until September 26, 2024.
