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June 28, 2024 - Healthcare, United States, Pharma, Medical Devices + Diagnostics

USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action


On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative action. This follows from a string of other recent Notices where the USPTO is seeking public input on other areas of patent law, including a recent Notice of Proposed Rulemaking on Terminal Disclaimer practice.

The USPTO explained that the current experimental use exception is a common law exception that was created to prevent punishing someone who infringes a patent “merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the [invention] to produce its desired effects.” This led to the availability of the experimental use exception based on whether the alleged infringement involved profit-making or other commercial purposes. The USPTO describes the current state of the experimental use exception as being a “very narrow and strictly limited experimental use defense.”

The USPTO’s request for public input on the “narrow” experimental use exception appears to stem, at least in part, from divergent views of the exception and its narrow breadth. The USPTO explains that some argue that “a narrow exception enhances innovation by rewarding innovators with robust patent rights, while others noted that restricting researcher access to patented technologies would impede innovation.”

This is not the first time there has been discussion of codifying the common law experimental use exception. Unsuccessful attempts at enacting legislation to codify the exception occurred in Acts proposed in 1990 and again in 2002. This stands in contrast to many foreign jurisdictions where statutory experimental use exceptions have been enacted, including jurisdictions where life sciences research and development are robust. This includes European countries, such as Germany, the UK, France, Spain, Italy, Switzerland, and the Netherlands, Asian countries, such as Japan and China, and countries across the Americas, such as Canada and many Latin America jurisdictions, including Brazil.

A limited type of experimental use exception has, however, been codified in the U.S. in the Hatch-Waxman Act as 35 U.S.C. § 271(e), which is commonly referred to as the “safe harbor” exception rather than the experimental use exception. Section 271(e) provides that making, using, offering to sell, or selling certain patented inventions “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products” shall not be considered an act of infringement. This “safe harbor” provision allows, for instance, a company to perform the testing required to obtain regulatory approval of a generic drug product without having to first wait for the patents covering the drug product to expire, thereby accelerating the timeline by which generic drug products can reach the market. Although certain acts can be shielded from liability for patent infringement under the § 271(e) exception where there is regulatory intent, the scope of the exception is ever evolving.

The USPTO will be accepting public comments over the next 90 days relating to the experimental use exception.

While the USPTO welcomes comments on any issues relating to the experimental use exception and its potential codification, they are particularly seeking out comments relating to the following issues:

  1. Please explain how the current state of U.S. experimental use exception jurisprudence impacts investment and/or research and development in any field of technology, including, but not limited to: (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.
  2. Do you believe there are any technologies that are negatively affected by the current state of experimental use exception jurisprudence in the United States? If yes, please identify which technologies and explain how you believe they are affected.
  3. Please explain what impact, if any, a statutory experimental use exception would have on the innovation and commercialization of new technologies, including with respect to: (a) research and development; (b) ability to obtain funding; (c) investment strategy; (d) licensing of patents and patent applications; (e) product development; (f) sales, including downstream and upstream sales; (g) competition; and (h) patent enforcement and litigation.
  4. Has the current state of experimental use exception jurisprudence impacted decisions you have made with respect to filing, purchasing, licensing, selling, or maintaining patent applications and patents in the United States? If yes, please explain how.
  5. Please explain whether you believe the United States should adopt a statutory experimental use exception. In doing so, please identify your reasons, including by providing evidence and data to support your views.
  6. Please explain how a statutory experimental use exception, if any, should be defined. Please include specific limitations and restrictions you believe would be needed to ensure that patent rights are preserved.
  7. Please identify public policy reasons in support of maintaining the status quo or changing the experimental use exception in the United States.
  8. Please provide any additional recommendations on how best to enhance and facilitate experimental research on patented inventions in the United States.