The Patent Eligibility Restoration Act of 2023 is a bipartisan piece of legislation introduced this summer by U.S. Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.). It is designed to provide “significant modification and clarification” for section 101 of title 35 of the United States Code and, as Senator Coons described it, to “reform patent eligibility law to bring vital clarity for inventors and innovators.

We’re examining the implications of the bill and its potential impact on institutional technology transfer and intellectual property protection.

Why does the patent system need legal clarification?

In the bill, the senators argue that the current law, which the Supreme Court has failed to clarify, is prone to judicial interpretation that has led to “rendering an increasing number of inventions ineligible for patent protection.” The Senators note that all 12 judges of the U.S. Court of Appeals for the Federal Circuit have expressed their concern around the lack of clarity. This gpa in the legislation has caused confusion in the research and investment communities and concerns around the US’s ability to compete globally.

Patent protection as advancement for global competitiveness

The current law has not aged well with advancements in technology— failing to provide US protection for developments that are patentable in Europe and China like artificial intelligence and medical diagnostic technologies. The Senators argue that this lack of clarity and inability to protect certain types of technologies is dampening our competitive edge. 

The Senators believe that the bill will “restore the United States to a position of global strength and leadership in key areas of technology and innovation, such as medical diagnostics, biotechnology, personalized medicine, artificial intelligence, 5G, and blockchain.”

What are the key pieces of the Patent Eligibility Restoration Act of 2023?

The key pieces of this bill are “aimed at promoting technology-based innovation” by providing clarification and explicit exclusions.

What is eligible for patent protection under the new legislation?

The legislation states: “Any invention or discovery that can be claimed as a useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, is eligible for patent protection” excepting those that are explicitly outlined in the amendment to the existing code.

What is explicitly excluded under the new patent legislation?

Mental Processes cannot be patented

  • Mathematical formulas 
  • Formulas can be eligible for patent as long as they are included as a part of a patent-eligible invention, but the mathematical formula cannot be patented on its own.
  • Ideas and Mental Processes
  • defined as “A mental process performed solely in the mind of a human being.”

Naturally Occurring Materials and Human Genes cannot be patented

  • Discovery of Human Genes 
  • defined as, “An unmodified human gene, as that gene exists in the human body.” 
  • Discovery of Natural materials 
  • defined as “An unmodified natural material, as that material exists in nature.”

Ways of Doing Common things cannot be patented

  • Processes and Methods for Common Activities 
  • The description for this exclusion is especially illustrative: “Methods of doing business, performing dance moves, offering marriage proposals, and the like[…]”
  • Introducing the Non-Essential  Use of a Computer to a Common Activity or Process
  • defined as “adding a non-essential reference to a computer by merely stating, for example, “do it on a computer” shall not establish such eligibility.”

The last two exclusions seem especially aimed at refocusing and advancing the true technological nature of the patent system. In order to apply for patent eligibility, there must be a tangibly new and novel process, discovery, or physical invention to reference — not just a creative application, particular approach, or unique idea.

How will this bill impact future patents?

What new Patent technologies will be covered by the Patent Eligibility Restoration Act of 2023?

The act clarifies, restores, or introduces eligibility for the following —

  • Machine (and computer) dependant processes
  • Defined as “ any process that cannot be practically performed without the use of a machine (including a computer) or manufacture shall be eligible for patent coverage.
  • Modified Naturally occurring materials and Modified Human genes
  • While naturally occurring human genes and natural materials as they exist in nature are explicitly excluded, the legislation introduces the ability to patent these materials if they have been substantially modified. Eligible modifications include: “ isolated, purified, enriched, or otherwise altered by human activity.” Similar to the mathematical formula exclusion criteria, a gene or natural material can be included as an element as it is employed within the patent of an eligible “ useful invention or discovery.”

Notably, the above addition creates a mechanism for obtaining patents for diagnostics. Which is critical to the rapidly accelerating landscape of medical AI, biotechnology, and gene therapy.

Consensus seems clear that clarification of the law is warranted and overdue. AUTM – an association that represents 3,000 professionals involved in commercializing academic research — has written a letter of support to the Senators thanking them for introducing the legislation. The association also said that “ without adequate patent protection, too many great ideas developed in our labs may never see the light of day in the commercial sector, where they can make a difference.”

This act helps to eliminate long-standing uncertainty and update the patent system to bring it up to speed with current science. If enacted, it should help to prevent lengthy and expensive legal proceedings, accelerate novel technologies on their path to market, and enhance US global competitiveness.

Voting is expected to take place in September.