Congress’ latest attempt to address subject matter eligibility

Article co-written by Yuri Levin-Schwartz, Ph.D., a law clerk at MBHB.

Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution. They chaired a series of Congressional hearings in 2019 and have proposed several bills providing various iterations of these solutions.  This week, they co-sponsored their latest attempt, entitled “The Patent Eligibility Restoration Act of 2023.”

After reciting a preamble of “Findings” amounting to a litany of all the reasons why Supreme Court decisions and how they have been implemented by district courts, the Federal Circuit, and the Patent and Trademark Office have “led to extensive confusion and a lack of consistency” regarding eligibility, the bill provides specific proposed modifications of the statute. These begin with the provisions defining a “process” (Section 100), by deleting the phrase ‘‘includes a new use of a known process’’ and inserting ‘‘includes a use, application, or method of manufacture of a known or naturally-occurring process.” Also provided is a definition of the word “useful” to mean “with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.’’ 

Section 101 is amended in the bill to abrogate the so-called “judicial exceptions” by enumerating an explicit and exclusive set of ineligible subject matter.

These include: 

  • a mathematical formula that is not part of a claimed invention in a category [of process, machine, manufacture, or composition 16 of matter, or any useful improvement thereof];  
  • a process that is substantially economic, financial, business, social, cultural, or artistic, even though not less than one step in the process refers to a machine or manufacture, but not if the process cannot practically be performed without the use of a machine or manufacture; 
  • a mental process performed solely in the human mind, or that occurs in nature wholly independent of and prior to any human activity; 
  • an unmodified human gene as it exists in the human body; or 
  • an unmodified natural material as that material occurs in nature. 

Importantly, the term “unmodified” as it is used in the proposed amendments with regard to human genes or natural products does not include embodiments that have been “isolated, purified, enriched, or otherwise altered by human activity” or “otherwise employed in a useful invention or discovery.” 

The amendments to Section 101 also include a section on how eligibility is to be determined which includes: 

  • by considering the claimed invention as a whole and without discounting or disregarding any claim element; 
  • without regard to “the manner in which the claimed invention was made,” “whether a claim element is known, conventional, routine, or naturally occurring,” “the state of the applicable art, as of the date on which the claimed invention is invented,” or any other considerations in the other statutory sections (specifically Section 102, 103, or 112).



Finally, the amendments provide that in infringement actions, eligibility can be addressed by motion of a party when there are no genuine issues of material fact, and that the court can consider permitting “limited discovery” before ruling.  

The draft bill has two immediate impediments to passage.  The first is that to the extent the Supreme Court has based its subject matter eligibility jurisprudence as an exercise in its role in limiting Congress to the constraints in the Constitution, that its power to grant patents must “promote progress,” it is likely to strike down (or at least not give any effect to) any law that abrogates its judicial exceptions as being ultra vires of the proper exercise of Article I power.  It is also likely that some groups, particularly the American Civil Liberties Union and its allies in the Myriad case, will argue that the definition of “unmodified” would permit patenting of isolated human genes, to which these groups are intractably opposed.  

Neither of these impediments are incapable of being overcome by amending the scope of the statute, but their existence makes less likely from the outset that the bill will provide the solution the Senators seek.