Senator Tillis’ Attempts to Change Patent Subject Matter Eligibility

In early August of 2022, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022, which attempts to modify 35 U.S.C. §101, subject matter eligibility. The bill addresses problematic areas that have become confusing or complicated due to recent judicial holdings while retaining the core features of §101.

Attribution

Official Senate Headshot of Sen. Thom Thillis

Background

The bill holds to the core features of the original statute, expressing that "whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent." It continues by keeping with the generally understood exceptions while specifically mentioning mathematical formulas, unmodified human genes, and unmodified natural material as further exceptions barring them from patent eligibility.

The bill deviates from the standard by extending patent eligibility to genes, or natural materials that inventors prove are "purified, enriched, or otherwise altered by human activity, or otherwise employed in a useful invention or discovery,"  as these would no longer be considered 'unmodified' under this bill. This change would effectively override past case law and allow some patents for inventions previously excluded as abstract ideas, such as various diagnostic inventions.

Opportunities and Obstacles

This bill attempts to make the muddy waters of §101 clearer and more manageable for both the court system and inventors. Whereas the original statute might need clarification and is often applied inconsistently, this bill lays out the exceptions making it more digestible.

On the other hand, some of the changes explicitly allowing the patenting of some abstract ideas is controversial as many are worried about the future implications, especially concerning the patenting of human genes. In Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court determined that naturally occurring D.N.A. segments, in this case, the Brca gene, an early detector for breast cancer, was not patentable merely because the scientist isolated it. They came to this holding partly because naturally occurring things act as "basic tools of scientific and technological work" to facilitate innovation. While some remain perturbed that this stops compensation for scientists' groundbreaking discoveries, more are concerned that the bill will allow monopolization in the diagnostic technology industry, only allowing those with a patent to conduct further research, thus stopping competitors from creating cheaper alternatives.

Similarly, while the bill helps inventors overcome the subject matter eligibility obstacle, it does not clearly state what is necessary to clear the §101 hurdle, thus leaving significant room for speculation. Determining how much of a modification, purification, or enrichment is needed will take time and seems to defeat the initial purpose to remove ambiguity.

USPTO's Response

Less than a week after the bill's introduction, the USPTO publicly presented its guidance for subject matter eligibility, restating the necessity to follow Supreme Court rulings concerning the exclusion of abstract ideas in patent eligibility and previous biotech cases. The USPTO further emphasized the importance of understanding the nuances of the Alice-Mayo test, explaining that the first step identifies if the patent claim falls into a judicial exception, such as an abstract idea or natural law. If it does, the second step is to determine if the claims contain additional elements that make it an inventive concept and thus eligible for a patent. 

Conclusion

As the bill progresses through the legislative process, it is necessary to consider both the ambiguity the bill itself works to correct along with the potential ambiguity and consequences the bill itself may have in various industries.

Originally Written August 15, 2022.