Patent Eligibility Restoration Act
On August 3, 2022, North Carolina Senator Thom Tillis (R) introduced the Patent Eligibility Restoration Act of 2022, which aims to address challenges in the intellectual property space, such as patent eligibility standards, inconsistent case decisions, and further define what exactly can be patented. Tillis believes this bill will provide Americans with clear and predictable patent laws, resulting in more technology-based innovation.
Later, on September 28, 2022, at an event celebrating the Council for Innovation Promotion (C4IP) launch, Delaware Senator Chris Coons (D) announced he would be co-sponsoring the bill, giving it the bipartisan support it likely needs to pass through Congress. Depending on the outcome of November’s midterm elections, one of the senators co-sponsoring this bill will take over as Chair of the Senate Judiciary Subcommittee on Intellectual Property in January. The committee is currently chaired by Vermont Senator Patrick Leahy (D), who will resign from the Senate after the current term. With this bill likely to become law in the coming months, it’s imperative to look deeper into what it proposes.
This legislation would overhaul two landmark Supreme Court decisions related to intellectual property, Mayo Collaborative v Prometheus Labs and Association for Molecular Pathology v Myriad Genetics. Mayo v Prometheus was fought over two patents relating to the use of thiopurine medicines in the treatment of autoimmune diseases. When consumed by patients, these medications are metabolized by the body, resulting in some number of metabolites being introduced to the bloodstream. Because people metabolize these medications differently, resulting in different concentrations of metabolites, doctors had difficulty determining proper dosages. Prometheus’s patents outlined testing methods that produced a proper dose based on biological reactions they had researched. In March 2012, the US Supreme Court ruled that the patents were invalid under 35 U.S.C.S. § 101, meaning that a patent cannot solely apply a law of nature, as this would monopolize a correlation that exists for all, and that a patent must have an inventive application to be valid. Association for Molecular Pathology v Myriad Genetics involved patents that determined the position and sequence of genes related to an increased risk for certain cancers, as well as synthetic portions of DNA sequences. In June 2013, the Supreme Court ruled that human genes cannot be patented because they are a product of nature. The court ruled there was no inventive process for discovering a gene.
If the Patent Eligibility Restoration Act of 2022 passes, these rulings will no longer be relevant. The first change proposed by this bill relates to patent eligibility for 35 U.S.C.S. § 101. If passed, it would prevent patents from being issued for claims that are mathematical formulas, unmodified human genes, unmodified natural material, and processes that are economical, financial, entrepreneurial, social, cultural, artistic, mental, or occurring naturally independent of human activities.
The bill also provides clarity in the form of "eligibility exclusions," noting that Section 101's wide provisions are subject "only to" the exclusions mentioned above. In addition, the bill's first draft would make a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity patent eligible, overturning the decision from Molecular Pathology v Myriad Genetics. This proposed change is intended to usher in a new era of research and development for companies in fields that have a strong incentive to innovate in gene modifications, such as pharmaceuticals and agriculture. Protection over modified genes can help agriculture companies make crops more resistant to changing environments. Genetic research companies would be incentivized to increase spending on researching new gene therapies and improving medicines such as mRNA vaccines and cancer treatments. The protection provided by this bill would help to create stronger and more valuable IP assets for many US companies.
A second change proposed by this bill relates to patent eligibility for 35 U.S.C.S. § 100. If passed, it would modify section (A), subsection (b), which would define the term ‘useful’ as “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.” It would also define the term process as “process, art or method, and could include a use, application, or method of manufacture of a known or naturally occurring process, the machine, manufacture, the composition of matter, or material.” While the concrete impact of these changes in language can be challenging to gauge, IP professionals who focus on patent development will likely feel this burden. Changes in language mean that patent applications will have to be altered to fit this language to increase the chances of the patent being granted.
While the bill is subject to change as it passes through Congress, it is likely to be passed with its newfound bipartisan support. This bill has been met with both praise and criticism in the IP community, as its potential impacts have many people questioning what will happen upon its passing.
Author
Editorial Team at Lumenci
Through Lumenci blogs and reports, we share important highlights from the latest technological advancements and provide an in-depth understanding of their Intellectual Property (IP). Our goal is to showcase the significance of IP in the ever-evolving world of technology.