As the debate around PERA continues, it’s clear that any changes to Section 101 will have significant impacts on innovation, research, and the patent landscape as a whole.
The landscape of patent eligibility in the United States has been a topic of heated debate for years, particularly in the realms of biotechnology, software, and medical diagnostics. The Patent Eligibility Restoration Act (PERA), recently introduced in Congress, aims to address some of the controversies surrounding 35 U.S.C. § 101 and potentially reshape how we determine patent eligibility.
Key Provisions of PERA
The proposed legislation seeks to clarify and broaden what constitutes patent-eligible subject matter. Some of the key provisions include:
1. Addressing Natural Materials: PERA explicitly states that “unmodified natural material, as that material exists in nature” is not patentable. However, it provides exceptions for isolated, purified, enriched, or otherwise altered natural materials.
2. Human Genes: The Act specifies that human genes and natural materials may be patentable if they are “isolated, purified, enriched, or otherwise altered by human activity” or “employed in a useful invention or discovery.”
3. Holistic Consideration: PERA mandates that patent eligibility should be determined by considering the claimed invention as a whole, without discounting or disregarding any claim elements.
4. Removing Certain Considerations: The Act proposes that eligibility should be determined without regard to:
– The manner in which the invention was made
– Whether claim elements are known, conventional, routine, or naturally occurring
– The state of the applicable art at the time of invention
Potential Impacts
If enacted, PERA could have far-reaching implications for patent law and innovation:
1. Biotechnology and Pharmaceuticals: The Act’s provisions regarding natural materials and human genes could open new avenues for patenting in these fields, potentially spurring increased research and development.
2. Diagnostic Methods: By focusing on the invention as a whole and removing considerations of conventionality, PERA might make it easier to patent diagnostic methods that have faced eligibility challenges in recent years.
3. Software and Business Methods: The emphasis on considering inventions as a whole could potentially broaden eligibility for software and business method patents, areas that have faced scrutiny under current jurisprudence.
4. Shift in Patent Examination: The proposed changes would likely require a significant shift in how patent examiners approach eligibility determinations, potentially streamlining the process but also requiring extensive training and guideline updates.
Historical Context
The proposed changes in PERA echo some historical approaches to patent eligibility. For instance, the Act’s focus on utility and technical effect harkens back to earlier interpretations of patent law, such as the landmark decision in Parke-Davis & Co. v. H.K. Mulford Co. (1911), where Judge Learned Hand emphasized the practical utility of a purified natural substance (adrenaline) in finding it patent-eligible.
Challenges and Considerations
While PERA aims to provide clarity, it also raises new questions:
1. How will courts interpret terms like “isolated” or “purified” in the context of natural materials?
2. How will the USPTO implement these changes in examination procedures?
3. Could broadening eligibility lead to an increase in patent thickets or hinder innovation in certain fields?
As the debate around PERA continues, it’s clear that any changes to Section 101 will have significant impacts on innovation, research, and the patent landscape as a whole. Stakeholders across industries should closely monitor the progress of this legislation and consider its potential effects on their patent strategies.
At Allen, Dyer, Doppelt + Gilchrist, P.A., we’re closely following these developments and are prepared to guide our clients through any changes in patent eligibility law. As always, we recommend consulting with experienced patent counsel to navigate the complex and evolving landscape of patent eligibility.
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