The Patent Eligibility Restoration Act (PERA) is a Critically Needed, Balanced Solution for Maintaining U.S. Leadership
U.S. courts have developed an increasingly byzantine framework of judicial exceptions to the inventor rights granted by 35 U.S.C. § 101, thereby rendering a number of creative inventions ineligible for patent protection and causing unnecessary confusion in this area of the law.
Products of Nature Cannot Be Patented
There has never been a time in the United States when it was possible to patent a principle of nature. Congress originally permitted the broad patenting of any machine, manufacture, or composition of matter in the Patent Act of 1793. By 1810 U.S. courts were expressly confirming that these rights had certain limits, in that principles of nature could not be patented.1
Early U.S. Jurisprudence Required Practical Application for Patent Eligibility
In the early 1900’s, the contours of patent-eligibility as it pertained to natural products became further defined, and the consensus in the legal community was that although a principle of nature could not be patented, a practical application of the natural principle was eligible for patenting.2 This was generally agreed to be a reasonable and workable approach.
The Supreme Court Improperly Raised the Bar for Patent Eligibility in Funk Brothers
Unfortunately, all of that changed in 1948 when the Supreme Court decided the Funk Brothers case, finding that the creation of unique bacterial mixture inoculants for leguminous plants was only a discovery of natural phenomena.3 Following this decision, a practical application of a natural principle was no longer sufficient to establish patent-eligibility. Instead, an inventive application of the principle was now required, thus significantly departing from a century of precedent.4 As a result, rather than simply providing a threshold test for whether an invention fell into a particular category of eligible subject matter, 35 U.S.C. § 101 had become conflated with other statutory requirements for patentability such as nonobviousness under 35 U.S.C. § 103. From a historical perspective, it has been observed that Justice Douglas, who authored the Funk Brothers decision, had a notoriously anti-patent bias.5
The Supreme Court’s Error in Funk Brothers has Propagated to Subsequent Decisions
Although the Funk Brothers decision is strongly condemned,6,7 the Supreme Court has continued to rely upon it when deciding patent-eligibility cases where the invention involves a product of nature. For example, in the Myriad case,8 the Supreme Court cited Funk Brothers when finding that an isolated DNA segment is a product of nature and therefore not eligible for patenting under 35 U.S.C. § 101, thus perpetuating this faulty reasoning.
PERA Will Restore Clarity and Predictability for Cases Involving Natural Products
PERA has bipartisan, bicameral support and will restore patent eligibility to certain categories of inventions which are currently considered patent-ineligible, including many inventions that involve natural products. According to PERA, a number of U.S. judges have expressed the need for better guidance with respect to § 101, and other stakeholders in the patent process have found that the interpretation of current § 101 law is extremely confusing and difficult to interpret and apply with any confidence.9
PERA simplifies 35 U.S.C. § 101 by succinctly stating that an unmodified natural material, as that material exists in nature, shall not be eligible for patenting. And importantly, PERA clarifies that a natural material is patent-eligible if it is (a) isolated, purified, enriched, or otherwise altered by human activity, or (B) otherwise employed in a useful invention or discovery.
The Council for Innovation Promotion has published an informational letter further explaining the need for PERA in providing clarity on the patent-eligibility of inventions involving products of nature,10 and the American Intellectual Property Law Association (AIPLA) supports the passage of this bill as well.11
The Time for Congressional Action is Now
According to Article 1, Section 8, Clause 8 of the U.S. Constitution, Congress has the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”
By passing PERA, Congress will foster the development of next-generation technologies involving natural products, and ensure that the U.S. remains a leader in the global patent system.
1 Michael Risch, America’s First Patents, 64 Fla. L. Rev. 1279 (2012) [PDF]
2 Jeffrey A. Lefstin, Inventive Application: A History, 67 Fla. L. Rev. 565 (2015) [PDF]
3 Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) [PDF]
4 See Lefstin
5 Martin J. Adelman et al., Session 8C, Competition and Patent Law Session, U.S. Patent Developments, Fordham University Law School (2019) [PDF]
6 Jared M. Graff, Funk Brothers, Myriad, & Products of Nature: How a Lack of Understanding Scientific Principles is Damaging the Patent System, Southwestern Law Review, Vol 49, Issue 2, 330 (2020) [PDF]
7 Oskar Liivak, Don’t Cite Funk, 72 Cath. U. L. Rev. 43 (2023) [PDF]
8 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) [PDF]
9 S. 2140 – Patent Eligibility Restoration Act of 2023, 118th Congress (2023-2024) [PDF]
10 Myths vs. Facts: The Patent Eligibility Restoration Act (PERA) Diagnostics and Life Sciences [PDF]
11 AIPLA Letter in Support of S. 2140, PERA [PDF]