Written by Andrew Costa, Law Clerk at ND Galli Law
Under Section 101 of the Patent Act, only inventions that are a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof,” are what is commonly referred to as “patent eligible.” Though only one sentence, especially as interpreted by the United States Supreme Court and the US Court of Appeals for the Federal Circuit over the last decade, Section 101 is an extremely important barrier to patentability. On August 3, 2022, North Carolina Senator Thom Tillis introduced the Patent Eligibility Restoration Act of 2022 (“Restoration Act”) which would greatly change the existing statute. If passed, the Restoration Act would expand Section 101 by adding numerous additional requirements, as well as a list of exceptions to eligibility and rules for interpretation, all in an effort to provide more clarity and predictability to the patent system.
As Sen. Tillis explained in a press release, the Restoration Act derives from concerns that “our current Supreme Court’s patent eligibility jurisprudence is undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations.” Sen. Tillis refrains from saying directly, three Supreme Court decisions have shaped patent eligibility jurisprudence over the past decade: Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013), Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012) and Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014). In Myriad, the Supreme Court held that a naturally occurring DNA segment was not patent eligible under § 101 merely because it has been isolated. In Mayo, the Supreme Court held that a natural phenomenon must be “sufficiently” transformed or added upon to make an abstract idea patentable. Finally, in Alice, the Supreme Court, relying on Mayo held that the implementation of an abstract idea through the generic use of a computer is not a sufficient transformation of the idea to support patent protection, i.e. a software that executes a method is generally not patentable. These decisions, along with the Federal Circuit’s glosses on them, have led to an ambiguous standard for eligibility and numerous inventions in the life sciences and technology arts being deemed patent ineligible and patents declared invalid. Since the purpose of patents is to fuel innovation and scientific advancement, being unable to reliably obtain a patent for many types of inventions such as medical diagnostic testing and software has led many to be concerned about the future of innovation in America.
Tillis’s proposal attempts to remedy this result; however, as discussed further below, the Restoration Act itself introduces new ambiguities into the statute. It thus remains to be seen whether Senator Tillis’s proposal will allay confusion and add needed certainty, thus driving innovation, or simply add new and different text with which courts will wrestle.
Clarity for Life Science Inventions §§ 101(b)(1)(B)-(D) and (b)(2)(B)
Senator Tillis’ proposal specifically carves out two key provisions to directly address life science inventions. First, the bill provides a list of categorically excluded subject matter. The new §§ 101(b)(1)(B)-(D), proscribe patentability for “any process” that “occurs in nature wholly independent of, and prior to, any human activity; . . . An unmodified human gene, as that gene exists in the human body . . . [or] An unmodified natural material, as that material exists in nature.” (emphasis added). Secondly, in § 101(b)(2)(B), the bill explains that human genes or natural materials that are “isolated, purified, enriched, or otherwise altered by human activity or that is otherwise employed in a useful invention or discovery, shall not be considered unmodified” (emphasis added).
When read together, these provisions seem to overrule Myriad and Mayo, and open the door for inventors in the life sciences to patent isolated gene sequences and modified organic compounds, which were previously considered unpatentable, or at least help such inventions survive a § 101 challenge. For example, under Tillis’ proposal, the isolated DNA at issue in Myriad could survive a § 101 challenge because the statute specifies isolated human genes are not unmodified. Thus the isolated DNA would not be excluded from patent protection under the new § 101. This outcome would realign patent law closer to the prior Supreme Court precedent in Diamond v. Chakrabarty, 447 U.S. 303 (1980) where the Supreme Court affirmed that a manufactured microorganism can be patentable subject matter as a “new or useful manufacture or composition of matter.” Considering recent events like the COVID-19 pandemic, the growing use of mRNA vaccines (like the Pfizer-BioNTech and Moderna Vaccines) and the growing use of gene therapy to treat cancer, these new provisions may provide added certainty of protection necessary to spur greater innovation in the life sciences, especially in the growing cell and gene therapy sector.
“Certain Processes” Condition for Technology § 101(b)(2)(A)
Another important provision in the proposed statute is the somewhat tortured provision, § 101(b)(2)(A), relating to “Certain Processes.” This section provides that a process invention that is “a non-technological economic, financial, business, social, cultural, or artistic process . . . if . . . embodied in a machine or manufacture,” would be patentable unless that invention “is recited in a patent claim that does not integrate, beyond merely storing and executing, the steps of the process that the machine or manufacture perform[s].” What this provision means for software patents is entirely unclear. As one inventor has asked, “what if the storing and execution process steps embodied in a machine or manufacture improves the machine or manufacture?” Another commentator believes this provision would require the Supreme Court’s decision in Alice to at least come into question, if not be clearly overruled. If the proposal becomes law without further clarifying revision, this will likely be a question for future courts to resolve.
However, regardless of whether the Patent Eligibility Restoration Act of 2022 is ultimately held to overrule Alice, the proposed legislation does not define “technological” nor provide any guidance concerning what “non-technological” means within the context of this section. This uncertainty could result in even less protection for future technological innovations than today. Given the importance of § 101(b)(2)(A) to technology inventions, it is likely that this section will be modified during the legislative process to address these concerns.
Interpretation Guidance § 101(c)
Interestingly, the final section of the Patent Eligibility Restoration Act of 2022 would provide guidelines courts must follow when interpreting § 101. Specifically, the proposal would require eligibility to be determined “(B) without regard to (i) the manner in which the claimed invention was made; (ii) whether a claim element is known, conventional, routine, or naturally occurring; (iii) the state of the applicable art, as of the date on which the claimed invention is invented; or (iv) any other consideration in section 102, 103, or 112 [i.e., novelty, nonobviousness, written description or enablement].” This is a major departure from the framework of Mayo where the Court had to first determine whether the methods at issue were well known in the art, and then proceed to determine if the invention sufficiently transformed those methods so as to be patentable. Mayo, 132 S.Ct. 1289, 1297-1298 (2012). Similarly, these restrictions would impact an analysis of software and business method patents under Alice, because a court must first determine whether a claim was directed at an abstract idea, and then whether the claim possessed enough of an inventive concept to transform that idea into a new or useful invention. Alice, 134 S. Ct. 2347, 2355 (2014). If the proposal passes, it is hard to imagine these analyses remaining the same if a court cannot consider whether, for example, an invention is known, conventional, routine or naturally occurring in assessing the inventive step.
The Patent Eligibility Restoration Act of 2022 presents many (possibly welcome) changes to § 101 that seek to clarify patent eligibility, help more inventors get patents and spur innovation. Though not without its own ambiguities, perhaps this is the type of change necessary to give inventors greater confidence in the validity and value of patents in the life sciences and technology sectors, and thus more willing to invest time and money in developing their inventions.