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Examining the Biotechnological Ramifications of the Patent Eligibility Restoration Act

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The Progress Clause, which grants Congress the authority “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,” serves as the constitutional basis for the  intellectual property system in existence today and underpins the establishment of the United  States Patent and Trademark Office. However, not all useful products and processes from  human creation are rewarded a patent. The Supreme Court has indoctrinated over the past 150  years, several exceptions to patentability for inventions that are abstract ideas, laws of nature,  products of nature, or materials isolated from products of nature if those materials behave in the  same way they would in nature. Nevertheless, in June of this year, the Patent Eligibility  Restoration Act of 2023 (“PERA”) was introduced signifying profound shift in the future of  patent eligibility.  

Under the proposed act, 35 U.S.C. §§ 101 would undergo a significant reconstruction  whereby the previously ineligible patent subject matter would now possibly be allowed. The act  introduces two fundamental changes to U.S. patent law. The first provision broadens the  definition of patent-eligible subject matter, stating that any invention or discovery that provides a  specific and practical application should be eligible for a patent. The second provision allows for  patents on inventions related the abstract ideas, laws of nature, or natural phenomena, if they  meet the “inventive concept” rule. In summary, the second provision eliminates all judicial  exceptions to patent eligibility. This holds notable significance as a considerable percentage – ranging from 25% to 75% – of litigated patents are deemed invalid during legal proceedings due to their overly broad scope, encompassing unpatentable subject matter falling within judicial  exceptions.

Under the new §§ 101 (b), the new judicial exceptions include “A 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 . . . Unless isolated, enriched, purified, or otherwise altered  by human activity; or otherwise employed in a useful invention or discovery.” The “human  alteration” rule for inventions pertaining to the human gene would overturn several landmark  U.S. Supreme Court decisions that barred the patenting of human genes.  

In the landmark case Myriad Genetics, the Supreme Court held that naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. Prior to Myriad’s discovery of the precise location and sequence of the BRAC1 and BRAC2  genes, the scientific community did not know which genes were associated with breast cancer. In Myriad’s patent application, it sought to patent a claim on the DNA code that tells a cell to  produce the string of BRAC1 amino acids and a second claim that asserts a patent on the cDNA  nucleotide sequence, which codes for the typical BRAC1 gene. Had the first claim of Myriad’s  patent been found valid, it would give it the exclusive right to isolate and individual’s BRAC1  and BRAC2 genes. However, the Court explained, “isolation is necessary to conduct genetic  testing, and Myriad was not the only entity to offer BRCA testing after it discovered the genes.

The Court explains in its decision to deny the patentability of isolated of DNA that “we  have long held that this provision [of section 101] contains an important implicit exception.  Laws of nature, natural phenomena, and abstract ideas are not patentable. Rather, they are the  basic tools of scientific and technologic work’” that lie beyond the domain of patent protection.

The Court further cautions that “without this exception, there would be considerable danger that  the grant of patents would “tie up” the use of such tools and thereby ‘inhibit future innovation  premised upon them.’ This would be at odds with the very point of patents, which exist to  promote creation. This potential risk materialized in a scenario involving Myriad, where the  company issued letters to an alternative genetic testing laboratory asserting infringement on  Myriad’s patents related to genetic testing for BRCA. In response, the laboratories refused to  accept patient samples, thereby restricting patient access to the diagnosis of breast cancer risk. In  light of the Myriad decision, the Supreme Court granted other diagnostic companies the ability to  offer such tests without fear of infringement lawsuits. Consequently, the Patent Eligibility  Restoration Act (PERA) may introduce changes that, if prohibiting the use of isolated genetic  information for research purposes, could potentially impede scientific research and innovation. 

In response to the mounting criticism of their bill’s potential impact on patenting human  genes and basic research discoveries, Senators Coons and Tillis clarified their intentions during a  series of patent reform hearings. Senator coons underscored that their proposed changes were  not meant to overturn restrictions, particularly the 2013 Myriad decision, which prohibits the  patenting of genes as they naturally exist in the human body. Despite this clarification, witnesses  at the hearings presented differing interpretations, expressing concerns about the bill’s language  potentially permitting broad scientific research to be patented inadvertently. Charles Duan, a  patent policy researcher, argued that the proposed text might inadvertently facilitate the patenting  of “pure scientific research.” Senator Tillis assured that the bill’s provisions on the “usefulness”  of inventions were designed to prevent the patenting of naturally occurring genes or fundamental laws of nature. He further indicated a willingness to revise the language for clarity based on  input from legal scholars and other stakeholders. 

The European Patent Convention has historically permitted patents for isolated genes and  other biological samples. Thus, proponents of the bill argue that the United States’ prohibition  against patents for isolated genes puts the United States at a competitive disadvantage. One main  distinction between the current proposed PERA and the National Patent Acts of the European  Union is the research and experimental use exemptions from patent infringement. Additionally,  the European Directive stipulates that inventions are considered unpatentable “if their  commercial exploitation would be contrary to public order or morality.” This includes processes  such as cloning human beings, modifying the human germline, or genetically altering animals in  ways likely to cause them suffering without substantial medical benefit to humans or animals, as  well as animals resulting from such processes. These provisions play a vital role in cultivating a  competitive biotech market that promotes responsible innovation while supporting research and  development in line with societal values. 

The inclusion of research and experimental use exemptions in the European Directive is  essential to prevent situations such as to the one encountered by Myriad. Notably, Myriad made a  groundbreaking discovery related to breast cancer by mapping out genes associated with  BRACA. However, the subsequent monopoly on the use of these genes could hinder broader  progress in the field. The exemptions act as a safeguard against such monopolies. Should Myriad  be allowed to patent the claim on the DNA code containing BRCA, no other scientist could build  and grow breast cancer research. In essence, the exemptions not only prevent monopolistic control over critical genetic information, but also encourage a collaborative ecosystem where  breakthroughs can be shared and built upon.  

In conclusion, the evolution of patent eligibility, as reflected in the proposed Patent  Eligibility Restoration Act (PERA) and international frameworks like the European Patent  Convention, highlights the delicate balance between incentivizing innovation and preventing  undue monopolies. While PERA aims to redefine patent-eligible subject matter in the United  States, particularly in the context of genes and biological samples, the provisions raise concerns  about unintentional implications for scientific research. The historical backdrop, illustrated by  the Myriad case, emphasizes the potential pitfalls of exclusive rights over genetic information.  The European Directive’s incorporation of research and experimental use exemptions serves as a  valuable precedent, demonstrating a commitment to fostering a competitive biotech market that  aligns with ethical considerations and societal values. As the legislative landscape continues to  evolve, the challenge lies in striking a balance that encourages innovation while safeguarding  against impediments to broader scientific progress. The ongoing dialogue, as evidenced by  Senator Coons and Tillis’ hearings, underscores the importance of clarity in language to prevent  unintended consequences and ensure a regulatory environment that nurtures both innovation and  collaboration in the biotech industry.

1) U.S. Cons)tu)on, Ar)cle 1, Sec)on 8, Clause 8.  

2) Lori Andrews, The “Progress Clause”: An Empirical Analysis Based on the Cons)tu)onal Founda)on of Patent Law

3) hGps://www.crowell.com/en/insights/client-alerts/patent-eligibility-restora)on-act-of-2023what-in-house-counsel-need-to-know

4) Associa’on for Molecular Pathology v. Myriad Gene’cs, Inc., 569 U.S. 576 (2013)

5) hGps://www.science.org/content/ar)cle/controversial-us-bill-would-liV-supreme-court-ban-paten)ng-human genes#:~:text=A%20congressional%20proposal%20that%20would,scien)fic%20socie)es%20and%20pa)ent%20advocates.

6) Mehlman et al. Gene,cs: Ethics, Law and Policy. Fi:h Edi,on.