There’s a reason Congress doesn’t want people to patent nature---it decreases innovation.

Abstract: The subject matter eligibility doctrine initially existed as a means of limiting the scope of an inventor’s patent claim. Over the past decade, the Supreme Court has broadened the scope of the doctrine to invalidate patents that effectively recite a claim for processes or products that exist in nature. These recent decisions have led to confusion over what inventions qualify as patent eligible under 35 U.S.C. § 101. The Federal Circuit and commentators have implored the legislature to weigh in on the issue and establish clearer guidance for what constitutes patentable subject matter. Two proposed bills introduced in the House and Senate seek to clarify the doctrine by allowing for patents to be granted more broadly to inventions that incorporate biological materials and other routine scientific practices. This Note argues that neither proposed law adequately addresses the underlying policy concerns left unaddressed by the Supreme Court in their recent decisions regarding the patentability of biological materials and processes. Rather than adopt either proposed law, Congress should draft an exclusionary rule for patent eligibility that precludes inventors from claiming a genetic sequence that exists in nature within their patent claim. Such a rule would impose a necessary limit to the scope of patent claims that reinforces the original goals of the subject matter eligibility doctrine.

INTRODUCTION Interest in the biotechnology (“biotech”) industry has continually grown in recent years due to the rapid development of therapeutics spurred by the COVID-19 pandemic.1 The biotech industry relies heavily on patent protection for the development of their therapeutics because of the number of regulatory hurdles pharmaceutical companies must overcome for federal approval.2 The importance of patents has led to inventors spending millions of dollars to pro- 1 See Annalee Armstrong, 10 Ways COVID-19 Rocked Biotech—Plus an Honorable Mention for Omicron, FIERCE BIOTECH (Apr. 4, 2022), https://www.fiercebiotech.com/special-reports/how-covid19-rocked-biotech [https://perma.cc/6JXR-GWFK] (explaining that the pandemic spurred the biotech industry to invest in and quickly develop therapeutics for COVID-19). 2 See Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L.REV. 1575, 1580, 1581–82 (2003) (noting that the biotech industry relies on patents to protect investment in new developments). 726 Boston College Law Review [Vol. 65:725 tect and enforce their patent rights.3 For example, Moderna continues to battle with other companies over the full patent rights to mRNA vaccines for COVID-19.4 Sales of the COVID-19 vaccine generated over thirty billion dollars in revenue for Pfizer in 2022 alone, creating an incentive for companies to dispute the rights over the vaccine.5 Unlike mechanical inventions, new drugs and therapeutics in the biotech industry rely on products of nature, such as DNA and proteins.6 DNA exists in all living organisms, including human beings, and acts as a code that directs cells to build proteins.7 DNA consists of nucleotides, or four unique building blocks that can be arranged into different sequences.8 Specific DNA sequences, known as genes, dictate different attributes about a person, ranging from a person’s physical appearance to their susceptibility to certain diseases.9 Living 3 See Carly Klein, The Complications Around Patenting Biotechnology, LABIOTECH (Oct. 5, 2020), https://www.labiotech.eu/in-depth/biotechnology-patents-intellectual-property/ [https://perma. cc/TX6X-QQQR] (highlighting that over ten million dollars has been spent in the ongoing dispute over patent rights to CRISPR technology). 4 See Aparajita Lath, COVID-19 Vaccine Patent Infringement? The Battle Between Moderna and Pfizer/BioNTech Continues, BILL OF HEALTH (Jan. 12, 2023), https://blog.petrieflom.law.harvard.edu/ 2023/01/12/covid-vaccine-patents-moderna-pfizer-biontech/ [https://perma.cc/R8HM-TFCJ] (summarizing the ongoing infringement claims and defenses in Moderna’s lawsuits over their COVID-19 patents). Because Moderna pledged not to enforce its patent rights for the duration of the pandemic, various biotech companies argue that Moderna cannot renege on their promise. See id. (highlighting that Moderna pledged not to enforce their patents). 5 See Spencer Kimball, The Covid Pandemic Drives Pfizer’s 2022 Revenue to a Record $100 Billion, CNBC (Jan. 31, 2023), https://www.cnbc.com/2023/01/31/the-covid-pandemic-drives-pfizers2022-revenue-to-a-record-100-billion.html [https://perma.cc/FM76-A7M7] (noting that Pfizer generated billions of dollars in revenue from the COVID-19 vaccine); see also Leroy Leo, Moderna Meets

Forecast with $18.4 Billion in COVID Vaccine Sales in 2022, REUTERS (Jan. 9, 2023), https://www. nasdaq.com/articles/moderna-meets-forecast-with-$18.4-billion-in-covid-vaccine-sales-in-2022 [https://perma.cc/WFT5-YD95] (highlighting that the COVID-19 vaccine generated nearly twenty billion dollars in revenue for Moderna). 6 See Suliman Khan et al., Role of Recombinant DNA Technology to Improve Life, INT’L J. GENOMICS, Dec. 8, 2016, at 2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178364/pdf/IJG2016- 2405954.pdf [https://perma.cc/YAJ7-2BDV] (explaining that recombinant DNA plays an integral role in the development of therapeutics for combatting human disease); Benjamin Leader, Quentin J. Baca & David E. Golan, Protein Therapeutics: A Summary and Pharmacological Classification, 7 NATURE REVS. DRUG DISCOVERY 21, 21 (2008) (acknowledging the high volume of protein-based therapeutics and their advantages over genetic treatments). 7 See DNA and Disease, GARVAN INST. MED. RSCH., https://www.garvan.org.au/research/ kinghorn-centre-for-clinical-genomics/learn-about-genomics/dna-base/dna-and-disease [https://perma. cc/Y4PN-Q9CJ] (explaining the function of DNA in living organisms); Rachel Rettner, What Is DNA?, LIVE SCI.(Mar. 17, 2023), https://www.livescience.com/37247-dna.html [https://perma.cc/R7EH-FDSU] (explaining the basic structure of DNA and noting that all living organisms rely on DNA). 8 See Rettner, supra note 7 (noting that nucleotides serve as the building blocks of DNA and thus all genetic code). A similarly structured molecule, RNA, also exists in living organisms as a shortlived copy of a specific sequence of DNA. See id. (explaining that RNA molecules copy the DNA sequence to then direct the cell to generate proteins). 9 See DNA and Disease, supra note 7 (explaining that each person has a genome, or a DNA sequence, that affects their appearance); Odatha W. Kotagama, Chanika D. Jayasinghe & Thelma 2024] Legislative Solutions to Patentable Subject Matter 727 things also contain proteins, a vast array of molecules that carry out various functions on a cellular level.10

Recent developments in biotechnology, such as the discovery of CRISPRCas9’s ability to directly edit a DNA sequence, open the door to new therapeutics for combatting disease.11 The discovery that CRISPR technology could directly edit human genes led to extensive litigation between the pioneers of the technique over ownership of the patent rights.12 Throughout the course of the near decade-long battle for patent rights, no party has brought a challenge to the eligibility of CRISPR for patent protection.13 Recent Supreme Court Abeysinghe, Era of Genomic Medicine: A Narrative Review on CRISPR Technology as a Potential Therapeutic Tool for Human Diseases, BIOMED RSCH. INT’L, Oct. 7, 2019, at 1, https://doi.org/10. 1155/2019/1369682 [https://perma.cc/24NR-QPBJ] (highlighting that many known diseases originate from mutations to genes within the human genome). 10 See Nathan Ahlgren, What Is a Protein? A Biologist Explains, CONVERSATION (Jan. 13, 2021), https://theconversation.com/what-is-a-protein-a-biologist-explains-152870 [https://perma.cc/PPD3- YV6L] (observing that proteins carry out a vast number of roles in organisms, such as upholding the structure of a person’s body). Genes code for the structure of different proteins by using smaller molecules known as amino acids. See Rettner, supra note 7 (explaining the process by which RNA and amino acids create proteins). 11 See Kotagama et al., supra note 9, at 5–6, 7, 9 (explaining that research into gene editing with CRISPR-Cas9 enabled researchers to determine potential therapeutic treatments for sickle cell anemia as well as the elimination of breast cancer cells). CRISPR refers to “clustered regularly interspaced short palindromic repeats,” short sequences of DNA in an organism that enable a cellular protein to remove short sections of the organism’s DNA. See Daphne Ng, A Brief History of CRISPR-Cas9 Genome-Editing Tools, BITESIZE BIO (Nov. 10, 2023), https://bitesizebio.com/47927/history-crispr/ [https://perma.cc/5AFM-6WHL] (stating that CRISPR sequences appear naturally in bacteria and enable the organism to remove short sequences of DNA once infected by a virus). Scientists have developed a way of incorporating CRISPR into human DNA and using bacterial proteins to correct mutations in human genes. See Martin Jinek et al., A Programmable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity, 337 SCIENCE 816, 820 (2012) (demonstrating that a strand of RNA, that contains a copy of an organism’s genetic information, can program the Cas9 protein using CRISPR sequences edited into the RNA to modify an organism’s genomic sequence). The scientists who first discovered how bacterial proteins could edit DNA sequences earned a Nobel Prize for their work. Heidi Ledford & Ewen Callaway, Pioneers of Revolutionary CRISPR Gene Editing Win Chemistry Nobel, 586 NATURE 346, 346 (2020). 12 See Heidi Ledford, Major CRISPR Patent Decision Won’t End Tangled Dispute, 603NATURE 373, 373 (2022) (noting the extensive litigation battle over the licensing rights to CRISPR and technology associated with gene-editing). 13 See Deborah Ku, The Patentability of the CRISPR-Cas9 Genome Editing Tool, 16CHI.-KENT J. INTELL. PROP. 408, 422 (2017) (noting that no issues under 35 U.S.C. § 101 arose before federal courts regarding CRISPR patents). Challenges made as to the validity of patents within the field of biotechnology undermine the security of licensing agreements between the patent holder and other companies. See Jon Cohen, New CRISPR Patent Hearing Continues High-Stakes Legal Battle, SCIENCE (Feb. 4, 2022), https://www.science.org/content/article/new-crispr-patent-hearing-continueshigh-stakes-legal-battle [https://perma.cc/V9WQ-ZBBD] (acknowledging that companies with licensing arrangements will sustain losses if the patent underlying these arrangements become invalid); see also Information About Licensing CRISPR Systems, Including For Clinical Use, BROAD INST., https:// www.broadinstitute.org/partnerships/office-strategic-alliances-and-partnering/information-aboutlicensing-crispr-genome-edi [https://perma.cc/9YK2-LHKR] (stating that the Broad Institute intends 728 Boston College Law Review [Vol. 65:725 decisions regarding the eligibility of DNA-based therapeutics have threatened the validity of patents that incorporate genes and other naturally occurring materials into their claims.14 CRISPR technology’s reliance on proteins and cellular materials found in nature threaten the technique’s eligibility for patent protection.15

For a patent application to be successful, the applicant must demonstrate that the claimed invention does not merely embody a natural phenomenon or discovery, but instead applies or embodies that naturally occurring element in a process or device.16 Although many developments in biotechnology utilize discoveries of naturally occurring processes in cells and other living organisms to develop useful products, these developments run the risk of failing to satisfy eligibility requirements.17 The current requirements for subject matter eligibility have drawn criticism from members of the biotech and life sciences industry because they exclude many of these new technologies.18 Unlike other pa- to negotiate exclusive licenses for its CRISPR patents with companies that seek to develop human therapeutics). 14 See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013) (determining that a patent for naturally occurring products like DNA cannot be valid); see also Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66, 72 (2012) (stating that mere application of natural laws, such as ideal concentration of therapeutic drugs, do not satisfy subject matter eligibility requirements). The Supreme Court decisions regarding the eligibility of genetic patent claims raise concerns regarding the validity of patents encompassing genetic elements. See Christopher W. Genheimer, A Myriad of Solutions? A Guide for Biotech Companies in Response to the Myriad & Mayo

Decisions, 7 ELON L. REV. 431, 431 (2015) (stating that the patent eligibility requirements eliminate protection for developments in genetics such as diagnostic testing). 15 See Klein, supra note 3 (explaining that biotechnology that reflects a discovery in nature and not a manmade creation may fail to satisfy the requirements for patent protection). A decision invalidating the patents for CRISPR technology would undermine years of litigation establishing who first invented the technology, litigation that the parties have spent over ten million dollars on. See id. (observing that millions of dollars have been spent over the ownership rights of CRISPR patents). But see Ku, supra note 13, at 436 (arguing that the structural differences in the cellular components of CRISPR applied to humans should satisfy the threshold question of eligibility). 16 See Mayo, 569 U.S. at 71 (stating that a claimed patent involving naturally occurring elements must apply the element in some manner for subject matter eligibility); see also 35 U.S.C. § 101 (imposing a requirement that a patent only covers an invention or discovery of a “process. . . or composition of matter”). 17 See Kotagama et al., supra note 9, at 2 (highlighting that various bacteria utilize CRISPR without human interferences); Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 751 (Fed. Cir.) (affirming that a method for detecting antibodies to test for underlying diseases fails to satisfy patent requirements for subject matter eligibility), reh’g denied, 927 F.3d 1333 (Fed. Cir. 2019) (en banc). Public response to the Supreme Court’s decisions regarding subject matter eligibility for patents highlights the impact the decisions have had on the life sciences. See U.S. PAT. & TRADEMARK OFF., PATENT ELIGIBLE SUBJECT MATTER: REPORT ON VIEWS AND RECOMMENDATIONS FROM THE PUBLIC 34–35 (2017), https://www.uspto.gov/sites/default/files/documents/101-Report_ FINAL.pdf [https://perma.cc/9DMB-2SA8] [hereinafter PTO RESPONSE TO PUBLIC] (observing that subject matter eligibility requirements affect the life sciences because of the subject’s close link to natural phenomena). 18 See PTO RESPONSE TO PUBLIC, supra note 17, at 35 (noting that individuals from various biotechnology companies expressed “especially strong” criticism of the subject matter eligibility re- 2024] Legislative Solutions to Patentable Subject Matter 729 tent requirements, the legislature has yet to weigh in on the scope of the eligibility requirements.19

In response to the backlash arising from the subject matter eligibility requirements, members of Congress have begun working toward legislative solutions to the concerns over biotechnology patents.20 House Representative Thomas Massie introduced to the 117th Congress the Restoring America’s Leadership in Innovation Act of 2021 (RALIA), which seeks to expand patent eligibility by replacing the current framework for analyzing patentable subject matter with a single statutory rule.21 Senator Thom Tillis introduced the Patent Eligibility Restoration Act (PERA) of 2022 to address uncertainty over eligibility of various discoveries and inventions for patent protection.22 PERA would amend 35 U.S.C. § 101 to directly address what “useful process” or “composition of matter” remains eligible for a patent by creating a list of excluded processes and materials.23 In 2023, Senators Tillis and Chris Coons reintroduced PERA with slight changes to the language of the eligibility exclu- quirements for patents). Circuit judges have also expressed frustration with the lack of clarity on how to apply the Supreme Court’s framework and encouraged Congress to adopt new legislation defining the outer bounds of subject matter eligibility. See, e.g., Athena 927 F.3d at 1337 (Hughes, J., concurring) (expressing that necessary distinctions between patents for natural laws and inventions should come from Congress); id. at 1363 (Moore, J., dissenting) (expressing that current subject matter eligibility rules prevent diagnostic tests from patent protection despite the statute permitting such protection).19 See infra notes 33–34 and accompanying text (explaining that subject matter eligibility does not exist as a statutory requirement, but instead as a limitation imposed by the Supreme Court). 20 See Malathi Nayak, Tillis, Coons Vet Patent Eligibility Bill Principles with Stakeholders, BL (Mar. 26, 2019), https://news.bloomberglaw.com/ip-law/tillis-coons-vet-patent-eligibility-bill-principleswith-stakeholders [https://perma.cc/274F-6J5N] (reporting that Senators Chris Coons and Thom Tillis convened with members of the pharmaceutical industry to discuss legislative changes to patent eligibility requirements); Press Release, Thom Tillis, Tillis Introduces Landmark Legislation to Restore American Innovation (Aug. 3, 2022), https://www.tillis.senate.gov/2022/8/tillis-introduces-landmarklegislation-to-restore-american-innovation [https://perma.cc/7YP8-VH28] [hereinafter Tillis Press Release] (announcing that Senator Tillis introduced legislation to propose a list of ineligible subject matter for patent protection). 21 See Press Release, Thomas Massie, Massie Introduces Patent Reform Legislation Restoring “First to Invent” Protection to Inventors (Nov. 5, 2021), https://massie.house.gov/news/documentsingle.aspx? DocumentID=395411 [https://perma.cc/86Y5-76CM] [hereinafter Massie Press Release] (announcing the introduction of RALIA to the House of Representatives); KEVIN J. HICKEY,CONG.RSCH. SERV., R45918, PATENT-ELIGIBLE SUBJECT MATTER REFORM:BACKGROUND AND ISSUES FOR CONGRESS 40 (2022) (explaining that RALIA abrogates Section 101 jurisprudence of the Supreme Court). RALIA also reverses the change to a first to invent system of granting patents adopted by the America Invents Act. Massie Press Release, supra. 22 See Tillis Press Release, supra note 20 (stating that the Senate received PERA for consideration).23 See Patent Eligibility Restoration Act of 2022, S. 4734, 117th Cong. § 2 (2022) (amending the text of 35 USC § 101 to grant patents for any “useful process” or “composition of matter” except those subject to a list of exclusions added to the code). 730 Boston College Law Review [Vol. 65:725 sions.24 Either PERA or RALIA would effectively supersede the framework adopted by the Supreme Court for addressing eligible subject matter, but each bill approaches this change in a different manner.25 This Note argues that legislative action must be taken to clarify the uncertainty surrounding patentable subject matter, and that although PERA better addresses the main concerns with the eligibility requirement than RALIA, any legislative bill must also clearly establish that genes and nucleotide sequences cannot receive patent protection.26

Part I of this Note explores the history of the subject matter eligibility doctrine following the Supreme Court’s reexamination of Section 101 and assesses the impact of these decisions on patents for biotechnology.27 Part II addresses both RALIA and PERA amendments to Section 101, as well as their efforts to provide greater guidance to the life sciences industry for patenting technologies that utilize natural biological products.28 Part III suggests that PERA takes necessary steps to clarify subject matter eligibility of biological products, but requires further revisions to properly define what biological materials should remain excluded from patent claims.29