By: Bianca Moazez. Bianca Moazez is a 1L at the Sandra Day O’Connor College of Law at Arizona State University, with a strong interest in law, science, and innovation. She is a Law, Science, and Innovation (LSI) Center Scholar. She serves as a 1L Representative for the Law and Science Student Association (LASSA), an Admissions Student Representative, and a Barbri 1L Representative, engaging with her peers about legal education resources. Bianca is passionate about the intersection of law, technology, and scientific innovation, exploring how emerging advancements shape legal frameworks and policies. In addition to her interest in intellectual property, she possesses a deep passion for writing, whether analyzing legal and societal issues or expressing herself through poetry.
Introduction
The American intellectual property system can be traced to England’s Statute of Monopolies, enacted in 1623.¹ This law limited the monarchy’s power, allowing patents only for useful inventions that could benefit society, with a maximum duration of fourteen years.² In the United States, Congress derived its authority to legislate on patents and copyrights through the IP Clause of the Constitution.³ Over time, the United States Patent and Trademark Office established specific criteria to determine what constitutes patentable subject matter.⁴
Under 35 U.S.C. § 101, a patentable invention must serve a useful function and fall in an approved subject matter, which includes any new and useful process, machine, manufacture, or composition of matter.⁵ However, exceptions exist, such as physical phenomena, abstract ideas, and laws of nature.6 More recently, the USPTO started granting gene patents, which gave patent holders exclusive rights to control the use of specific genes in clinical testing and research. This practice led to widespread debate over the ethical and practical implications of such control.
The Myriad Case
The Supreme Court case Association for Molecular Pathology v. Myriad Genetics, Inc. addressed a fundamental question in patent law: Can human genes be patented?7 The case involved Myriad Genetics, Inc., which discovered the precise location and DNA sequence of the BRCA1 and BRCA2 genes.8 Mutations in these genes significantly increase a woman’s risk of developing breast and ovarian cancer.9 Recognizing the significance of these mutations, Myriad developed diagnostic tests to detect them.10 The company subsequently obtained several patents related to its discoveries, including patents that granted it exclusive rights to isolate these genes and another patent covering the synthetic creation of complementary DNA—a form of DNA that contains only the gene’s exons and is generated in a laboratory.11
By securing these patents, Myriad effectively controlled the ability to isolate an individual’s BRCA genes for testing and create BRCA cDNA, restricting other laboratories from offering similar testing services.12 Concerned that these patents inhibited scientific research and limited patient access to diagnostic testing, a coalition of medical organizations, researchers, and patients led by the Association for Molecular Pathology (AMP) filed a lawsuit to challenge Myriad’s patents.13 The plaintiffs argued that Myriad’s patents were invalid under 35 U.S.C. § 101, asserting that isolated DNA and cDNA were products of nature and, therefore, not patentable.14
The Myriad Decision
In its 2013 ruling, the United States Supreme Court invalidated Myriad’s patents on isolated DNA, holding that naturally occurring genetic sequences are products of nature and thus ineligible for patent protection under § 101.15 However, the Court upheld the patentability of cDNA, reasoning that it is synthetically created and does not naturally occur in the human body.16
This decision significantly narrowed the scope of what could be patented, particularly regarding genetic materials.17 By affirming that naturally occurring DNA sequences cannot be patented, the decision expanded access to genetic testing and led to further innovation. However, by allowing cDNA patents, the Court maintained incentives for biotechnology companies to develop synthetic genetic technologies. This ruling continues to shape intellectual property law, ensuring a delicate balance between encouraging innovation and preserving public access to genetic information.
Legal Developments Following Myriad
One of the earliest cases to grapple with Myriad was In re Roslin Institute.18 The United States Court of Appeals for the Federal Circuit ruled that cloned animals are not patentable because they are identical to naturally occurring animals and, therefore, constitute products of nature.19 The court’s reasoning mirrored the principles established in Myriad, reaffirming that mere replication or isolation of natural phenomena does not meet the requirements for patent eligibility under 35 U.S.C. § 101.20
Another critical development arose in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC.21 Here, the Federal Circuit ruled that certain diagnostic methods for detecting autoimmune diseases were not patentable because they were based on a natural biological process and did not include enough new or innovative features.22 Although Athena did not directly address DNA, it extended Myriad’s logic to the broader field of biotechnology, tightening restrictions on patent claims involving natural phenomena.23
Legislative efforts have also sought to challenge the boundaries established by Myriad. In 2022, a controversial bill proposed lifting the ban on gene patenting, aiming to allow companies to claim patents on naturally occurring genetic sequences under specific circumstances.24 Although the bill failed to pass, it underscored ongoing tensions between fostering innovation and ensuring public access to genetic information.25
Conclusion
The Supreme Court’s ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. was a watershed moment that fundamentally reshaped the biotechnology industry. Previously, companies like Myriad Genetics held monopolistic control over gene testing markets, restricting other entities from offering similar testing services. This decision had profound implications for business strategies, innovation, and competition within the sector by limiting the scope of what could be patented. The Myriad ruling significantly lowered entry barriers for smaller biotechnology firms and startups by invalidating patents on naturally occurring DNA sequences.
Post-Myriad, the biotechnology landscape underwent a significant shift. Companies such as 23andMe and Ancestry.com thrived in this open market, offering direct-to-consumer genetic testing at competitive prices. This shift democratized access to genetic testing and spurred innovation as companies explored novel ways to deliver genetic insights. The Myriad ruling has left an everlasting mark on biotechnology, intellectual property law, and public discourse. While the decision addressed key issues in patent law, its broader implications continue to evolve, shaping the future of genetic research and biotechnology innovation.
1 History and Sources of Intellectual Property Law, LawShelf Educational Media, https://www.lawshelf.com/coursewarecontentview/history-and-sources-of-intellectual-property-law.
2 Id.
3 U.S. Const. art. I, § 8, cl. 8.
4 U.S. Patent & Trademark Office, Patent Subject Matter Eligibility (2018), https://www.uspto.gov/web/offices/pac/mpep/s2106.html.
5 35 U.S.C. § 101 (2012).
6 Id.
7 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013).
8 Id. at 583.
9 Id. at 584–85.
10 Id. at 595.
11 Id. at 587.
12 Id. at 586.
13 Id. at 589.
14 Id. at 590.
15 Id. at 594–95.
16 Id. at 596.
17 Id. at 598.
18 In re Roslin Inst. (Edinburgh), 750 F.3d 1333, 1335 (Fed. Cir. 2014).
19 Id. at 1337–38.
20 Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333, 1337 (Fed. Cir. 2019).
21 Id. at 1340–41.
21 Id. at 1343.
23 Kelly Servick, Controversial U.S. Bill Would Lift Supreme Court Ban on Patenting Human Genes, Science (June 4, 2019), https://www.science.org/content/article/controversial-u-s-bill-would-lift-supreme-court-ban-patenting-human-genes.
24 Id.
25 Id.