Gene Patenting: Are Your Genes Really Yours?
"The landmark Myriad Genetics case changed the game for gene patents. Learn what's patentable, what's not, and how it impacts your health and research."
The discovery of DNA's double-helix structure in 1953 revolutionized medicine, transforming our understanding and treatment of diseases. This breakthrough also ignited a competitive race to patent genetic discoveries, granting companies significant control over their use. However, the question of whether naturally occurring genes should be patentable has sparked considerable debate.
The Supreme Court case Association for Molecular Pathology v. Myriad Genetics, Inc., addressed this very issue. The Court had to decide when a research result, specifically the isolation of genes, could be patented under federal law, thus giving the patent holder the power to control its future applications.
The case centered on Myriad Genetics' patents on the BRCA1 and BRCA2 genes, which are associated with increased risk of breast and ovarian cancer. Myriad had exclusive rights to these genes, impacting research and diagnostic testing. This article explores the complexities of the Myriad case, its legal and scientific background, and its lasting impact on genetic research and patient access.
BRCA Patents and Shared Variant Data
Myriad Genetics filed patent applications covering the locations and sequences of the BRCA1 and BRCA2 breast cancer genes in 1994 and 1995, eventually resulting in seven patents. A public resource called the BRCA Exchange includes data on thousands of inherited variants in those genes. It was created through the BRCA Challenge, a long-term project initiated by the Global Alliance for Genomics and Health to improve sharing of BRCA1 and BRCA2 data. Together, these sources describe both the patent history and a later effort to make variant information broadly available.
Patents, Testing, and Access
A database discussed by ScienceDirect Topics showed DNA patents increasing from 2,722 in 2005 to 4,389 in 2011. The source notes that genes such as BRCA1 and BRCA2 are connected to pathological processes, making patents on human genes more controversial than patents on other human-made products. In BRCA testing, patenting and licensing were associated with a sole-provider business model, while colorectal cancer genetic testing had multiple laboratories. These sources point to concentration of testing provision as a limitation of the patent-based approach.
The BRCA1 & BRCA2 Gene Patent Battle: What Was Myriad's Claim?
In the 1990s, the race to identify genes linked to breast cancer intensified. In 1994, Myriad Genetics "sequenced" BRCA1, determining the order of its nucleotide bases. They secured patents covering the gene itself, specific mutations, and diagnostic tests to identify these mutations.
- Exclusive Control: These patents gave Myriad exclusive rights to conduct diagnostic tests on BRCA1 and BRCA2.
- Impact on Research: Researchers were limited in their ability to study these genes without Myriad's permission.
- Patient Access: Concerns arose about the affordability and accessibility of Myriad's tests.
Corporate Concentration in Marine Gene Patents
A study of corporate control and global governance of marine genetic resources reported that one corporation registered 47% of all marine sequences included in gene patents. That share exceeded the combined 37% registered by 220 other companies. The figures highlight a highly concentrated distribution of registrations in the marine sequences covered by the study.
Bilski and Patent-Eligible Subject Matter
The cited legal review reports that the U.S. Supreme Court issued its decision in *Bilski v. Kappos* on June 28, 2010, at the end of that Court Term. The decision addressed patent-eligible subject matter. The source identifies the case as *Bilski v. Kappos*, 130 S. Ct., but the supplied excerpt does not specify the ruling's detailed reasoning or its direct effect on gene patents.
The Supreme Court's Verdict: A Win for Innovation, but a Loss for Patents on Naturally Occurring Genes
The Supreme Court unanimously ruled that while synthetically created cDNA is patentable, naturally isolated genes are not. Justice Clarence Thomas, writing for the Court, affirmed that patents cannot cover "laws of nature, natural phenomena, and abstract ideas."
Conflicting BRCA Market Forecasts
Market forecasts in the supplied sources differ. Market Research Future projects the BRCA1 and BRCA2 gene market to grow from USD 6.169 billion in 2024 to USD 13.63 billion by 2035, with a 7.47% CAGR during 2025–2035. Emergen Research instead expects a USD 7.2 billion market in 2034 and reports a 9.8% CAGR. Another source describes genetic testing as the dominant test type in the BRCA1 and BRCA2 gene testing market, followed by carrier, predictive, and prenatal testing.
The Civil Rights Challenge to BRCA Patents
In recounting the civil-rights challenge to gene patenting, the Harvard Bill of Health source says advocates selected Myriad Genetics and its BRCA1 and BRCA2 patents after consulting scientific and medical experts. It reports that variants of those genes can elevate a woman’s lifetime risk of breast and ovarian cancer by 8–10 times. The ACLU describes Myriad’s patents as covering the BRCA1 and BRCA2 sequences, mutations along those genes, methods for locating mutations, and correlations between mutations and cancer susceptibility. These claims put control over genetic information and cancer-risk testing at the center of the challenge.
Exclusive Access to BRCA Testing
Duke University’s account says Myriad Genetics used its intellectual property to dominate the American genetic-testing market for BRCA1 and BRCA2, genes associated with inherited susceptibility to breast and ovarian cancers in women and, more rarely, men. Another account reports that Myriad’s patents gave it the exclusive right to perform clinical BRCA testing in the United States and that its BRACAnalysis test was the sole commercially available option for well over a decade. Myriad argued that its patents were needed to recoup its investment in discovering the genes and developing the first diagnostic test. These sources show how patent rights shaped both company control and where patients could obtain testing.
The Court distinguished Myriad's work from true invention. While Myriad discovered the location and sequence of the BRCA1 and BRCA2 genes, the Court determined that merely isolating these genes wasn't enough to warrant patent protection. They cited previous cases to emphasize that even groundbreaking discoveries don't automatically qualify for patents if they involve naturally occurring substances.
The Myriad Genetics decision has had a profound impact, clarifying the boundaries of gene patenting. It promotes innovation by ensuring that basic genetic information remains accessible for research and development, but also protecting investments in truly novel applications like cDNA.