DNA strand with gavel, representing the intersection of genetics and law.

Gene Patenting: Are Your Genes Really Yours?

Soraya Malik in Law & Justice December 2025 • 4 min read.

"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.

The BRCA1 & BRCA2 Gene Patent Battle: What Was Myriad's Claim?

DNA strand with gavel, representing the intersection of genetics and law.

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.

Myriad also created a synthetic form of BRCA1 called cDNA, containing only the gene's "working parts" involved in protein synthesis. As they raced to sequence BRCA2, they obtained patents for this gene as well, along with its mutations and related diagnostic tests.

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.

The patents Myriad held significantly influenced the landscape of breast cancer research and testing. Their exclusive rights became a point of contention, ultimately leading to legal challenges.

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."

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.

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Everything You Need To Know

What was the main issue in the Myriad Genetics case?

The Supreme Court case *Association for Molecular Pathology v. Myriad Genetics* determined the patentability of genes. The central issue was whether naturally occurring genes, once isolated, could be patented under federal law. Myriad Genetics had patents on the BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancer risk. The Supreme Court ultimately decided that naturally isolated genes are not patentable, while synthetically created cDNA is. This decision directly impacted how gene research and diagnostic testing are conducted.

What did Myriad Genetics claim regarding the BRCA1 and BRCA2 genes?

Myriad Genetics claimed patents on the BRCA1 and BRCA2 genes, their specific mutations, and diagnostic tests. They "sequenced" the BRCA1 gene in 1994, identifying the order of its nucleotide bases, and later sequenced BRCA2. The patents gave Myriad Genetics exclusive rights to conduct diagnostic tests, limiting other researchers' ability to study the genes. This exclusive control raised concerns about test affordability and accessibility for patients. The case highlights the importance of intellectual property rights in the context of biotechnology and its potential impacts on research and patient care.

What did the Supreme Court decide about gene patenting?

The Supreme Court's decision in the *Association for Molecular Pathology v. Myriad Genetics* case ruled that naturally isolated genes cannot be patented. This ruling means that a company cannot obtain a patent simply for isolating a gene from the human body. However, the Court stated that synthetically created cDNA, which contains only the gene's functional parts, is patentable. This distinction is crucial because it balances the interests of encouraging innovation with the principle that naturally occurring phenomena should not be exclusively controlled. The decision has significant implications for the future of genetic research and the development of diagnostic tests.

How did the Myriad Genetics case impact healthcare and research?

The Myriad Genetics case has a profound impact on both healthcare and research. Before the Supreme Court's ruling, Myriad Genetics had exclusive rights to the BRCA1 and BRCA2 genes. This gave them control over diagnostic testing and research related to these genes. The inability of other labs to perform tests on these genes had implications on access to testing and possibly on the cost of testing. The ruling ensures that researchers have greater freedom to study naturally occurring genes without fear of patent infringement. As a result, competition and innovation in the field of genetic testing are likely to increase, which could lead to improved patient care and more affordable testing options. The distinction between patentable cDNA and unpatentable naturally occurring genes is critical.

Why was the discovery of DNA's structure significant to the issue of gene patenting?

In 1953, the discovery of the double-helix structure of DNA fundamentally changed medicine, transforming our understanding and treatment of diseases. The double-helix revelation sparked intense competition to patent genetic discoveries. Patenting granted companies control over their use, leading to the Supreme Court case of *Association for Molecular Pathology v. Myriad Genetics*. This case specifically dealt with patenting the BRCA1 and BRCA2 genes. The Supreme Court's ruling was a landmark event in the field of genetic research, opening the door to further innovation by clarifying what is patentable and what is not, particularly in regard to naturally occurring genes versus synthetic cDNA.