On This Day in Health: June 13, 2013
On June 13, 2013, the U.S. Supreme Court in Washington, D.C., ruled that naturally occurring DNA could not become patent-eligible simply because it had been isolated. The case, Association for Molecular Pathology v. Myriad Genetics, centered on patents involving the BRCA1 and BRCA2 genes and carried direct consequences for genetic testing. Justice Clarence Thomas delivered the opinion, and all nine justices agreed on the judgment. The decision separated the discovery of genetic information found in nature from the creation of a patentable invention. For patients and laboratories, that distinction mattered because testing for harmful BRCA changes could help assess inherited risks of breast and ovarian cancer.
BRCA1 and BRCA2 normally help protect cells through roles in repairing damaged DNA. Certain inherited changes can raise cancer risk, making laboratory testing useful in appropriate families. A harmful result does not establish that cancer is inevitable, and interpreting a test can require specialist counseling. Myriad had identified the genes' precise locations and sequences and obtained patents that supported its exclusive position in testing. The challengers, including medical and research organizations, questioned whether a company could hold such rights over naturally occurring genetic material. The dispute reached the Supreme Court after conflicting lower-court decisions about whether removing DNA from its surrounding chromosome made it sufficiently different to qualify for patent protection.
The Court concluded that isolation alone did not turn a natural DNA segment into an invention. At the same time, it distinguished complementary DNA, or cDNA, which is synthesized and generally omits the intervening regions present in genomic DNA. The opinion held that cDNA could be patent-eligible because it was not naturally occurring in the same way, while recognizing a qualification for very short sequences. Patent eligibility was only the threshold question; it did not guarantee that any particular claim satisfied every other patent requirement. The ruling also did not decide every possible patent issue involving genes, laboratory methods or altered genetic sequences. Its boundaries were narrower and more precise than a general prohibition on biotechnology patents.
The immediate effect was to remove the challenged natural-DNA claims as a barrier to other laboratories working with the BRCA sequences. That did not automatically make every test affordable, ensure insurance coverage or eliminate the difficulties of interpreting uncertain variants. The quality and meaning of a result still depended on clinical evidence and careful communication. The longer significance of the decision lies in how it helped define the conditions under which genomic medicine could develop. Information about inherited cancer risk was becoming increasingly useful in care, and the Court drew an important boundary between discovering that information and inventing something new. The anniversary therefore belongs to health history as well as legal history: it shaped access to the tools used to understand cancer susceptibility.
BRCA1 and BRCA2 have normal roles in DNA repair. Harmful inherited variants can increase cancer risk without making a future cancer certain.
The lawsuit challenged patents on isolated genetic material after disagreements in the lower courts about whether isolation created an invention.
The Court rejected patent eligibility for naturally occurring DNA based merely on isolation, while drawing a distinction for synthesized cDNA.
Eligibility is only one patent requirement. The decision did not invalidate every biotechnology patent or settle every laboratory-method claim.
The ruling reduced a patent barrier to laboratories working with the BRCA sequences, linking intellectual-property rules to genetic testing.
Price, insurance coverage, laboratory quality and interpretation remained separate questions after the decision; removing a patent did not resolve them automatically.
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