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- Federal patent law is the main framework for questions about DNA patent eligibility
- The Supreme Court addressed isolated DNA and cDNA in the Myriad decision
- The Court’s core holding turned on whether the claimed DNA was a product of nature
- The opinion also described topics that were not decided in the case
- The Supreme Court docket shows that the American Bar Association filed an amicus curiae brief
- Confusion often comes from mixing up scientific discovery and patent eligibility
- Why this topic can feel personal even though the legal issue is technical
- Sources
Key Facts
- Federal level: Patent eligibility in the United States is governed by federal statute, including 35 U.S.C. § 101.
- Federal level: In Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court held that a naturally occurring DNA segment is not patent-eligible merely because it has been isolated.
- Federal level: In the same decision, the Supreme Court held that cDNA can be patent-eligible because it is not naturally occurring in that form.
- Federal level: The Supreme Court decided the Myriad case on June 13, 2013.
- Federal level: The Court emphasized that a discovery can be “groundbreaking” without meeting the separate requirements for patent eligibility.
- Federal level: The Court noted that the case did not involve method claims, patents on new applications of knowledge about the genes, or DNA with an altered nucleotide order.
- Federal level: The Supreme Court docket for case No. 12-398 lists many “amicus curiae” briefs submitted by organizations that were not the named parties.
- Federal level: The Supreme Court docket reflects that an “American Bar Association” amicus curiae brief was filed in the Myriad case.
Federal patent law is the main framework for questions about DNA patent eligibility
In the United States, the starting point for patent eligibility is federal law in Title 35 of the U.S. Code, which describes what types of inventions “may obtain a patent” under 35 U.S.C. § 101.
The Supreme Court addressed isolated DNA and cDNA in the Myriad decision
The Supreme Court’s U.S. Reports opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) drew a key distinction between DNA that occurs in nature and certain lab-created DNA.
The Court’s core holding turned on whether the claimed DNA was a product of nature
In plain terms, the Court said that a naturally occurring DNA segment does not become patent-eligible just because someone isolates it from the human genome, while cDNA may be treated differently because it is created in the laboratory and is not naturally occurring in the same way.
The opinion also described topics that were not decided in the case
According to the Court, the decision did not address method claims, patents on new applications of knowledge about the BRCA genes, or DNA in which the order of naturally occurring nucleotides has been altered.
The Supreme Court docket shows that the American Bar Association filed an amicus curiae brief
The Supreme Court’s official docket for No. 12-398 lists an “American Bar Association” amicus curiae brief among many other amicus curiae filings in the case.
Confusion often comes from mixing up scientific discovery and patent eligibility
One theme in the Court’s reasoning is that discovering the location and sequence of a gene can be scientifically important without automatically meeting the legal standard for patent-eligible subject matter under federal patent law.
Why this topic can feel personal even though the legal issue is technical
Gene-related patents are often discussed alongside medical testing and patient care, but the Myriad decision itself focused on patent eligibility under federal law rather than medical standards, clinical decision-making, or insurance coverage rules.
