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Key Facts
- Federal level: The American Bar Association adopted Resolution 101A in February 2013 to guide its policy on patent-eligible subject matter.
- Federal level: The resolution established the organization’s advocacy framework for an amicus brief in the U.S. Supreme Court case regarding gene patents.
- Federal level: Resolution 101A took the position that patent eligibility under Section 101 should be evaluated independently from novelty and obviousness.
- Federal level: The U.S. Supreme Court subsequently ruled in 2013 that naturally occurring human DNA is a product of nature and cannot be patented.
- Federal level: The Supreme Court held that synthetically created complementary DNA remains patent eligible because it does not occur naturally.
- Federal level: The U.S. Patent and Trademark Office currently uses a multi-step framework to determine if a patent claim is directed to a judicial exception.
- State level: Patent issuance and eligibility standards are governed exclusively by federal law, meaning no state system manages these applications.
- National overview: While federal law controls the validity of a patent, state courts often handle contract disputes involving biotechnology and licensed genetic applications.
Last reviewed: May 2026. Legal rules, forms, deadlines, and procedures can change by jurisdiction, agency, and court system.
In February 2013, the American Bar Association House of Delegates adopted Resolution 101A during its Midyear Meeting. The resolution established the organization’s historical policy position on patent-eligible subject matter under federal law. Specifically, it provided a framework for an amicus curiae brief in the highly anticipated U.S. Supreme Court case, Association for Molecular Pathology v. Myriad Genetics, Inc.
The federal case addressed whether isolated human genes, specifically the BRCA1 and BRCA2 genes associated with an increased risk of breast and ovarian cancer, could be patented under 35 U.S.C. Section 101. The American Bar Association sought to influence how the Supreme Court interpreted the boundaries of federal patent law regarding natural phenomena and abstract ideas.
The Scope of Resolution 101A
Resolution 101A supported the U.S. Court of Appeals for the Federal Circuit’s earlier finding that certain processes involving genetic material could be patent eligible. The resolution articulated two main principles regarding the federal patent statute. First, the organization took the position that questions of patent eligibility under Section 101 of the Patent Act should be evaluated independently from other statutory requirements, such as novelty, non-obviousness, and claim definiteness.
Second, the resolution stated that a claimed process should be considered patent eligible if it involves a specific application of a law of nature, natural phenomenon, or abstract idea. The organization adopted this stance to encourage the Supreme Court to maintain broad eligibility standards for inventions, even if the Court ultimately rejected the patentability of isolated human genes themselves.
The Supreme Court Decision in Myriad Genetics
In June 2013, the U.S. Supreme Court issued its landmark decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. 576). The Court held that a naturally occurring DNA segment is a product of nature and cannot be patented merely because it has been isolated from the surrounding genetic material. The justices concluded that discovering the location of the BRCA1 and BRCA2 genes did not create anything new.
However, the Court also ruled that complementary DNA, which is synthetically created, remains patent eligible because it is distinct from naturally occurring DNA. The decision shifted the biotechnology landscape by invalidating existing federal patents on isolated human genes while preserving protections for synthetic genetic creations.
The Current Federal Patent Framework
The U.S. Patent and Trademark Office continues to evaluate patent applications involving genetic material under the federal guidelines shaped by the Myriad Genetics decision. The federal patent system evaluates applications through a multi-step test to identify claims that are directed to a judicial exception, such as a law of nature.
If a claim involves a judicial exception, federal patent examiners evaluate whether additional elements of the claim provide an inventive concept. While the 2013 resolution represented a historical policy resolution aimed at broader eligibility, current federal guidelines rely heavily on binding judicial precedents that limit the patenting of products of nature.
