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Key Facts
- Federal level: 35 U.S.C. § 101 permits patents on “process, machine, manufacture, or composition of matter” (or improvements) for inventions that are “new and useful,” subject to the conditions and requirements of Title 35.
- Federal level: In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held that a naturally occurring DNA segment is not patent eligible merely because it has been isolated, while cDNA can be patent eligible because it is not naturally occurring.
- Federal level: The Myriad Court stated that Myriad did not create or alter genetic information and that the claims focus on the genetic information encoded rather than chemical composition changes from isolation.
- Federal level: The Myriad decision emphasized that the case does not involve method claims and does not decide the patentability of DNA where the order of the naturally occurring nucleotides has been altered.
- Federal level: In Mayo Collaborative Services v. Prometheus Laboratories, the Supreme Court held that more than stating a law of nature and adding “apply it” is required, and the claim must limit the law to a particular inventive application.
- Federal level: USPTO guidance in MPEP 2106 describes an eligibility analysis that asks whether the claim falls within one of the four statutory categories and whether the claim adds limitations amounting to “significantly more” than a judicial exception.
- National overview: Federal law governs patent eligibility under 35 U.S.C. § 101, while state law may address separate genetics policy topics that do not change the federal eligibility standard; this varies by state.
Last reviewed: May 2026. Legal rules, forms, deadlines, and procedures can change by jurisdiction, agency, and court system.
- What 35 U.S.C. § 101 covers in gene patenting
- The Myriad decision separated naturally occurring DNA from non naturally occurring cDNA
- Mayo explained why adding “apply it” often does not supply eligibility
- How the USPTO applies these holdings through MPEP 2106
- The 2019 PEG reshaped Step 2A and the “directed to” inquiry
- Earlier interim guidance and supersession statements
- A compact comparison of the core rules that drive gene patenting disputes
- Policy and ethical debates alongside the legal framework
- Sources
Gene patenting disputes often turn on federal patent law’s subject matter eligibility rules under 35 U.S.C. § 101, where claims must fit within statutory categories and avoid judicial exceptions such as “products of nature.” Public debates about gene patents frequently connect to how courts and the USPTO apply those standards to naturally occurring genetic material versus non-naturally occurring genetic constructs.
What 35 U.S.C. § 101 covers in gene patenting
Federal patent law permits patents on certain types of inventions, but it limits eligibility through 35 U.S.C. § 101’s structure, including the “subject to the conditions and requirements of this title” language. The statute provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101 is the starting point for evaluating whether DNA- and gene-related claims begin in an eligible statutory category and whether they run into judicial exceptions.
The Myriad decision separated naturally occurring DNA from non naturally occurring cDNA
In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held that a naturally occurring DNA segment is not patent eligible merely because it has been isolated. By contrast, the Court held that cDNA can be patent eligible because it is not naturally occurring. The opinion also described the reasoning for focusing on genetic information in the claim analysis, stating that Myriad did not create or alter genetic information and that the claims were “simply not expressed in terms of chemical composition,” focusing instead on the genetic information encoded.
The Court also described limits on the scope of the decision, stating that the case “does not involve method claims” and that it does not decide “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Those stated boundaries matter because many gene-patenting arguments turn on how a claim is framed and what features it recites within or outside those limits.
Mayo explained why adding “apply it” often does not supply eligibility
Gene-related eligibility disputes also fit within the broader § 101 approach reflected in Mayo’s treatment of laws of nature. In Mayo Collaborative Services v. Prometheus Laboratories, the Supreme Court held that to transform an unpatentable law of nature into a patent-eligible application, a patent must do more than “simply state the law of nature while adding the words ‘apply it.’” The Court required limiting language that confines the claimed application to a “particular, inventive application of the law.”
Mayo’s syllabus-level discussion also illustrates why some additional claim steps may be treated as insufficient for eligibility: it described components of the claims as simply identifying relevant actors, telling a professional about natural laws, and measuring metabolite levels through “well known” processes, rather than adding an inventive limitation that meaningfully transforms the nature-based relationship into a patent-eligible application.
How the USPTO applies these holdings through MPEP 2106
The USPTO summarizes its subject matter eligibility examination approach in MPEP 2106, which translates Supreme Court doctrine into a structured evaluation. MPEP 2106 describes two criteria for subject matter eligibility: first, the claimed invention must fall into one of the four statutory categories under § 101; second, the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to “significantly more” than the exception.
MPEP 2106 also describes “products of nature” as part of the judicial exception inquiry and explains a “markedly different characteristics analysis” that compares the claimed nature-based product to its closest naturally occurring counterpart in its natural state. This comparison concept helps explain why the Myriad DNA-versus-cDNA distinction often drives examination discussions, because the analysis focuses on whether the claimed nature-based product differs in relevant characteristics from what occurs in nature.
The 2019 PEG reshaped Step 2A and the “directed to” inquiry
USPTO practice updates after Myriad and Mayo include the 2019 Revised Patent Subject Matter Eligibility Guidance. The USPTO states that it revises Step 2A into a two-prong inquiry focused on whether a judicial exception is integrated into a practical application of the exception, and that a claim is not “directed to” a judicial exception unless it satisfies that two-prong inquiry. The 2019 PEG also states that it supersedes portions of earlier USPTO materials, including MPEP 2106.04(II) and earlier abstract-idea quick reference materials.
Earlier interim guidance and supersession statements
In December 2014, the USPTO issued interim guidance with a stated supersession effect. The 2014 Interim Guidance on Patent Subject Matter Eligibility memo states that the guidance supersedes the prior Mayo/Myriad guidance issued March 4, 2014 and supplements Alice Corp. examination instructions, while providing an eligibility analysis procedure for claims requiring that evaluation.
A compact comparison of the core rules that drive gene patenting disputes
| Control point | What the source emphasized | How it affects DNA- and gene-related eligibility framing |
|---|---|---|
| Myriad (DNA vs. cDNA) | Naturally occurring DNA is not eligible merely due to isolation; cDNA can be eligible because it is not naturally occurring | Examining claims often centers on whether the claimed DNA is framed as naturally occurring versus a non-naturally occurring construct |
| Mayo (laws of nature and “apply it”) | Claims must do more than state a law of nature and add “apply it,” and they must limit to a particular inventive application | Additional claim language that functions as routine instruction or well-known measurement may be treated as insufficient |
| USPTO (MPEP 2106 and 2019 PEG) | The eligibility workflow uses statutory categories plus judicial exception logic, including “significantly more” and integration into a practical application | Examining procedures apply judicial exception concepts to nature-based products and use structured “directed to” analysis |
Policy and ethical debates alongside the legal framework
Public discussions sometimes connect gene patent eligibility standards to broader policy questions in genetics, including concerns about how genetic technology affects privacy and other interests. For a separate look at privacy concerns raised by genetic technology, see privacy concerns raised by genetic technology.
A common confusion is treating Myriad as a blanket rule about all gene inventions. The Supreme Court’s stated limitations—“does not involve method claims” and does not decide certain altered-nucleotide scenarios—mean that gene-related eligibility disputes often turn on claim structure and how USPTO eligibility procedures apply the judicial exception logic to the specific claim elements.
