A major discovery and a separate patent question
Association for Molecular Pathology v. Myriad Genetics concerned claims covering material associated with the BRCA1 and BRCA2 genes. The Supreme Court decided the case on 13 June 2013. The central distinction was between isolated naturally occurring DNA and complementary DNA, or cDNA. The Court did not equate the effort involved in discovery with creating patent-eligible subject matter. [1]
Editorial inference: the case is especially useful for research teams because it requires a change of perspective. An account of a scientific achievement explains what has been learned about the world. A proposed claim must additionally identify the product or activity over which exclusivity is sought. These questions are connected but not interchangeable.
What the Court actually decided
A naturally occurring DNA segment does not become patent-eligible under US § 101 merely through isolation. By contrast, cDNA could pass that threshold because it was not the same product of nature. The Court noted an exception for very short sequences that may be indistinguishable from natural DNA and left other requirements for patentability undecided. [1]
The Court did not rule generally on every application of genetic knowledge, methods of studying genes or DNA with an altered nucleotide order. The judgment therefore cannot accurately be reduced to either “genetics cannot be patented” or “synthetic DNA always receives a patent.” [1]
How the judgment affected the patent office
On the day of the judgment, the USPTO issued a memorandum to examiners. It instructed them to reject product claims directed solely to naturally occurring nucleic acids or their fragments, whether isolated or not, as ineligible. The document distinguished claims clearly limited to non-naturally occurring material and announced further guidance. It records the Office’s response in 2013 rather than providing a complete description of today’s procedure. [2]
Comparative method: the claimed subject matter and its natural counterpart
The USPTO’s MPEP § 2106 describes an analysis of characteristics that markedly distinguish a product from its natural counterpart. Comparison may address structure, function or other properties. Human production alone is insufficient. The starting point is the claim considered as a whole, while eligibility under § 101 remains separate from novelty, non-obviousness and disclosure requirements. [3]
Methodological proposal: prepare a three-column table identifying the claimed characteristic, its natural counterpart and evidence of the difference. Record separately whether the difference actually appears in the claim. An experiment may concern only one variant; broad wording should not automatically inherit the full evidential force of that result.
Lessons for commercializing research
Editorial inference: a discussion of biotechnology protection can begin by separating observations, engineered products, procedures and specific applications. For each element, check the jurisdiction, possible claim scope and evidential basis separately. This is a way of organizing a project, not an assurance that every category can obtain protection.
A second inference concerns communication between scientists and those assessing patent law. Both need the same material but answer different questions. The researcher explains the experiment and the significance of a difference. The legal analysis examines whether the requested exclusivity corresponds to that difference and satisfies the relevant criteria. Describing both perspectives carefully helps prevent assertions of scientific breakthrough from replacing arguments.
This study does not decide the position in Poland or the European patent system. A comparison between systems must establish the applicable legal basis and claim wording afresh. The US outcome offers a reference point for framing questions, not an answer about every right connected with genetic research.
Documentation proposal: record sample identifiers, sequence versions and the sources of reference data. When comparing results from different laboratories, note differences in material preparation. This information makes the comparison reviewable; it does not replace the legal test or an assessment of the reliability of the results.
Lessons from the analysis
- Separate a discovery’s scientific value from the legal assessment of a claim.
- Compare claimed characteristics with the appropriate natural counterpart.
- Passing patent eligibility does not decide whether other requirements are met.
Limits of interpretation
The judgment concerns § 101 of the US Patent Act and particular claims. The 2013 USPTO memorandum is cited historically. The proposed tables and working steps are editorial commentary, not findings of the Court.
Sources and further reading
- 1Association for Molecular Pathology v. Myriad Genetics, Inc. — official reports ↗
12-398; 569 U.S. 576–596 (2013)
Primary source: United States Reports, volume 569, pp. 576–596; reasoning and boundaries of the holding.
- 2USPTO — memorandum following Myriad ↗
Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 13.06.2013
Historical preliminary instructions to examiners, issued on the date of the judgment.
- 3USPTO — Manual of Patent Examining Procedure ↗
MPEP § 2106; § 2106.04(c)
Official guidance on patent eligibility and comparison of characteristics of nature-based products; checked 16 October 2026.