Are human genes patentable under Section 101?

No. Naturally occurring DNA segments are products of nature and are not patent-eligible under Section 101.

cDNA can be patent-eligible because it is not naturally occurring; it is an exons-only molecule created in the lab.

Did isolating a gene make it patentable?

No. Isolation alone does not create a new composition; the information content of the gene remains a natural phenomenon.

What did Myriad actually claim?

Claims covered BRCA1/BRCA2 DNA sequences and related methods. The natural DNA claims failed; cDNA composition could qualify.

Why is this case important for diagnostics?

It opened research and testing by keeping natural genes unpatentable while allowing protection for lab-made cDNA constructs.

Association of Molecular Pathology v. Myriad Genetics, Inc.

Association of Molecular Pathology v. Myriad Genetics, Inc. (2013)

A classroom-style guide to gene patenting: why natural DNA is not patentable under Section 101, and why cDNA may qualify.

U.S. Supreme Court 2013 — 569 U.S. 576 Patent Law ~6 min read

gene patenting Section 101 cDNA

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Quick Summary

The Supreme Court said: natural DNA segments are not patentable because they are products of nature. Simply finding and isolating a gene does not make it an invention. But cDNA (lab-made, exons-only DNA) does not exist in nature and can be patent-eligible. Myriad’s claims to natural BRCA1/BRCA2 sequences failed; cDNA composition could qualify under Section 101.

Issues

Are isolated human gene sequences patent-eligible under Section 101?
Do Myriad’s claims to BRCA1/BRCA2 DNA and cDNA fit within patentable “composition of matter”?

Rules

35 U.S.C. §101: Patents cover processes, machines, manufactures, or compositions of matter that are new and useful.
Product of Nature: Natural phenomena and laws of nature are not patent-eligible.
cDNA Exception: A lab-created exons-only molecule, not occurring in nature, may be eligible.

Citation: Association of Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

Facts (Timeline)

Patents Filed: Myriad secures patents on BRCA1/BRCA2 sequences and related uses.

Medical Link: BRCA genes are tied to higher risks of breast and ovarian cancer.

Lawsuit: Association for Molecular Pathology challenges the patents as covering natural gene sequences.

Key Dispute: Is isolated DNA a human-made invention or a product of nature?

Supreme Court: Natural DNA not patent-eligible; cDNA may be.

Timeline visual for Myriad Genetics gene patent case

Arguments

Petitioners

Natural gene sequences are products of nature.
Isolating a gene does not make a new composition.
Patents would block research and testing.

Respondents (Myriad)

Isolation and sequencing required skill and effort.
Claims cover isolated DNA and cDNA.
Patents incentivize innovation in diagnostics.

Gavel and DNA helix symbolizing Supreme Court decision on gene patents

Judgment

The Court held that naturally occurring DNA is not patent-eligible under §101. Discovering the precise location and sequence of a gene is an important scientific achievement, but it does not create a new composition of matter. However, cDNA is patent-eligible because it is not naturally occurring; it is an engineered, exons-only construct.

Ratio

Section 101 excludes products of nature. Isolation does not transform a natural gene into an invention. cDNA, being lab-made and different in structure from natural DNA, may pass §101.

Why It Matters

Protects access to natural genetic information for research and testing.
Still allows patents on engineered DNA like cDNA.
Sets a clear line between discovery and invention in biotech.

Key Takeaways

Natural DNA ≠ patent-eligible.
cDNA may be eligible.
Discovery ≠ invention under §101.

Focus on human-made change.
Diagnostics landscape opened.
Balanced innovation & access.

Mnemonic + 3-Step Hook

Mnemonic: “NATURE? NO. cDNA? GO.”

Spot the Subject: Natural gene vs engineered DNA.
Ask §101: Product of nature barred?
Check Creation: Lab-made change (cDNA) may pass.

IRAC

Issue	Rule	Application	Conclusion
Are isolated genes and cDNA patent-eligible under §101?	§101; product-of-nature exception; eligibility requires human-made invention.	Isolated BRCA DNA remains natural information; cDNA is engineered and not naturally occurring.	Natural DNA claims fail; cDNA composition claims may qualify.

Glossary

Section 101: Defines what kinds of inventions are patent-eligible in the U.S.
Product of Nature: A natural phenomenon excluded from patent protection.
cDNA: Complementary DNA made in a lab; typically lacks introns and can be patent-eligible.