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#natural-gene-isolation-barConstitutional BarSynthetic Biology, Genetics & Bio-Jurisprudence
Read on Primary Statutory Source

Isolated Natural DNA Patentability Prohibition

Statutory Hook: 35 U.S.C. § 101 (Product of Nature Doctrine)

The definitive Supreme Court rule holding that naturally occurring DNA sequences (such as BRCA1/BRCA2) are unpatentable products of nature, whereas synthetic cDNA remains eligible.

Doctrinal Framework & Legal Mechanics

In Association for Molecular Pathology v. Myriad Genetics (2013), the Supreme Court unanimously held that isolating a naturally occurring segment of DNA from the human genome is not an inventive act. Because the genetic information sequence is dictated by nature, it remains an unpatentable product of nature under 35 U.S.C. § 101. By contrast, synthetic cDNA (complementary DNA omitting introns) is human-made and eligible for patent protection.

Benchmark Precedents (1)
Leading judicial decisions governing this sub-discipline

AMP v. Myriad Genetics

Decided / Filed (2013)
Engineering & Architecture Compliance Advisory
Draft synthetic biology patent claims strictly directed toward recombinant cDNA, synthetic vector backbones, modified enzyme formulations, or targeted therapeutic delivery mechanisms rather than native genomic sequence reads.
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