Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics
Level 5 - mechanism / opinion, no new human data
Level 5 by design analogy; this is a narrative legal analysis with no empirical clinical data.
OpenAlex W2147001242 · doi:10.1093/jlb/lsu007
What was done
The author analyzed the legal history, rulings, and commercial consequences of the 2013 US Supreme Court decision in *Association for Molecular Pathology v. Myriad Genetics Inc.*, tracing the dispute across the Federal District Court, Federal Circuit, and Supreme Court regarding patent eligibility under 35 U.S.C. § 101 for isolated genomic DNA (gDNA), complementary DNA (cDNA), and diagnostic screening methods.
What was found
The Supreme Court unanimously ruled that isolated naturally occurring gDNA is an unpatentable product of nature, whereas synthetic cDNA remains patent-eligible. The ruling left intact Federal Circuit decisions invalidating mutation-analysis method claims while upholding drug-screening method claims. As a commercial consequence, Myriad leveraged its proprietary sequence database (with a 3% rate of variants of unknown significance compared to 20% for competitors), highlighting a shift toward trade secrecy.
Why it matters
The paper outlines the boundary between unpatentable natural biological sequences and patent-eligible synthetic DNA in the United States, illustrating how diagnostic companies adapt to lost patent protections through proprietary data holdings.
Limits
This is a legal commentary and case analysis rather than an empirical scientific or quantitative study. It evaluates a single judicial controversy and relies on descriptive industry figures presented without formal statistical evaluation.
Cited by
- supports In 2013, the US Supreme Court ruled in the Myriad Genetics case that naturally occurring human genes (BRCA1 and BRCA2) cannot be patented.