Sorry you asked? Mayo, Myriad, and the battles over patent-eligibility
Level 5 - mechanism / opinion, no new human data
Expert legal and policy analysis (by design analogy, not clinical CEBM)
OpenAlex W4399401367 · doi:10.1093/jlb/lsae010
What was done
This policy commentary evaluated the consequences of the US Supreme Court rulings in Mayo v. Prometheus (2012) and Myriad v. Association for Molecular Pathology (2013), and analyzed proposed congressional legislation intended to abrogate those decisions by narrowing statutory patent-eligibility exclusions under §101 of the US Patent Act.
What was found
The author notes that multi-gene sequencing supplanted oligo-gene testing as sequencing costs dropped 10,000-fold. No other quantitative figures are reported in the abstract. The paper describes how multiple co-occurring factors—including shifting payer reimbursement practices, prospective FDA regulation, open-access clinical interpretation databases, and the collapse of Theranos—confound attempts to attribute declining venture capital investment in molecular diagnostics solely to patent-eligibility rulings. Re-establishing patent eligibility is argued to shift pressure onto doctrines such as obviousness, enablement, and written description.
Why it matters
The analysis clarifies that economic and investment trends in molecular diagnostics cannot be cleanly isolated to patent jurisprudence given massive contemporaneous shifts in technology, regulation, and market structure.
Limits
The work is a qualitative legal and policy commentary, not a controlled empirical or econometric investigation. No empirical dataset or formal statistical analysis is presented in the abstract.
Cited by
- context Naturally occurring substances made of amino acids cannot be patented.