Patents and Proprietary Assays

摘要: Gene patents have been highly controversial in clinical diagnostics. Proponents claim that these promote gene discovery and encourage the production of novel diagnostic tests. Opponents argue are unnecessary for discovery, they raise costs, decrease patient access, harm innovation field molecular pathology. In two recent Supreme Court cases, Mayo v. Prometheus Association Molecular Pathology Myriad Genetics, ruled biological correlations human DNA sequences represent natural laws cannot be patented. These cases appear to eliminated patent-based monopolization testing mutations genes genotype–phenotype relationships, will help facilitate introduction large-scale sequencing into practice. The has thereby encouraged advancement, development, implementation personalized medicine.