Diagnostics Patentsin the Crosshairs For medical diagnostic companies, the Prometheus decision pote

Diagnostics Patentsin the Crosshairs
For medical diagnostic companies, the Prometheus decision potentially has far-reaching consequences. The Supreme Court’s decision could be used to invalidate broad patent claims and spur the renegotiation of royalties on licensed patents. In addition, the Prometheus decision could accelerate new developments in medical diagnostics if broad blocking patents are deemed invalid and removed as obstacles.

The patent claims in Prometheus were directed to diagnostic methods for determining patient-specific dosage of a drug. The Supreme Court’s decision likely will have wide implications for all companies attempting to develop assays for personalized medicine based on correlations between biomarkers and pathologies. In addition to methods for optimizing therapeutic efficacy of a drug, the Prometheus decision is likely to make it difficult to secure patent claims to diagnostic methods to determine a propensity of a patient to develop a disease based on the presence or absence of a genetic marker associated with the disease, as well as methods to diagnose a disease based on the presence of an abnormal level of a biomarker associated with the disease. Not being able to obtain patent protection for this innovative technology may have a chilling effect on commercialization of diagnostic assays that form the basis for personalized medicine.