Personalized medicine relies on diagnostics to analyze a patient
for individualized therapy and for monitoring a patient's
health status. Some diagnostic tests use natural products, for
example gene sequences, either as the target of the diagnostic test
or as a tool to identify a genetic trait or anomaly. Personalized
medicine also may rely on the analysis and management of large data
sets using computer processes and analytics to identify
correlations between a therapy and an individual's genetic or
clinical markers.
The U.S. Supreme Court's recent decisions regarding
patent-eligibility (Ass'n for Molecular Pathology v. Myriad
Genetics, Inc., 133 S. Ct. 2107 (2013)
("Myriad") and Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)
("Mayo") and to a lesser extent Alice Corp.
Pty. Ltd. v. CLS Bank Intl, 134 S. Ct. 2347 (2014)
("Alice"), have challenged the personalized
medicine and pharmaceutical industries by limiting patent
protection for