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ARTICLE · 09 SEPTEMBER 2014

Federal Circuit Frames Test For Patent-Eligibility

Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status.

United StatesIntellectual Property

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

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