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Vanda V. West-Ward Pharmaceuticals: Good News For The Patent Eligibility Of Diagnostics And Personalized Medicine, With Some Important Caveats, Christopher M. Holman

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In Mayo v. Prometheus, decided in 2011, the U.S. Supreme Court invalidated patent claims directed towards diagnostic methods useful in the optimization of drug dosage for the needs of an individual patient, i.e., an example of personalized medicine, based on the Court’s determination that the claims were directed towards a patent ineligible law of nature. Notably, the claims in Mayo did not recite a step of applying the information generated by the test, e.g., a step of administering the drug to a patient at the optimized dosage. Some, including this author, have speculated that inclusion of such a step might …