IP Alerts

IP Alert
IP Alert: U.S. Supreme Court to Decide Patent Eligibility of Drug Dosage and Diagnostic Claims

June 22, 2011

On June 20, 2011, the U.S. Supreme Court granted a writ of certiorari accepting an appeal from the Court of Appeals for the Federal Circuit in Mayo Collaborative Services (D/B/A Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc. The Mayo case concerns the scope of patent-eligible subject matter under the patent statute 35 U.S.C. 101. The patent claims at issue pertain to a “method of optimizing therapeutic efficacy,” in which the pharmaceutical dosage administered to a patient may be adjusted after determining the concentration of a specified metabolite in that patient. The Court will decide whether claims of this nature are eligible for patent protection.

The Court’s ruling on the scope of patent-eligible subject matter is expected to affect patents directed to medical diagnostics and personalized medicine. Depending on the scope of the ruling, the Court’s decision might also affect patent claims in other areas, such as a claim to a manufacturing process that involves monitoring the process to determine whether to adjust the process.

Fitch Even attorneys are watching this case closely and will report once the Court has rendered its decision, which is expected next spring.  For more information, please contact Fitch Even partner Kendrew H. Colton.  

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