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Diagnostic Test For Genetic Mutation Fails Written Description Requirement Where Mutation Was Not Disclosed

Posted in Federal Circuit Decisions

In Billups-Rothenberg, Inc. v. Associated Regional And University Pathologists, Inc., the Federal Circuit affirmed the district court’s grant of summary judgment of invalidity based on a lack of written description. The claims at issue were directed to methods of diagnosing a disease by detecting a specific genetic mutation associated with that disease, but the patent did not disclose any such genetic mutation.

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