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Written Descriptions Supply Chain

Gardner Law

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

Gardner Law on

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

McDermott Will & Emery

Invalidating Means Plus Function Claim Requires Expert Testimony - Elcommerce.com, Inc. v. SAP AG, et. al

McDermott Will & Emery on

Revisiting the issue of written description support for a means plus function claim, the U.S. Court of Appeals for the Federal Circuit reversed a finding of invalidity of claims directed to supply chain monitoring, concluding...more

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