Section 156 of the Hatch-Waxman Act provides for restoring some of a patent’s term consumed during clinical testing and Food and Drug Administration (FDA) review of a New Drug Application (NDA) for a product covered by the patent. The extension afforded under Section 156 is of great importance to a drug manufacturer given that development of a new drug from discovery through FDA approval often takes a decade or more (10-15 years), leading to the loss of a significant portion of the term of a patent covering the drug. The dispute in Biogen International Gmbh v. Banner Life Sciences LLC, No. 2020-1373 (Fed. Cir. April 21, 2020) (Biogen v. Banner) centers around the very meaning of the term “product” as used in Section 156.

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