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Biogen International GmbH v. Banner Life Sciences LLC — Federal Circuit Holds Patent Term Extension Covers Only Approved Active Ingredient, Not Its Metabolite

The Federal Circuit held that a patent term extension under the Hatch-Waxman Act covers only the active ingredient actually approved by the FDA—and its salts and esters—but does not extend to a metabolite of that ingredient, even if the metabolite is what is pharmacologically active in the body.

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