Confusion Persists Around Drug Exclusivity and Patent Term Extensions For New Chemical Entities

When has an active ingredient in a drug product been previously approved by the U.S. Food and Drug Administration (FDA)? That question, and conflicting precedent from the U.S. Court of Appeals for the Federal Circuit discussing that question, were addressed recently in a lawsuit filed in the Eastern District of Virginia against the Commissioner of the United States Patent Office, after the Commissioner refused to grant a patent term extension (PTE) to Photocure ASA. See Photocure ASA v. Dudas.

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