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Home / Opinion Digests / Intellectual Property – Patent Term Extension – FDA Approval Process (access required)

Intellectual Property – Patent Term Extension – FDA Approval Process (access required)

An Alexandria U.S. District Court says plaintiff holder of a drug patent for “Metvixia” meets the requirements for extension of its patent term, which was effectively shortened by the lengthy Food & Drug Administration approval process. A statute, 35 U.S.C. § 156, permits patent term extensions in such circumstances, provided the applicant meets specific statutory elements. ...