Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could not be marketed. PTE is available for patents covering certain human drugs, food or color additives, animal drugs, veterinary biological products, and medical devices. On average, a granted PTE application adds 1059 days (nearly three years) to a patent’s term.
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