Patent Term Extension For Biologics

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). 

To be eligible for PTE, a patent must claim a drug product, a method of using a drug product, or a method of manufacturing a drug product, and PTE is only available for the first approval of an "active ingredient."

The Federal Circuit has addressed the question of what constitutes an active ingredient¹ several times in the context of small molecules. For example, claims directed to a metabolite do not cover the active ingredient,² enantiomers of the same compound are different active ingredients,³ and different salts of the same compound are considered the same active ingredient for purposes of PTE.^[4] Although the Federal Circuit case law on small molecules is more developed, it is not clear how the