the United States Government

“ Prior to amendment, par. (2) read as follows: “The term 'human drug product' means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.” ”

“ The rights derived from any patent the term of which is extended under this paragraph shall, during the period of interim extension— (i) in the case of a patent which claims a product, be limited to any use then under regulatory review; (ii) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent then under regulatory review; and (iii) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the product then under regulatory review. ”

“ Subsec. (e) . Pub. L. 107-273, Sec. 13206 (b) (1) (B) , made technical correction to directory language of Pub. L. 106-113, Sec. 1000 (a) (9) [title IV, Sec. 4732 (a) (10) (A) ] . See 1999 Amendment note below. ”