; or (ii) paragraph (6) or (7) of section 351(k) of the Public Health Service Act, and any extension of such a period granted under paragraph (2) or (3) of section 351(m) of such Act, has expired; and (C) (i) that is not being marketed in the United States; or (ii) that is being marketed in the United States by fewer than 3 manufacturers, and that— (I) in the previous 1-year period, has experienced a price increase that is greater than the medical component of the consumer price index for the same period; (II) is included in the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act; or (III) (aa) has an average manufacturer price that the Secretary determines to be a barrier to patient access; and (bb) is listed by the World Health Organization as an essential medicine; or (2) for which there is in effect a license, or patent use is authorized, under— (A) section 1498 of title 28, United States Code; (B) section 202 of title 35, United States Code; (C) section 203 of title 35, United States Code (march-in rights); (D) section 209 of title 35, United States Code; or (E) any other licensing authority of the Federal Government. (f) Authorization of appropriations There are authorized to be appropriated such sums as may be necessary to carry out this section. .