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Full Text of this Amendment
SA 150. Mr. ROCKEFELLER submitted an amendment intended to be proposed by him to the bill S. 23, to amend title 35, United States Code, to provide for patent reform; which was ordered to lie on the table; as follows
After section 17, insert the following:
SEC. 18. PROHIBITION OF AUTHORIZED GENERICS.
Chapter 10 of title 35, United States Code, is amended by adding at the end the following:"§106. Prohibition of authorized generic drugs
"(a) In General.--Notwithstanding any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the owner of any patent issued under this title that is the subject of a new drug application approved under section 505(c) of such Act (21 U.S.C. 355(c)), or the holder of a new drug application approved under such section 505(c), shall not manufacture, market, sell, or distribute an authorized generic drug, directly or indirectly, or authorize any other person to manufacture,
market, sell, or distribute an authorized generic drug.
"(b) Authorized Generic Drug; Listed Drug.--For purposes of this section--
"(1) the term `authorized generic drug'--
"(A) means any version of a listed drug that the owner of any patent issued under this title for that listed drug that is the subject of a new drug application approved under subsection (c) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or the holder of the new drug application approved under such subsection (c) for that listed drug, seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection
(j)(2)(B) of such section with respect to that listed drug; and
"(B) does not include any drug to be marketed, sold, or distributed--
"(i) by an entity eligible for 180-day exclusivity with respect to such drug under subsection (j)(5)(B)(iv) of such section; or
"(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv); and
"(2) the term `listed drug' has the meaning applied to such term in section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).".
(As printed in the Congressional Record for the Senate on Mar 4, 2011.)
After section 17, insert the following:
SEC. 18. PROHIBITION OF AUTHORIZED GENERICS.
Chapter 10 of title 35, United States Code, is amended by adding at the end the following:"§106. Prohibition of authorized generic drugs
"(a) In General.--Notwithstanding any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the owner of any patent issued under this title that is the subject of a new drug application approved under section 505(c) of such Act (21 U.S.C. 355(c)), or the holder of a new drug application approved under such section 505(c), shall not manufacture, market, sell, or distribute an authorized generic drug, directly or indirectly, or authorize any other person to manufacture,
market, sell, or distribute an authorized generic drug.
"(b) Authorized Generic Drug; Listed Drug.--For purposes of this section--
"(1) the term `authorized generic drug'--
"(A) means any version of a listed drug that the owner of any patent issued under this title for that listed drug that is the subject of a new drug application approved under subsection (c) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or the holder of the new drug application approved under such subsection (c) for that listed drug, seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection
(j)(2)(B) of such section with respect to that listed drug; and
"(B) does not include any drug to be marketed, sold, or distributed--
"(i) by an entity eligible for 180-day exclusivity with respect to such drug under subsection (j)(5)(B)(iv) of such section; or
"(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv); and
"(2) the term `listed drug' has the meaning applied to such term in section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).".
(As printed in the Congressional Record for the Senate on Mar 4, 2011.)
