S.Amdt. 134
What it does: Adds SEC. 18. PROHIBITION OF AUTHORIZED GENERICS after section 17
Sen. John D. Rockefeller IV (D-WV)What it changes
1 change to S. 23 · shown in the bill's text
Adds SEC. 18. PROHIBITION OF AUTHORIZED GENERICS after section 17
Adds a sectionIn S. 23 · Reported to Senate
(f) Effective Date.--The amendments made by this section shall apply to any civil action commenced on or after the date of the enactment of this Act.
Inserted: SEC. 18. PROHIBITION OF AUTHORIZED GENERICS.
Inserted: (a) Prohibition of Authorized Generics.--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:
Inserted: "(w) Prohibition of Authorized Generic Drugs.--
Inserted: "(1) In general.--Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall 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.
Inserted: "(2) Authorized generic drug.--For purposes of this subsection, the term 'authorized generic drug'--
Inserted: "(A) means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under 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) with respect to that listed drug; and
Inserted: "(B) does not include any drug to be marketed, sold, or distributed--
Inserted: "(i) by an entity eligible for 180-day exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or
Inserted: "(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).".
Inserted: (b) Conforming Amendment.--Section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(t)(3)) is amended by striking "In this section" and inserting "In this subsection".
Original wording
After section 17, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 134. Mr. ROCKEFELLER (for himself, Mrs. Shaheen, and Ms. Stabenow) 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.
(a) Prohibition of Authorized Generics.--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:
“(w) Prohibition of Authorized Generic Drugs.--
“(1) In general.--Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall 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.
“(2) Authorized generic drug.--For purposes of this subsection, the term ‘authorized generic drug'--
“(A) means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under 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) 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); or
“(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).”.
(b) Conforming Amendment.--Section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(t)(3)) is amended by striking “In this section” and inserting “In this subsection”.
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Senate amendment submitted
March 2, 2011