S.Amdt. 150

This amendment's own text couldn't be picked out of its Congressional Record passage, so the passage is shown in full.

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:

     ``Sec. 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)).''.
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