S.Amdt. 4361

SA 4361. Mr. NELSON of Florida submitted an amendment intended to be
proposed to amendment SA 4301 proposed by Mr. Baucus to the bill H.R.
4213 to amend the Internal Revenue Code of 1986 to extend certain
expiring provisions, and for other purposes, which was ordered to lie
on the table; as follows:

On page 363, between lines 3 and 4, insert the following:

SEC. 621. EXCLUSIVITY PERIOD.

(a) First Applicant.--Section 505(j)(5) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is
amended--
(1) in subparagraph (B)(iv)--
(A) in subclause (II), by striking item (bb) and inserting
the following:
``(bb) First applicant.--As used in this subsection, the
term `first applicant' means--
``(AA) an applicant that, on the first day on which a
substantially complete application containing a certification
described in paragraph (2)(A)(vii)(IV) is submitted for
approval of a drug, submits a substantially complete
application that contains and lawfully maintains a
certification described in paragraph (2)(A)(vii)(IV) for the
drug; or
``(BB) an applicant for the drug not described in item (AA)
that satisfies the requirements of subclause (III).''; and
(B) by adding at the end the following:

``(III) An applicant described in subclause (II)(bb)(BB)
shall--

``(aa) submit and lawfully maintain a certification
described in paragraph (2)(A)(vii)(IV) or a statement
described in paragraph (2)(A)(viii) for each unexpired patent
for which a first applicant described in item (AA) had
submitted a certification described in paragraph
(2)(A)(vii)(IV) on the first day on which a substantially
complete application containing such a certification was
submitted;
``(bb) with regard to each such unexpired patent for which
the applicant submitted a certification described in
paragraph (2)(A)(vii)(IV), no action for patent infringement
was brought against the applicant within the 45-day period
specified in paragraph (5)(B)(iii), or if an action was
brought within such time period, the applicant has obtained
the decision of a court (including a district court) that the
patent is invalid or not infringed (including any substantive
determination that there is no cause of action for patent
infringement or invalidity, and including a settlement order
or consent decree signed and entered by the court stating
that the patent is invalid or not infringed); and
``(cc) but for the effective date of approval provisions in
subparagraphs (B) and (F) and sections 505A and 527, be
eligible to receive immediately effective approval at a time
before any other applicant has begun commercial marketing.'';
and
(2) in subparagraph (D)--
(A) in clause (i)(IV), by striking ``The first applicant''
and inserting ``The first applicant, as defined in
subparagraph (B)(iv)(II)(bb)(AA),''; and
(B) in clause (iii), in the matter preceding subclause
(I)--
(i) by striking ``If all first applicants forfeit the 180-
day exclusivity period under clause (ii)''; and
(ii) by inserting ``If all first applicants, as defined in
subparagraph (B)(iv)(II)(bb)(AA), forfeit the 180-day
exclusivity period under clause (ii) at a time at which no
applicant has begun commercial marketing''.
(b) Effective Date and Transitional Provision.--
(1) Effective date.--The amendments made by subsection (a)
shall be effective only with respect to an application filed
under section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)) to which the amendments made by
section 1102(a) of the Medicare Prescription Drug Improvement
and Modernization Act of 2003 (Public Law 108-173) apply.
(2) Transitional provision.--An application filed under
section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)), to which the 180-day exclusivity period
described in paragraph (5)(iv) of such section does not
apply, and that contains a certification under paragraph
(2)(A)(vii)(IV) of such Act, shall be regarded as a previous
application containing such a certification within the
meaning of section 505(j)(5)(B)(iv) of such Act (as in effect
before the amendments made by Medicare Prescription Drug
Improvement and Modernization Act of 2003 (Public Law 108-
173)) if--
(A) no action for infringement of the patent that is the
subject of such certification was brought against the
applicant within the 45-day period specified in section
505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(5)(B)(iii)), or if an action was brought
within such time period, the applicant has obtained the
decision of a court (including a district court) that the
patent is invalid or not infringed (including any substantive
determination that there is no cause of action for patent
infringement or invalidity, and including a settlement order
or consent decree signed and entered by the court stating
that the patent is invalid or not infringed);
(B) the application is eligible to receive immediately
effective approval, but for the effective date of approval
provisions in sections 505(j)(5)(B) (as in effect before the
amendment made by Public Law 108-173), 505(j)(5)(F), 505A,
and 527 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)(B), 355(j)(5)(F), 355a, 360cc); and
(C) no other applicant has begun commercial marketing.
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