‘‘(ii) ACTION BROUGHT BEFORE EXPI-
RATION
OF
DAYS.—If an action is
brought for infringement of a patent that
is the subject of the certification before the
expiration of the 45-day period beginning
on the date the notice provided under sub-
section (b)(3)(B) was received, the ap-
proval shall be made effective on the expi-
ration of the 45-day period unless the
court grants a preliminary injunction pro-
hibiting the applicant from engaging in the
commercial manufacture or sale of the
drug until the court decides the issues of
patent validity and infringement.
‘‘(iii) PATENT
INVALID
OR
NOT
IN-
FRINGED.—If the court decides that the
patent is invalid or not infringed, the ap-
proval shall be made effective on the date
of the court decision.
‘‘(iv) PATENT
INFRINGED.—If the
court decides that the patent has been in-
fringed, the approval may be made effec-
tive on such date as the court orders under
section 271(e)(4)(A) of title 35, United
States Code.
‘‘(v) PROCEDURE.—In an action de-
scribed in clause (ii)—
‘‘(I) each of the parties shall rea-
sonably cooperate in expediting the
action;
‘‘(II) until the expiration of 45
days after the date the notice provided
under subsection (b)(3)(B) was re-
ceived, no civil action may be brought
under section 2201 of title 28, United
States Code, for a declaratory judg-
ment with respect to the patent, ex-
cept 
as 
provided 
in 
subsection
(j)(5)(H); and
‘‘(III) any such civil action shall
be brought in the judicial district
where the defendant has its principal
place of business or a regular and es-
tablished place of business.’’.
(c) EFFECTIVE DATE.—The amendments made by
this section shall not apply to an application submitted
under section 505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355) before the date of enactment
of this Act.
SEC. 7. PATENT INFORMATION.
Section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) is amended—
(1) in subsection (b), by striking ‘‘(b)(1) Any
person’’ and all that follows through paragraph (1)
and inserting the following:
‘‘(b) APPLICATIONS.—
‘‘(1) IN GENERAL.—
‘‘(A) FILING.—Any person may file with
the Secretary an application with respect to any
drug subject to subsection (a).
‘‘(B) CONTENTS.—A person that files an
application shall submit to the Secretary as a
part of the application with respect to a drug—
‘‘(i) full reports of investigations that
have been made to show whether or not
such drug is safe for use and whether the
drug is effective in use;
‘‘(ii) a full list of the articles used as
components of the drug;
‘‘(iii) a full statement of the composi-
tion of the drug;
‘‘(iv) a full description of the methods
used in, and the facilities and controls
used for, the manufacture, processing, and
packing of the drug;
‘‘(v) such samples of the drug and of
the articles used as components of the
drug as the Secretary may require; and
‘‘(vi) specimens of the labeling pro-
posed to be used for the drug.
‘‘(C) PATENT INFORMATION.—
‘‘(i) IN
GENERAL.—The applicant
shall file with the application the patent
number and expiration date of any patent
that claims a drug or method of using a
drug and with respect to which a claim of
patent infringement could reasonably be
asserted if a person not licensed by the
owner engaged in the manufacture, use, or
sale of the drug for which the applicant
submitted the application.
‘‘(ii) AMENDMENT OF APPLICATION.—
If an application is filed with respect to a
drug and a patent as described in clause
(i) is issued after the filing date but before
approval of the application, the applicant
shall amend the application to include the
information required by clause (i).
‘‘(iii) PUBLICATION
OF
INFORMA-
TION.—On approval of the application, the
Secretary shall publish information sub-
mitted under clauses (i) and (ii).
‘‘(D) GUIDANCE.—The Secretary shall, in
consultation with the Director of the National
Institutes of Health and with representatives of
the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclu-
sion of women and minorities in clinical trials
required by subparagraph (B)(i).’’; and
(2) in paragraph (2)(A)—
(A) by striking ‘‘which claims’’ the first
place it appears and all that follows through
‘‘subsection and’’; and
(B) by striking ‘‘subsection (c)—’’ and in-
serting ‘‘and with respect to which a claim of
patent infringement could reasonably be as-
serted if a person not licensed by the owner en-
gaged in the manufacture, use, or sale of the
drug for which the investigations were con-
ducted—’’;
(3) in the first sentence of subsection (c)(2)—
(A) by inserting ‘‘such patent information’’
after ‘‘shall file’’; and
(B) by striking ‘‘Secretary,’’ and all that
follows and inserting ‘‘Secretary.’’;