‘‘(1) CONTENTS.—
‘‘(A) IN GENERAL.—Any person may file
with the Secretary an application with respect
to any drug subject to the provisions of sub-
section (a). Such persons shall submit to the
Secretary as a part of the application—
‘‘(i) full reports of investigations
which have been made to show whether or
not such drug is safe for use;
‘‘(ii) a full list of the articles used as
components of such drug;
‘‘(iii) a full statement of the composi-
tion of such drug;
‘‘(iv) a full description of the methods
used in, and the facilities and controls
used for, the manufacture, processing, and
packing of such drug;
‘‘(v) such samples of such drug and of
the articles used as components thereof as
the Secretary may require; and
‘‘(vi) specimens of the labeling pro-
posed to be used for such drug.
‘‘(B) PATENT INFORMATION.—
‘‘(i) REQUIREMENT.—The applicant
shall file with the application the patent
number and the expiration date of any pat-
ent which claims the drug for which the
applicant submitted the application or
which claims a method of using such drug
and with respect to which a claim of patent
infringement could reasonably be asserted
if a person not licensed by the owner en-
gaged in the manufacture use, or sale of
the drug.
‘‘(ii) TYPES OF PATENTS.—
‘‘(I) PATENTS SUBJECT TO RE-
QUIREMENT.—The patents for which
information under clause (i) is re-
quired to be filed with the Secretary
are drug substance (ingredient) pat-
ents, drug product (formulation and
composition) patents, product by proc-
ess patents, and method of use pat-
ents.
‘‘(II) PROHIBITION
REGARDING
CERTAIN PATENTS.—Process patents,
patents claiming packaging, patents
claiming metabolites, and patents
claiming intermediates are not patents
described in subclause (I), and infor-
mation on such patents may not be
filed with the Secretary.
‘‘(III) PATENT REGARDING DRUG
SUBSTANCE.—For patents that claim
the drug substance, the applicant
shall submit information only on pat-
ents that claim the drug substance
that is the subject of the pending or
approved application or that claim a
drug substance that is the same as
the active ingredient that is the sub-
ject of an approved or pending appli-
cation within the meaning of sub-
section (j)(2)(A)(ii).
‘‘(IV) PATENT REGARDING DRUG
PRODUCT.—For patents that claim a
drug product, the applicant shall sub-
mit information only on those patents
that claim a drug product that is the
subject of a pending or approved ap-
plication.
‘‘(V) PATENT REGARDING METH-
OD OF USE.—For patents that claim a
method of use, the applicant shall
submit information only on those pat-
ents that claim indications or other
conditions of use that are the subject
of a pending or approved application.
For approved applications, the appli-
cant shall identify the indication or
other condition of use in the approved
labeling that corresponds to the listed
patent and claim identified.
‘‘(iii) FILING OF PATENT AFTER SUB-
MISSION OF APPLICATION.—If a applica-
tion is filed under this subsection for a
drug and a patent which claims such drug
or a method of using such drug is issued
after the filing date but before approval of
the application, the applicant shall amend
the application to include the information
required by clauses (i) and (ii).
‘‘(iv) PUBLICATION
OF
PATENT
IN-
FORMATION.—Upon approval of the appli-
cation, the Secretary shall publish informa-
tion submitted under clauses (i) through
(iii).
‘‘(C) GUIDANCE REGARDING INCLUSION OF
WOMEN
AND
MINORITIES
IN
CLINICAL
TRIALS.—The Secretary shall, in consultation