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and Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) solicit public comment regarding the types of 
patent information that should be included on, or re-
moved from, the list under section 507(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)); and 
(2) transmit to Congress a summary of such 
comments and actions the Food and Drug Adminis-
tration is considering taking, if any, in response to 
public comment pursuant to paragraph (1) about the 
types of patent information that should be included or 
removed from such list. 
(f) GAO REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Comptroller 
General of the United States (referred to in this sec-
tion as the ‘‘Comptroller General’’) shall submit to the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on 
the patents included in the list published under sec-
tion 505(j)(7) of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 355(j)(7)) that claim an active 
ingredient or formulation of a drug in combination
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with a device that is used for delivery of such drug, 
including an analysis of such patents and their 
claims. 
(2) CONTENT.—The Comptroller General shall 
include in the report under paragraph (1)— 
(A) data on— 
(i) the number of patents included in 
the list published under section 505(j)(7) of 
the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 355(j)(7)) that claim the active 
ingredient or formulation of a drug in com-
bination with a device that is used for de-
livery of the drug, and that together claim 
the finished dosage form of the drug; and 
(ii) the number of claims with respect 
to each patent included in the list published 
under such section 505(j)(7) that claim a 
device that is used for the delivery of the 
drug, but do not claim such device in com-
bination with an active ingredient or for-
mulation of a drug; 
(B) an analysis of the listing of patents de-
scribed in subparagraph (A)(ii), including the 
timing of listing such patents in relation to pat-
ents described in subparagraph (A)(i), and the
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effect listing the patents described in subpara-
graph (A)(ii) has on market entry of one or more 
drugs approved under section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act as compared 
to the effect of not listing the patents described 
in subparagraph (A)(ii); and 
(C) recommendations about which kinds of 
patents relating to devices described in subpara-
graph (A)(i) should be submitted to the Secretary 
of Health and Human Services for inclusion on 
the list under section 505(j)(7) of the Federal 
Food, Drug, and Cosmetic Act and which patents 
should not be required to be so submitted in 
order to reduce barriers to approval and market 
entry. 
(g) CONFORMING AMENDMENTS.—Section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 
amended— 
(1) in subsection (c)(3)(E), by striking ‘‘clause 
(A) of subsection (b)(1)’’ each place it appears and 
inserting ‘‘subsection (b)(1)(A)(i)’’; and 
(2) in subsection (j)(2)(A)(vi), by striking 
‘‘clauses (B) through (F) of subsection (b)(1)’’ and in-
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serting ‘‘clauses (ii) through (vi) of subsection 
(b)(1)(A)’’. 
Attest: 
Secretary.