I 
112TH CONGRESS 
1ST SESSION H. R. 3497 
To promote the development of meaningful treatments for patients. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 18, 2011 
Mr. LANCE introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committees on Ways 
and Means and the Judiciary, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
To promote the development of meaningful treatments for 
patients. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Modernizing Our Drug 
& Diagnostics Evaluation and Regulatory Network Cures 
Act of 2011’’ or the ‘‘MODDERN Cures Act of 2011’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Findings. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
Sec. 4. Definitions. 
TITLE I—ADVANCING DIAGNOSTICS FOR PATIENTS 
Sec. 101. Developing a common lexicon to facilitate progress on diagnostics. 
Sec. 102. Creating incentives for innovative diagnostics. 
Sec. 103. Promoting the development of innovative diagnostics. 
TITLE II—CAPTURING LOST OPPORTUNITIES FOR PATIENTS 
Sec. 201. Designation of dormant therapies. 
Sec. 202. Promoting the development of dormant therapies. 
SEC. 3. FINDINGS. 
The Congress makes the following findings: 
(1) More than 133 million Americans, or 45 
percent of the population, have at least one chronic 
condition. A quarter of Americans have multiple 
chronic conditions. 
(2) Chronic diseases have become the leading 
cause of death and disability in the United States. 
Seven out of every 10 deaths are attributable to 
chronic disease. Chronic diseases also compromise 
the quality of life of millions of Americans. 
(3) Despite $80,000,000,000 spent annually on 
research and development, many diseases and condi-
tions lack effective treatments. 
(4) Many commonly used drugs are effective in 
only 50 to 75 percent of the patient population, 
which can lead to devastating long-term side effects, 
resulting in the potential risks outweighing the bene-
fits for some patients. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(5) Advanced and innovative diagnostic tests 
have the potential to dramatically increase the effi-
cacy and safety of drugs by better predicting how 
patients will respond to a given therapy. 
(6) Despite their promise, many drugs and 
diagnostics may go undeveloped due to uncertain 
regulatory and reimbursement processes, among 
other reasons. 
(7) In addition, there is reason to believe that 
potential treatments with tremendous value to pa-
tients are never developed or are discontinued during 
research and development due to insufficiencies in 
the intellectual property system. 
(8) It is in the public interest to address the 
hurdles that may be precluding new treatments from 
reaching patients and to remove the disincentives for 
the development of therapies for these unmet needs. 
SEC. 4. DEFINITIONS. 
In this Act: 
(1) The term ‘‘biological product’’ has the 
meaning given to that term in section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(2) The term ‘‘drug’’ has the meaning given to 
that term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(3) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
TITLE I—ADVANCING 
DIAGNOSTICS FOR PATIENTS 
SEC. 101. DEVELOPING A COMMON LEXICON TO FACILI-
TATE PROGRESS ON DIAGNOSTICS. 
(a) IN GENERAL.—Not later than 180 days after the 
date of enactment of this Act, the Secretary shall establish 
within the Department of Health and Human Services the 
Advanced Diagnostics Education Council (in this section 
referred to as the ‘‘Council’’). 
(b) DUTIES.— 
(1) IN GENERAL.—The Council shall promote 
an improved understanding of key concepts related 
to innovative diagnostics by recommending standard 
terms and definitions for use by patients, physicians, 
health care providers, payers, and policymakers. 
(2) GUIDE.—The Secretary shall publish and 
disseminate a guide regarding such recommended 
terms and definitions for patients, physicians, health 
care providers, payers, and policymakers. 
(3) REPORT.—Not later than 12 months after 
the establishment of the Council, the Secretary shall 
prepare and submit a report to the Congress and to 
the public on the Council’s deliberations, activities, 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
and determinations with respect to meeting its du-
ties described in paragraphs (1) and (2). 
(c) CHAIRPERSON.—The Secretary, or the Sec-
retary’s designee, shall serve as chairperson of the Coun-
cil. 
(d) MEMBERS.—In addition to the Secretary, the 
Council shall consist of the following: 
(1) The head of each the following agencies (or 
a designee thereof): 
(A) The National Institutes of Health. 
(B) The Centers for Disease Control and 
Prevention. 
(C) The Food and Drug Administration. 
(D) The Agency for Healthcare Research 
and Quality. 
(E) The Centers for Medicare & Medicaid 
Services. 
(F) The Department of Defense. 
(G) The Department of Veterans Affairs. 
(H) The Health Resources and Services 
Administration. 
(I) The Substance Abuse and Mental 
Health Services Administration. 
(J) The Indian Health Service. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(2) Seven members appointed by the Secretary 
from among individuals who collectively— 
(A) represent a broad range of perspec-
tives; and 
(B) have expertise in— 
(i) basic and translational research, 
including with respect to molecular biology 
and genetics; 
(ii) bioinformatics; 
(iii) the discovery, development, and 
commercialization of in vitro diagnostics; 
and 
(iv) law and ethics. 
(3) Four members appointed by the Secretary 
who are each a chief medical or scientific officer of 
a patient advocacy organization. 
(e) PUBLIC INPUT.—In carrying out its duties, the 
Council shall solicit input from relevant stakeholders and 
the public. 
(f) TERMINATION.—The Council shall terminate 
after publishing the guide required by subsection (b)(2) 
and submitting the report required by subsection (b)(3), 
or later at the discretion of the Secretary. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
SEC. 
102. 
CREATING 
INCENTIVES 
FOR 
INNOVATIVE 
DIAGNOSTICS. 
(a) IMPROVEMENTS TO PROCESS FOR DETERMINING 
FEE SCHEDULE AMOUNTS FOR NEW TESTS.— 
(1) CLARIFYING
FACTORS
FOR
RATE-SET-
TING.— 
(A) IN GENERAL.—In determining the pay-
ment amount under gapfilling procedures (as 
described in section 414.508(b) of title 42, 
Code of Federal Regulations, or any successor 
regulation to such section) for new clinical diag-
nostic laboratory tests under section 1833(h)(8) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395l(h)(8)), the Secretary of Health and 
Human Services (in this section referred to as 
the ‘‘Secretary’’) shall take into account, as ap-
plicable and available, the following factors with 
respect to such a new test: 
(i) IMPACT ON PATIENT CARE.—The 
impact of the new test on patient care, pa-
tient management, or patient treatment. 
(ii) TECHNICAL CHARACTERISTICS.— 
The technical characteristics of the new 
test, and the resources required to develop, 
validate, and perform the new test. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(iii) CLAIMS DATA.—Data from claims 
for which payment is made under part B 
of title XVIII of the Social Security Act. 
(iv) 
LABORATORY
CHARGES.— 
Amounts charged by laboratories to self- 
pay patients for the new test. 
(v) PRIVATE
INSURANCE
RATES.— 
Amounts paid to laboratories for such new 
test under private health insurance cov-
erage offered in the group market and the 
individual market. 
(vi) ADVISORY PANEL RECOMMENDA-
TIONS.—The findings and recommenda-
tions of the independent advisory panel 
convened under paragraph (2) with respect 
to that new test and any comments re-
ceived during the open meeting of the advi-
sory panel. 
(vii) 
ADDITIONAL
FACTORS.—Such 
other factors as the Secretary may specify. 
(2) INPUT FROM PATIENTS, CLINICIANS, AND 
TECHNICAL EXPERTS.— 
(A) REQUIREMENT FOR INDEPENDENT AD-
VISORY
PANEL.—The Secretary shall convene 
an independent advisory panel from which the 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
Secretary shall request information and rec-
ommendations regarding any new test (as re-
ferred to under subparagraph (A) of section 
1833(h)(8) of the Social Security Act (42 
U.S.C. 1395l(h)(8))) for which payment is 
made under such section, including technical, 
clinical, and quality information. 
(B) COMPOSITION OF INDEPENDENT ADVI-
SORY PANEL.—The independent advisory panel 
shall be comprised of 19 members, including— 
(i) 4 individuals with expertise and ex-
perience with advanced clinical diagnostic 
laboratory tests, including expertise in the 
technical characteristics of the new test; 
(ii) 3 representatives of patients, in-
cluding a patient representative for rare 
disorders; 
(iii) 3 clinicians who use results of the 
new test in patient care; 
(iv) 3 individuals with expertise in the 
requirements to develop, validate, and per-
form the new test; 
(v) 2 laboratorians; 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(vi) 
experts 
in 
the 
area 
of 
pharmacoeconomics or health technology 
assessment; and 
(vii) 2 individuals with expertise on 
the impact of new tests on quality of pa-
tient care, including genetic counselors. 
(C) TERMS.—A member of the panel shall 
be appointed to serve a term of 6 years, except 
with respect to the members first appointed, 
whose terms of appointment shall be staggered 
evenly over 2-year increments. 
(D) EXPERT
CONSULTANTS.—The Sec-
retary may include to serve temporarily on the 
panel individuals who have expertise pertaining 
to the new test involved. 
(E) OPEN MEETINGS.—The Secretary shall 
receive or review the findings and recommenda-
tions of the independent advisory panel with re-
spect to the new tests described in subpara-
graph (A) involved during a meeting open to 
the public and provide opportunity for public 
comment. 
(F) CLARIFICATION
OF
AUTHORITY
OF 
SECRETARY TO CONSULT CARRIERS.—Nothing 
in this section shall be construed as affecting 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
the authority of the Secretary to consult with 
appropriate Medicare administrative contrac-
tors. 
(b) PROCESS
FOR ASSIGNMENT
OF TEMPORARY 
CODES FOR DIAGNOSTIC TESTS.—The Secretary shall es-
tablish a process for application for the assignment of a 
temporary national HCPCS code to uniquely identify a di-
agnostic test until a permanent national HCPCS code is 
available for assignment to that test. Assignments of a 
temporary national HCPCS code shall occur on a quar-
terly basis. The Secretary shall provide public notice 
through the Centers for Medicare & Medicaid Services 
website of applications made for such temporary national 
HCPCS codes. Upon assignment of a temporary code 
under this process, the Secretary shall treat such test as 
a new test for purposes of section 1833(h)(8) of the Social 
Security Act. 
(c) DEVELOPMENT OF FURTHER IMPROVEMENTS IN 
RATE-SETTING PROCESSES.—The Secretary shall analyze 
the process used for the gapfilling procedure used in deter-
mining payment amounts for new clinical diagnostic lab-
oratory tests under section 1833(h)(8) of the Social Secu-
rity Act. Taking into account the changes made by this 
section, the Secretary shall identify further changes to im-
prove the accuracy and appropriateness of resulting rates 
VerDate Mar 15 2010 
00:04 Nov 22, 2011
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
and the openness, transparency, and predictability of the 
process. The Secretary shall examine what and how many 
entities should perform gapfilling, under contract or other-
wise, and how to ensure that the process is informed by 
appropriate expertise and proceeds in a transparent and 
accountable manner. The Secretary shall implement im-
provements in the process, insofar as these are possible 
under the law through regulations, after public notice and 
opportunity for comment. For changes the Secretary de-
termines would require a change in law, the Secretary 
shall transmit recommendations to the Speaker of the 
House and the President of the Senate not later than July 
1, 2013. 
(d) DEFINITIONS.—For purposes of this section: 
(1) NEW
CLINICAL
DIAGNOSTIC
LABORATORY 
TESTS.—The term ‘‘new clinical diagnostic labora-
tory test’’ means a clinical diagnostic laboratory 
test— 
(A) that is assigned a new or substantially 
revised code on or after January 1, 2013; or 
(B) for which an application for a tem-
porary national HCPCS code is made under 
subsection (b) on or after January 1, 2013. 
(2) SELF-PAY
PATIENT.—The term ‘‘self-pay 
patient’’ means, with respect to a health care item 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
or service, an individual who pays out of pocket for 
such item or service and who does not have health 
insurance coverage for such item or service. 
(e) EFFECTIVE DATE.—This section shall take effect 
on the date of enactment of this Act, and shall apply with 
respect to new clinical diagnostic laboratory tests. 
SEC. 103. PROMOTING THE DEVELOPMENT OF INNOVATIVE 
DIAGNOSTICS. 
(a) DETERMINATION.— 
(1) REQUEST.—The manufacturer or sponsor 
of a drug or biological product may request the Sec-
retary to determine that— 
(A) a diagnostic test has been developed 
by, or with the participation of, the manufac-
turer or sponsor of the drug or biological prod-
uct; and 
(B) use of the diagnostic test, as dem-
onstrated through valid scientific information 
such as peer-reviewed literature— 
(i) provides for or improves the identi-
fication of a patient population for which 
the drug or biological product will or will 
not be used in accordance with its ap-
proved indications; or 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(ii) provides for or improves the deter-
mination of the most appropriate treat-
ment option for a patient population with 
the drug or biological product in accord-
ance with its approved indications. 
(2) RESPONSE BY SECRETARY.—Not later than 
30 days after the submission of a request under 
paragraph (1), the Secretary, shall— 
(A) make the requested determination and 
publish a notice of such determination and any 
extension under this section resulting from such 
determination; or 
(B) provide an explanation to the manufac-
turer or sponsor submitting the request of why 
the determination is not warranted. 
(b) APPLICABLE EXTENSION PERIOD.—For purposes 
of subsections (c) and (d), the applicable extension period 
is— 
(1) with respect to a diagnostic test developed 
(as described in subsection (a)(1)(A)) contempora-
neously with the development of the drug or biologi-
cal product involved, 12 months; and 
(2) with respect to a diagnostic test developed 
otherwise, 6 months. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(c) EXTENSION FOR DRUGS.—If, at the request of 
the manufacturer or sponsor of a drug, the Secretary 
makes the determination described in subsection (a)(1) 
with respect to such drug and a diagnostic test, then— 
(1) the four- and five-year periods described in 
subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 
505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355), the three-year periods described in 
clauses (iii) and (iv) of subsection (c)(3)(E) and 
clauses (iii) and (iv) of subsection (j)(5)(F) of such 
section 505, or the seven-year period described in 
section 527 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360cc), as applicable, shall be 
extended by the applicable extension period; 
(2) if the drug is the subject of— 
(A) a listed patent for which a certification 
has 
been 
submitted 
under 
subsection 
(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of such section 
505; or 
(B) a listed patent for which a certification 
has 
been 
submitted 
under 
subsection 
(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of such sec-
tion 505, 
then the period during which an application may not 
be approved under subsection (c)(3) or (j)(5)(B) of 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
such section 505 shall be extended by the applicable 
extension period after the date the patent expires 
(including any patent extensions); and 
(3) if the drug is the subject of a listed patent 
for which a certification has been submitted under 
subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of such 
section 505, and in the patent infringement litiga-
tion resulting from the certification the court deter-
mines that the patent is valid and would be in-
fringed, the period during which an application may 
not be approved under subsection (c)(3) or (j)(5)(B) 
of such section 505 shall be extended by the applica-
ble extension period after the date the patent expires 
(including any patent extension). 
(d) EXTENSION FOR BIOLOGICAL PRODUCTS.—If, at 
the request of the manufacturer or sponsor of a biological 
product, the Secretary makes the determination described 
in subsection (a)(1) with respect to such biological product 
and a diagnostic test, then the 12-year period described 
in subsection (k)(7)(A) of section 351 of the Public Health 
Service Act (42 U.S.C. 262), the 4-year period described 
in subsection (k)(7)(B) of such section 351, and the 7- 
year period described in section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc), as applicable, 
shall be extended by the applicable extension period. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(e) RELATION
TO PEDIATRIC EXCLUSIVITY.—Any 
extension under subsection (c) or (d) of a period shall be 
in addition to any extension of the period under section 
505A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a) with respect to the drug or biological prod-
uct. 
(f) LIMITATIONS.—Extensions under this section 
may apply— 
(1) not more than twice with respect to the 
same drug or biological product; and 
(2) not more than once with respect to the 
same indication to be treated by the same drug or 
biological product. 
TITLE II—CAPTURING LOST 
OPPORTUNITIES FOR PATIENTS 
SEC. 201. DESIGNATION OF DORMANT THERAPIES. 
(a) DESIGNATION.—The Secretary shall designate a 
drug or biological product as a dormant therapy if— 
(1) the sponsor of the drug or biological prod-
uct submits a request in accordance with subsection 
(b); and 
(2) the Secretary determines that— 
(A) the indication for which the drug or bi-
ological product is being investigated or is in-
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
tended to be investigated is to address one or 
more unmet medical needs; and 
(B) the sponsor intends to file an applica-
tion pursuant to section 505(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) or section 351(a) of the Public Health 
Service Act (42 U.S.C. 262(a)) for approval or 
licensing of the drug or biological product for 
such indication. 
(b) REQUEST FOR DESIGNATION.— 
(1) SUBMISSION.—The sponsor of a drug or bi-
ological product may submit a request to the Sec-
retary to designate the drug or biological product as 
a dormant therapy. 
(2) CONTENTS.—Any request under paragraph 
(1) with respect to a drug or biological product shall 
contain each of the following: 
(A) A listing of all patents and applica-
tions for patents— 
(i) under which the sponsor has 
rights; and 
(ii) which may be reasonably con-
strued to provide protection for the drug or 
biological product. 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(B) A waiver of enforcement rights in ac-
cordance with paragraph (3). 
(C) A certification by the sponsor that the 
new drug or new biological product has prospec-
tively insufficient patent protection. 
(3) WAIVER.— 
(A) 
REQUIREMENT.—A 
request 
under 
paragraph (1) shall contain a waiver of the 
right to enforce any patent or patent applica-
tion, which issues as a patent described in para-
graph (2)(A) with respect to any product de-
scribed in subparagraph (B). 
(B) PRODUCTS DESCRIBED.—A product is 
described in this subparagraph if— 
(i) it is approved or licensed pursuant 
to an application that is filed under section 
505(b)(2) or 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 
355(b)(2), (j)) or section 351(k) of the 
Public Health Service Act (42 U.S.C. 
262(k)); and 
(ii) the filing occurs after the expira-
tion of the protection period (as defined in 
section 202(a)(1) of this Act) applicable to 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
the drug or biological product to which the 
request under paragraph (1) relates. 
(C) EFFECTIVE
ONLY
UPON
DESIGNA-
TION.—A waiver under this paragraph shall be 
effective only upon the designation under this 
section of the drug or biological product to 
which it relates as a dormant therapy. 
(D) INABILITY TO WAIVE RIGHT TO EN-
FORCE ONE OR MORE PATENTS.—If a sponsor 
of a drug or biological product is unable to 
grant an effective waiver of the right to enforce 
one or more patents or applications for patent 
as described in subparagraph (A)— 
(i) the sponsor may not make a re-
quest under this subsection with respect to 
the drug or biological product; and 
(ii) if the sponsor has made such a re-
quest, the sponsor shall promptly withdraw 
the request. 
(4) TIMING.— 
(A) REQUEST.—Any request for designa-
tion of a drug or biological product as a dor-
mant therapy under subsection (a) shall be 
made before the submission of an application 
under section 505 of the Federal Food, Drug, 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
and Cosmetic Act (21 U.S.C. 355) or section 
351 of the Public Health Service Act (42 
U.S.C. 262) for the first approval or licensure 
of commercial marketing or use of a drug or bi-
ological product that shares at least one active 
moiety with an active moiety in the drug or bio-
logical product for which designation is being 
requested. 
(B) WITHDRAWAL
OF
REQUEST.—The 
sponsor of a drug or biological product may 
withdraw a request under paragraph (1) with 
respect to the drug or biological product, but 
only prior to approval or licensing of the drug 
or biological product. 
(5) EFFECTS OF WITHDRAWAL OF REQUEST.— 
If the sponsor of a drug or biological product with-
draws a request under paragraph (1) with respect to 
the drug or biological product— 
(A) any designation of the drug or biologi-
cal product as a dormant therapy under sub-
section (a) is cancelled; and 
(B) any waiver submitted under this sub-
section with respect to the drug or biological 
product is cancelled. 
(c) CRITERIA FOR DESIGNATION.— 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(1) IN GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
retary shall establish a comprehensive methodology 
and criteria for the designation of a drug or biologi-
cal product as a dormant therapy in accordance with 
subsection (a). No designation shall be made under 
subsection (a) during such 18-month period unless 
the Secretary has established such methodology and 
criteria. 
(2) PUBLIC INPUT.—The Secretary shall con-
sult with relevant stakeholders and provide an op-
portunity for public notice and comment in— 
(A) establishing the methodology and cri-
teria under paragraph (1); and 
(B) establishing criteria for determining 
whether the indication for which the drug or bi-
ological product is being investigated or is in-
tended to be investigated is to address one or 
more unmet medical needs (as described in sub-
section (a)(2)(A)). 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘prospectively insufficient patent 
protection’’ means, with respect to a drug or biologi-
cal product for which a request for designation is 
submitted under subsection (b) (in this paragraph 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
that is shown to lead to improved effects 
on serious outcomes. 
(e) PUBLIC NOTICE OF DESIGNATION.—The Sec-
retary request for and notice of the designation of a dor-
mant therapy under paragraph (4) shall be made available 
to the public. 
SEC. 202. PROMOTING THE DEVELOPMENT OF DORMANT 
THERAPIES. 
(a) PROTECTIONS FOR DORMANT THERAPY.— 
(1) PROTECTION PERIOD.—The term ‘‘protec-
tion period’’ means, with respect to a drug or bio-
logical product designated as a dormant therapy 
under section 201(a) (in this section referred to as 
the ‘‘dormant therapy’’), the 15-year period begin-
ning on the date on which the Secretary approves an 
application under section 505(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
or section 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)) for the drug or biological prod-
uct. 
(2) APPLICATIONS FILED DURING THE PROTEC-
TION PERIOD.—During the protection period for a 
dormant therapy, notwithstanding any other provi-
sion of the Federal Food, Drug, and Cosmetic Act 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(21 U.S.C. 301 et seq.) or the Public Health Service 
Act (42 U.S.C. 201 et seq.)— 
(A) absent a right of reference from the 
holder of such approved application for the dor-
mant therapy, the Secretary shall not approve 
an 
application 
filed 
pursuant 
to 
section 
505(b)(2) or section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(2), (j)) or section 351(k) of the Public 
Health Service Act (42 U.S.C. 262(k)) ref-
erencing or otherwise relying on the approval or 
licensure of the dormant therapy; 
(B) the Secretary shall not approve— 
(i) an application filed pursuant to 
such section 505(b)(2) or 505(j) that ref-
erences or otherwise relies on the approval 
or licensure of a drug or biological product 
that is not the dormant therapy but con-
tains the same active moiety as the dor-
mant therapy; or 
(ii) an application filed pursuant to 
such section 351(k) that references or oth-
erwise relies on the approval or licensure of 
a drug or biological product that is not the 
dormant therapy but contains an active 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
moiety highly similar to that of the dor-
mant therapy; and 
(C) the Secretary shall not approve an ap-
plication filed pursuant to section 505(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)) for a drug that contains the 
same active moiety as the dormant therapy, or 
an application filed pursuant to section 351(a) 
of the Public Health Service Act (42 U.S.C. 
262(a)) for a biological product that contains 
an active moiety highly similar to that of the 
dormant therapy, unless the information pro-
vided to support approval of such application is 
comparable in scope and extent (including with 
respect to design and extent of preclinical and 
clinical testing) to the information provided to 
support approval of the application (described 
in paragraph (1)) for the dormant therapy. 
(3) REGULATIONS.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
retary, in consultation with relevant Federal agen-
cies, shall promulgate such regulations as are re-
quired to implement the incentives described in 
paragraph (2). 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(4) PATENT
TERM
ALIGNMENT
WITH
DATA 
PACKAGE PROTECTION PERIOD.— 
(A) IN
GENERAL.—Notwithstanding any 
provision of title 35, United States Code, a 
sponsor of a drug or biologic product des-
ignated as a dormant therapy under section 
201(a), upon the approval or licensure thereof 
under the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.), and in lieu of fil-
ing a patent term extension application under 
section 156(d) of such title 35 (other than ap-
plications for interim extensions filed under 
paragraph (5) of such section 156(d)), shall be 
entitled to patent term extension in accordance 
with this paragraph. 
(B) SUBMISSION OF LISTING OF PATENTS 
AND APPLICATIONS FOR PATENTS.— 
(i) SUBMISSION.—The sponsor of the 
dormant therapy, within a period to be set 
by the Director of the United States Pat-
ent and Trademark Office (in this para-
graph referred to as the ‘‘Director’’), shall 
submit to the Director— 
(I) the listing of patents and ap-
plications for patents required by sec-
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
tion 201(b)(2)(A) with respect to the 
dormant therapy; and 
(II) a listing of any additional 
patents and applications for patents 
that, at the time of the submission, 
meet 
the 
description 
in 
section 
201(b)(2)(A). 
(ii) PERIOD.—The period set by the 
Director under clause (i) shall not be less 
than 6 months from the date on which the 
Secretary approves or licenses the dormant 
therapy. 
(C) EXTENSION OF PATENTS.— 
(i) IN
GENERAL.—For each patent 
identified pursuant to subparagraph (B)(i), 
and for each patent issuing based upon an 
application for patent so identified, the Di-
rector shall extend the patent to expire at 
the end of the protection period under 
paragraph (1) for the dormant therapy, if 
the patent would otherwise expire prior to 
the end of the protection period. 
(ii) APPLICATION OF CERTAIN PROVI-
SIONS.—During the period of an extension 
under clause (i)— 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00030
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS
(I) the rights under the patent 
shall be limited in the manner pro-
vided under section 156(b) of title 35, 
United States Code; and 
(II) the terms ‘‘product’’ and 
‘‘approved product’’ in such section 
156(b) shall be deemed to include 
forms of the active moiety of the dor-
mant therapy and highly similar ac-
tive moieties that might be approved 
by the Secretary based upon an appli-
cation filed under section 505(b)(2) or 
505(j) of the Federal Food, Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(b)(2), 
(j)) 
or 
under 
section 
351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) that ref-
erences or otherwise relies upon the 
dormant therapy. 
(D) NOTICE
OF
EXTENSION.—For each 
patent that is extended under this paragraph, 
the Director shall publish a notice of such ex-
tension. 
(E) NOTICE OF WAIVER.—For each patent 
identified pursuant to subparagraph (B)(i), and 
VerDate Mar 15 2010 
22:14 Nov 21, 2011
Jkt 019200
PO 00000
Frm 00031
Fmt 6652
Sfmt 6201
E:\BILLS\H3497.IH
H3497
srobinson on DSK4SPTVN1PROD with BILLS