1.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
.
2.The table of contents
for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
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.
3.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
conditions 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 benefits for some patients.
(5)Advanced and
innovative diagnostic tests have the potential to dramatically increase the
efficacy 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
patients 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.
4.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).
(3)The term
Secretary means the Secretary of Health and Human Services.
<enum>I</enum><header>Advancing
diagnostics for patients</header>
<section id="H833C99C103124BA68150CA8880A11F33"><enum>101.</enum><header>Developing a
common lexicon to facilitate progress on diagnostics</header>
<subsection id="H280FD240938C4920AE348CB092720414"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">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
<quote>Council</quote>).</text>
</subsection><subsection id="HC0C1AD51AB2141AFBA275C7911D02A37"><enum>(b)</enum><header>Duties</header>
<paragraph id="H7433415031584B9BBFF931FB00B895ED"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H1009725F5386456CADACB18BA993F024"><enum>(2)</enum><header>Guide</header><text display-inline="yes-display-inline">The Secretary shall publish and disseminate
a guide regarding such recommended terms and definitions for patients,
physicians, health care providers, payers, and policymakers.</text>
</paragraph><paragraph id="H4FD6A84F0B5B4CB9B1B7FF68454C7F5D"><enum>(3)</enum><header>Report</header><text display-inline="yes-display-inline">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,
and determinations with respect to meeting its duties described in paragraphs
(1) and (2).</text>
</paragraph></subsection><subsection id="H392D64888E34411BB1335B1FE39EEC62"><enum>(c)</enum><header>Chairperson</header><text display-inline="yes-display-inline">The Secretary, or the Secretary’s designee,
shall serve as chairperson of the Council.</text>
</subsection><subsection id="H6ADD7A361FA148F18BF5B30CFC6ED4AF"><enum>(d)</enum><header>Members</header><text display-inline="yes-display-inline">In addition to the Secretary, the Council
shall consist of the following:</text>
<paragraph id="H0079477AF19145989AD513FC8A143C04"><enum>(1)</enum><text display-inline="yes-display-inline">The head of each the following agencies (or
a designee thereof):</text>
<subparagraph id="H5EECD264969A417A919EB2AC988BBC41"><enum>(A)</enum><text display-inline="yes-display-inline">The National Institutes of Health.</text>
</subparagraph><subparagraph id="HB6A7FF50BB794863BA27EBE23B5D196E"><enum>(B)</enum><text>The Centers for
Disease Control and Prevention.</text>
</subparagraph><subparagraph id="H44AE3B82BD1C4A45A9AB755AF46F5D10"><enum>(C)</enum><text>The Food and Drug
Administration.</text>
</subparagraph><subparagraph id="HBFB3B03AE2EC4417AAF425AF6665A524"><enum>(D)</enum><text>The Agency for
Healthcare Research and Quality.</text>
</subparagraph><subparagraph id="HB2203DB85F574A83BEBBA24DFA23F2AF"><enum>(E)</enum><text>The Centers for
Medicare & Medicaid Services.</text>
</subparagraph><subparagraph id="H1FCD0A4428FA4261B57F8BD198769EEF"><enum>(F)</enum><text>The Department of
Defense.</text>
</subparagraph><subparagraph id="HD93AC5C286AF4FB3932EC81F1CD6BD65"><enum>(G)</enum><text>The Department of
Veterans Affairs.</text>
</subparagraph><subparagraph id="H2C9E948D1B944845B39FB6E74A67DCE5"><enum>(H)</enum><text>The Health
Resources and Services Administration.</text>
</subparagraph><subparagraph id="H9F5CB385953B4B5B9B9AD98123157190"><enum>(I)</enum><text>The Substance
Abuse and Mental Health Services Administration.</text>
</subparagraph><subparagraph id="HF063A942377C4D05A8201EB214B11926"><enum>(J)</enum><text>The Indian Health
Service.</text>
</subparagraph></paragraph><paragraph id="HF836C32A150F4AD48D5C29300DF699FE"><enum>(2)</enum><text display-inline="yes-display-inline">Seven members appointed by the Secretary
from among individuals who collectively—</text>
<subparagraph id="H3B7080A97C7D4B89AA45126DEEC58391"><enum>(A)</enum><text>represent a broad
range of perspectives; and</text>
</subparagraph><subparagraph id="HF37EEB785CFF48F392E21B64A952740B"><enum>(B)</enum><text>have expertise
in—</text>
<clause id="H9B7C29C1FCF24C49BC5790C7F610578D"><enum>(i)</enum><text display-inline="yes-display-inline">basic and translational research, including
with respect to molecular biology and genetics;</text>
</clause><clause id="HC29BF8EC88014A7A8811437D1DEB62DA"><enum>(ii)</enum><text>bioinformatics;</text>
</clause><clause id="HE841F8AC9F414F389BFB0369C0980339"><enum>(iii)</enum><text>the discovery,
development, and commercialization of in vitro diagnostics; and</text>
</clause><clause id="H9D8216FA635349EEA8348DDD654BBC51"><enum>(iv)</enum><text>law
and ethics.</text>
</clause></subparagraph></paragraph><paragraph id="H1A9696198D8548E893CAF012FF52D8D3"><enum>(3)</enum><text display-inline="yes-display-inline">Four members appointed by the Secretary who
are each a chief medical or scientific officer of a patient advocacy
organization.</text>
</paragraph></subsection><subsection id="HD555209F0A2D477A98F0D296609AA317"><enum>(e)</enum><header>Public
input</header><text display-inline="yes-display-inline">In carrying out its
duties, the Council shall solicit input from relevant stakeholders and the
public.</text>
</subsection><subsection id="H4A7DE840195C4FED9EA90E5069479512"><enum>(f)</enum><header>Termination</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section commented="no" id="H34D0572AAC824590897B0A76CBB0C01D"><enum>102.</enum><header>Creating
incentives for innovative diagnostics</header>
<subsection commented="no" id="HA1A514362FB04510878392B4C64CDC08"><enum>(a)</enum><header>Improvements to
process for determining fee schedule amounts for new tests</header>
<paragraph commented="no" id="H1C5409581F0A470B8ADDFF418F67A086"><enum>(1)</enum><header>Clarifying
factors for rate-setting</header>
<subparagraph commented="no" id="H613A0F685F4E443E96D67037AD04DC2C"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">In determining the
payment 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 diagnostic 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 <quote>Secretary</quote>)
shall take into account, as applicable and available, the following factors
with respect to such a new test:</text>
<clause commented="no" id="HC5DBE6454185416188935D805DFBB539"><enum>(i)</enum><header>Impact on
patient care</header><text display-inline="yes-display-inline">The impact of
the new test on patient care, patient management, or patient treatment.</text>
</clause><clause commented="no" id="H260F1263E74C470698E048C316D861DF"><enum>(ii)</enum><header>Technical
characteristics</header><text display-inline="yes-display-inline">The technical
characteristics of the new test, and the resources required to develop,
validate, and perform the new test.</text>
</clause><clause commented="no" id="HADC13E021AC44678A92A9612C3747103"><enum>(iii)</enum><header>Claims
data</header><text display-inline="yes-display-inline">Data from claims for
which payment is made under part B of title XVIII of the Social Security
Act.</text>
</clause><clause commented="no" id="HD9274F3E10D1423489F664FDFEC4AF2F"><enum>(iv)</enum><header>Laboratory
charges</header><text display-inline="yes-display-inline">Amounts charged by
laboratories to self-pay patients for the new test.</text>
</clause><clause commented="no" id="H82753F39078E4FBBA5E425E5BD6630B1"><enum>(v)</enum><header>Private
insurance rates</header><text display-inline="yes-display-inline">Amounts paid
to laboratories for such new test under private health insurance coverage
offered in the group market and the individual market.</text>
</clause><clause commented="no" id="H2B9DBEFBAF3F4C4A95D5B00B34563121"><enum>(vi)</enum><header>Advisory panel
recommendations</header><text display-inline="yes-display-inline">The findings
and recommendations of the independent advisory panel convened under paragraph
(2) with respect to that new test and any comments received during the open
meeting of the advisory panel.</text>
</clause><clause commented="no" id="HA3BF8DBF4B9043909EB409401F41536F"><enum>(vii)</enum><header>Additional
factors</header><text display-inline="yes-display-inline">Such other factors as
the Secretary may specify.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H69859EF6ED364B6CA005EDA2164CFCA7"><enum>(2)</enum><header>Input from
patients, clinicians, and technical experts</header>
<subparagraph commented="no" id="HA2A982E8DB554E2FBA8C26EC270D5D8E"><enum>(A)</enum><header>Requirement for
independent advisory panel</header><text display-inline="yes-display-inline">The Secretary shall convene an independent
advisory panel from which the Secretary shall request information and
recommendations regarding any new test (as referred 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.</text>
</subparagraph><subparagraph commented="no" id="H2806A1AD223C4A50A240C699D944E8A7"><enum>(B)</enum><header>Composition of
independent advisory panel</header><text display-inline="yes-display-inline">The independent advisory panel shall be
comprised of 19 members, including—</text>
<clause commented="no" id="H844E5E5960A24B348E2B5AE99982551A"><enum>(i)</enum><text display-inline="yes-display-inline">4 individuals with expertise and experience
with advanced clinical diagnostic laboratory tests, including expertise in the
technical characteristics of the new test;</text>
</clause><clause commented="no" id="HEB8BA6F8C82F40DF90839693DF609109"><enum>(ii)</enum><text>3 representatives
of patients, including a patient representative for rare disorders;</text>
</clause><clause commented="no" id="HE1485BE78B404E9DA523C22CA3C94098"><enum>(iii)</enum><text>3 clinicians who
use results of the new test in patient care;</text>
</clause><clause commented="no" id="H68E8E941CBE44F329938E09A1F59FD16"><enum>(iv)</enum><text>3 individuals
with expertise in the requirements to develop, validate, and perform the new
test;</text>
</clause><clause commented="no" id="HB2877617326A42BDB6464D139174DF30"><enum>(v)</enum><text>2
laboratorians;</text>
</clause><clause commented="no" id="H0B3CE6F751544C56A3ED636A23C3E21E"><enum>(vi)</enum><text>2 experts in the
area of pharmacoeconomics or health technology assessment; and</text>
</clause><clause commented="no" id="HFDF6164FDF0C436AB0FEA2000DC24F23"><enum>(vii)</enum><text>2 individuals
with expertise on the impact of new tests on quality of patient care, including
genetic counselors.</text>
</clause></subparagraph><subparagraph commented="no" id="HB1C080195DCB4C3B965D6B0B174F784F"><enum>(C)</enum><header>Terms</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph id="H1857D3530449484BBC8F7B7928E9AD78"><enum>(D)</enum><header>Expert
consultants</header><text>The Secretary may include to serve temporarily on the
panel individuals who have expertise pertaining to the new test
involved.</text>
</subparagraph><subparagraph commented="no" id="HB4D037FF176247C9B788A834C0FE7386"><enum>(E)</enum><header>Open
meetings</header><text display-inline="yes-display-inline">The Secretary shall
receive or review the findings and recommendations of the independent advisory
panel with respect to the new tests described in subparagraph (A) involved
during a meeting open to the public and provide opportunity for public
comment.</text>
</subparagraph><subparagraph commented="no" id="H3C19BB32F6384815AAAA6B5E7A733588"><enum>(F)</enum><header>Clarification of
authority of secretary to consult carriers</header><text display-inline="yes-display-inline">Nothing in this section shall be construed
as affecting the authority of the Secretary to consult with appropriate
Medicare administrative contractors.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HDDFBDC79D93444718D086B686FA4AE45"><enum>(b)</enum><header>Process for
assignment of temporary codes for diagnostic tests</header><text display-inline="yes-display-inline">The
Secretary shall establish a process for application for the assignment of a
temporary national HCPCS code to uniquely identify a diagnostic 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 quarterly
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.</text>
</subsection><subsection commented="no" id="HDB130CE92770461F93BEF31ABD61380F"><enum>(c)</enum><header>Development of
further improvements in rate-Setting processes</header><text display-inline="yes-display-inline">The Secretary shall analyze the process
used for the gapfilling procedure used in determining payment amounts for new
clinical diagnostic laboratory tests under section 1833(h)(8) of the Social
Security Act. Taking into account the changes made by this section, the
Secretary shall identify further changes to improve the accuracy and
appropriateness of resulting rates and the openness, transparency, and
predictability of the process. The Secretary shall examine what and how many
entities should perform gapfilling, under contract or otherwise, and how to
ensure that the process is informed by appropriate expertise and proceeds in a
transparent and accountable manner. The Secretary shall implement improvements
in the process, insofar as these are possible under the law through
regulations, after public notice and opportunity for comment. For changes the
Secretary determines 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.</text>
</subsection><subsection id="HCEE6EEEA2AFD4BAA9ABBD5AB1A1341F0"><enum>(d)</enum><header>Definitions</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<paragraph id="H898E079AE7E340F485EA71657AC5FA87"><enum>(1)</enum><header>New clinical
diagnostic laboratory tests</header><text display-inline="yes-display-inline">The term <term>new clinical diagnostic
laboratory test</term> means a clinical diagnostic laboratory test—</text>
<subparagraph id="HEA1380BB28764416B8C6FF2BA8DA9471"><enum>(A)</enum><text>that is assigned a
new or substantially revised code on or after January 1, 2013; or</text>
</subparagraph><subparagraph id="H517341236DDD40319EE553F80C083402"><enum>(B)</enum><text>for which an
application for a temporary national HCPCS code is made under subsection (b) on
or after January 1, 2013.</text>
</subparagraph></paragraph><paragraph id="HB874A9BC7F304444AED0D558C06CE105"><enum>(2)</enum><header>Self-pay
patient</header><text>The term <term>self-pay patient</term> means, with
respect to a health care item 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.</text>
</paragraph></subsection><subsection commented="no" id="H764AC3DC777349BB8D0E7231626B4382"><enum>(e)</enum><header>Effective
date</header><text display-inline="yes-display-inline">This section shall take
effect on the date of enactment of this Act, and shall apply with respect to
new clinical diagnostic laboratory tests.</text>
</subsection></section><section id="H3DF86E358CF049E9A5CA1BFD36092F2D"><enum>103.</enum><header>Promoting the
development of innovative diagnostics</header>
<subsection commented="no" display-inline="no-display-inline" id="H97A6225D583642CB9DDDE312CB9EFF15"><enum>(a)</enum><header>Determination</header>
<paragraph id="H786784707FAB4A7BACC67167D45E9821"><enum>(1)</enum><header>Request</header><text display-inline="yes-display-inline">The manufacturer or sponsor of a drug or
biological product may request the Secretary to determine that—</text>
<subparagraph id="H0F7BE6A09FCD4866AA64B64882322720"><enum>(A)</enum><text>a diagnostic test
has been developed by, or with the participation of, the manufacturer or
sponsor of the drug or biological product; and</text>
</subparagraph><subparagraph id="H4DD09BAA2E27475D8BAA3060BF4EECFA"><enum>(B)</enum><text>use of the
diagnostic test, as demonstrated through valid scientific information such as
peer-reviewed literature—</text>
<clause id="H2206E46E7C2546EBB23F7D15697E0E92"><enum>(i)</enum><text>provides for or
improves the identification of a patient population for which the drug or
biological product will or will not be used in accordance with its approved
indications; or</text>
</clause><clause id="HFC495AA7FBC4460FAC2F5A497723EEBE"><enum>(ii)</enum><text display-inline="yes-display-inline">provides for or improves the determination
of the most appropriate treatment option for a patient population with the drug
or biological product in accordance with its approved indications.</text>
</clause></subparagraph></paragraph><paragraph id="HB7926919E9304DEC9BDFE13C3617F0F3"><enum>(2)</enum><header>Response by
Secretary</header><text>Not later than 30 days after the submission of a
request under paragraph (1), the Secretary, shall—</text>
<subparagraph id="HA7FAC61700FC44109014905350EA1A78"><enum>(A)</enum><text display-inline="yes-display-inline">make the requested determination and
publish a notice of such determination and any extension under this section
resulting from such determination; or</text>
</subparagraph><subparagraph id="H8FCB87FD299E4789A674776076E3EA45"><enum>(B)</enum><text>provide an
explanation to the manufacturer or sponsor submitting the request of why the
determination is not warranted.</text>
</subparagraph></paragraph></subsection><subsection id="H839747D9C3A343B5A1360C8448F2C2A6"><enum>(b)</enum><header>Applicable
extension period</header><text>For purposes of subsections (c) and (d), the
applicable extension period is—</text>
<paragraph id="H7E1E030016554DC792C08C4D0AA64662"><enum>(1)</enum><text>with respect to a
diagnostic test developed (as described in subsection (a)(1)(A))
contemporaneously with the development of the drug or biological product
involved, 12 months; and</text>
</paragraph><paragraph id="H5826C0A4FA1F46F3802E88817744794A"><enum>(2)</enum><text>with respect to a
diagnostic test developed otherwise, 6 months.</text>
</paragraph></subsection><subsection commented="no" id="H5262DE1E0F8F4C01B9930628B85994F2"><enum>(c)</enum><header>Extension for
drugs</header><text>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—</text>
<paragraph commented="no" id="HD6A3C2274A044D389B0C6D9CB73120BB"><enum>(1)</enum><text display-inline="yes-display-inline">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 Cosmetic Act (21 U.S.C. 360cc), as
applicable, shall be extended by the applicable extension period;</text>
</paragraph><paragraph commented="no" id="HD381FF6966064FABAF83E17C352142E2"><enum>(2)</enum><text>if the drug is the
subject of—</text>
<subparagraph commented="no" id="HF64602CAF5B547DA8FDA66AB86E0C468"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph commented="no" id="H818BD00E406C4B89B21A8FCD667C7844"><enum>(B)</enum><text>a listed patent
for which a certification has been submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of such section 505,</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">then 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 applicable extension period after the date
the patent expires (including any patent extensions); and</continuation-text></paragraph><paragraph commented="no" id="H0B367987BF5942E6A6D58F6CC07B4E71"><enum>(3)</enum><text>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 litigation resulting from the certification the court
determines that the patent is valid and would be infringed, 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 applicable extension period after
the date the patent expires (including any patent extension).</text>
</paragraph></subsection><subsection id="HF8CA7DFB10044889AE00D72B32B7A8D5"><enum>(d)</enum><header>Extension for
biological products</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection display-inline="no-display-inline" id="HC8A6F5589E1B489CBC219DF06118B3C7"><enum>(e)</enum><header>Relation to
pediatric exclusivity</header><text>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 product.</text>
</subsection><subsection id="H7D2C6553A5A2405996D1AB4D5036B314"><enum>(f)</enum><header>Limitations</header><text display-inline="yes-display-inline">Extensions under this section may
apply—</text>
<paragraph id="H817B95BE8239411088630F1CE997A86E"><enum>(1)</enum><text>not more than
twice with respect to the same drug or biological product; and</text>
</paragraph><paragraph id="HE3E5F4095EC7466DA2E32BDBB336B26D"><enum>(2)</enum><text>not more than once
with respect to the same indication to be treated by the same drug or
biological product.</text>
</paragraph></subsection></section><enum>II</enum><header>Capturing lost
opportunities for patients</header>
<section id="H51A7F2AFB6654E8AAF347FFA473DE511"><enum>201.</enum><header>Designation of
dormant therapies</header>
<subsection id="HF90E86F151FA4C5BB0C769978B0B06AC"><enum>(a)</enum><header>Designation</header><text>The
Secretary shall designate a drug or biological product as a dormant therapy
if—</text>
<paragraph id="H5F96AEC953A147C88AF8920BC85411D9"><enum>(1)</enum><text>the sponsor of the
drug or biological product submits a request in accordance with subsection (b);
and</text>
</paragraph><paragraph id="HFCCCCB1A87AB4EFCA030404F57CD1AFC"><enum>(2)</enum><text display-inline="yes-display-inline">the Secretary determines that—</text>
<subparagraph id="H3B0786374EC54719BF79DAD0159E706B"><enum>(A)</enum><text display-inline="yes-display-inline">the indication for which the drug or
biological product is being investigated or is intended to be investigated is
to address one or more unmet medical needs; and</text>
</subparagraph><subparagraph id="H76A06A0A5E0E4D28ABF3A84B1CFBF904"><enum>(B)</enum><text>the sponsor
intends to file an application 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.</text>
</subparagraph></paragraph></subsection><subsection id="HF59C95D2F0DA4D7B9571AB6720DEE382"><enum>(b)</enum><header>Request for
designation</header>
<paragraph id="H6921913DE9764AF295BE3E5DB3634112"><enum>(1)</enum><header>Submission</header><text>The
sponsor of a drug or biological product may submit a request to the Secretary
to designate the drug or biological product as a dormant therapy.</text>
</paragraph><paragraph id="H8DF40AEEC65F4A869E143C012632EB56"><enum>(2)</enum><header>Contents</header><text>Any
request under paragraph (1) with respect to a drug or biological product shall
contain each of the following:</text>
<subparagraph id="HDA450E423A4D436AAF1C7CDF3B6778C5"><enum>(A)</enum><text display-inline="yes-display-inline">A listing of all patents and applications
for patents—</text>
<clause id="HA86A39D79D894D0D86DF27B57B3CC015"><enum>(i)</enum><text>under which the
sponsor has rights; and</text>
</clause><clause id="H47A397BA3BC549BC9C0330430F01B8BC"><enum>(ii)</enum><text>which may be
reasonably construed to provide protection for the drug or biological
product.</text>
</clause></subparagraph><subparagraph id="HC372BDC4434B49668C93F11C84962B8C"><enum>(B)</enum><text>A waiver of
enforcement rights in accordance with paragraph (3).</text>
</subparagraph><subparagraph id="H9F8C7B803DEA4686BE8F64A17A79B603"><enum>(C)</enum><text>A certification by
the sponsor that the new drug or new biological product has prospectively
insufficient patent protection.</text>
</subparagraph></paragraph><paragraph id="HFD679B07C6E7454DB5E4E6C8B06B35F0"><enum>(3)</enum><header>Waiver</header>
<subparagraph id="HF26AEEB160F848BBBDD1AC8959F32F95"><enum>(A)</enum><header>Requirement</header><text>A
request under paragraph (1) shall contain a waiver of the right to enforce any
patent or patent application, which issues as a patent described in paragraph
(2)(A) with respect to any product described in subparagraph (B).</text>
</subparagraph><subparagraph id="HCCE9298133F0440C8853C4CF955A53B8"><enum>(B)</enum><header>Products
described</header><text display-inline="yes-display-inline">A product is
described in this subparagraph if—</text>
<clause id="H3AA102EA33584750A72E8C1398234BFC"><enum>(i)</enum><text>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</text>
</clause><clause id="H46E3107CF248429496CB657155EE8EFC"><enum>(ii)</enum><text>the
filing occurs after the expiration of the protection period (as defined in
section 202(a)(1) of this Act) applicable to the drug or biological product to
which the request under paragraph (1) relates.</text>
</clause></subparagraph><subparagraph id="H52130BACFB9A4B0D935AA9BAE617332A"><enum>(C)</enum><header>Effective only
upon designation</header><text>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.</text>
</subparagraph><subparagraph id="H0FDAFDA2E7E043BC90D71448AD41FDE9"><enum>(D)</enum><header>Inability to
waive right to enforce one or more patents</header><text>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)—</text>
<clause id="H4C29BB903AA74884AF2725342FE97067"><enum>(i)</enum><text>the
sponsor may not make a request under this subsection with respect to the drug
or biological product; and</text>
</clause><clause id="H47E95136E864468295663C3637FA991E"><enum>(ii)</enum><text>if
the sponsor has made such a request, the sponsor shall promptly withdraw the
request.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="HF8646E349A6642DFBB854119D6F837D0"><enum>(4)</enum><header>Timing</header>
<subparagraph commented="no" id="HD1B4D0C6D9504057B0B68B49834A99C6"><enum>(A)</enum><header>Request</header><text display-inline="yes-display-inline">Any request for designation of a drug or
biological product as a dormant therapy under subsection (a) shall be made
before the submission of an application under section 505 of the Federal Food,
Drug, 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 biological product that shares at least one
active moiety with an active moiety in the drug or biological product for which
designation is being requested.</text>
</subparagraph><subparagraph commented="no" id="H18F3F2F24D104ECD9DB40831DA66B9EB"><enum>(B)</enum><header>Withdrawal of
request</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph commented="no" id="HEEB1C8248CD74D71A978A3D6AA54AC85"><enum>(5)</enum><header>Effects of
withdrawal of request</header><text>If the sponsor of a drug or biological
product withdraws a request under paragraph (1) with respect to the drug or
biological product—</text>
<subparagraph commented="no" id="H6EE8B1592A0D447B830E4A39A697FF8E"><enum>(A)</enum><text display-inline="yes-display-inline">any designation of the drug or biological
product as a dormant therapy under subsection (a) is cancelled; and</text>
</subparagraph><subparagraph commented="no" id="H42B5B64EA26F4A6AAD62C0324D88F524"><enum>(B)</enum><text display-inline="yes-display-inline">any waiver submitted under this subsection
with respect to the drug or biological product is cancelled.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HA5B7638C7FFC4A299694790FA9795DAB"><enum>(c)</enum><header>Criteria for
designation</header>
<paragraph commented="no" id="H5F609DBD189047E4A70095897965337D"><enum>(1)</enum><header>In
general</header><text>Not later than 18 months after the date of the enactment
of this Act, the Secretary shall establish a comprehensive methodology and
criteria for the designation of a drug or biological 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.</text>
</paragraph><paragraph commented="no" id="H550683B3E4BA4CFCA8E706820F8731AE"><enum>(2)</enum><header>Public
input</header><text display-inline="yes-display-inline">The Secretary shall
consult with relevant stakeholders and provide an opportunity for public notice
and comment in—</text>
<subparagraph id="H16D0631752FF49988D2FD7E7FF361F71"><enum>(A)</enum><text>establishing the
methodology and criteria under paragraph (1); and</text>
</subparagraph><subparagraph commented="no" id="HB64BB392F4174B26988D4A1D96F5EA95"><enum>(B)</enum><text display-inline="yes-display-inline">establishing criteria for determining
whether the indication for which the drug or biological product is being
investigated or is intended to be investigated is to address one or more unmet
medical needs (as described in subsection (a)(2)(A)).</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HCA97FC3A536A4338BFE7CF55BB4882E2"><enum>(d)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text>
<paragraph commented="no" id="HB27D68B75593462ABB79728C4BF41ED2"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>prospectively insufficient
patent protection</term> means, with respect to a drug or biological product
for which a request for designation is submitted under subsection (b) (in this
paragraph referred to as the <quote>dormant therapy</quote>), that the
protection afforded under patents and patent applications, when issued as a
patent, relating to the dormant therapy, in the aggregate—</text>
<subparagraph commented="no" id="H73D21C2E21004DC195A711FDB8BBF467"><enum>(A)</enum><text>are not reasonably
anticipated by the sponsor of the dormant therapy to provide an adequate scope
of protection to prevent the approval of products that would rely upon or
reference the dormant therapy, in an application 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)),
or</text>
</subparagraph><subparagraph commented="no" id="H2CD4E102713B4DEBA1C3B16AF81F9AD2"><enum>(B)</enum><text>are not reasonably
anticipated by the sponsor of the dormant therapy to provide patent protection
under such patents and applications, when issued as a patent,</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">for a period of 14 years from the
date of first approval or licensing of the dormant therapy for marketing
pursuant to 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)).</continuation-text></paragraph><paragraph id="HD7FDA60126B94D9FA3E141E1F3E39434"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>address one or more unmet
medical needs</term> refers to—</text>
<subparagraph id="H3BECA3A7C3F94141838B7D7BAE8B7A57"><enum>(A)</enum><text>addressing a need
for drugs or biological products for the treatment of one or more
life-threatening or other serious diseases or conditions for which no therapy
exists; or</text>
</subparagraph><subparagraph id="HB3A8A259BE6040C8A5D1623C37472EDC"><enum>(B)</enum><text>if one or more
therapies are available for the treatment of such a disease or condition,
demonstrating through clinical investigations—</text>
<clause id="HC69A67E4A1D54456AEE748B53902595C"><enum>(i)</enum><text>one
or more improved effects on serious outcomes of the disease or condition that
are affected by alternative therapies, such as superiority of the drug or
biological product used alone or in combination with other therapies in an
active controlled trial assessing an endpoint reflecting serious
morbidity;</text>
</clause><clause display-inline="no-display-inline" id="H71DD45BA137142B1A4432655BF30A784"><enum>(ii)</enum><text display-inline="yes-display-inline">one or more effects on serious outcomes of
the disease or condition not known to be affected by alternative therapies,
such as progressive disability in multiple sclerosis when alternative therapies
have shown an effect on exacerbations but have not shown an effect on
progressive disability;</text>
</clause><clause id="HECA25775B45E40B48BFAFF3B2960EB73"><enum>(iii)</enum><text display-inline="yes-display-inline">an ability—</text>
<subclause id="HF5C9840451594C5491B86298633253A9"><enum>(I)</enum><text>to provide one or
more benefits in patients who are unable to tolerate or are unresponsive to
alternative therapies, such as an antipsychotic agent that is effective in
people failing standard therapy; or</text>
</subclause><subclause id="HFFD98FB321FC4D92AD9ACB435D51CBCD"><enum>(II)</enum><text>to be used
effectively in combination with other critical agents that cannot be combined
with alternative therapies;</text>
</subclause></clause><clause id="H57BEE32DB83B4056BC0D322BBBD398EF"><enum>(iv)</enum><text display-inline="yes-display-inline">an ability to provide one or more benefits
similar to those of alternative therapies while—</text>
<subclause id="H1C3B0A0AF4C14430B3D63CC4195637A0"><enum>(I)</enum><text>avoiding serious
toxicity that is present in alternative therapies; or</text>
</subclause><subclause id="HCC04AB4B8625475D90B374BA8EF0FF69"><enum>(II)</enum><text display-inline="yes-display-inline">avoiding less serious toxicity that is
common in alternative therapies and causes discontinuation of treatment of a
life-threatening or serious disease; or</text>
</subclause></clause><clause id="H04BDA8B19EC84DA3B2263574CB4A28B0"><enum>(v)</enum><text display-inline="yes-display-inline">an ability to provide one or more benefits
similar to those of alternative therapies but with improvement in some factor,
such as compliance or convenience, that is shown to lead to improved effects on
serious outcomes.</text>
</clause></subparagraph></paragraph></subsection><subsection id="H40D0203DDC63420AAD6FC2E48D785856"><enum>(e)</enum><header>Public notice of
designation</header><text display-inline="yes-display-inline">The Secretary
request for and notice of the designation of a dormant therapy under paragraph
(4) shall be made available to the public.</text>
</subsection></section><section id="HEB20973EA25B41879C971ACE679F80EB"><enum>202.</enum><header>Promoting the
development of dormant therapies</header>
<subsection id="H6227DB51F0F148C4883D1B09481FF1BE"><enum>(a)</enum><header>Protections for
dormant therapy</header>
<paragraph id="H8BF45673EC30479BB862673CDF866BB3"><enum>(1)</enum><header>Protection
period</header><text display-inline="yes-display-inline">The term
<term>protection period</term> means, with respect to a drug or biological
product designated as a dormant therapy under section 201(a) (in this section
referred to as the <quote>dormant therapy</quote>), the 15-year period
beginning 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 product.</text>
</paragraph><paragraph id="H1A80D85419F247C49D8B365ED6ED1832"><enum>(2)</enum><header>Applications
filed during the protection period</header><text display-inline="yes-display-inline">During the protection period for a dormant
therapy, notwithstanding any other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42
U.S.C. 201 et seq.)—</text>
<subparagraph id="H8CC8C40C1EBD4902BDEE976E9DBDDA84"><enum>(A)</enum><text>absent a right of
reference from the holder of such approved application for the dormant 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)) referencing or otherwise relying on the approval or licensure of
the dormant therapy;</text>
</subparagraph><subparagraph id="HA611D1F2D514474CBD5624EACB5FACCB"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary shall not approve—</text>
<clause id="HC30EFB8579E34FAEB8604299F98E0C00"><enum>(i)</enum><text>an
application filed pursuant to such section 505(b)(2) or 505(j) that references
or otherwise relies on the approval or licensure of a drug or biological
product that is not the dormant therapy but contains the same active moiety as
the dormant therapy; or</text>
</clause><clause id="H6C679D4E1D00408A809384F1E5AE3421"><enum>(ii)</enum><text>an
application filed pursuant to such section 351(k) that references or otherwise
relies on the approval or licensure of a drug or biological product that is not
the dormant therapy but contains an active moiety highly similar to that of the
dormant therapy; and</text>
</clause></subparagraph><subparagraph id="HE36101E92CBE40E491CA0AE022F79634"><enum>(C)</enum><text display-inline="yes-display-inline">the Secretary shall not approve an
application 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 provided 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.</text>
</subparagraph></paragraph><paragraph id="H7793E64D8CFB438297F02760012B3B57"><enum>(3)</enum><header>Regulations</header><text>Not
later than 18 months after the date of the enactment of this Act, the
Secretary, in consultation with relevant Federal agencies, shall promulgate
such regulations as are required to implement the incentives described in
paragraph (2).</text>
</paragraph><paragraph commented="no" id="HC2F84ED67C9B4FE6BDE9CE418129B6D5"><enum>(4)</enum><header>Patent term
alignment with data package protection period</header>
<subparagraph commented="no" id="HD79720F915174274B846B7AFC6795280"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any provision of title 35, United States
Code, a sponsor of a drug or biologic product designated 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 filing a
patent term extension application under section 156(d) of such title 35 (other
than applications for interim extensions filed under paragraph (5) of such
section 156(d)), shall be entitled to patent term extension in accordance with
this paragraph.</text>
</subparagraph><subparagraph commented="no" id="H5D008A04228F41F0921DD69AAB2F2978"><enum>(B)</enum><header>Submission of
listing of patents and applications for patents</header>
<clause commented="no" id="HE507D29C646D47D0B099E22702B547A5"><enum>(i)</enum><header>Submission</header><text>The
sponsor of the dormant therapy, within a period to be set by the Director of
the United States Patent and Trademark Office (in this paragraph referred to as
the <quote>Director</quote>), shall submit to the Director—</text>
<subclause commented="no" id="H216C0F1C250D4FAE9C0B2AF8958AE511"><enum>(I)</enum><text>the listing of
patents and applications for patents required by section 201(b)(2)(A) with
respect to the dormant therapy; and</text>
</subclause><subclause commented="no" id="HEE081C3963DD40DD8889EB86757D9DCE"><enum>(II)</enum><text>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).</text>
</subclause></clause><clause commented="no" id="H88A1BE34415347ED9F3D290F2A31E5D9"><enum>(ii)</enum><header>Period</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" id="HA241C5EE90974F0C8CFA44C90F31E5F3"><enum>(C)</enum><header>Extension of
patents</header>
<clause commented="no" id="H49AC3B7509E545069956F1BF35AC151D"><enum>(i)</enum><header>In
general</header><text>For each patent identified pursuant to subparagraph
(B)(i), and for each patent issuing based upon an application for patent so
identified, the Director 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.</text>
</clause><clause commented="no" id="H6DEFC3FE30AC49449A338A922DAC4658"><enum>(ii)</enum><header>Application of
certain provisions</header><text>During the period of an extension under clause
(i)—</text>
<subclause commented="no" id="H7674107791EA48CB857FC769CC1C990A"><enum>(I)</enum><text>the rights under
the patent shall be limited in the manner provided under section 156(b) of
title 35, United States Code; and</text>
</subclause><subclause commented="no" id="HE7C1975246CC49BDAB8F6839FD1677CF"><enum>(II)</enum><text>the terms
<term>product</term> and <term>approved product</term> in such section 156(b)
shall be deemed to include forms of the active moiety of the dormant therapy
and highly similar active moieties that might be approved by the Secretary
based upon an application 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
references or otherwise relies upon the dormant therapy.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="H812D9E134BE24D3383131682C6DF8297"><enum>(D)</enum><header>Notice of
extension</header><text>For each patent that is extended under this paragraph,
the Director shall publish a notice of such extension.</text>
</subparagraph><subparagraph commented="no" id="H367A1A7F8265416F8A0B0D2219E3F070"><enum>(E)</enum><header>Notice of
waiver</header><text display-inline="yes-display-inline">For each patent
identified pursuant to subparagraph (B)(i), and each patent issuing based upon
an application for patent so identified, that expires subsequent to the end of
the protection period for the dormant therapy under paragraph (1), the Director
shall publish a notice that the patent is subject to the waiver of the right to
enforce as described section 201(b)(3).</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H233E017C764549D98FD8E3DE5D01B0AD"><enum>(b)</enum><header>Orphan
products</header><text>If a drug or biological product has been designated as a
dormant therapy under section 201(a) of this Act, the protections otherwise
applicable with respect to such drug or biological product under section 527 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) shall not
apply.</text>
</subsection><subsection id="H607DF19298F944B9A64E51D33D0416EB"><enum>(c)</enum><header>Study regarding
dormant therapies</header><text display-inline="yes-display-inline">Not later
than one year after the enactment of this Act, the Secretary shall enter into
an agreement with the Director of the Institute of Medicine—</text>
<paragraph id="H209583BD732D4F78A9B51D36FD47AAE6"><enum>(1)</enum><text>to conduct a study
on intellectual property laws and their impact on therapy and diagnostic
development in order to formulate recommendations on how to facilitate the
clinical evaluation and development of therapies currently available on the
market for new potential indications; and</text>
</paragraph><paragraph id="HF2682A7951174965A8F771475260A6D0"><enum>(2)</enum><text>not later than 18
months after the date of the enactment of this Act, to submit a report to the
Secretary and the Congress containing the results of such study.</text>
</paragraph></subsection></section>