Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011 or the MODDERN Cures Act of 2011 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers.; and (2) publish a guide regarding such terms and definitions.
Sets forth additional factors for the Secretary to consider in determining the payment amount for new clinical diagnostic laboratory tests under gap filling procedures which are used when no comparable existing test is available.
Extends the exclusivity period for a drug or biological product if the diagnostic test related to such drug has been determined by the Secretary to have been developed by, or with the participation of, the manufacturer or sponsor of the drug or biological product, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the drug or biological product; or (2) the determination of the most appropriate treatment option for a patient population with the drug or biological product.
Establishes a dormant therapy designation for drugs or biological products that address unmet medical needs. Gives such a drug or biological product 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3497 Introduced in House (IH)]
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 Representatives 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.
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 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.
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).
(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 FACILITATE 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, and determinations with
respect to meeting its duties described in paragraphs (1) and
(2).
(c) Chairperson.--The Secretary, or the Secretary's designee, shall
serve as chairperson of the Council.
(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.
(2) Seven members appointed by the Secretary from among
individuals who collectively--
(A) represent a broad range of perspectives; 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.
SEC. 102. CREATING INCENTIVES FOR INNOVATIVE DIAGNOSTICS.
(a) Improvements to Process for Determining Fee Schedule Amounts
for New Tests.--
(1) Clarifying factors for rate-setting.--
(A) In general.--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
``Secretary'') shall take into account, as applicable
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, patient
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.
(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 coverage offered in the group
market and the individual market.
(vi) Advisory panel recommendations.--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.
(vii) Additional factors.--Such other
factors as the Secretary may specify.
(2) Input from patients, clinicians, and technical
experts.--
(A) Requirement for independent advisory panel.--
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.
(B) Composition of independent advisory panel.--The
independent advisory panel shall be comprised of 19
members, including--
(i) 4 individuals with expertise and
experience with advanced clinical diagnostic
laboratory tests, including expertise in the
technical characteristics of the new test;
(ii) 3 representatives of patients,
including 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 perform
the new test;
(v) 2 laboratorians;
(vi) 2 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 patient 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 Secretary 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 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.
(F) Clarification of authority of secretary to
consult carriers.--Nothing in this section shall be
construed as affecting the authority of the Secretary
to consult with appropriate Medicare administrative
contractors.
(b) Process for Assignment of Temporary Codes for Diagnostic
Tests.--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.
(c) Development of Further Improvements in Rate-Setting
Processes.--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.
(d) Definitions.--For purposes of this section:
(1) New clinical diagnostic laboratory tests.--The term
``new clinical diagnostic laboratory 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 temporary
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 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 Secretary to determine
that--
(A) a diagnostic test has been developed by, or
with the participation of, the manufacturer or sponsor
of the drug or biological product; and
(B) use of the diagnostic test, as demonstrated
through valid scientific information such as peer-
reviewed literature--
(i) 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
(ii) 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.
(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 manufacturer 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)) contemporaneously with the
development of the drug or biological product involved, 12
months; and
(2) with respect to a diagnostic test developed otherwise,
6 months.
(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
Cosmetic 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 section 505,
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
(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 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).
(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.
(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
product.
(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 product submits a
request in accordance with subsection (b); and
(2) the Secretary determines that--
(A) 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
(B) 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.
(b) Request for Designation.--
(1) Submission.--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.
(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 applications for
patents--
(i) under which the sponsor has rights; and
(ii) which may be reasonably construed to
provide protection for the drug or biological
product.
(B) A waiver of enforcement rights in accordance
with paragraph (3).
(C) A certification by the sponsor that the new
drug or new biological product has prospectively
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 application, which issues as a patent
described in paragraph (2)(A) with respect to any
product described 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 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.
(C) Effective only upon designation.--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 enforce 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 request
under this subsection with respect to the drug
or biological product; and
(ii) if the sponsor has made such a
request, the sponsor shall promptly withdraw
the request.
(4) Timing.--
(A) Request.--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.
(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 withdraws a request under paragraph
(1) with respect to the drug or biological product--
(A) any designation of the drug or biological
product as a dormant therapy under subsection (a) is
cancelled; and
(B) any waiver submitted under this subsection with
respect to the drug or biological product is cancelled.
(c) Criteria for Designation.--
(1) In general.--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.
(2) Public input.--The Secretary shall consult with
relevant stakeholders and provide an opportunity for public
notice and comment in--
(A) establishing the methodology and criteria under
paragraph (1); and
(B) 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)).
(d) Definitions.--In this section:
(1) The term ``prospectively insufficient patent
protection'' 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 ``dormant
therapy''), that the protection afforded under patents and
patent applications, when issued as a patent, relating to the
dormant therapy, in the aggregate--
(A) 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
(B) 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,
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)).
(2) The term ``address one or more unmet medical needs''
refers to--
(A) 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
(B) if one or more therapies are available for the
treatment of such a disease or condition, demonstrating
through clinical investigations--
(i) 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;
(ii) 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;
(iii) an ability--
(I) 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
(II) to be used effectively in
combination with other critical agents
that cannot be combined with
alternative therapies;
(iv) an ability to provide one or more
benefits similar to those of alternative
therapies while--
(I) avoiding serious toxicity that
is present in alternative therapies; or
(II) avoiding less serious toxicity
that is common in alternative therapies
and causes discontinuation of treatment
of a life-threatening or serious
disease; or
(v) 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.
(e) Public Notice of Designation.--The Secretary request for and
notice of the designation of a dormant 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 ``protection period''
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 ``dormant therapy''), 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.
(2) Applications filed during the protection period.--
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.)--
(A) 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;
(B) the Secretary shall not approve--
(i) 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
(ii) 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
(C) 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.
(3) Regulations.--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).
(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 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.
(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 Patent and
Trademark Office (in this paragraph referred to
as the ``Director''), shall submit to the
Director--
(I) the listing of patents and
applications for patents required by
section 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 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.
(ii) Application of certain provisions.--
During the period of an extension under clause
(i)--
(I) the rights under the patent
shall be limited in the manner provided
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 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.
(D) Notice of extension.--For each patent that is
extended under this paragraph, the Director shall
publish a notice of such extension.
(E) Notice of waiver.--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).
(b) Orphan Products.--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.
(c) Study Regarding Dormant Therapies.--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--
(1) 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
(2) 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.
<all>
Introduced in House
Introduced in House
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.
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
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