Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - 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 medicine 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 medicine, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the medicine; or (2) the determination of the most appropriate treatment option for a patient population with the medicine.
Establishes a dormant therapy designation for medicine that addresses unmet medical needs. Gives such medicine 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.
Directs the Secretary to arrange with the Institute of Medicine (or, if it declines, another appropriate entity) to study 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.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3116 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 3116
To promote the development of meaningful treatments for patients.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 17, 2013
Mr. Lance (for himself, Mr. Roskam, Mr. Guthrie, Mr. Paulsen, Mr.
Rangel, Mr. Runyan, Ms. Schwartz, Mr. King of New York, Mr. McCaul, Mr.
Walden, Mr. Tiberi, Mr. Loebsack, Mr. Ben Ray Lujan of New Mexico, Mr.
Ellison, Mr. Jones, and Mr. Long) 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 2013'' or the ``MODDERN
Cures Act of 2013''.
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. Dormant therapies.
Sec. 202. Study regarding new indications for existing 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 billion 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 ``medicine'' means a biological product or a
drug.
(4) 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 of 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.--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:
(A) Impact on patient care.--The impact of the new
test on patient care, patient management, or patient
treatment.
(B) Technical characteristics.--The technical
characteristics of the new test, and the resources
required to develop, validate, and perform the new
test.
(C) Claims data.--Data from claims for which
payment is made under part B of title XVIII of the
Social Security Act.
(D) Laboratory charges.--Amounts charged by
laboratories to self-pay patients for the new test.
(E) 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.
(F) 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.
(G) 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.--
Subject to subparagraph (D), the independent advisory
panel shall be comprised of 19 members, including--
(i) 7 individuals with expertise and
experience with clinical diagnostic laboratory
tests including expertise in the technical
characteristics of the new test as well as
expertise in the requirements to develop,
validate, and perform 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) 2 laboratorians;
(v) 2 individuals with expertise in the
area of pharmacoeconomics or health technology
assessment; and
(vi) 2 individuals with expertise on the
impact of new tests on quality of patient care,
including genetic counselors.
(C) Terms.--Subject to subparagraph (D), 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) Temporary appointment of experts.--Insofar as
the Secretary determines with respect to a new test
that there are an insufficient number of members of the
panel with expertise with respect to that specific
test, the Secretary may appoint individuals who have
expertise pertaining to the new test involved to serve
on the panel.
(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.
(3) Justification for payment determinations.--
(A) Initial justification.--With respect to
decisions regarding payments made under the clinical
laboratory fee schedule for new clinical diagnostic
laboratory tests, the Secretary shall publicly provide
a justification for the payment basis and payment rate
determination, including a detailed summary of the
information submitted to, or obtained by, the Secretary
regarding the factors specified in paragraph (1), such
that interested stakeholders can readily understand the
Secretary's rationale for the payment basis and rate
determinations.
(B) Reconsideration period.--After providing such
justification for a payment basis and payment rate
determination, the Secretary shall provide for a
reasonable period of reconsideration to receive any
appeal of the determination and to evaluate any
additional information received regarding the
justification and the factors specified in paragraph
(1).
(C) Final determination.--After the period of
reconsideration the Secretary shall make a final
payment basis and payment rate determination and
provide a justification for such final determination
explaining what additional information was evaluated
during the reconsideration and how such information was
taken into account with respect to the final
determination. Nothing in this paragraph shall be
construed as authorizing the Secretary to reveal
proprietary information which is otherwise prohibited
from disclosure under law.
(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 Web site 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, 2014.
(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 a temporary national HCPCS code is
granted under subsection (b) on or after January 1,
2014.
(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.--
(1) In general.--Subject to paragraph (2), this section
shall take effect on the date of enactment of this Act and
shall apply with respect to new clinical diagnostic laboratory
tests.
(2) Application of justifications to current rate
determinations.--Subsection (a)(3) shall apply to payment basis
and payment rate determinations made on or after January 1,
2013.
SEC. 103. PROMOTING THE DEVELOPMENT OF INNOVATIVE DIAGNOSTICS.
(a) Determination.--
(1) Request.--The manufacturer or sponsor of a medicine 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 medicine; 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 medicine will or will not be used in
accordance with its approved indications;
(ii) provides for or improves the
determination of the most appropriate treatment
option for a patient population with the
medicine in accordance with its approved
indications; or
(iii) provides for the detection of a
qualifying pathogen (as defined in section
505E(f) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(f)).
(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 medicine 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 medicine.
(f) Limitations.--Extensions under this section may apply--
(1) not more than twice with respect to the same medicine;
and
(2) not more than once with respect to the same indication
to be treated by the same medicine.
TITLE II--CAPTURING LOST OPPORTUNITIES FOR PATIENTS
SEC. 201. DORMANT THERAPIES.
(a) Designation as Dormant Therapy.--The Secretary shall designate
a medicine as a dormant therapy if--
(1) the sponsor of the medicine submits a request for such
designation meeting the requirements under subsection (b), and
the request has not been withdrawn under subsection (d)(1); and
(2) the Secretary determines that--
(A) the medicine is being investigated or is
intended to be investigated for an indication to
address one or more unmet medical needs;
(B) a suitable clinical plan for such
investigations of the medicine has been developed by
the sponsor;
(C) 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 medicine for an indication
described in subparagraph (A); and
(D) the request for designation was made on or
before the date of submission of any 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 approval or
licensure of commercial marketing or use of a medicine
that in the case of a drug shares an active moiety that
is the same as, and in the case of a biologic contains
an active moiety that is highly similar to, an active
moiety in the medicine for which designation is being
requested.
(b) Requirements for Request for Designation as Dormant Therapy.--A
request under subsection (a)(1) with respect to a medicine may only be
made by the sponsor of the medicine and shall contain each of the
following:
(1) A listing of all patents and applications for patents
under which the sponsor has rights and that may be reasonably
construed to provide protection for the medicine.
(2) A waiver of patent rights to the extent required under
subsection (c) to take effect, if at all, as provided under
subsection (c)(3).
(3) Such additional information as the Secretary may
require by regulation in order to determine eligibility for
designation under subsection (a).
(c) Waiver of Patent Rights Expiring After the Protection Period
Ends.--
(1) Patent waiver.--
(A) In general.--Subject to subparagraph (B), the
request under this subsection shall include a waiver of
the right to enforce or otherwise assert any patent
described in subsection (b)(1) (or any patent issued on
the basis of an application described in subsection
(b)(1)), which may expire after the end of the
protection period for the dormant therapy, against any
applicable product described in paragraph (2). The
waiver shall be made by the owner of the patent or
application for patent, as the case may be.
(B) Limitations on patent waiver.--Any patent
waiver provided pursuant to this section, should it
become effective--
(i) shall have no effect during the
protection period for the medicine to which the
waiver relates; and
(ii) shall have no effect with respect to
the subject matter of a claimed invention in a
patent that does not provide any protection for
such medicine with respect to an applicable
product described in paragraph (2).
(2) Applicable products described.--An applicable product
is described in this paragraph only if--
(A) it is approved or licensed pursuant to an
application that--
(i) 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) references or otherwise relies upon
the approval or licensure of the dormant
therapy to which the waiver relates; and
(B) the approval of the product occurs after the
expiration of the protection period applicable to the
medicine to which the request under subsection (a)(1)
relates.
(3) Effective date of waiver.--A waiver under subsection
(b)(2) with respect to a patent shall take effect, if at all,
on the date the Director publishes the notice required under
subsection (e)(2)(F) relating to the patent.
(d) Withdrawal of Request for Designation, Revocation by the
Secretary.--
(1) In general.--The sponsor of a medicine may withdraw a
request for designation under subsection (a)(1) with respect to
a medicine unless the medicine has been approved or licensed
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). The Secretary shall deny a designation request
or revoke any designation granted if at any time the Secretary
finds that the sponsor is not in compliance with subsections
(c)(1) and (g)(1).
(2) Effects of withdrawal of request or revocation of
designation.--If the sponsor of a medicine withdraws a request
under subsection (b) or the Secretary denies a designation
request or revokes a designation with respect to the medicine--
(A) any patent waiver submitted under this section
with respect to the medicine, but not yet effective, is
canceled and deemed a nullity;
(B) any patent waiver that has taken effect under
this section with respect to the medicine shall remain
in effect;
(C) any patent term extension granted by the
Director under subsection (e)(2) with respect to the
medicine shall be canceled, except that the Director
shall maintain the patent term extension for one
patent, to be selected by the sponsor of the medicine,
for the period of extension that would have been
applicable under section 156 of title 35, United States
Code; and
(D) the designation, if made, otherwise shall be
treated as never having been requested or made or
having effect.
(3) Basis for revocation.--The Secretary may revoke a
designation made under subsection (a), but only based upon a
finding by the Secretary under paragraph (1).
(e) Guaranteed Protections for Dormant Therapies.--
(1) 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 medicine that is not the dormant therapy,
was approved subsequent to the approval of the
dormant therapy, and contains the same active
moiety as the active moiety in the dormant
therapy (or if the dormant therapy contains
more than one active moiety, all of the active
moieties are the same); or
(ii) an application filed pursuant to such
section 351(k) that references or otherwise
relies on the approval or licensure of a
medicine that is not the dormant therapy, was
approved subsequent to the approval or
licensure of the dormant therapy, and contains
an active moiety that is highly similar to the
active moiety in the dormant therapy (or if the
dormant therapy contains more than one active
moiety, all of the active moieties are highly
similar); 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
active moiety in the dormant therapy (or if the dormant
therapy contains more than one active moiety, all of
the active moieties are the same), 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 that is highly similar
to the active moiety in the dormant therapy (or if the
dormant therapy contains more than one active moiety,
all of the active moieties are highly similar),
unless--
(i) 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 for the dormant
therapy 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)); and
(ii) if such clinical testing had not
commenced before the approval of the
application for the dormant therapy, the
clinical testing establishes clinical
superiority in the form of a significant
therapeutic advantage over and above that
provided by the dormant therapy in one or more
of the following ways:
(I) Greater effectiveness on a
clinically meaningful endpoint.
(II) Greater safety in a
substantial portion of the target
populations.
(III) Where neither greater safety
nor greater effectiveness has been
shown, a demonstration that the drug
otherwise makes a major contribution to
patient care.
(2) Patent term alignment with data package protection
period.--
(A) In general.--Notwithstanding any provision of
title 35, United States Code, a sponsor of a medicine
designated as a dormant therapy under subsection
(a)(1), upon the approval or licensure thereof 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), and in lieu of filing a
patent term extension application under section 156(d)
of such title 35, shall be entitled to patent term
extensions in accordance with this paragraph.
(B) Submission of final listing of patents and
applications for patents following approval.--
(i) Submission.--The sponsor of the dormant
therapy, within a period to be set by the
Director of not less than 2 months beginning on
the date the Secretary approves or licenses the
dormant therapy, shall submit to the Director--
(I) the listing of patents and
applications for patents provided to
the Secretary under subsection (b)(1);
(II) any revisions to such listing
as may be required for compliance with
subsection (b)(1); and
(III) any documentation the
Director may require from the patentee
or patent applicant (as the case may
be) of the waiver of patent rights
required under subsection (b)(2).
(ii) Failure to provide sufficient
documentation of waiver.--If the Director
determines that the sponsor has not complied
with the waiver requirements under subsection
(c), after providing the sponsor the
opportunity to remedy any insufficiency, the
Director shall so notify the Secretary that the
patent waiver requirements for designation have
not been satisfied.
(C) Extension of patents.--
(i) In general.--Unless the Director has
notified the Secretary of a determination under
subparagraph (B)(ii), for each patent
identified in a submission pursuant to
subparagraph (B)(i), and for each patent
issuing based upon an application for patent so
identified, the Director shall, within the 3-
month period beginning on the date of the
submission, extend the patent to expire at the
end of the protection period for the dormant
therapy, if the patent would otherwise expire
before the end of the protection period. If the
Director has so notified the Secretary under
subparagraph (B)(ii), the Director shall extend
one such patent, selected by the sponsor, for
the period that would have been applicable had
an application for extension been filed under
section 156 of title 35, United States Code,
with respect to such patent.
(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) Interim patent extensions.--Notwithstanding any
provision of title 35, United States Code, with respect
to any patent listed (or patent issuing on an
application listed) under subsection (b)(1) that would
otherwise expire before the sponsor could make a
submission under subparagraph (B), the Director, upon
application of the patentee, shall grant to the
patentee an interim extension of such patent, subject
to the limitations in section 156(d)(5)(F) of such
title 35, for such period as may be necessary to permit
the sponsor to submit the listing under subparagraph
(B) and, if the patent is therein listed, to extend the
patent as provided under subparagraph (C). The Director
may require, for any patent extended under this
subparagraph, that the sponsor of the dormant therapy
to which the patent relates provide periodic
certifications that development of the dormant therapy
is continuing. The Director may terminate any interim
extension for which a required certification has not
been made.
(E) Notice of extension.--For each patent that is
extended under this paragraph, the Director shall
publish a notice of such extension and issue a
certificate of extension described in section 156(e)(1)
of title 35, United States Code.
(F) Notice of waiver.--For each patent identified
in a submission under subparagraph (B)(i), and each
patent issuing based upon an application for patent so
identified, that expires after the end of the
protection period for the dormant therapy, the Director
shall publish a notice that the patent is subject to
the limited waiver of the right to enforce described in
subsection (c)(1).
(f) Certain FDA Protections Inapplicable.--If a medicine has been
designated as a dormant therapy under subsection (a), the protections
otherwise applicable with respect to such medicine under sections 505A,
505E, and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a, 355f, 360cc) shall not apply. The preceding sentence shall not be
construed to affect any protections applicable with respect to a drug,
including a drug designated under section 526 of such Act (21 U.S.C.
360bb) for a rare disease or condition, under provisions other than
such sections 505A, 505E, and 527.
(g) Development Certifications.--
(1) In general.--The Secretary shall require that the
sponsor of a dormant therapy provide periodic certifications
that development of the dormant therapy to address one or more
unmet medical needs is continuing.
(2) Determination of noncompliance.--If the Secretary
concludes that the sponsor has not complied with paragraph (1),
after providing the sponsor the opportunity to remedy any
insufficiency, the Secretary shall, for purposes of subsection
(d)(1), determine that the sponsor is not in compliance with
the certification requirement under paragraph (1).
(h) Collaboration.--Nothing in this section shall be construed as
preventing a sponsor from collaborating with other entities in
developing a dormant therapy or applying for a dormant therapy
designation.
(i) Definitions.--For purposes of this section:
(1) The term ``address one or more unmet medical needs''
refers to--
(A) addressing a need for medicines 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 medicine 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.
(2) The term ``Director'' means the Under Secretary of
Commerce for Intellectual Property and Director of the United
States Patent and Trademark Office.
(3) The term ``dormant therapy'' means a medicine
designated as a dormant therapy under subsection (a).
(4) The term ``protection period'' for a dormant therapy
means the period that--
(A) begins on the date on which the Secretary first
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 dormant therapy for any
indication; and
(B) ends on the date that is 15 years after the
date of such approval.
(5) The term ``sponsor'' for a dormant therapy is the
person who takes responsibility for the designation and
development of the dormant therapy. The sponsor may be a single
entity or an entity collaborating with one or more other
entities.
SEC. 202. STUDY REGARDING NEW INDICATIONS FOR EXISTING THERAPIES.
Not later than one year after the date of the enactment of this
Act, the Secretary shall enter into an arrangement with the Institute
of Medicine (or, if the Institute declines, another appropriate
entity)--
(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 such date of the
enactment, 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 Courts, Intellectual Property, and the Internet.
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