prove 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 other-
wise, and how to ensure that the process is informed by 
appropriate expertise and proceeds in a transparent and 
accountable manner. The Secretary shall implement im-
provements in the process, insofar as these are possible 
under the law through regulations, after public notice and 
opportunity for comment. For changes the Secretary de-
termines would require a change in law, the Secretary 
shall transmit recommendations to the Speaker of the 
House of Representatives and the President of the Senate 
not later than July 1, 2015. 
(d) DEFINITIONS.—For purposes of this section: 
(1) NEW
CLINICAL
DIAGNOSTIC
LABORATORY 
TESTS.—The term ‘‘new clinical diagnostic labora-
tory test’’ means a clinical diagnostic laboratory 
test— 
(A) that is assigned a new or substantially 
revised code on or after January 1, 2015; or 
(B) for which an application for a tem-
porary national HCPCS code is made under 
subsection (b) on or after January 1, 2015. 
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(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 medicine may request the Secretary to deter-
mine that— 
(A) a diagnostic test has been developed 
by, or with the participation of, the manufac-
turer or sponsor of the medicine; and 
(B) use of the diagnostic test, as dem-
onstrated through valid scientific information 
such as peer-reviewed literature— 
(i) provides for or improves the identi-
fication of a patient population for which 
the medicine will or will not be used in ac-
cordance with its approved indications; 
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(ii) provides for or improves the deter-
mination of the most appropriate treat-
ment option for a patient population with 
the medicine in accordance with its ap-
proved 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 manufac-
turer or sponsor submitting the request of why 
the determination is not warranted. 
(b) APPLICABLE EXTENSION PERIOD.—For purposes 
of subsections (c) and (d), the applicable extension period 
is— 
(1) with respect to a diagnostic test developed 
(as described in subsection (a)(1)(A)) contempora-
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neously with the development of the medicine in-
volved, 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 Cos-
metic Act (21 U.S.C. 360cc), as applicable, shall be 
extended by the applicable extension period; 
(2) if the drug is the subject of— 
(A) a listed patent for which a certification 
has 
been 
submitted 
under 
subsection 
(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of such section 
505; or 
(B) a listed patent for which a certification 
has 
been 
submitted 
under 
subsection 
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(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of such sec-
tion 505, 
then the period during which an application may not 
be approved under subsection (c)(3) or (j)(5)(B) of 
such section 505 shall be extended by the applicable 
extension period after the date the patent expires 
(including any patent extensions); and 
(3) if the drug is the subject of a listed patent 
for which a certification has been submitted under 
subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of such 
section 505, and in the patent infringement litiga-
tion resulting from the certification the court deter-
mines that the patent is valid and would be in-
fringed, the period during which an application may 
not be approved under subsection (c)(3) or (j)(5)(B) 
of such section 505 shall be extended by the applica-
ble extension period after the date the patent expires 
(including any patent extension). 
(d) EXTENSION FOR BIOLOGICAL PRODUCTS.—If, at 
the request of the manufacturer or sponsor of a biological 
product, the Secretary makes the determination described 
in subsection (a)(1) with respect to such biological product 
and a diagnostic test, then the 12-year period described 
in subsection (k)(7)(A) of section 351 of the Public Health 
Service Act (42 U.S.C. 262), the 4-year period described 
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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 re-
quest for such designation meeting the requirements 
under subsection (b), and the request has not been 
withdrawn under subsection (d)(1); and 
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(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 inves-
tigations of the medicine has been developed by 
the sponsor; 
(C) the sponsor intends to file an applica-
tion pursuant to section 505(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) or section 351(a) of the Public Health 
Service Act (42 U.S.C. 262(a)) for approval or 
licensing of the medicine for an indication de-
scribed in subparagraph (A); and 
(D) the request for designation was made 
on or before the date of submission of any ap-
plication 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 bio-
logic contains an active moiety that is highly 
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similar to, an active moiety in the medicine for 
which designation is being requested. 
(b) REQUIREMENTS FOR REQUEST FOR DESIGNA-
TION
AS DORMANT THERAPY.—A request under sub-
section (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 re-
quired under subsection (c) to take effect, if at all, 
as provided under subsection (c)(3). 
(3) Such additional information as the Sec-
retary may require by regulation in order to deter-
mine 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 subpara-
graph (B), the request under this subsection 
shall include a waiver of the right to enforce or 
otherwise assert any patent described in sub-
section (b)(1) (or any patent issued on the basis 
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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 pro-
tection 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 pro-
tection for such medicine with respect to 
an applicable product described in para-
graph (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— 
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(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 ap-
plicable 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 sub-
section (a)(1) with respect to a medicine unless the 
medicine has been approved or licensed under sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) or section 351 of the Public 
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Health Service Act (42 U.S.C. 262). The Secretary 
shall deny a designation request or revoke any des-
ignation granted if at any time the Secretary finds 
that the sponsor is not in compliance with sub-
sections (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 re-
vokes 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 nul-
lity; 
(B) any patent waiver that has taken ef-
fect under this section with respect to the medi-
cine shall remain in effect; 
(C) any patent term extension granted by 
the Director under subsection (e)(2) with re-
spect 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 
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(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 PROTEC-
TION PERIOD.—During the protection period for a 
dormant therapy, notwithstanding any other provi-
sion 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 dor-
mant therapy, the Secretary shall not approve 
an 
application 
filed 
pursuant 
to 
section 
505(b)(2) or section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(2), (j)) or section 351(k) of the Public 
Health Service Act (42 U.S.C. 262(k)) ref-
erencing or otherwise relying on the approval or 
licensure of the dormant therapy; 
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(B) the Secretary shall not approve— 
(i) an application filed pursuant to 
such section 505(b)(2) or 505(j) that ref-
erences or otherwise relies on the approval 
or licensure of a 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 oth-
erwise relies on the approval or licensure of 
a medicine that is not the dormant ther-
apy, was approved subsequent to the ap-
proval or licensure of the dormant therapy, 
and contains an active moiety that is high-
ly similar to the active moiety in the dor-
mant therapy (or if the dormant therapy 
contains more than one active moiety, all 
of the active moieties are highly similar); 
and 
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(C) the Secretary shall not approve an ap-
plication filed pursuant to section 505(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)) for a drug that contains the 
same active moiety as the 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 bi-
ological 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 sup-
port approval of such application is com-
parable in scope and extent, including with 
respect to design and extent of preclinical 
and clinical testing, to the information pro-
vided to support approval of the applica-
tion for the dormant therapy under section 
505(b) of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 355(b)) or sec-
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tion 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 ap-
plication for the dormant therapy, the clin-
ical testing establishes clinical superiority 
in the form of a significant therapeutic ad-
vantage 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 substan-
tial portion of the target populations. 
(III) Where neither greater safe-
ty 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 ap-
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proval 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 fil-
ing 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 ap-
proves or licenses the dormant therapy, 
shall submit to the Director— 
(I) the listing of patents and ap-
plications 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 Di-
rector may require from the patentee 
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or patent applicant (as the case may 
be) of the waiver of patent rights re-
quired under subsection (b)(2). 
(ii) FAILURE TO PROVIDE SUFFICIENT 
DOCUMENTATION OF WAIVER.—If the Di-
rector determines that the sponsor has not 
complied with the waiver requirements 
under subsection (c), after providing the 
sponsor the opportunity to remedy any in-
sufficiency, the Director shall so notify the 
Secretary that the patent waiver require-
ments for designation have not been satis-
fied. 
(C) EXTENSION OF PATENTS.— 
(i) IN GENERAL.—Unless the Director 
has notified the Secretary of a determina-
tion under subparagraph (B)(ii), for each 
patent identified in a submission pursuant 
to subparagraph (B)(i), and for each pat-
ent 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 pat-
ent to expire at the end of the protection 
period for the dormant therapy, if the pat-
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ent would otherwise expire before the end 
of the protection period. If the Director 
has so notified the Secretary under sub-
paragraph (B)(ii), the Director shall ex-
tend one such patent, selected by the spon-
sor, 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 PROVI-
SIONS.—During the period of an extension 
under clause (i)— 
(I) the rights under the patent 
shall be limited in the manner pro-
vided under section 156(b) of title 35, 
United States Code; and 
(II) the terms ‘‘product’’ and 
‘‘approved product’’ in such section 
156(b) shall be deemed to include 
forms of the active moiety of the dor-
mant therapy and highly similar ac-
tive moieties that might be approved 
by the Secretary based upon an appli-
cation filed under section 505(b)(2) or 
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505(j) of the Federal Food, Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(b)(2), 
(j)) 
or 
under 
section 
351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) that ref-
erences or otherwise relies upon the 
dormant therapy. 
(D) INTERIM PATENT EXTENSIONS.—Not-
withstanding 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 submis-
sion under subparagraph (B), the Director, 
upon application of the patentee, shall grant to 
the patentee an interim extension of such pat-
ent, 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 pat-
ent 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 
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provide periodic certifications that development 
of the dormant therapy is continuing. The Di-
rector 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 ex-
tension and issue a certificate of extension de-
scribed 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 sub-
section (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 
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(21 U.S.C. 355a, 355f, 360cc) shall not apply. The pre-
ceding sentence shall not be construed to affect any pro-
tections 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 peri-
odic 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 compli-
ance with the certification requirement under para-
graph (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 ap-
plying for a dormant therapy designation. 
(i) DEFINITIONS.—For purposes of this section: 
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(1) The term ‘‘address one or more unmet med-
ical 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 condi-
tion that are affected by alternative thera-
pies, such as superiority of the medicine 
used alone or in combination with other 
therapies in an active controlled trial as-
sessing an endpoint reflecting serious mor-
bidity; 
(ii) one or more effects on serious out-
comes of the disease or condition not 
known to be affected by alternative thera-
pies, such as progressive disability in mul-
tiple sclerosis when alternative therapies 
have shown an effect on exacerbations but 
have not shown an effect on progressive 
disability; 
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(iii) an ability— 
(I) to provide one or more bene-
fits in patients who are unable to tol-
erate or are unresponsive to alter-
native 
therapies, 
such 
as 
an 
antipsychotic agent that is effective in 
people failing standard therapy; or 
(II) to be used effectively in com-
bination with other critical agents 
that cannot be combined with alter-
native 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 thera-
pies and causes discontinuation of 
treatment of a life-threatening or seri-
ous 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, 
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that is shown to lead to improved effects 
on serious outcomes. 
(2) The term ‘‘Director’’ means the Under Sec-
retary of Commerce for Intellectual Property and 
Director of the United States Patent and Trade-
mark Office. 
(3) The term ‘‘dormant therapy’’ means a med-
icine designated as a dormant therapy under sub-
section (a). 
(4) The term ‘‘protection period’’ for a dormant 
therapy means the period that— 
(A) begins on the date on which the Sec-
retary first approves an application under sec-
tion 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 des-
ignation and development of the dormant therapy. 
The sponsor may be a single entity or an entity col-
laborating with one or more other entities. 
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