(8) The term ‘‘qualifying pathogen’’ means— 
(A) community-acquired methicillin-resist-
ant staphylococcus areus (CA–MRSA); 
(B) life-threatening gram negative bac-
teria, such as Escherichia coli (E. coli), 
Acinetobacter, 
Klebsiella 
species, 
and 
Pseudomonas aeruginosa; 
(C) influenza; 
(D) extensively drug resistant tuberculosis 
(XDR–TB); or 
(E) any other infectious pathogen identi-
fied for purposes of this Act by the Secretary 
of Health and Human Services, in concurrence 
with infectious disease clinicians and appro-
priate professional associations, as a significant 
threat to public health because of drug resist-
ance or other factors (or likely to become such 
a threat). 
(9) The term ‘‘vaccine’’ means a vaccine in-
tended for human use. 
SEC. 4. PATENT PROTECTION. 
(a) PURPOSE.—The purpose of this section is to pro-
vide an incentive for research and development relating 
to qualified infectious disease products. 
(b) RESTORATION OF PATENT TERMS.— 
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(1) IN
GENERAL.—Chapter 14 of title 35, 
United States Code, is amended by inserting after 
section 156 the following: 
‘‘SEC. 156a. RESTORATION OF PATENT TERMS RELATING TO 
QUALIFIED INFECTIOUS DISEASE PRODUCTS. 
‘‘(a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘diagnostic test’ has the meaning 
given to that term in section 3 of the Beating Infec-
tions through Research and Development Act of 
2007; 
‘‘(2) the term ‘qualified infectious disease prod-
uct’ has the meaning given to that term in section 
3 of the Beating Infections through Research and 
Development Act of 2007; 
‘‘(3) the term ‘regulatory review period’ means 
the period of time that— 
‘‘(A) starts on the date that is the later 
of— 
‘‘(i) the date that an eligible patent 
sought to be extended under this section is 
issued; 
‘‘(ii) the date that an exemption under 
section 505(i) of the Federal Food, Drug, 
and Cosmetic Act became effective for the 
product; or 
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‘‘(iii) the date on which an investiga-
tional device exemption is approved pursu-
ant to section 520(g) of the Federal Food, 
Drug and Cosmetic Act; and 
‘‘(B) ends on the date that is— 
‘‘(i) in the case of a drug, the date on 
which an application submitted for such 
drug under section 505(b) of the Federal 
Food, Drug, and Cosmetic Act is approved; 
‘‘(ii) in the case of a biologic, the date 
on which an application submitted under 
section 351 of the Public Health Service 
Act is approved; or 
‘‘(iii) in the case of a medical device, 
the date on which an application for pre-
market approval submitted for such device 
under the Federal Food, Drug, and Cos-
metic Act is approved; and 
‘‘(4) the term ‘eligible patent’ means a patent 
that— 
‘‘(A) claims a qualified infectious disease 
product, or claims an active ingredient of such 
product, or a process of making or using the 
product or an active ingredient of such product; 
and 
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‘‘(B) is owned by or licensed to an entity 
that sponsored the application described in 
paragraph (3)(B) for the product. 
‘‘(b) PATENT TERM EXTENSION.—The term of an el-
igible patent shall be extended from the expiration date 
of the patent that would otherwise apply, which shall in-
clude any patent term adjustment granted under section 
154(b), by a period equal to the number of days in the 
regulatory review period if each of the following is met: 
‘‘(1) An application in conformance with the re-
quirements of subsection (c) is submitted to the Di-
rector by either the owner of record of the patent or 
its agent by the later of 60 days after the end of the 
regulatory review period or 45 days after issuance of 
the patent. 
‘‘(2) The patent that is the basis of the applica-
tion has not been previously extended under this sec-
tion, or under section 156. 
‘‘(3) The term of the patent that is the basis 
of the application has not expired before the date 
that the application is submitted under subsection 
(c). 
‘‘(4) The regulatory review period for the quali-
fied infectious disease product has not been relied 
upon to support an application to extend the term 
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of another patent under this section or under section 
156. 
‘‘(c) ADMINISTRATIVE PROVISIONS.— 
‘‘(1) IN GENERAL.—To obtain an extension of 
the term of a patent under this section, the owner 
of record of the patent or its agent shall submit an 
application to the Director. 
‘‘(2) CONTENT.—The application shall con-
tain— 
‘‘(A) a description of the qualified infec-
tious disease product and the Federal statute 
under which regulatory review occurred; 
‘‘(B) the identity of the patent for which 
an extension is sought under this section; and 
‘‘(C) such other information as the Direc-
tor may require including to establish that the 
applicant meets the requirements of this sec-
tion. 
‘‘(3) IRREVOCABLE
ELECTION.—The submis-
sion of an application under this section is an irrev-
ocable election of the application of this section to 
the patent that is the basis of the application. A pat-
ent that has been the basis of an application made 
under this section may not be the subject of an ap-
plication made under section 156 or 158.’’. 
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(2) TECHNICAL
AND
CONFORMING
AMEND-
MENT.—The table of sections for chapter 14 of title 
35, United States Code, is amended by inserting 
after the item relating to section 156 the following: 
‘‘156a. Restoration of patent terms relating to qualified infectious disease prod-
ucts.’’. 
(c) EXTENSION OF PATENT TERMS.— 
(1) CERTIFICATION OF SUCCESSFUL DEVELOP-
MENT.— 
(A) APPLICATION.—An entity may submit 
to the Secretary of Health and Human Services 
(in this section referred to as the ‘‘Secretary’’) 
an application for certification that the entity— 
(i) has successfully developed a quali-
fied infectious disease product, as that 
term is defined in section 158 of title 35, 
United States Code; and 
(ii) the entity may receive a patent 
term extension under the provisions of 
such section. 
(B) CERTIFICATION.—With respect to an 
application submitted by an entity under this 
paragraph, the Secretary shall— 
(i) approve the application if the Sec-
retary determines that the entity has suc-
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cessfully developed the qualified infectious 
disease product; 
(ii) deny the application if the Sec-
retary determines that the entity has not 
successfully developed the product; and 
(iii) notify the entity of the approval 
or denial, and the reasons therefore. 
(C) SUCCESSFUL DEVELOPMENT.—In car-
rying out subparagraph (B), the Secretary shall 
determine that an entity has successfully devel-
oped a product if— 
(i) the product is a qualified infectious 
disease product; and 
(ii) the product has been approved 
under section 505 or 515 of the Federal 
Food, Drug, and Cosmetic Act or section 
351 of the Public Health Service Act. 
(D) EFFECT OF CERTIFICATION.—If the 
Secretary approves an application submitted by 
an entity under this paragraph, the entity may 
use the patent extension provisions of section 
158 of title 35, United States Code. 
(E) APPLICATION.—This paragraph and 
the amendment made by paragraph (2) apply 
only with respect to a product that is approved 
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under section 505 or 515 of the Federal Food, 
Drug, and Cosmetic Act or section 351 of the 
Public Health Service Act after the date of the 
enactment of this Act. 
(2) IN
GENERAL.—Chapter 14 of title 35, 
United States Code, is amended by adding at the 
end the following: 
‘‘§ 158. Extension of patent terms relating to qualified 
infectious disease products 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) The term ‘qualified infectious disease 
product’ means a qualified infectious disease prod-
uct, as that term is defined in section 3 of the Beat-
ing Infections through Research and Development 
Act of 2007. 
‘‘(2) The term ‘designated product’ means a 
drug, antibiotic drug, or device, as those terms are 
defined in section 201 of the Federal Food, Drug 
and Cosmetic Act (21 U.S.C. 321), or a biological 
product, as that term is defined in section 351 of 
the Public Health Service Act. 
‘‘(3) The term ‘diagnostic test’ has the meaning 
given to that term in section 3 of the Beating Infec-
tions through Research and Development Act of 
2007. 
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‘‘(4) The term ‘eligible entity’ means a natural 
or legal person that has successfully developed a 
qualified infectious disease product. 
‘‘(5) The term ‘eligible patent’ means a patent 
that at the time the eligible entity entered into the 
contract to develop the qualified infectious disease 
product involved, was owned by or licensed to that 
eligible entity, and claims a designated product, an 
active ingredient of a designated product, a method 
of making or using a designated product or a meth-
od of making or using an active ingredient of a des-
ignated product. 
‘‘(b) PATENT TERM EXTENSION.—The term of an el-
igible patent shall be extended for a period of 2 years, 
in addition to the term which would otherwise apply except 
for this section, if— 
‘‘(1) an application under subsection (c) is sub-
mitted to the Director by either the owner of record 
of the patent or its agent on or before the date spec-
ified in subsection (c)(3); 
‘‘(2) the patent has not been previously ex-
tended under this section, or under section 156 or 
156a; 
‘‘(3) the patent has not expired before the date 
that the application is submitted; 
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‘‘(4) the term of no other patent has been ex-
tended based on the certification being relied upon 
by the eligible entity to request extension of the pat-
ent; and 
‘‘(5) no other patent that claims the designated 
product, an active ingredient of the designated prod-
uct, a method of making or using a designated prod-
uct or a method of making or using an active ingre-
dient of a designated product has been extended 
under this section or under section 156a. 
‘‘(c) ADMINISTRATIVE PROVISIONS.— 
‘‘(1) IN GENERAL.—To obtain an extension of 
the term of a patent under this section, the owner 
of record of the patent or the agent of the owner 
shall submit an application to the Director. 
‘‘(2) CONTENT.—An application filed under this 
section shall contain— 
‘‘(A) a description of the approved quali-
fied infectious disease product and the Federal 
statute under which regulatory review occurred; 
‘‘(B) the identity of the eligible patent for 
which an extension is sought under this section; 
‘‘(C) the identity of the eligible entity and 
the applicant (if different from the eligible enti-
ty); 
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‘‘(D) the identity of the designated product 
to which the eligible patent relates; 
‘‘(E) information concerning the certifi-
cation specified in section 4(c)(1) of the Beat-
ing Infections through Research and Develop-
ment Act of 2007 being relied upon as the basis 
of the extension being requested; 
‘‘(F) information indicating that the entity 
owned or licensed the eligible patent at the time 
it entered into the contract to develop the quali-
fied infectious disease product; and 
‘‘(G) such other information as the Direc-
tor may require including to establish that the 
applicant meets the requirements of this sec-
tion. 
‘‘(3) SUBMISSION OF APPLICATION.—An appli-
cation under this section shall be submitted to the 
Director within 60 days after the date of the certifi-
cation specified in section 4(c)(1) of the Beating In-
fections through Research and Development Act of 
2007 that is being relied upon to request extension 
of the patent that is the subject of the application. 
‘‘(d) IRREVOCABLE ELECTION.—The submission of 
an application under this section is an irrevocable election 
of the application of this section to the patent that is the 
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basis of the application. A patent that has been the basis 
of an application made under this section may not be the 
subject of an application made under sections 156 or 
156a.’’. 
(3) TECHNICAL
AND
CONFORMING
AMEND-
MENT.—The table of sections for chapter 14 of title 
35, United States Code, is amended by adding at 
the end the following: 
‘‘158. Extension of patent terms relating to countermeasure products.’’. 
SEC. 5. ACCELERATED APPROVAL OF QUALIFIED INFEC-
TIOUS DISEASE PRODUCTS. 
(a) DESIGNATION AS FAST-TRACK PRODUCT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall designate qualified infectious 
disease products as fast-track products, pursuant to 
section 506 or section 515(d)(5), as applicable, of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356, 360e(5)). Such designation may be 
made prior to the submission of— 
(A) a request for designation by the spon-
sor or applicant; or 
(B) an application for the investigation of 
the qualified infectious disease product under 
section 505 or 520(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or 
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section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
(2) RULE OF CONSTRUCTION.—Nothing in this 
section shall be construed to prohibit a sponsor or 
applicant from declining a designation under para-
graph (1). 
(b) GRANTS FOR CLINICAL TESTS.—Subpart 6 of 
part C of title IV of the Public Health Service Act (42 
U.S.C. 285f et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 447C. CLINICAL TRIALS ON QUALIFIED INFECTIOUS 
DISEASE PRODUCTS. 
‘‘(a) GRANTS.—In carrying out section 446, the Di-
rector of the Institute shall expand and intensify efforts 
to assist small manufacturers to conduct end-stage clinical 
trials on qualified infectious disease products, including by 
awarding grants for such clinical trials. 
‘‘(b) DEFINITION.—In this section, the term ‘quali-
fied infectious disease product’ has the meaning given to 
that term in section 3 of the Beating Infections through 
Research and Development Act of 2007.’’. 
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SEC. 6. TAX CREDIT FOR MEDICAL RESEARCH RELATED TO 
DEVELOPING QUALIFIED INFECTIOUS DIS-
EASE PRODUCTS. 
(a) IN GENERAL.—Subpart D of part IV of sub-
chapter A of chapter 1 of the Internal Revenue Code of 
1986 (relating to business-related credits) is amended by 
adding at the end the following new section: 
‘‘SEC. 45O. CREDIT FOR MEDICAL RESEARCH RELATED TO 
DEVELOPING QUALIFIED INFECTIOUS DIS-
EASE PRODUCTS. 
‘‘(a) GENERAL RULE.—For purposes of section 38, 
the infectious disease research credit determined under 
this section for the taxable year is an amount equal to 
50 percent of the qualified infectious disease research ex-
penses for the taxable year. 
‘‘(b) QUALIFIED INFECTIOUS DISEASE RESEARCH 
EXPENSES.—For purposes of this section— 
‘‘(1) QUALIFIED
INFECTIOUS
DISEASE
RE-
SEARCH EXPENSES.—Except as otherwise provided 
in this subsection, the term ‘qualified infectious dis-
ease research expenses’ means the amounts which 
are paid or incurred by the taxpayer during the tax-
able year with respect to any research and develop-
ment of qualified infectious disease products which 
would be described in subsection (b) of section 41 if 
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such subsection were applied with the modifications 
set forth in paragraph (2). 
‘‘(2) MODIFICATIONS; INCREASED
INCENTIVE 
FOR
CONTRACT
RESEARCH
PAYMENTS.—For pur-
poses of paragraph (1), subsection (b) of section 41 
shall be applied— 
‘‘(A) by substituting ‘qualified infectious 
disease research’ for ‘qualified research’ each 
place it appears in paragraphs (2) and (3) of 
such subsection, and 
‘‘(B) by substituting ‘100 percent’ for ‘65 
percent’ in paragraph (3)(A) of such sub-
section. 
‘‘(3) EXCLUSION
FOR
AMOUNTS
FUNDED
BY 
GRANTS, ETC.—The term ‘qualified infectious dis-
ease research expenses’ shall not include any amount 
to the extent such amount is funded by any grant, 
contract, or otherwise by another person (or any 
governmental entity). 
‘‘(4) QUALIFIED
INFECTIOUS
DISEASE
RE-
SEARCH.—The term ‘qualified infectious disease re-
search’ means qualified research (as defined in sec-
tion 41(d)) which relates to the development of a 
qualified infectious disease product, except that 
qualified infectious disease research shall include ex-
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penses related to re-formulating existing qualified in-
fectious disease products. 
‘‘(5) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCTS.—The term ‘qualified infectious disease prod-
ucts’ has the meaning given such term in section 3 
of the Beating Infections through Research and De-
velopment Act of 2007. 
‘‘(c) COORDINATION WITH CREDIT FOR INCREASING 
RESEARCH EXPENDITURES.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), any qualified infectious disease research 
expenses for a taxable year to which an election 
under this section applies shall not be taken into ac-
count for purposes of determining the credit allow-
able under section 41 for such taxable year. 
‘‘(2) EXPENSES
INCLUDED
IN
DETERMINING 
BASE PERIOD RESEARCH EXPENSES.—Any qualified 
infectious disease research expenses for any taxable 
year which are qualified research expenses (within 
the meaning of section 41(b)) shall be taken into ac-
count in determining base period research expenses 
for purposes of applying section 41 to subsequent 
taxable years. 
‘‘(d) SPECIAL RULES.— 
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‘‘(1) CERTAIN
RULES
MADE
APPLICABLE.— 
Rules similar to the rules of paragraphs (1) and (2) 
of section 41(f) shall apply for purposes of this sec-
tion. 
‘‘(2) COORDINATION WITH CREDIT FOR CLIN-
ICAL TESTING EXPENSES FOR CERTAIN DRUGS FOR 
RARE
DISEASES.—Any qualified infectious disease 
research expenses for a taxable year to which an 
election under this section applies shall not be taken 
into account for purposes of determining the credit 
allowable under section 45C for such taxable year. 
‘‘(3) ELECTION.—This section shall apply to 
any taxpayer for any taxable year only if such tax-
payer elects (at such time and in such manner as 
the Secretary may by regulations prescribe) to have 
this section apply for such taxable year.’’. 
(b) INCLUSION IN GENERAL BUSINESS CREDIT.— 
Section 38(b) of the Internal Revenue Code of 1986 is 
amended by striking ‘‘plus’’ at the end of paragraph (30), 
by striking the period at the end of paragraph (31) and 
inserting ‘‘, plus’’, and by adding at the end the following 
new paragraph: 
‘‘(32) the infectious disease research credit de-
termined under section 45O.’’. 
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(c) DENIAL OF DOUBLE BENEFIT.—Section 280C of 
the Internal Revenue Code of 1986 (relating to certain 
expenses for which credits are allowable) is amended by 
adding at the end the following new subsection: 
‘‘(e) CREDIT FOR QUALIFIED INFECTIOUS DISEASE 
RESEARCH EXPENSES.— 
‘‘(1) IN GENERAL.—No deduction shall be al-
lowed for that portion of the qualified infectious dis-
ease research expenses (as defined in section 
45O(b)) otherwise allowable as a deduction for the 
taxable year which is equal to the amount of the 
credit determined for such taxable year under sec-
tion 45O(a). 
‘‘(2) CERTAIN RULES TO APPLY.—Rules similar 
to the rules of paragraphs (2), (3), and (4) of sub-
section (c) shall apply for purposes of this sub-
section.’’. 
(d) DEDUCTION FOR UNUSED PORTION OF CRED-
IT.—Section 196(c) of the Internal Revenue Code of 1986 
(defining qualified business credits) is amended by strik-
ing ‘‘and’’ at the end of paragraph (12), by striking the 
period at the end of paragraph (13) and inserting ‘‘, and’’, 
and by adding at the end the following new paragraph: 
‘‘(14) the infectious disease research credit de-
termined under section 45O(a) (other than such 
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credit determined under the rules of section 
280C(e)(2)).’’. 
(e) TECHNICAL AMENDMENT.—The table of sections 
for subpart D of part IV of subchapter A of chapter 1 
of the Internal Revenue Code of 1986 is amended by add-
ing at the end the following new item: 
‘‘Sec. 45O. Credit for medical research related to developing qualified infectious 
disease products.’’. 
(f) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2006. 
SEC. 7. INCENTIVES FOR THE CONSTRUCTION OF QUALI-
FIED INFECTIOUS DISEASE PRODUCTS MANU-
FACTURING FACILITIES. 
(a) QUALIFIED INFECTIOUS DISEASE PRODUCTS 
MANUFACTURING FACILITIES INVESTMENT TAX CRED-
IT.— 
(1) ALLOWANCE OF CREDIT.—Section 46 of the 
Internal Revenue Code of 1986 (relating to amount 
of investment credit) is amended by striking ‘‘and’’ 
at the end of paragraph (3), by striking the period 
at the end of paragraph (4) and inserting ‘‘, and’’, 
and by adding at the end the following new para-
graph: 
‘‘(5) the qualified infectious disease products 
manufacturing facilities investment credit.’’. 
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(2) AMOUNT OF CREDIT.—Subpart E of part 
IV of subchapter A of chapter 1 of such Code (relat-
ing to rules for computing investment credit) is 
amended by inserting after section 48B the following 
new section: 
‘‘SEC. 48C. QUALIFIED INFECTIOUS DISEASE PRODUCTS 
MANUFACTURING FACILITIES CREDIT. 
‘‘(a) IN GENERAL.—For purposes of section 46, the 
qualified infectious disease products manufacturing facili-
ties investment credit for any taxable year is an amount 
equal to 20 percent of the qualified investment for such 
taxable year. 
‘‘(b) QUALIFIED INVESTMENT.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a), the qualified investment for any taxable year is 
the basis of each qualified infectious disease prod-
ucts manufacturing facilities property placed in serv-
ice by the taxpayer during such taxable year. 
‘‘(2) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCTS MANUFACTURING FACILITIES PROPERTY.—For 
purposes of this section, the term ‘qualified infec-
tious disease products manufacturing facilities prop-
erty’ means real and tangible personal property— 
‘‘(A)(i) the original use of which com-
mences with the taxpayer, or 
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‘‘(ii) which is acquired through purchase 
(as defined by section 179(d)(2)), 
‘‘(B) which is depreciable under section 
167, 
‘‘(C) which is used for the manufacture, 
distribution, or research and development of 
qualified infectious disease products, and 
‘‘(D) which is in compliance with any 
standards and regulations which are promul-
gated by the Food and Drug Administration, 
the Occupational Safety and Health Adminis-
tration, or the Environmental Protection Agen-
cy and which are applicable to such property. 
‘‘(3) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCTS.—For purposes of this subsection, the term 
‘qualified infectious disease products’ has the mean-
ing given such term in section 3 of the Beating In-
fections through Research and Development Act of 
2007. 
‘‘(c) CERTAIN
PROGRESS
EXPENDITURE
RULES 
MADE APPLICABLE.—Rules similar to rules of subsections 
(c)(4) and (d) of section 46 (as in effect on the day before 
the date of the enactment of the Revenue Reconciliation 
Act of 1990) shall apply for purposes of this subsection. 
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‘‘(d) TERMINATION.—This subsection shall not apply 
to any property placed in service after December 31, 
2011.’’. 
(b) TECHNICAL AMENDMENTS.— 
(1) Subparagraph (C) of section 49(a)(1) of 
such Code is amended by striking ‘‘and’’ at the end 
of clause (iii), by striking the period at the end of 
clause (iv) and inserting ‘‘, and’’, and by adding at 
the end the following new clause: 
‘‘(v) the basis of any qualified infec-
tious disease products manufacturing fa-
cilities property under section 48C.’’. 
(2) Subparagraph (E) of section 50(a)(2) of 
such Code is amended by inserting ‘‘or 48C(c)’’ be-
fore the period. 
(3) The table of sections for subpart E of part 
IV of subchapter A of chapter 1 of such Code is 
amended by inserting after the item relating to sec-
tion 48B the following: 
‘‘Sec. 48C. Qualified infectious disease products manufacturing facilities cred-
it.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to property placed in service after 
December 31, 2006, under rules similar to the rules of 
section 48(m) of the Internal Revenue Code of 1986 (as 
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