I 
113TH CONGRESS 
2D SESSION 
H. R. 4287 
To advance the public health by encouraging independent innovators to pursue 
drug repurposing research and develop new treatments and cures by 
providing appropriate intellectual property protections for those innova-
tions, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 24, 2014 
Mr. CASTRO of Texas (for himself and Mr. FORBES) introduced the following 
bill; which was referred to the Committee on the Judiciary 
A BILL 
To advance the public health by encouraging independent 
innovators to pursue drug repurposing research and de-
velop new treatments and cures by providing appropriate 
intellectual property protections for those innovations, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Independent Innovator 
and Repurposing Act’’. 
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claim of such patent that claims the method of using 
the biological product; 
(3) information demonstrating to the Director 
that— 
(A) the patent was issued to an inde-
pendent innovator; 
(B) the owner of record is— 
(i) the independent innovator; or 
(ii) a qualified small business in which 
the independent innovator has an owner-
ship interest; 
(C) an application under section 351(a) of 
the Public Health Service Act (42 U.S.C. 
262(a)) for commercial marketing of the bio-
logical product for a method of use claimed in 
the patent has been filed; and 
(D) a period of not less than 10 years 
elapsed between the original date of submission 
of an application for an exemption under sec-
tion 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) for inves-
tigating such method of use and the date on 
which the Food and Drug Administration ap-
proved the application described in subpara-
graph (C); and 
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(4) a brief description of the activities under-
taken by the owner of record of the patent, or the 
agent of such owner, during such period with respect 
to the biological product and the significant dates 
applicable to such activities to the extent such infor-
mation is possessed by such owner. 
(c) DETERMINATION OF EXTENSION.— 
(1) IN GENERAL.—A determination that a pat-
ent is eligible for extension shall be made by the Di-
rector solely on the basis of the representations con-
tained in the application for the extension. If the Di-
rector determines that a patent is eligible for exten-
sion under subsection (a) and that the requirements 
of subsection (b) have been complied with, the Direc-
tor shall issue to the applicant for the extension of 
the term of the patent a certificate of extension, 
under seal, for 5 years. Such certificate shall be re-
corded in the official file of the patent and shall be 
considered as part of the original patent. 
(2) INTERIM EXTENSION.—If the term of a pat-
ent for which an application has been submitted 
under subsection (b) would expire before a certifi-
cate of extension is issued or denied under para-
graph (1) respecting the application, the Director 
shall extend, until such determination is made, the 
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term of the patent for periods of up to one year if 
the Director determines that the patent is eligible 
for extension. 
(d) DEFINITIONS.—In this section: 
(1) BIOLOGICAL PRODUCT.—The term ‘‘biologi-
cal product’’ has the meaning given to such term in 
section 351(i)(1) of the Public Health Service Act 
(42 U.S.C. 262(i)(1)). 
(2) DIRECTOR.—The term ‘‘Director’’ means 
the Under Secretary of Commerce for Intellectual 
Property and Director of the United States Patent 
and Trademark Office. 
(3) INDEPENDENT INNOVATOR.— 
(A) The term ‘‘independent innovator’’ 
means any person or entity that— 
(i) obtains a method of use patent for 
a biological product; and 
(ii) is not, at the time of invention or 
patent filing, affiliated with the holder of a 
marketing application approved under sec-
tion 351(a) of the Public Health Service 
Act (42 U.S.C. 262(a)) for the commercial 
marketing of such biological product. 
(B) For purposes of subparagraph (A) and 
paragraph (4), the term ‘‘affiliated’’ refers to 
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any relationship of employment, control, or 
common ownership, whether direct or indirect, 
including through one or more intermediaries. 
(4) QUALIFIED
SMALL
BUSINESS.—The term 
‘‘qualified small business’’ means any entity with 
fewer than 500 employees, including employees of 
affiliates, and which is not affiliated with the holder 
of the marketing application approved under section 
351(a) of the Public Health Service Act (42 U.S.C. 
sec. 262(a)) for the commercial marketing of such 
biological product. 
(e) EFFECTIVE DATE.—This section shall take effect 
on the date of the enactment of this Act and shall apply 
to any unexpired patent issued before, on, or after that 
effective date. 
Æ 
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