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 innovations, 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 develop new treatments and cures by providing appropriate 

intellectual property protections for those innovations, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Independent Innovator 

5 and Repurposing Act’’. 


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1 SEC. 2. EXTENSION OF PATENT TERM FOR METHOD OF 

2 USING BIOLOGICAL PRODUCT. 

3 (a) EXTENSION FOR REGULATORY DELAY.—The 

4 term of a patent claiming a method of using a biological 

5 product shall be extended for 5 years from the original 

6 expiration date of the patent, which shall include any pat7 ent term adjustment granted under section 154(b) of title 

8 35, United States Code, if— 

9 (1) an application for an extension is submitted 

10 by the owner of record of the patent or its agent in 

11 accordance with the requirements of subsection (b); 

12 and 

13 (2) the term of the patent— 

14 (A) has not expired before the application 

15 is so submitted; and 

16 (B) has not been extended under sub17 section (c) of this section or section 156 of title 

18 35, United States Code. 

19 (b) APPLICATION FOR EXTENSION.—To obtain an 

20 extension of the term of a patent under this section, the 

21 owner of record of the patent or its agent shall submit 

22 an application to the Director. The application shall con23 tain— 

24 (1) the identity of the biological product; 

25 (2) the identity of the patent for which an ex26 tension is being sought and the identity of each 


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1 claim of such patent that claims the method of using 

2 the biological product; 

3 (3) information demonstrating to the Director 

4 that— 

5 (A) the patent was issued to an inde6 pendent innovator; 

7 (B) the owner of record is— 

8 (i) the independent innovator; or 

9 (ii) a qualified small business in which 

10 the independent innovator has an owner11 ship interest; 

12 (C) an application under section 351(a) of 

13 the Public Health Service Act (42 U.S.C. 

14 262(a)) for commercial marketing of the bio15 logical product for a method of use claimed in 

16 the patent has been filed; and 

17 (D) a period of not less than 10 years 

18 elapsed between the original date of submission 

19 of an application for an exemption under sec20 tion 505(i) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 355(i)) for inves22 tigating such method of use and the date on 

23 which the Food and Drug Administration ap24 proved the application described in subpara25 graph (C); and 


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1 (4) a brief description of the activities under2 taken by the owner of record of the patent, or the 

3 agent of such owner, during such period with respect 

4 to the biological product and the significant dates 

5 applicable to such activities to the extent such infor6 mation is possessed by such owner. 

7 (c) DETERMINATION OF EXTENSION.— 

8 (1) IN GENERAL.—A determination that a pat9 ent is eligible for extension shall be made by the Di10 rector solely on the basis of the representations con11 tained in the application for the extension. If the Di12 rector determines that a patent is eligible for exten13 sion under subsection (a) and that the requirements 

14 of subsection (b) have been complied with, the Direc15 tor shall issue to the applicant for the extension of 

16 the term of the patent a certificate of extension, 

17 under seal, for 5 years. Such certificate shall be re18 corded in the official file of the patent and shall be 

19 considered as part of the original patent. 

20 (2) INTERIM EXTENSION.—If the term of a pat21 ent for which an application has been submitted 

22 under subsection (b) would expire before a certifi23 cate of extension is issued or denied under para24 graph (1) respecting the application, the Director 

25 shall extend, until such determination is made, the 


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1 term of the patent for periods of up to one year if 

2 the Director determines that the patent is eligible 

3 for extension. 

4 (d) DEFINITIONS.—In this section: 

5 (1) BIOLOGICAL PRODUCT.—The term ‘‘biologi6 cal product’’ has the meaning given to such term in 

7 section 351(i)(1) of the Public Health Service Act 

8 (42 U.S.C. 262(i)(1)). 

9 (2) DIRECTOR.—The term ‘‘Director’’ means 

10 the Under Secretary of Commerce for Intellectual 

11 Property and Director of the United States Patent 

12 and Trademark Office. 

13 (3) INDEPENDENT INNOVATOR.— 

14 (A) The term ‘‘independent innovator’’ 

15 means any person or entity that— 

16 (i) obtains a method of use patent for 

17 a biological product; and 

18 (ii) is not, at the time of invention or 

19 patent filing, affiliated with the holder of a 

20 marketing application approved under sec21 tion 351(a) of the Public Health Service 

22 Act (42 U.S.C. 262(a)) for the commercial 

23 marketing of such biological product. 

24 (B) For purposes of subparagraph (A) and 

25 paragraph (4), the term ‘‘affiliated’’ refers to 


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1 any relationship of employment, control, or 

2 common ownership, whether direct or indirect, 

3 including through one or more intermediaries. 

4 (4) QUALIFIED SMALL BUSINESS.—The term 

5 ‘‘qualified small business’’ means any entity with 

6 fewer than 500 employees, including employees of 

7 affiliates, and which is not affiliated with the holder 

8 of the marketing application approved under section 

9 351(a) of the Public Health Service Act (42 U.S.C. 

10 sec. 262(a)) for the commercial marketing of such 

11 biological product. 

12 (e) EFFECTIVE DATE.—This section shall take effect 

13 on the date of the enactment of this Act and shall apply 

14 to any unexpired patent issued before, on, or after that 

15 effective date. 

Æ 


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