Independent Innovator and Repurposing Act

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Independent Innovator and 
Repurposing Act''.

SEC. 2. EXTENSION OF PATENT TERM FOR METHOD OF USING BIOLOGICAL 
              PRODUCT.

    (a) Extension for Regulatory Delay.--The term of a patent claiming 
a method of using a biological product shall be extended for 5 years 
from the original expiration date of the patent, which shall include 
any patent term adjustment granted under section 154(b) of title 35, 
United States Code, if--
            (1) an application for an extension is submitted by the 
        owner of record of the patent or its agent in accordance with 
        the requirements of subsection (b); and
            (2) the term of the patent--
                    (A) has not expired before the application is so 
                submitted; and
                    (B) has not been extended under subsection (c) of 
                this section or section 156 of title 35, United States 
                Code.
    (b) Application for Extension.--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. The application 
shall contain--
            (1) the identity of the biological product;
            (2) the identity of the patent for which an extension is 
        being sought and the identity of each 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 independent 
                innovator;
                    (B) the owner of record is--
                            (i) the independent innovator; or
                            (ii) a qualified small business in which 
                        the independent innovator has an ownership 
                        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 biological 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 section 505(i) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(i)) for investigating such method of use and the 
                date on which the Food and Drug Administration approved 
                the application described in subparagraph (C); and
            (4) a brief description of the activities undertaken 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 information is possessed by such owner.
    (c) Determination of Extension.--
            (1) In general.--A determination that a patent is eligible 
        for extension shall be made by the Director solely on the basis 
        of the representations contained in the application for the 
        extension. If the Director determines that a patent is eligible 
        for extension under subsection (a) and that the requirements of 
        subsection (b) have been complied with, the Director 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 recorded 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 patent for which 
        an application has been submitted under subsection (b) would 
        expire before a certificate of extension is issued or denied 
        under paragraph (1) respecting the application, the Director 
        shall extend, until such determination is made, the 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 ``biological 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 section 
                        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 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.

Summary: Independent Innovator and Repurposing Act - Establishes procedures under which the term of an unexpired patent claiming a method of using a biological product shall be extended for five years from its original expiration date.  Requires an application for such an extension to demonstrate that: (1) the patent was issued to an independent innovator, and (2) the owner of record is the independent innovator or a small business (with fewer than 500 employees and which is not affiliated with the holder of the marketing application approved under licensing requirements of the Public Health Service Act for the commercial marketing of such biological product) in which the independent innovator has an ownership interest. Defines &quot;independent innovator&quot; as a person or entity that obtains a method of use patent for a biological product and is not, at the time of invention or patent filing, affiliated with the holder of an approved application for the commercial marketing of the product.