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.