To amend section 156 of title 35, United States Code, to provide for the interim extension of patents subject to that section.

Summary: Authorizes the owner of record of a product patent who expects that the applicable regulatory review period for the product may extend beyond the patent term to submit, during the period beginning six months and ending 30 days before the term is due to expire, an application to the Commissioner of Patents and Trademarks for an interim extension.  Permits up to four subsequent interim extensions. 
Requires any interim extension to terminate at the end of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use unless the applicant submits specified additional information not previously contained in the interim extension application in which case the patent shall be extended for up to five years from the expiration date of the original patent term.

SECTION 1. INTERIM PATENT EXTENSIONS.

    Section 156(d) of title 35, United States Code, is amended--
            (1) in the second sentence of paragraph (1) by striking 
        ``Such'' and inserting ``Except as provided in paragraph (5), 
        such''; and
            (2) by adding at the end the following new paragraph:
    ``(5)(A) If the owner of record of the patent or its agent 
reasonably expects that the applicable regulatory review period 
described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), 
or (5)(B)(ii) of subsection (g) that began for a product that is the 
subject of such patent may extend beyond the expiration of the patent 
term in effect, the owner or its agent may submit an application to the 
Commissioner for an interim extension during the period beginning 6 
months, and ending 30 days, before such term is due to expire. The 
application shall contain--
            ``(i) the identity of the product subject to regulatory 
        review and the Federal statute under which such review is 
        occurring;
            ``(ii) the identity of the patent for which interim 
        extension is being sought and the identity of each claim of 
        such patent which claims the product under regulatory review or 
        a method of using or manufacturing the product;
            ``(iii) information to enable the Commissioner to determine 
        under subsection (a)(1), (2), and (3) the eligibility of a 
        patent for extension;
            ``(iv) a brief description of the activities undertaken by 
        the applicant during the applicable regulatory review period to 
        date with respect to the product under review and the 
        significant dates applicable to such activities; and
            ``(v) such patent or other information as the Commissioner 
        may require.
    ``(B) If the Commissioner determines that, except for permission to 
market or use the product commercially, the patent would be eligible 
for an extension of the patent term under this section, the 
Commissioner shall publish in the Federal Register a notice of such 
determination, including the identity of the product under regulatory 
review, and shall issue to the applicant a certificate of interim 
extension for a period of not more than 1 year.
    ``(C) The owner of record of a patent, or its agent, for which an 
interim extension has been granted under subparagraph (B), may apply 
for not more than 4 subsequent interim extensions under this paragraph. 
Each such subsequent application shall be made during the period 
beginning 60 days before, and ending 30 days before, the expiration of 
the preceding interim extension.
    ``(D) Each certificate of interim extension under this paragraph 
shall be recorded in the official file of the patent and shall be 
considered part of the original patent.
    ``(E) Any interim extension granted under this paragraph shall 
terminate at the end of the 60-day period beginning on the date on 
which the product involved receives permission for commercial marketing 
or use, except that, if within that 60-day period the applicant 
notifies the Commissioner of such permission and submits any additional 
information under paragraph (1) of this subsection not previously 
contained in the application for interim extension, the patent shall be 
further extended in accordance with the provisions of this section, not 
to exceed 5 years from the date of expiration of the original patent 
term.
    ``(F) The rights derived from any patent the term of which is 
extended under this paragraph shall, during the period of interim 
extension--
            ``(i) in the case of a patent which claims a product, be 
        limited to any use then under regulatory review;
            ``(ii) in the case of a patent which claims a method of 
        using a product, be limited to any use claimed by the patent 
        then under regulatory review; and
            ``(iii) in the case of a patent which claims a method of 
        manufacturing a product, be limited to the method of 
        manufacturing as used to make the product then under regulatory 
        review.''.

SEC. 2. CONFORMING AMENDMENTS.

    Section 156 of title 35, United States Code, is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1) by striking ``(d)'' and 
                inserting ``(d)(1)''; and
                    (B) in paragraph (3) by striking ``subsection (d)'' 
                and inserting ``paragraphs (1) through (4) of 
                subsection (d)'';
            (2) in subsection (b) by striking ``The rights'' and 
        inserting ``Except as provided in subsection (d)(5)(F), the 
        rights''; and
            (3) in subsection (e)--
                    (A) in paragraph (1) by striking ``subsection (d)'' 
                and inserting ``paragraphs (1) through (4) of 
                subsection (d)''; and
                    (B) in paragraph (2) by striking ``(d)'' and 
                inserting ``(d)(1)''.