Sec. 403. 180-day exclusivity period amendments regarding agreements to defer commercial marketing
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Section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B) ), as amended by section 402, is further amended by adding at the end the following: An agreement described in this subclause is an agreement between a first applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the 180-day exclusivity period whereby that applicant agrees, directly or indirectly,
(aa)not to seek an approval of its application that is made effective on the earliest possible date under this subparagraph, subparagraph
(F)of this paragraph, section 505A, or section 527,
(bb)not to begin the commercial marketing of its drug on the earliest possible date after receiving an approval of its application that is made effective under this subparagraph, subparagraph
(F)of this paragraph, section 505A, or section 527, or
(cc)to both items
(aa)and (bb). An agreement described in this subclause is an agreement between an applicant and the holder of the application for the listed drug or an owner of one or more of the patents as to which any applicant submitted a certification qualifying such applicant for the 180-day exclusivity period whereby that applicant agrees, directly or indirectly, not to seek an approval of its application or not to begin the commercial marketing of its drug until a date that is after the expiration of the 180-day exclusivity period awarded to another applicant with respect to such drug (without regard to whether such 180-day exclusivity period is awarded before or after the date of the agreement). If an agreement described in clause (vii)(I) includes more than 1 possible date when an applicant may seek an approval of its application or begin the commercial marketing of its drug— the applicant may seek an approval of its application or begin such commercial marketing on the date that is the earlier of— the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph, subparagraph
(F)of this paragraph, section 505A, or section 527, or begin the commercial marketing of such drug, without regard to any other provision of such agreement pursuant to which the commercial marketing could begin on an earlier date; or 180 days after another first applicant begins commercial marketing of such drug; and the latest date set forth in the agreement on which that applicant can receive an approval that is made effective under this subparagraph, subparagraph
(F)of this paragraph, section 505A, or section 527, or begin the commercial marketing of such drug, without regard to any other provision of such agreement pursuant to which commercial marketing could begin on an earlier date, shall be the date used to determine whether an applicant is disqualified from first applicant status pursuant to clause (vii)(II). . Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) is amended by adding at the end the following: The holder of an abbreviated application under this subsection shall submit to the Secretary a notification that includes— the text of any agreement entered into by such holder described under paragraph (5)(B)(vii)(I); or if such an agreement has not been reduced to text, a written detailed description of such agreement that is sufficient to disclose all the terms and conditions of the agreement; and the text, or a written detailed description in the event of an agreement that has not been reduced to text, of any other agreements that are contingent upon, provide a contingent condition for, or are otherwise related to an agreement described in clause (i). The notification described under subparagraph
(A)shall be submitted not later than 10 business days after execution of the agreement described in subparagraph (A)(i). Such notification is in addition to any notification required under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Any information or documentary material filed with the Secretary pursuant to this paragraph shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this paragraph is intended to prevent disclosure to either body of the Congress or to any duly authorized committee or subcommittee of the Congress. . Section 301(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(e) ) is amended by striking 505
(i)or
(k)and inserting 505 (i), (j)(11), or
(k). Section 271(e) of title 35, United States Code, is amended by adding at the end the following: The exclusive remedy under this section for an infringement of a patent for which the Secretary of Health and Human Services has published information pursuant to subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act shall be an action brought under this subsection within the 45-day period described in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal Food, Drug, and Cosmetic Act. . The amendment made by subsection (a)(1) shall apply only with respect to— an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) to which the amendments made by section 1102(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ) apply; and an agreement described under section 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)(1)) executed after the date of enactment of this Act. The amendments made by paragraphs
(2)and
(3)of subsection
(a)shall apply only with respect to an agreement described under section 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)(1)) executed after the date of enactment of this Act.
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Sec. 403
180-day exclusivity period amendments regarding agreements to defer commercial marketing
Pub. L.Pub. L. 108-173
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