Sec. 402. 180-day exclusivity period amendments regarding first applicant status
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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) ) is amended— in clause (iv)(II)— by striking item (bb); and by redesignating items
(cc)and
(dd)as items
(bb)and (cc), respectively; and by adding at the end the following: As used in this subsection, the term first applicant means an applicant— that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug; and that has not entered into a disqualifying agreement described under clause (vii)(II); or for the drug that is not described in subclause
(I)and that, with respect to the applicant and drug, each requirement described in clause
(vi)is satisfied; and that has not entered into a disqualifying agreement described under clause (vii)(II). The requirements described in this clause are the following: The applicant described in clause (v)(II) submitted and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) or a statement described in paragraph (2)(A)(viii) for each unexpired patent for which a first applicant described in clause (v)(I) had submitted a certification described in paragraph (2)(A)(vii)(IV) on the first day on which a substantially complete application containing such a certification was submitted. With regard to each such unexpired patent for which the applicant described in clause (v)(II) submitted a certification described in paragraph (2)(A)(vii)(IV), no action for patent infringement was brought against such applicant within the 45-day period specified in paragraph (5)(B)(iii); or if an action was brought within such time period, such an action was withdrawn or dismissed by a court (including a district court) without a decision that the patent was valid and infringed; or if an action was brought within such time period and was not withdrawn or so dismissed, such applicant has obtained the decision of a court (including a district court) that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity, and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed). If an applicant described in clause (v)(I) has begun commercial marketing of such drug, the applicant described in clause (v)(II) does not begin commercial marketing of such drug until the date that is 30 days after the date on which the applicant described in clause (v)(I) began such commercial marketing. . Section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(D)(i)(IV) ) is amended by striking The first applicant and inserting The first applicant, as defined in subparagraph (B)(v)(I), . The amendments made by subsection
(a)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.
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Sec. 402
180-day exclusivity period amendments regarding first applicant status
Pub. L.Pub. L. 108-173
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