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Code · BILL · 118th Congress · S. 142 (Reported in Senate) — To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug i... · Sec. 5

Sec. 5. Notification of agreements

161 words·~1 min read·/bill/118/s/142/rs/section-5

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Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( 21 U.S.C. 355 note), as amended by section 4(b), is further amended by adding at the end the following: An agreement that is required under subsection
(a)or
(b)shall include agreements resolving any outstanding disputes, including agreements resolving or settling a Patent Trial and Appeal Board proceeding. For purposes of subparagraph (A), the term Patent Trial and Appeal Board proceeding means a proceeding conducted by the Patent Trial and Appeal Board of the United States Patent and Trademark Office, including an inter partes review instituted under chapter 31 of title 35, United States Code, a post-grant review instituted under chapter 32 of that title (including a proceeding instituted pursuant to the transitional program for covered business method patents, as described in section 18 of the Leahy-Smith America Invents Act ( 35 U.S.C. 321 note)), and a derivation proceeding instituted under section 135 of that title. .
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Sec. 5
Notification of agreements
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