Patent Law Updates | New Proposed Legislation
June 25, 2009
Sen. Nelson’s Bill Benefits Generic-Drug Makers By Expanding ANDA First-Filer 180-Day Exclusivity
Drug Price Competition Act of 2009
S. 1315, 6/22/2009
Sen. Bill Nelson, D-Fl., has filed a proposed legislation to amend Hatch-Waxman Act’s definition of “first applicant” for abbreviated new drug application (“ANDA”) filers to give generic-drug makers challenging brand-name patents an opportunity at receiving 180-day market exclusivity.
Under the present law, Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) § 505(j)(5)(B)(iv)(II)(bb) defines the term “first applicant” to mean:
“an applicant that, on the first day on which a substantially complete application containing a [Paragraph IV] certification . . . is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a [Paragraph IV]…
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View a PDF of the proposed legislation