Sen. Nelson’s Bill Benefits Generic-Drug Makers By Expanding ANDA First-Filer 180-Day Exclusivity

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] certification . . . for the drug.”

The 180-day exclusivity period takes places by virtue of the first commercial marketing of the drug product by a first applicant This period prevents the Food and Drug Administration (“FDA”) from approving ANDAs submitted by subsequent applicants until the expiration or forfeiture of such exclusivity period.

Under the proposed legislation, an applicant that is today considered a subsequent applicant subject to a first applicant’s 180-day exclusivity eligibility could qualify as a “first applicant,” and could obtain approval and avail of the 180-day exclusivity benefit for all first applicants if there is no timely filed patent infringement lawsuit arising from its Paragraph IV certification, or if there is a timely filed lawsuit and there is a court decision (including a district court decision) of patent invalidity or non-infringement or a “substantive determination that there is no cause of action for patent infringement or invalidity.”

In other words, the bill provides for a shared (and not a sole) exclusivity to a generic challenger who, although not first to file a paragraph iv certification, is first to succeed in addressing the listed patents.

The legislation bears the title “A bill to amend the Federal Food, Drug, and Cosmetic Act to define the term “first applicant” for purposes of filing an abbreviated application for a new drug,” and was introduced on June 22, 2009. On the day, the Senate read the bill twice and referred it to the Committee on Health, Education, Labor, and Pensions for study and deliberations.

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