US Congress Senate Bill 1882 (Prior Session Legislation)

---

Spectrum: Moderate Partisan Bill (Democrat 11-1-1)
Status: Introduced on November 16 2011 - 25% progression, died in committee
Action: 2011-11-16 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S7616-7617)
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patentholder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant). Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing. Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug. Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement. Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.

Fair And Immediate Release of Generic Drugs Act

Sen. Jeff Bingaman [D-NM]	Sen. Sherrod Brown [D-OH]	Sen. Richard Durbin [D-IL]	Sen. Al Franken [D-MN]
Sen. Tim Johnson [D-SD]	Sen. Amy Klobuchar [D-MN]	Sen. Herb Kohl [D-WI]	Sen. Jeff Merkley [D-OR]
Sen. Bernard Sanders [I-VT]	Sen. Jeanne Shaheen [D-NH]	Sen. Tom Udall [D-NM]	Sen. David Vitter [R-LA]
Sen. Jim Webb [D-VA]

Date	Chamber	Action
2011-11-16	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S7616-7617)
2011-11-16	Senate	Sponsor introductory remarks on measure. (CR S7616)

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/senate-bill/1882/all-info
Text	https://www.congress.gov/112/bills/s1882/BILLS-112s1882is.pdf