HR 1506 · 116th Congress · Health

FAIR Generics Act

Introduced 2019-03-05· Sponsored by Rep. Barragan, Nanette Diaz [D-CA-44]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.(2019-04-08)

Plain Language Summary

[AI summary unavailable — showing source text] Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act This bill disqualifies from being a first applicant an applicant submitting a generic drug application to the Food and Drug Administration if the applicant has entered into a specified disqualifying agreement. Currently, any generic drug applicant submitting an application on the first day an application is submitted for that drug is a first applicant and is granted a 180-day marketing exclusivity period. A disqualifying agreement is an agreement between the applicant and the holder of the application or a patent for the brand-name drug whereby the applicant agrees not to seek approval or begin marketing the generic drug until the expiration of the exclusivity period awarded to another applicant. The bill expands the definition of  first applicant to include applicants that did not submit an application on the first day an application was submitted. To be included, these first applicants must not have a patent infringement action pending against them and must not have been found to have infringed a patent. If an applicant that submitted an application on the first day an application was submitted has begu…

Summarized by Claude AI · Non-partisan · For informational purposes only