New Orange Book And Purple Book Patent Listing Laws Impose New Requirements
By EsqSocial Corporation 30/03/21
Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). The Orange Book Transparency Act primarily codifies current FDA practices, but adds a new requirement for delisting patents invalidated by the Patent Trial and Appeal Board of the USPTO. The Purple Book Continuing Act codifies a number of FDA’s current Purple Book practices, and imposes a new requirement for publishing the reference product sponsor’s “patent lists”...
By: Foley & Lardner LLP