“Purple Book” Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect?
By EsqSocial Corporation 08/04/21
The Biological Product Patent Transparency Act (“BPPT”) – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the first-ever provision requiring public listing in the FDA’s “Purple Book” of certain patents associated with biologic drug products (e.g., monoclonal antibody products and other protein drug products). See the text of the BPPT here....
By: King & Spalding