"Purple Book" Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect? | King & Spalding
The Biological Product Patent Transparency Act (“BPPT”) 1 – 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. The BPPT sidestepped some of...
Source: jdsupra.com