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Brand pharma companies invest valuable resources, time, and money in moving drugs from development to FDA approval. The new drug approval may also enjoy some type of FDA exclusivity. ....
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 the more controversial approaches to biologics patent listing, by piggybacking off of the patent lists that reference product sponsors ( i.e., biologics innovators) are already required to exchange with biosimilar applicants ....