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Patent Transparency for Biologics & Biosimilars: The Revamped Purple Book, BioProcess Online

July 12, 2021

Partners Jacqueline Berman and Jeffrey Gargano and associates Zachary Miller and Maria Kalousi-Tatum published an analysis of the latest updates to the US Food and Drug Administration’s (FDA’s) Purple Book.

The book, a database containing information about all licensed biological products, will now include patent information relating to biologics as well as FDA regulatory exclusivity information for the first time. According to the lawyers, the revamped database will present new opportunities for those in the industry to identify (i) potential partnerships for licensing of existing intellectual property; (ii) new strategies regarding intellectual property enforcement and protection; and, potentially, (iii) opportunities for the development of new technology.

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