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Recent Bayh-Dole Act News: Comments on the Draft Framework; HHS Refuses to March-In on Xtandi; and Delayed Contracting Doesn’t Avoid Bayh-Dole

U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences.  Universities often out-license patents protecting inventions created using federal funding to private companies including many startups.  Hundreds of drugs have been developed by collaboration between universities and private industry. The…

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The Purple Book and The Orange Book - When do Patents Expire and Regulatory Exclusivities end for FDA Approved Products?

The Food and Drug Administration (FDA) maintains two searchable online databases for approved products: the Purple Book (approved licensed biological products) and the Orange Book (approved drug products). The Orange Book provides details about an approved drug product, including the patents covering the approved drug product and the expiration dates…

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