The U.S. Patent and Trademark Office (USPTO), together with the Food and Drug Administration (FDA), published the Drug Patent and Exclusivity Study Report, which aims to provide a baseline approach that researchers and policy makers can use in future analysis for examining the number of years from the time a New Drug Application (NDA) is first approved until the first generic launch.
The study confirms that strong IP protections foster innovation across industries, and notably debunks patent critic assertions regarding “evergreening” and “patent thickets.” The document corrects the record on patent exclusivity periods, calling for a balance between protecting IP to incentivize drug innovation and ensuring that patents do not unduly hinder access to affordable medicines.
The study was conducted with 25 drug products listed in the FDA’s Orange Book between 2005-2018, which were analysed altogether with their regulatory exclusivities at each stage of drug development, the limits on their scope, duration and overlap, and why numerous patents cover a single successful drug product.
