Reissue Patents and FDA’s Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?
By Kurt R. Karst –
We don’t like loose ends – especially loose ends in the Hatch-Waxman world! Last June, we posted on FDA’s decisions to require sponsors of ANDAs for generic versions of ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Extended-release Capsules to demonstrate bioequivalence using certain partial AUC metrics (see here), and to approve Actavis’ ANDA No. 077302. As we noted back then, ADDERALL XR is listed in FDA’s Orange Book with four unexpired patents – U.S. Patent Nos. 6,322,819 (“the ‘819 patent), 6,605,300 (“the ‘300 patent”), RE41,148 (“the ‘148 patent”), and RE42,096 (“the ‘096 patent”) – that are all scheduled to expire on October 21, 2018, but that are each subject to a period of pediatric exclusivity that expires on April 21, 2019. The ‘148 patent is a reissue of the ‘300 patent, and the ‘096 patent is a reissue of the ‘819 patent. The lack of any mention of 180-day exclusivity in the approval letter for ANDA No. 077302 perplexed us.