As of July 20, 2017, from the more than 420 inter partes review (“IPR”) petitions filed to date against drug patents (patents listed in the FDA’s Orange Book and patents identified as reading on biologic drugs listed in the FDA’s Purple Book), there have been at least 72 duplicative final written decisions (“FWDs”) (FWDs that concern drug patents that were also the subject of at least one other FWD). Of these 72 duplicative FWDs, 55 (76%) were on joined IPRs.1 The remaining 17 FWDs were separate decisions that issued on IPRs that had not been joined.
Looking first at the joined IPRs that reached FWD: 35 (64%) resulted in FWDs in which all instituted claims were unpatentable; and the remaining 20 (36%) resulted in FWDs in which all instituted claims were not unpatentable. Turning next to duplicative FWDs that were not joined: the Patent Trial and Appeal Board (“PTAB”) found that in 10 (59%) all instituted claims were unpatentable; and in the remaining 7 (41%) all instituted claims were not unpatentable. In other words, slightly more challenged drug patents lost claims when duplicative IPRs were not joined, but the difference was minimal.
1. The number of individual FWDs issued was 24, because each FWD ruled on at least two joined IPR proceedings.
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