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).

We have compared the statistics for these duplicative FWDs with those for FWDs issued on drug patents that have to date only been challenged in one IPR resulting in a FWD (“single FWDs”).  In total, combining all duplicative FWDs on drug patents as of July 20, 2017 (joined and not joined): the Patent Trial and Appeal Board (“PTAB”) found all instituted claims unpatentable in 45 (63%) of these FWDs; and all instituted claims not unpatentable in 27 (38%) of these FWDs.  Comparing this to the same metrics for single FWDs on drug patents: in single FWDs, the PTAB found all instituted claims unpatentable in 19 (43%) FWDs; some instituted claims patentable and some unpatentable in two (5%) FWDs; and all instituted claims not unpatentable in 23 (52%) FWDs.

In other words, challenged claims of drug patents are much more likely to be found unpatentable when there have been multiple versus single FWDs on the same patent – 63% versus 43% – although this may be a product of the strength of the patents themselves as opposed to a “second bite of the apple” being more successful.

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