Statistics at a Glance

Statistics
at a Glance

 

 

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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    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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