Statistics at a Glance

Statistics
at a Glance

 

This figure shows PGR overall outcomes by invalidity challenge type.  Where there were multiple challenge types in a petition each was reviewed separately.  Infrequently raised challenges such as improper narrowing of dependent claims, ornamentality and double-patenting were not included in our analysis due to the limited data available for those challenges.  As previously noted, because claims are often challenged under multiple grounds, they are sometimes found not unpatentable under one ground but are invalidated under another ground. 

In contrast to our analysis in the “PGR FWD Outcomes by Invalidity Challenge Type” figure, which considers only FWDs, this figure considers outcomes in both Decisions Not to Institute (DNIs) and FWDs.  Considering both DNIs and FWDs, 67% of PGR challenges resulted in no claims being found unpatentable compared to 58% for IPR challenges.[1]  The >70% claim survival rate is consistent across PGR invalidity challenge types. Accordingly, patent owners have a higher success rate for survival of all claims in a PGR compared to an IPR.

[1] IPR overall outcomes are based on PTO data available at: https://www.uspto.gov/patents/ptab/statistics/aia-trial-statistics-archive.

 

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    Methodology

    Information contained in the Venable 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 BiologicsHQ database.

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