Statistics at a Glance

Statistics
at a Glance

 

This figure shows Final Written Decision (FWD) outcomes for PGRs (N=120) and IPRs (N=5,020).[1] We also evaluated FWD outcomes for TC 1600 PGRs (N=33).  The rate for FWD invalidation of all claims is similar for PGRs and IPRs, and is also relatively similar for TC 1600 patents, suggesting that invalidity outcomes for biotechnology patents are similar to that for other technologies, although the data set for TC 1600 is still small (N=33).  The outcome of some or no claims being found unpatentable is also similar in PGRs (35%) and IPRs (37%).  A similar outcome of 30% is found in TC 1600 patents, although once again the data set is small.  This suggests that at the FWD stage claim survival rates are similar for PGRs and IPRs.

As of June 30, 2024, there have been too few PGR FWDs for Orange Book-listed and biologic drug patents to determine any trends regarding FWD outcomes for these patents.

[1]  IPR final written decision 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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