Statistics at a Glance

Statistics
at a Glance

 

This figure shows PGR and IPR institution rates over time.[1]  PGR institution rates (teal line) have trended lower since their inception, with FY 2021 having the lowest institution rate with only 31% (n=24 of 78) of petitions being instituted.  Thus far, in FY 2022, PGR institution rates are at 52% (n=17 of 33) but it is too early in the fiscal year to determine whether this represents an upward trend.

The decrease in PGR institution rates in FY 2020 and FY 2021 is significant in comparison to IPRs (red line), which have decreased since their inception but remain at about 60% instituted, nearly double that of PGRs in the last full fiscal year.  If this trend continues, one possibility for this difference could be the differing ways in which IPRs and PGRs are used to challenge different collections/technologies of patents.

[1] IPR institution rates 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 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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