PGR and IPR Filings Over Time

PGR and IPR Filings Over Time

by | Dec 31, 2023

  This figure shows the number of PGR and IPR petitions filed since their inception in 2012 through December 31, 2023.  For our analysis, we reviewed PGR filings for all patent technologies (teal line) as well as the subsets of PGRs filed on Orange Book-listed...
PGR Institution Rates by Technology

PGR Institution Rates by Technology

by | Dec 31, 2023

  This figure shows PGR institution rates by technology.  Within this relatively small data set, PGR institution rates varied, with TC 1600 patent challenges being instituted at a similar rate compared to that for all PGR institutions, while Orange Book-listed...
PGR and IPR Institution Rates

PGR and IPR Institution Rates

by | Dec 31, 2023

  This figure shows institution rates for PGRs compared to IPRs[1] for all technologies as well as Orange Book and biologic drug IPRs.  It is noteworthy that compared to the 51% institution rate for PGRs, IPRs have been instituted at a higher rate (65%).  This...
PGR and IPR Institution Rates over Time

PGR and IPR Institution Rates over Time

by | Dec 31, 2023

  This figure shows PGR and IPR institution rates over time.[1]  PGR institution rates (teal line) were generally trending lower from their inception through FY 2021, but increased in FY 2022 and FY 2023 and surpassed IPRs in FY 2023 for the first time since FY...
Bases for PGR Denial over Time

Bases for PGR Denial over Time

by | Dec 31, 2023

  This figure shows the bases for PGR denials over time.  FY 2024 estimates are calculated based on statistics from October 1, 2023 through December 31, 2023. The PTAB has increasingly denied PGR (and IPR) institutions for procedural reasons.  In 2021, procedural...

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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