PGR Institution Rates by Invalidity Challenge Type

PGR Institution Rates by Invalidity Challenge Type

by | Dec 31, 2023

  This figure shows PGR institution rates by invalidity challenge type under §§ 101, 102, 103, and 112 (indefiniteness, written description, and enablement).  Where there were multiple challenge types in a petition each was reviewed separately.  Infrequently...
PGR and IPR Final Written Decision Outcomes

PGR and IPR Final Written Decision Outcomes

by | Dec 31, 2023

  This figure shows Final Written Decision (FWD) outcomes for PGRs (N=108) and IPRs (N=4,825).[1] We also evaluated FWD outcomes for TC 1600 PGRs (N=31).  The rate for FWD invalidation of all claims is similar for PGRs and IPRs, and is also relatively similar for...
PGR FWD Outcomes by Invalidity Challenge Type

PGR FWD Outcomes by Invalidity Challenge Type

by | Dec 31, 2023

  This figure shows PGR FWD outcomes by invalidity challenge type under §§ 101, 102, 103, and 112 (indefiniteness, written description, and enablement).  Where there were multiple challenge types in a petition each was reviewed separately.  Infrequently raised...
PGR Overall Outcomes by Invalidity Challenge Type

PGR Overall Outcomes by Invalidity Challenge Type

by | Dec 31, 2023

  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...

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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