Statistics at a Glance

Statistics
at a Glance

 

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 raised invalidity 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.

 

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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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