News

Venable has released its annual statistical report on AIA trials before the USPTO’s Patent Trial and Appeal Board, including stats for IPRs, PGRs, and CBMs. The in-depth study analyzes the types of arguments that succeed more often than others and the trends over time in PTAB decisions.

The analysis has again shown the advantage of obviousness challenges over anticipation challenges for IPRs, along with a corresponding downward trend in the use of anticipation challenges. Additionally, the report shows a slight uptick in IPR unpatentability findings (the chance of a claim being found unpatentable is now about 50%). For PGRs and CBMs, the analysis further confirms the dominance of patent eligibility challenges. This year’s analysis also shows another increase in the success rate for motions to amend.

Venable presents this analysis to provide practitioners additional data points in order to make informed decisions throughout the AIA trial process.

Download the Report here.


    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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