Overview
Steptoe associates Fievel Lim and Michael Green, and partner John Molenda authored an article that appeared in Law360, “Checking in on Biologics-Related Patent Review Trends.” The article provides a comprehensive look at more than a decade of inter partes review (IPR) and post-grant review (PGR) activity involving biologics-related patents. Drawing on 330 biologics-related IPR petitions and 43 PGR petitions filed since 2012, the authors identify key filing patterns, institution trends, and appellate outcomes. Key insights include institution rates historically favoring challengers (around 63%) and high success rates at final written decision (up to about 77% for method-of-treatment patents). However, the U.S. Patent and Trademark Office (USPTO) has recently implemented patent-owner-friendly changes to institution of IPRs, which has led to an increase in PGR filings by patent challengers and may shift patent challengers towards other tools like ex parte reexaminations. Finally, Federal Circuit affirmance rates are high, with the court affirming 82% of appeals.
The full article is available on Law360 (subscription may be required).
