Overview
Steptoe associates Fievel Lim and Michael Green, and partner John Molenda authored an article that appeared in Law360 titled: "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 between the creation of the Patent Trial and Appeal Board (PTAB) in 2012 and the end of 2025, the authors identify key filing patterns, institution trends, and appellate outcomes – while also assessing how recent U.S. Patent and Trademark Office (USPTO) policy shifts may affect future challenges.
Key insights from their analysis include:
- Method‑of‑treatment patents remain the most frequently challenged, making up 45% of biologics‑related IPR petitions.
- Institution rates historically favored challengers, with the PTAB granting 63% of biologics‑related IPR petitions overall, however that rate has declined significantly following USPTO procedural changes in 2025.
- Petitioners saw high success rates at final written decision, particularly in challenges to method‑of‑treatment patents, where approximately 77% of instituted proceedings resulted in all claims being held unpatentable.
- Federal Circuit affirmance rates are high, with the court affirming PTAB decisions on every issue in 82% of appeals.
- Use of PGRs has increased, and may continue to increase due to the USPTO’s emphasis on "settled expectations" as a discretionary factor for IPR, but not PGR, institution.
- Recent USPTO rule changes may also shift challengers toward ex parte reexaminations.
The authors note that although the USPTO has implemented certain patent‑owner‑friendly rule changes, IPRs and PGRs remain potent tools for innovators and biosimilar applicants seeking to clear paths to market. They expect biologics‑related challenges to continue evolving alongside regulatory and industry developments.
The full article is available at Law360 (subscription may be required).
