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ARTICLE · 29 SEPTEMBER 2026

Changes To PTAB And Takeaways For Life Sciences Stakeholders

Ballard Spahr LLP
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The Patent Trial and Appeal Board has undergone significant procedural changes since early 2025, consolidating institution authority under the Director and expanding grounds for discretionary denial of inter partes review proceedings. These shifts have resulted in dramatically lower institution rates and increased uncertainty for patent challengers, fundamentally altering the landscape for life sciences companies seeking to invalidate or defend patents through PTAB proceedings.

United StatesIntellectual Property
Caryn Borg-Breen
Caryn Borg-Breen
Kenneth H. Sonnenfeld, Ph.D.
Kenneth H. Sonnenfeld, Ph.D.
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Since early 2025, the Patent Trial and Appeal Board (PTAB) has shifted toward a more restrictive, Director-controlled institution regime. Expanded use of discretionary denials—including revived Fintiv-based considerations and “settled expectations” factors—has resulted in fewer inter partes review (IPR) proceedings being instituted and has made it more difficult to challenge issued patents. These changes generally strengthen and de-risk patent portfolios, particularly for branded pharmaceutical and biotechnology companies. However, the large number of institution- and merits-stage reversals and late-stage interventions by the Director increases uncertainty complicating patent litigation strategy.

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