The Patent Trial and Appeal Board (PTAB) has recently concluded Amgen Inc.’s challenge to a now-disclaimed patent covering Bristol-Myers Squibb Co.’s cancer drug Opdivo and denied Bristol-Myers’ request to pursue a replacement patent. This decision underscores the PTAB’s stance against what it perceives as strategic maneuvers to extend patent protection.
In July 2025, Acting Director of the U.S. Patent and Trademark Office, Coke Morgan Stewart, exercised discretion to deny institution of inter partes review (IPR) for two of Amgen’s petitions challenging Bristol-Myers’ patents related to Opdivo and Yervoy. The denial was based on the “strong settled expectations” due to the patents being in force for six and seven years, respectively. This marked a significant shift in PTAB policy, as settled expectations had not previously been cited as grounds for discretionary denial in biosimilar-related IPRs, potentially making it more difficult for biosimilar manufacturers to challenge older patents. ([trial.medpath.com](https://trial.medpath.com/news/7ba6eb8330ff6898/ptab-director-denies-amgen-s-ipr-challenges-against-bristol-myers-squibb-s-opdivo-patents-based-on-settled-expectations?utm_source=openai))
Amgen, developing ABP 206, a biosimilar version of Opdivo, argued that denying IPRs based on potential Biologics Price Competition and Innovation Act (BPCIA) proceedings would create a chilling effect. They emphasized the efficiency benefits of IPRs compared to BPCIA proceedings, noting that a final written decision in the IPR would be issued by October 2026, likely years earlier than any resolution via the BPCIA procedures. ([bigmoleculewatch.com](https://www.bigmoleculewatch.com/2025/08/18/ptab-discretionarily-denies-two-petitions-refers-a-third-to-the-board-in-amgen-v-bristol-myers-squibb/?utm_source=openai))
This decision could create significant challenges for biosimilar manufacturers in timing their IPR filings. It suggests that IPRs may become less useful for biosimilar manufacturers if the patents they are challenging have not been issued very recently. ([trial.medpath.com](https://trial.medpath.com/news/7ba6eb8330ff6898/ptab-director-denies-amgen-s-ipr-challenges-against-bristol-myers-squibb-s-opdivo-patents-based-on-settled-expectations?utm_source=openai))
The PTAB’s recent actions reflect a broader scrutiny of patent strategies that may be perceived as attempts to unduly extend market exclusivity. This development is particularly significant for legal professionals advising clients in the pharmaceutical sector, as it may influence strategies related to patent filings, challenges, and the timing of biosimilar market entries.