USA Trends and Developments Contributed by: Matthew D Powers, Samantha Jameson, Azra Hadzimehmedovic and Aaron Nathan, Tensegrity Law Group LLP
These cases provide important guidance on the criti ‑ cal facts and analytical frameworks that determine the outcomes of life science and pharmaceutical liti ‑ gations. It is important for litigants on both sides to consider and address the points raised in these cases when litigating written description issues. New IPR Institution Procedures Patent owners and petitioners need to be aware of the significant changes to the institution procedures for IPRs this year. While they have greatly reduced the number of instituted IPRs overall, thus far there has not been as significant a decline in life science and pharmaceutical patent IPR institutions based on the Patent Office’s data. However, it is still too early to tell what the effect of recently introduced changes will be. IPRs have been a central part of patent litigation strat ‑ egy since their introduction in the America Invents Act as they provide an alternative venue for raising certain patent validity challenges. If fewer IPRs are instituted, this will significantly change litigation dynamics and the venue where invalidity issues are litigated. On 26 March 2025, the process for deciding whether to institute IPRs changed significantly. First, the deci ‑ sion whether to institute IPRs was bifurcated between (i) discretionary considerations and (ii) merits and other non-discretionary statutory considerations. Interim Processes for PTAB Workload Management (26 March 2025) (“Interim Process”), www.uspto. gov/sites/default/files/documents/InterimProcesses- PTABWorkloadMgmt-20250326.pdf. The Director and a panel of three Patent Trial and Appeal Board (PTAB) judges would determine whether discretionary denial is appropriate and then send the petition for a decision on the merits if institution was not denied. Id. Sec ‑ ond, additional factors beyond those listed in Apple Inc. v Fintiv, Inc. (IPR2020-00019, Paper No 11) were identified as relevant to the discretionary denial analy ‑ sis, including “[t]he extent of the petition’s reliance on expert testimony” and “[s]ettled expectations of the parties, such as the length of time the claims have been in force.” Interim Process. These new factors give rise to additional arguments against institution. These changes appear to have resulted in a decline in the number of instituted IPRs overall: from 68% in the year ending 30 September 2024, to 50% in the
year ending 30 September 2025, despite the fact that the Interim Process was only introduced in late March. PTAB Trial Statistics (14 November 2025) at slide 7, www.uspto.gov/sites/default/files/documents/ Trial_StatsFY25_Q4.pdf. However, the rate for “Bio/ Pharma” institutions remains higher, and the decline was from 73% to 65% for the same periods. Id. at slide 9; PTAB Trial Statistics (2024) at slide 8, www. uspto.gov/sites/default/files/documents/ptab_aia_ fy2024__roundup.pdf. The Federal Circuit has thus far not granted man ‑ damus on petitions challenging these new institu ‑ tion procedures. For example, in Cambridge , two of five filed IPRs were subject to discretionary denial based on factors including the “settled expectations” addressed in the Interim Process. In reCambridge Indus. USA Inc. , No 2026-101, 2025 LX 501919, at *4 (Fed. Cir. 9 December 2025) (non-precedential). The court denied mandamus, stressing that 35 U.S.C. § 314 (d) makes institution decisions “final and nonap ‑ pealable,” including denials for “efficiency reasons.” Id. at *5, *8. However, the court did recognise that arguments that the Patent Office needed to promul ‑ gate the institution considerations through notice and comment rulemaking could be raised in an APA action in a district court. Id. at *6. Effective 20 October 2025, there was another signifi ‑ cant change in IPR institution practice that built upon the Interim Process. First, the Patent Office Director began determining whether to institute IPRs based on the discretionary, merits, and non-discretionary fac ‑ tors. Memorandum (17 October 2025), www.uspto. gov/sites/default/files/documents/open-letter-and- memo_20251017.pdf. Second, while the Director may issue a decision addressing facts or refer a decision to a member of the PTAB, decisions are generally being made with a “summary notice” that does not contain reasoning. Id. It remains to be seen what effect these additional changes will have on IPR institution rates for life sci ‑ ence and pharmaceutical patents. Initial data from the Patent Office for the period 1 October 2025 to 30 November 2025, showed a 37% institution rate for IPRs overall, but a 67% institution rate for “Bio/ Pharma” technologies. PTAB Trial Statistics (Novem ‑
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