USA Trends and Developments Contributed by: Matthew D Powers, Samantha Jameson, Azra Hadzimehmedovic and Aaron Nathan, Tensegrity Law Group LLP
ber 2025) at slides 6, 8, www.uspto.gov/sites/default/ files/documents/Trial_Stats_November_2025.pdf. It is too early to know whether the Bio/Pharma institution rates will remain higher. Only about half of this period was under the new procedures, and petitions previ ‑ ously referred to the PTAB under the Interim Process remain with the three-member panel, which means this data does not yet fully show the effect of the new procedures on Bio/Pharma patents. Based on sum ‑ mary notices issued to date, it is apparent that some life science and pharmaceutical petitions are being discretionarily denied while others are being institut ‑ ed. BPI Labs, LLC v Eli Lilly & Co. , IPR2025-01346, Paper 10 (summary notice denying institution based on discretionary considerations); Imperative Care, Inc. v Inari Medical, Inc ., IPR2025-01264, Paper 11 (sum ‑ mary notice instituting IPR). There may also be additional changes to the pro ‑ cedures for IPR institution based on proposed rules published on 17 October 2025. Revision to Rules of Practice Before the Patent Trial and Appeal Board, 90 Fed. Reg. 48,335. For example, the new rules would require the patent challenger to more broadly waive invalidity challenges in district court or the International Trade Commission (ITC) than is currently required. Id. at 48,338. While 35 U.S.C. § 315 prohibits a petitioner or real party in interest in an IPR that results in a final writ ‑ ten decision from asserting in district court or the ITC that a claim is invalid on “any ground that the petition ‑ er raised or reasonably could have raised during that inter partes review,” the new rule says that an IPR will not be “instituted or maintained unless each petitioner files a stipulation” saying that “if a trial is instituted, the petitioner and any real party in interest or privy of the petitioner will not raise grounds of invalidity or unpa ‑ tentability with respect to the challenged patent under 35 U.S.C. 102 or 103 in any other proceeding.” 90 Fed. Reg. at 48,341. If adopted, this new rule would thus require a stipulation not to challenge validity on bases that could not have been brought in the IPR, which could reduce the number of IPR petitions if petitioners are not willing to provide such a waiver. Inventorship of Inventions Created With the Assistance of AI The Patent Office has recently changed its approach to the inventorship of inventions created with the
assistance of AI. While the Patent Office previously signalled that claims might be rejected where human contribution was insufficient in AI-assisted inven ‑ tions, it has now reversed that approach. This reversal effectively eliminates litigation based on claims being rejected in prosecution for an insufficient contribution by natural persons, but there remains uncertainty about the standard that will be applied in courts. Both guidance in 2024 and 2025 has been consistent with Thaler v Vidal , 43 F.4th 1207, (Fed. Cir. 2022), and confirmed that inventors must be natural persons. “Inventorship Guidance for AI-Assisted Inventions,” 89 Fed. Reg. 10,043, at 10,045-46 (the “2024 Guid ‑ ance”); “Revised Inventorship Guidance for AI-Assist ‑ ed Inventions,” 90 Fed. Reg. 54,636, at 54,636 (the “2025 Guidance”). The 2024 Guidance recognised that “an AI system – like other tools – may perform acts that, if performed by a human, could constitute inventorship under our laws.” 2024 Guidance at 10,045. Under the 2024 Guid ‑ ance, use of an AI system “does not preclude a natural person(s) from qualifying as an inventor (or joint inven ‑ tors) if the natural person(s) significantly contributed to the claimed invention” under the factors from Pannu that are “generally applied to two or more people who create an invention (ie, joint inventors).” 89 Fed. Reg. at 10,046, 10,048; Pannu v Iolab Corp. , 155 F.3d 1344, 1351 (Fed. Cir. 1998). Thus, the 2024 Guidance allowed for the possibility that a claim could be cancelled if a natural person “did not significantly contribute to the claimed invention,” and thus litigation related to the same was a possibility. Id. at 10,049-50. The 2025 Guidance rescinded the 2024 Guidance and does not require the use of the Pannu factors when an invention is created with the assistance of AI. 2025 Guidance, at 54,636. The 2025 Guidance treats AI systems merely as “instruments used by human inventors,” “analogous to laboratory equip ‑ ment, computer software, research databases, or any other tool that assists in the inventive process.” Id. at 54,637. This effectively eliminates the possibility of claims being rejected during prosecution for an insuf ‑ ficient contribution by natural persons and defers to litigation, likely years later, application of a potentially uncertain and evolving legal standard of inventorship.
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