Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
Jane Dai, Ph.D. & Susan M. Janicki, Ph.D.
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated value of their patents to maintain them after grant.[1] The intention is to raise revenue and reduce the government’s budget deficit. However, the proposed changes have the potential to dramatically remodel the biotech industry’s intellectual property landscape as well as to disrupt its current business models. The new fee structure could also undermine the US patent system’s goal of incentivizing innovation. News of the proposed changes led to an immediate decline in the stock prices of several major players in the biotech space, as investors anticipated higher costs and potential profit reductions.[2]
Currently, many pharmaceutical and biotech companies file broadly, and maintain all of their issued patents for strategic reasons, including defensive patents to block competitors, and for licensing to generate revenue. Biotech often relies on venture capital and licensing deals anchored on patent strength. Higher maintenance fees could lead to fewer filings, weakened IP positions, and reduced funding availability.
FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries
Agnes Juang, Ph.D. & Makoto Tsunozaki, Ph.D.
On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation of Americans’ sensitive genetic data by adversaries, under a “broader national effort to implement Executive Orders 14117 and 14292.”[1]
Executive Order 14117 was issued by the Biden administration in 2024 to establish new export control regulations that prohibit or restrict a U.S. person from engaging in certain data transactions with countries of concern and covered persons.[2] The final rules implementing the executive order specifically prohibits a U.S. person from engaging in “any covered data transaction with a country of concern or covered person that involves access by that country of concern or covered person to bulk U.S. sensitive personal data that involves bulk human ’omic data, or to human biospecimens from which bulk human ’omic data could be derived.”[3],[4] However, the Final Rules provided exemptions for: transactions that involve regulatory approval data and are necessary to obtain or maintain regulatory authorization of a drug, biological product, or device; transactions ordinarily incident to and part of clinical investigations regulated by the FDA or clinical investigations that support applications to the FDA for research or marketing permits for drugs, biological products, devices, combination products, or infant formula; and transactions ordinarily incident to and part of the collection and processing of clinical care data or post-marketing surveillance data necessary to support or maintain authorization by the FDA.[5]
CRISPR Dispute Heats Up With Recent Federal Court Decision
Jane Dai, Ph.D. & Geetha Durairaj, Ph.D.
On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents, overturning a 2022 decision by the Patent Trial and Appeal Board (PTAB)[1]. The main issue centers on inventions related to the CRISPR-Cas9 editing in eukaryotic cells. The Patent Trial and Appeal Board (PTAB) had previously ruled in favor of Broad, finding that the Regents did not demonstrate whether CRISPR-Cas9 editing worked in eukaryotes prior to Broad’s reduction to practice. The Court partially vacated and remanded PTAB’s ruling, finding that PTAB incorrectly applied the legal standard for conception in awarding priority to the Broad Institute for certain gene-editing patents.
The Court criticized the PTAB for conflating legal concepts of conception and reduction to practice. Emphasizing that conception is established when an inventor has “a definite and permanent idea of the complete and operative invention,” the Court criticized the PTAB for focusing almost exclusively on the Regents scientists’ statements expressing uncertainty about their experiments’ success[2]. The Court explained that such scientific uncertainty, common in complex research, does not negate conception unless it leads to substantive modifications of the original invention.
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