The Farm Bill’s New Biotechnology Office, And What It Means for Agricultural IP
- Alison Baldwin
- May 14
- 4 min read
When a federal court vacated the SECURE Rule in 2023, developers of gene-edited crops lost the clearest regulatory pathway they’d had in decades. Case-by-case USDA review returned. Unfortunately that meant uncertainty and delays, increasing the difficulty of building an effective patent strategy.
That history provides important context when reading the Farm Bill’s new Office of Biotechnology Policy provision. But there is a second piece of context that much of the coverage has missed: between 2022 and 2024, the federal government mounted an ambitious interagency coordination effort on agricultural biotech. It is the combined impact of these prior government efforts of coordination that shapes everything about what the new office means for agricultural patent strategy.
The Fragmentation Problem
The Coordinated Framework for Regulation of Biotechnology, initially put into force in 1986, divided oversight of agricultural biotech products among three agencies: USDA, EPA, and FDA (among other organizations such as APHIS). When it was last comprehensively updated in 2017, the regulatory categories fit the existing technologies. But the development of CRISPR-based gene editing, RNA interference, and precision breeding tools have since created a generation of innovations that don’t fit neatly into frameworks built for transgenic organisms.
The result is regulatory fragmentation, inconsistent review timelines, and genuine uncertainty about which agency reviews which product, on what schedule. For patent strategy, that uncertainty has a direct dollar cost. Every year a product spends in regulatory review is a year of commercial patent value consumed before the product reaches market. Patent term adjustment compensates for USPTO delays; patent term extension can address certain regulatory review delays. Neither is a substitute for predictable timelines.
What the Prior Administration Built
In September 2022, President Biden signed Executive Order 14081, directing the federal government to take a whole-of-government approach to biotechnology. Section 8 of the EO gave USDA, EPA, and FDA a specific mandate: identify gaps in the Coordinated Framework, publish plain-language guidance on each agency’s role, and build a unified mechanism so developers could submit inquiries and receive a single, coordinated response from all three agencies.
The agencies followed through. In May 2024, USDA, EPA, and FDA jointly published the Coordinated Framework for the Regulation of Biotechnology — Plan for Regulatory Reform. The document covered modified plants, animals, microorganisms, and human biologics. Its centerpiece was a cross-agency mechanism: one submission point, joint agency meetings, a coordinated response. For biotech developers navigating three separate regulatory processes for the same product, this was a meaningful structural change.
The coordination extended to the patent system. In March 2023, USDA launched an Interagency Working Group on Competition and Intellectual Property in Seeds, with USPTO, the DOJ Antitrust Division, and the FTC at the table. USDA and USPTO exchanged letters committing to making the patent system more transparent for farmers and seed growers and pledged to explore joint examiner training and enhanced prior art search capabilities for agricultural innovations. A new USDA Farmer Seed Liaison role was created specifically to bridge the IP system and the farming community.
Where Things Stand Now
The Biden administration left office in January 2025. Whether the Trump administration continued, stalled, or reversed the Coordinated Framework reform work is unclear as of this writing. The applicability of joint filing mechanism, the planned update to the Coordinated Framework, and the interagency information-sharing Memorandum of Understanding is an open question.
Now we add the Farm Bill’s newly-formed Office of Biotechnology Policy. The House-passed provision gives USDA a dedicated coordinating body for biotechnology regulation — the first of its kind inside the department. Its mandate includes coordinating USDA’s approach across the Coordinated Framework. That mandate either builds on the infrastructure the prior administration assembled, or it’s starting with less support than it might have had.
Uncertainty remains the overriding issue. Senate action could change the provision.Appropriations could underfund the office. The underlying fragmentation across USDA, EPA, and FDA won’t simply disappear because a new coordinating body exists. But at least there is an opportunity.
What This Means for Your Ag Biotech Portfolio
Patent strategy in agricultural biotech has to account for the full picture of where regulatory certainty stands right now, not just where it was heading two years ago.
If you’re developing gene-edited traits and your regulatory strategy conversation is separate from your patent strategy conversation, that’s a gap worth closing. Filing timing, claim scope, and continuation architecture all need to account for how long your product will spend in regulatory review, and under what framework. A strong patent on a trait that spends six years in regulatory limbo produces far less commercial value than the same patent with a clear, fast pathway to market.
The Office of Biotechnology Policy is a meaningful step. The right patent strategy question isn’t “what does this new office do?” It’s “what is the regulatory environment this office is operating in, and does your portfolio account for it?”
Alison Baldwin is a registered patent attorney with 25+ years of experience in agricultural and life sciences IP. Baldwin IP focuses on the innovations that feed, heal, and sustain the world.
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