2025 AI Intellectual Property Year in Review: Analysis & Trends
This year, intellectual property (IP) law and policy directly addressed the realities of generative artificial intelligence (AI). With a new director at the helm, the U.S. Patent and Trademark Office (USPTO) issued new guidance for AI-assisted inventions.
Litigation Developments
On the litigation side, the Federal Circuit issued its first Alice analysis for machine learning patents in Recentive Analytics, Inc. v. Fox Corp., 2023-2437, addressing subject matter eligibility under § 101. Several federal district courts also weighed in on fair use in the context of training generative AI.
AI’s Impact on Industries
AI is reshaping industries, including life sciences, with the FDA issuing draft guidance for AI use in medical devices, drugs, and biologics. Globally, the European Union implemented the world’s first comprehensive legal framework for AI through the Artificial Intelligence Act, setting enforceable requirements that affect how AI systems are developed, deployed, and licensed.
Other major jurisdictions, including the United States, China, and Brazil, are advancing parallel AI governance regimes that rely heavily on deployment and procurement controls, increasingly shaping technical design choices around auditability, traceability, provenance, and safety.
Legal Firms and AI Technology
We also saw law firms innovate and leverage AI technology in IP practice. In March 2025, Sterne Kessler introduced Patent Assist AI, a proprietary tool designed to streamline patent specification drafting. Additionally, Sterne Kessler launched its internal R&D team, Sterne Kessler Labs, responsible for building, testing, and integrating AI technology into IP practice.
Regulatory Updates
FDA Guidance for AI in Medical Devices
In January 2025, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents discussing:
- The use of AI to produce information supporting regulatory decisions regarding the safety, effectiveness, or quality of drugs and biological products.
- The development and marketing of safe and effective AI-enabled devices.
The draft guidance emphasizes maintaining AI credibility throughout a product’s lifecycle, addressing challenges such as dataset bias, model opacity, output accuracy verification, and performance drift.
EU Artificial Intelligence Act
The EU Artificial Intelligence Act—the world’s first comprehensive regulatory framework for AI—will reshape how companies build, document, and protect innovations deployed in Europe. The Act’s major compliance obligations will phase in through 2026 and 2027, expanding the scope of technical information companies must disclose to regulators.
High-risk AI systems must undergo a conformity assessment before entering the EU market, requiring detailed technical documentation covering system architecture, datasets, testing methodologies, and more.
IP Considerations
Disclosure Risks
Regulatory disclosures may become prior art, and technical submissions must be sequenced to avoid pre-filing exposure of inventive concepts. The Act creates new disclosure risks that can threaten novelty and patent enforceability.
Best Practices for Practitioners and IP Owners
- Align patent filings with regulatory timelines; file before submitting documentation.
- Use mixed protection strategies: patent where disclosure is unavoidable; maintain trade secrets only where confidentiality can be preserved.
- Conduct portfolio audits to identify assets intersecting with EU AI Act compliance obligations.
The landscape of AI regulation is evolving rapidly, and businesses must adapt to remain compliant while protecting their innovations.
