A new course at Berkeley Law's LL.M. Certificate in AI Law and Regulation program is giving legal professionals the tools to handle the intersection of artificial intelligence and biotechnology. Taught by two industry experts from International Flavors & Fragrances Inc. (IFF), the class addresses the legal, regulatory, and ethical questions that AI-driven innovation brings to the life sciences - a field where the technology is already reshaping patent law, data privacy, and medical diagnostics.
Amanda Casale, intellectual property counsel for IFF's Grain Processing and Scent businesses, and Matthew Show, IFF's Biosciences IP Team Lead, designed AI in Biotechnology Law to reflect the rapid changes in both sectors. Casale, a former neuroscientist, said the course's novelty forced a different approach. "Because there is so little case law and guidance in this space, we would have the chance to think creatively and critically in a way that is distinct from other law courses, and I wanted to give students that opportunity."
Show said the growth of AI in his own practice drove him to create the course. "Over the last two years, I have seen the use of AI grow exponentially across the biosciences industry and in the practice of law itself," he said. "It is influencing everything from scientific research and medical practice to contracts, intellectual property, privacy, and trade secret protection. Lawyers who understand both the technology and the legal framework surrounding it will be much better positioned to help shape the future of innovation in the life sciences."
Focus on real-world impact
The course uses case studies, analysis, and guest lecturers to examine patenting AI-assisted inventions, regulatory compliance with data privacy laws, and the implications of algorithmic accountability in medicine and drug development. Students also explore algorithmic bias and the ethical boundaries of AI-enabled genetic engineering. For legal professionals, these topics are not abstract; they are already influencing day-to-day work in AI for Legal practice.
Show said he wants students to understand that AI is not a separate area of law but a force that is transforming every existing discipline. "AI is not creating a completely separate area of law; rather, it is transforming virtually every area of biotechnology law that lawyers already practice," he said. The class structure reflects that breadth, with an emphasis on preparing students to think critically when clear precedents don't exist.
Built into a first-of-its-kind program
The LL.M. certificate, launched in August 2024, is the first of its kind at an American law school. It has drawn students from more than 40 countries. The executive track can be completed over two summers or through remote study with one summer on campus. AI in Biotechnology Law is one of two new courses this summer, joining Corporate Strategy in the Age of AI and Geopolitics. The initial curriculum includes The Law and Governance of Artificial Intelligence, Global Regulation of AI, and Making AI Work for the People.
Francesca Di Lazzaro, an Italian LL.M. student with a Ph.D. in copyright, AI, and sustainability, said the course's structure stood out. "Rather than focusing solely on doctrine, the course brought together leading practitioners and experts working at the forefront of AI and biotechnology, giving us firsthand insight into the legal and practical challenges shaping the field," she said. "Their contributions made it possible to appreciate how rapidly this area is evolving and how legal frameworks must continuously adapt to scientific and technological innovation."
A fast-moving target
Developing the course meant grappling with a subject that shifts by the month. Materials gathered in the spring were outdated by the time the class began in late June. Unlike traditional law school subjects, there is no deep body of precedent to rely on. Show and Casale framed the course as a guide for orienting a legal lens rather than a set of fixed rules. For patent professionals, this approach is especially relevant when dealing with AI-assisted inventions, an area covered in the AI Learning Path for Patent Agents.
Casale said the diversity of the student cohort - lawyers from different practice areas and countries - enriched the discussion. "Having such a diverse group of LL.M. students, coming from different practice areas, enriched the discussion," she said. "We learned from them." She wants students to leave feeling empowered. "This area of law is rapidly changing, and the technology is going to affect every person on the planet. The students are uniquely positioned to shape how that happens."
Why this matters for legal professionals
AI is already embedded in biotechnology - from drug discovery to patent filings. Lawyers who ignore it risk falling behind on the very contracts, IP strategies, and regulatory filings that define their daily work. The Berkeley course signals that the next generation of legal counsel will need to understand both the science and the code, and that the time to build that expertise is now, not when the case law catches up.
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