Biotechnology Expert Witnesses
Biotechnology disputes involve products and platforms that take years and substantial capital to develop, which makes the underlying intellectual property and commercial agreements exceptionally valuable. Innovators and competitors litigate patents covering antibodies, therapeutic proteins, vaccines, gene constructs, diagnostic assays, and engineered crops, and biosimilar and follow-on entry frequently triggers complex infringement and validity contests. Collaboration, licensing, and supply agreements generate disputes over milestones, royalties, development diligence, and ownership of improvements, while manufacturing and regulatory questions arise when a product fails to meet specifications or FDA expectations. The central issue is typically what the science actually shows about a molecule, process, or organism and how that science maps onto the parties' legal rights and obligations.
A biotechnology expert helps counsel translate complex laboratory and development records into opinions a court can evaluate. In patent matters, the analysis may involve sequence and structural comparisons, assay and characterization data, and the state of the art at the priority date, supporting positions on infringement, obviousness, written description, and enablement. In contract disputes, experts can assess whether a party used commercially reasonable efforts, whether a development program was scientifically sound, and whether a milestone was actually achieved. Manufacturing and regulatory specialists can evaluate process validation, analytical methods, and compliance with FDA requirements, while industry economists address commercial success, market dynamics, and royalty rates. Together, those opinions support liability and damages theories and give counsel the tools to challenge overstated scientific claims by the opposing side.
Biotechnology spans molecular biology, immunology, protein chemistry, plant genetics, bioprocess engineering, regulatory science, and industry economics, so the expert who can explain an antibody's binding characteristics may not be the right witness on royalty rates or crop transformation. Experts in our network include inventors holding dozens of patents in drug design and delivery, immunologists who have testified on novelty, inventiveness, and enablement, and crystallization scientists who have testified repeatedly on polymorphism and solubility. It also includes FDA regulatory specialists who have testified many times, patent practitioners experienced in inequitable conduct and licensing disputes, pharmaceutical economists who have testified on commercial success and survey design, and founders who have taken biotechnology companies through successful public offerings. Round Table Group has completed more than 75,000 expert searches for litigators and applies that experience to matching the scientific and commercial expertise your biotechnology dispute requires. Let us help you find the right biotechnology expert by calling us at (202) 908-4500.