Biotech Pharma Expert Witnesses
Biotechnology and pharmaceutical disputes involve enormous investments in research, manufacturing, and regulatory approval, and the conflicts that arise often determine who controls a product's commercial future. Innovator and generic manufacturers litigate patent validity and infringement under Hatch-Waxman and biosimilar frameworks, licensors and licensees contest milestone payments and diligence obligations, and sponsors pursue contract research and manufacturing organizations over failed batches, data integrity problems, and missed timelines. Collaboration agreements, supply contracts, and acquisition disputes frequently turn on whether a development program was managed competently. In each case, the underlying question is scientific and regulatory: what the data showed, what the industry standard required, and whether a party's conduct met it.
A biotech or pharmaceutical expert gives counsel a disciplined framework for evaluating that evidence. Depending on the dispute, the expert may analyze formulation chemistry, pharmacokinetics, crystallization and polymorphism, molecular biology, or manufacturing process controls, then compare a party's work with good manufacturing practice, good clinical practice, and FDA expectations at the relevant time. In patent matters, the analysis addresses claim construction, the state of the art, obviousness, and whether an accused product or process practices the claimed invention. These opinions help counsel establish or rebut infringement and invalidity positions, determine whether a development or manufacturing failure caused the alleged loss, and support damages tied to delayed launches, lost exclusivity, or royalties.
The field spans dozens of specialized disciplines, and an expert's credibility depends on having worked directly with the technology or development stage at issue. Round Table Group works with medicinal and organic chemists holding numerous patents, pharmaceutical scientists who have founded drug delivery companies, senior industry researchers who trained in the laboratories of Nobel laureates, NIH-funded academic investigators, and specialists in contract development and manufacturing, clinical drug development, and regulatory affairs. Some are registered to practice before the U.S. Patent and Trademark Office, and many have testified on patent infringement and validity, drug formulation, clinical trials, and contract research disputes. Drawing on more than 75,000 expert searches for litigators, we welcome the opportunity to assist with your biotech or pharmaceutical matter by calling us at (202) 908-4500.