David McClure, Ph.D.
David McClure is Of Counsel to the firm. David is a registered patent attorney and represents clients before the US Patent and Trademark Office (USPTO) and the US Food and Drug Administration (FDA).
- Over 30 years of experience in biomedical research
- 20 years of experience in FDA-regulated product development
- 18 years of experience in patent law
- 12 years of experience as general counsel in FDA-regulated industry
- Former chief intellectual property counsel for public company
- Former director of (FDA) regulatory affairs for pharmaceutical and medical device company
- Former chief patent counsel for pharmaceutical company
David’s practice consists of advocacy, strategic counsel, and litigation support. As an advocate, he drafts, files, and prosecutes patent applications at the USPTO, prepares and files regulatory submissions at the FDA, and represents clients in meetings with FDA officials. As a strategic adviser, he counsels businesses and innovators on comprehensive global intellectual property strategy, including licensing, due diligence and optimal international patent portfolio management, as well as on questions of patentability and freedom-to-operate, and advises on regulatory strategy and compliance throughout the product life-cycle. Such advice may include diverse components: defining a path-to-market when a product is just at concept stage, reviewing the content of marketing materials, or training manufacturing team members for successful inspections and audits.
David received his JD degree in 2001 from the University of Kentucky College of Law, where he was a Dorothy Salmon Scholar. Prior to that time, he was a patent agent working in industry, having been admitted to practice before the USPTO in 1998.
David is also a graduate of Harvard University (A.B. History), the University of Louisville (M.S. Neurobiology and Anatomy), and the University of North Texas (Ph.D. Biochemistry), where he was a Robert A. Welch Foundation Fellow. David performed postdoctoral research in protein and lipid chemistry and immunology at the University of Texas Southwestern Medical Center and in protein and lipid chemistry and metabolic engineering at the University of Kentucky College of Agriculture. His research has been published in journals such as Biochemistry, The Journal of Biological Chemistry and Journal of Toxicology and Environmental Health. David likewise has worked extensively in industry in both legal and non-legal research sciencist roles. Among other things he has served as chief patent counsel for a pharmaceutical company, chief intellectual property counsel for a publicly traded metals company, director of regulatory affairs for a pharmaceutical and medical device company, intellectual property consultant for a publicly traded health benefits company, and general counsel and chief scientific officer for medical device companies.
Over the course of his legal career, David has worked for various law firms including major regional firms such Stoll, Keenon and Park (now Stoll Keenon Ogden) and Middleton Reutlinger. He has been a member of the Licensing Executives Society, the Food and Drug Law Institute, the Association of University Technology Managers, the American Chemical Society, the American Society for Biochemistry and Molecular Biology, and the Regulatory Affairs Professionals Society. His clients have included universities; pharmaceutical, medical device, cosmetics, medical food, dietary supplement and tobacco companies; and individual faculty and independent innovators, particularly those developing novel chemicals, materials and healthcare products.