Dr. Ralph E. Gaskins’ practice primarily focuses on intellectual property and commercial litigation matters involving pharmaceuticals, medical and surgical devices, biotechnology, digital imaging, communications-enabled transportation systems, electronics and internet technologies, as well as criminal and civil investigations under the Federal Food, Drug, and Cosmetic Act, the Biologics Price Competition and Innovation Act, and the Federal False Claims Act.
Ralph also counsels pharmaceutical and other life science clients on compliance and enforcement issues, including FDA inspections, product seizures and injunction actions, warning letters, product recalls, and Formal Dispute Resolution proceedings within the FDA. He regularly utilizes his corporate and legal experience to assist pharmaceutical and biotechnology clients with FDA-related due diligence, Hatch-Waxman product lifecycle management strategies, prescription to OTC switch applications, and other related matters involving acquisitions or valuation determinations.
Prior to joining Kasowitz, Ralph served as the founding CEO for Spectropath, an optical imaging company that licensed the global rights to novel cancer detection technologies. He previously served as both Vice President of Intellectual Property and Legal Affairs, and as Vice President for Clinical Affairs for CeloNova BioSciences. Ralph was also the founding CEO for MitralSolutions and CEO of MD3Technologies, both early stage biomedical companies. He served as General Counsel for the American Cardiovascular Research Institute, a national nonprofit medical research organization. Prior to his corporate roles, Ralph practiced as a patent and regulatory attorney with two large, national law firms.
Before law school, Ralph was an otolaryngologist (a head and neck surgeon), with a subspecialty practice in rhinology and surgery of the nose and sinuses. He was actively involved in the design and development of several products related to sinus surgery, some of which remain in commercial use after almost 30 years.