Boutique law firm specializing in IP (patent, trademark, trade secrets), FDA (counseling, investigations, enforcement, GMP compliance), and commercial law (contracts, supply chain, breach of contract, trade secrets) dedicated to the pharmaceuticals, medical devices, food & beverage, CBD, and related areas. Our attorneys also work closely with pharmaceutical companies through the entire development pipeline, from prototype development and clinical trials with an eye towards gaining FDA approval, through eventual patent applications and possible infringement challenges in court. We are well known in the representation of drug companies in Hatch Waxman Act/Paragraph IV litigation. 505(b)(2) Specialist – Drug Reformulation & Re-positioning We also maintain a robust practice with drug re-positioning and life cycle management. We help pharmaceutical clients with the 505(b)(2) NDA process, with an emphasis on creating savvy business and legal strategies around intellectual property, FDA, and supply chain. We can assist 505(b)(2) applicants to interpret the “innovative change” and “conditions of approval” standards and whether a 505(b)(2) will be blocked by an exclusivity. Litigation Our Litigation practice group steps in when our clients face adversarial challenges from government entities, competitor corporations, and from consumers in class actions alleging labeling, advertising and safety violations. Our firm has deep experience in FDA, USDA, and FTC disputes, patent and trademark infringement, commercial breach of contract claims and Paragraph IV challenges. By thoroughly understanding the complexities of all facets of the food and drug industries, we are highly qualified to vigorously defend our clients’ interests in a range of forums from state and federal courts to regulatory agencies to alternative dispute resolution. Our team is prized for innovative litigation strategies which are increasingly emulated by others in this field.