Green, Griffith & Associates

We are a preeminent boutique intellectual property law firm, focusing on pharmaceuticals, chemistry and biotechnology—specializing in litigation. Our attorneys share decades of experience partnering with both brand and generic companies to navigate the most complex IP and related FDA issues, including the Hatch-Waxman Act. Acknowledged leaders in our field, we help clients build and execute targeted, timely and cost-effective IP strategies from project initiation through litigation, with an eye toward securing market position and overcoming obstacles to new product entry. Our range of services includes counseling regarding strategic formulation, portfolio and due diligence, as well as handling all stages of trial and appeals concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2) and ANDA applications, and their related drug products and therapies. Each of our attorneys has extensive scientific backgrounds that permit exploration of technical solutions at a deep level. This expertise, coupled with our unparalleled experience litigating at the PTO and in the federal courts, positions us to work with each client to craft and execute the best strategy to attain our clients’ goals. Specialties Include: • Litigation (505(b)(1), 505(b)(2), ANDA) • Pre-litigation Planning • Inter Partes Reviews (IPR) • Assessing FDA Exclusivity (NCE, Orphan Drug, Data and Marketing Exclusivities) and Patent Term Extension Issues • Analysis, Development and Management of Patent Portfolios, including Orange Book patents • Providing Pre- or Post-Product Development Advice • Identifying and Evaluating Potential “Design-Around” Formulations • Analyzing Potential Section viii “Carve-out” Strategies