David Silverstein is a registered patent attorney with nearly 20 years of experience handling legal and regulatory matters, on the generic and the branded side, relating to pharmaceutical and biotech products. Mr Silverstein has served as lead counsel in matters before the US district courts, the US Patent Trial and Appeal Board and the US Court of Appeals for the Federal Circuit. In addition, Mr Silverstein’s practice includes performing due diligence, licence negotiation and counselling in connection with complex commercial transactions involving pharmaceutical and biotech products. Mr Silverstein is frequently involved in Food and Drug Administration (FDA) strategy and counselling, including filing or responding to citizen petitions, and coordinating FDA strategy with patent litigation strategy.
Mr Silverstein previously practised in-house at Par Pharmaceutical and, prior to that, at major New York firms. While in-house, Mr Silverstein oversaw and managed all aspects of patent, antitrust, unfair competition and trade secret litigation. He also served as Par’s in-house regulatory counsel, advising on regulatory strategies and frequently representing Par before the FDA’s Office of Chief Counsel and other regulators.
Together with his graduate training at Cornell University in protein crystallography and structure-based drug design, Mr Silverstein combines his courtroom and industry experience to develop strategies that enable his clients to achieve their technical, legal and commercial objectives simultaneously.