Neil M. McCarthy is a senior counsel in Crowell & Moring's Intellectual Property Group, resident in the Washington, D.C. office. He has over 25 years of experience in patent law, beginning with his service as a patent examiner at the United States Patent and Trademark Office (USPTO). In his more than ten years at the USPTO, he served as an Examiner in the plastics molding and water purification arts, eventually becoming a Primary Examiner.
In the private practice of law, Neil was an associate, counsel and partner at a prominent national law firm specializing in intellectual property. Thereafter, he helped to establish the Washington, D.C. Office of another well known IP firm. He has a diverse range of experience in patent law, including providing infringement and validity opinions, focusing primarily on pharmaceuticals; conducting due diligence and patent landscape analyses; counseling in pharmaceutical litigation arising under the Hatch-Waxman Act; preparing and prosecuting patent applications in the chemical, medical device and pharmaceuticals areas; and participating in inter partes interferences.
The vast majority of Neil's practice over the past 15 years has focused on representing the generic pharmaceutical industry in patent matters related to their Abbreviated New Drug Application (ANDA) filings. His clients have included the largest generic drug manufacturers in the world. He has assisted these companies in hundreds of matters involving new chemical entities, physical forms and synthesis, formulations and indications. He counsels on patent issues arising during all phases of the ANDA process, beginning with initial product selection, development of appropriate filing positions on "Orange-Book" listed patents and strategic counseling during ensuing litigation.
Neil has been an integral member of litigation teams in numerous Hatch-Waxman cases, relying heavily on his experience with countless diverse factual and legal issues that arise in this context. He has spoken on current issues related to patent law in the pharmaceutical / Hatch-Waxman arena and has been an instructor in continuing legal education programs.
Neil received a B.S. in chemical engineering from the University of Michigan in 1983 and a J.D., summa cum laude, from the American University Washington College of Law in 1997.