Kevin is an intellectual property attorney with a focus on large-scale complex patent infringement litigation.
For more than 15 years, he has guided clients through the legal and regulatory challenges and changes associated with obtaining approval to commercially market a product under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. In addition to helping clients develop a strategy for filing an abbreviated new drug application (ANDA), Kevin has represented clients in every phase of patent litigation and has successfully argued before the United States Court of Appeals for the Federal Circuit. His matters have involved patents purportedly covering well-known pharmaceutical products and methods for using those products. He also has successfully represented clients in inter partes review (IPR) proceedings.
In the face of an evolving and uncertain biosimilar industry in the United States, Kevin has counseled clients on navigating the biosimilar legal and regulatory pathways. He has also advised clients on regulatory matters before the U.S. Food and Drug Administration, such as opposing citizen petitions. Rounding out his experience, Kevin has handled cases involving trademark and copyright infringement, false or unfair advertising, and unfair competition claims.
Hatch-Waxman and Biosimilars
Articles in the National Law Review database by Kevin M. Kevin M. Nelson