Product Line Extensions and New Product Development:
Trademark Considerations & Lawful Pre-Approval Communication Strategies
October 29, 2009
The October 29, 2009Coffee, Croissants and CLE Programfeatured a two-part discussion on trademark issues surrounding pharmaceutical proprietary names, and lawful pre-approval communications. Carole E. DeNatale, Of Counsel, Porzio Bromberg & Newman, P.C., and Steven H. Hartman, Vice President, Trademarks & Copyrights, Novartis Corporation led the discussion on trademarks, and Linda Pissott Reig, Esq., Principal, Porzio Bromberg & Newman, P.C., and Vice President, of Compliance Services, Porzio Pharmaceutical Services, LLC led the latter discussion.
DeNatale educated the attendees about the dual review process and highlighted the often competing views and policies of the U.S. Food & Drug Administration (FDA) and the U.S. Patent & Trademark Office. She also described FDA's promotional and safety review of drug names. Hartman provided insight into the lengthy process undertaken by a pharmaceutical company to develop trademarks for its prescription drug products.
Reig's discussion focused on how pharmaceutical companies can develop practices to avoid the appearance of unlawful marketing and promotion in the pre-approval phase of drug development. She provided a detailed look at companies' uses of press releases, websites, clinical trial registration and results posting, interactions with medical professionals and patients, and publication planning and reprint distribution.