Drug companies face intellectual property hurdles that are unique compared with all other industries because of a linkage forged between patent and FDA law. These unique aspects of the law were first implemented in 1984 through the Hatch-Waxman amendments and then substantially changed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Members of the Pharmaceutical Practice Group are intimately familiar with these statutes and the ever changing regulations and case law, and strategically advise our pharmaceutical clients to predict and plan for tactics employed by market competitors, with careful attention to exclusivity issues.
Greenblum and Bernstein has been intensively representing pharmaceutical clients for over 30 years. The Pharmaceutical Practice Group assists clients, including both generic and innovator companies, with product design-around, strategic planning, due diligence, patent portfolio development and management, and studies. The Group also specializes in strategies for the submission of Abbreviated New Drug Applications (”ANDAs”) and 505(b)(2) applications (”paper NDAs”). When matters lead to litigation, the firm aggressively and creatively fights for clients’ rights, including patent rights and rights to market both generic and new drug products.
Attorneys on the Pharmaceutical team are recognized internationally and are regularly invited to speak at domestic and international conferences. Co-Managing Partner Neil Greenblum is the U.S. Legal Update editor for the Journal of Generic Medicines and the Director of the firm’s Litigation and Trial Practice Group. Among other Greenblum and Bernstein events, Paul Braier organizes workshops for pharmaceutical companies on intellectual property and Hatch-Waxman issues at annual conferences of the International Generic Pharmaceutical Alliance, and the European Generic Medicines Association. In addition, the firm’s monthly Pharmaceutical Newsletter has been in demand since 1996 to recipients on nearly every continent, a testament to the firm’s commitment and longevity in the pharmaceutical arenas.
The length and breadth of our experience with patents and Hatch-Waxman makes Greenblum and Bernstein an ideal choice for today’s pharmaceutical companies.