Brian J. Malkin is a partner in the New York Office of Frommer Lawrence & Haug LLP. Mr. Malkin's practice areas include litigation and strategy related to patent validity and infringement as well as food and drug law and, in particular, the interrelation between patent law and food and drug law. Mr. Malkin's experience uniquely bridges more than 15 years of food and drug law practice with over 5 years of intellectual property law practice.
Mr. Malkin's practice includes strategic analysis associated with both biotechnology and pharmaceutical products, including new product development, life cycle management, and generic or 505(b)(2) new drug application products. His intellectual property practice includes the areas of patent, trademark, trade secret, copyright, and unfair competition and involves prosecution, due diligence, licensing, and litigation. Mr. Malkin's litigation practice is centered on representing pharmaceutical companies in patent cases under the Hatch-Waxman Act and administrative law in the food and drug areas.
Prior to joining Frommer Lawrence and Haug LLP, Mr. Malkin worked as a regulatory counsel at the U.S. Food and Drug Administration in both the Center for Drug Evaluation and Research and the Office of the Commissioner, specializing in the areas of intellectual property and exclusivity related to the Hatch-Waxman Act, new product evaluations, and compliance issues related to clinical investigations. In private practice, Mr. Malkin has continued to work on developing strategies regarding regulatory requirements and clinical development plans for pharmaceutical and biotechnology companies.
Mr. Malkin has a bachelor's degree in biochemistry from the University of Maryland, and a J.D. from George Washington University.
Mr. Malkin is admitted to the Maryland, District of Columbia, and New York Bars and is registered to practice before the U.S. Patent and Trademark Office.
