Brian J. MalkinFDA Counsel
Arent Fox LLP
Brian is an attorney in Arent Fox’s FDA, Intellectual Property, and Health Care Groups. He has more than 23 years of food and drug law practice and over 12 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian’s regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies. Brian began his legal career as a regulatory counsel at the U.S. Food and Drug Administration, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At FDA he focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration). Brian’s work resulted in new product approvals as well as new industry guidance documents and policies, such as the animal efficacy rule for counter-terrorism products. Following several years of practice in an FDA law firm, Brian recognized an unmet need to understand both food and drug and intellectual property law for life cycle management and diligence, particularly concerning products affected by the Hatch-Waxman Act such as generic and 505(b)(2) new drug applications. As a result, Brian returned to university to obtain a Bachelor of Science degree in biochemistry. Prior to joining Arent Fox, Brian practiced for more than nine years at an intellectual property law firm, where he worked on a variety of new product evaluations, FDA and patent litigations, due diligence projects, patent prosecutions, and licensing and commercial transactions and has also led an FDA Group at an international law firm for nearly three years.