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Brian J. Malkin

Frommer Lawrence & Haug LLP

1667 K Street, NW
Washington, D.C. 20006
Telephone: 202-292-1530
Facsimile: 202-292-1531

Editor, FDA Lawyers Blog,

  • Practice Areas:
  • Food and Drug Law
  • Intellectual Property Law
  • Litigation
  • Patent Prosecution
  • Due Diligence
  • Scientific Areas
  • Biotechnology
  • Biochemistry
  • Chemistry
  • Pharmaceuticals
  • Medical Devices
  • Nutraceuticals


Brian Malkin's practice include litigation and strategy related to patent validity and infringement as well as food and drug law with an emphasis in the interrelation between patent law and food and drug law. Mr. Malkin's experience uniquely bridges more than 19 years of food and drug law practice with over 9 years of intellectual property law practice. Mr. Malkin is an Editor for FDA Lawyers Blog,, which focuses on FDA legal issues and related developments for individuals interested in FDA-regulated products.


Frommer Lawrence & Haug LLP [Partner] 2004-Present

Mr. Malkin's practice includes strategic analyses associated with both biotechnology and pharmaceutical products, including new product development, life cycle management, and generic, biosimilar, 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, litigation, and licensing. Mr. Malkin's litigation practice focuses on representing pharmaceutical companies in patent cases under the Hatch-Waxman Act and administrative law in the food and drug areas.

Hyman, Phelps & McNamara, P.C. [Associate] January 2001- May 2002

Mr. Malkin developed strategies for pharmaceutical and biotechnology companies regarding regulatory requirements and clinical development, resulting in new product approvals or removal of clinical holds.

Food and Drug Administration [Regulatory Counsel] 1991-2000

Mr. Malkin counseled compliance offices and FDA product review centers regarding new regulatory issues, focusing on intellectual property and exclusivity under the Hatch-Waxman Act and clinical investigations involving human subject protection, resulting in new industry guidance documents and policies. Mr. Malkin worked both in the Center for Drug Evaluation and Research and the Office of the Commissioner.


B.S. Biochemistry, University of Maryland, College Park, 2004
B.A. Economics / Political Science Minor, The George Washington University, 1988
The Johns Hopkins Univeristy, 1983-1985
J.D., The George Washington University Law School, 1991
Editor-in-Chief, The Advocate

  • Bar Admissions

  • Maryland
  • District of Columbia
  • New York
  • District of Maryland
  • Southern District of New York
  • Eastern District of New York
  • U.S. Patent and Trademark Registered Attorney
  • Bar Memberships

  • Maryland State Bar Association
  • District of Columbia Bar Association
  • New York State Bar Association
  • (Chair, Food Drug and Cosmetic Law Section)
  • New York Intellectual Property Law Association
  • Federal Bar Association
  • American Bar Association

Other Memberships

Food and Drug Law Institute
Regulatory Affairs Professionals Society
Massachusetts Biotechnology Council (MassBio)
Tech Council of Maryland (Md Bio / MdTech)
Washington Biotechnology and Biomedical Assocation (WBBA)
Council Member, Gerson Lehrman Group, Inc. Research

Editorial Boards

FDAnews, Generic Line, Editorial Board
Food and Drug Law Institute, Primer Committee
Rare Disease Report, Advisory Board

Recent Representative Publications

October 1, 2013, Financier Worldwide, "Will the FDA provide more guidance or manage the process to share risk evaluation and mitigation strategies (REMS)?"

September 1, 2013, Aspatore / Thompson Reuters Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases, "Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?"

January 2013, Food and Drug Law Institute, The Drug/Biologics Approval Process: An FDLI Primer

December 3, 2012, Aspatore / Thompson Reuters Recent Developments in Food and Drug Law (2013 Edition), "Challenges to the Development of a Biosimilars Industry in the United States"

February 23, 2011, Food and Drug Law Institute Policy Forum, "Should FDA Undertake More Than a "Ministerial" Role with Respect to Patent Information?"

February 1, 2011, Food and Drug Law Institute Update Magazine, "Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009"

June 1, 2010, Food and Drug Law Institute Update Magazine, "Biosimilars Are a Reality: Key Features of the Biologics Price Competition and Innovation Act"

August 1, 2009, Tobacco Reporter, "The Letter of the Law: How FDA Regulation Will Impact Your Business"

Recent Representative Speeches

November 8, 2013, Korea-MD, USA Bio Expo, (1) "Current Good Manufacturing Practice (cGMP) and its Role in Regulatory Drug Quality", (2) "Current Drug Shortages and Orphan Drug Disease Pharmaceutical Development", and (3) "Innovative Strategies for New Drug Development/Biobetters"

October 29, 2013, Q1 Productions, Clinical Data Management Innovation Conference, "Update on FDA's Draft Guidance for Electronic Source Data in Clinical Investigations"

July 25, 2013, Food and Drug Administration, Public Meeting, Standardizing and Evaluating Risk Evaluation and Mitigation Strategies, "Standardizing Shared REMS"

July 11, 2013, Q1 Productions, Global Clinical Risk Management & Regulatory Policy Conference, "Developing a Single Shared REMS in a Collaborative Setting"

April 23, 2013, Food and Drug Law Institute, Annual Conference, "Center for Biologics Evaluation and Research Breakout Session"

January 24, 2013, New York State Bar Association Annual Meeting, Food, Drug and Cosmetic Law Section, "Pivotal Court Cases for FDA Practitioners: 2012-2013 Updates" and "In-House/Outside Counsel Panel: Effective Communication Regarding FDA/Regulatory Advice"

November 29, 2012, American Conference Institute, Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process, "Mastering the Intricacies of the Orphan Drug Designation Process: A Step-by-Step Guide to Navigating the Pathway"

July 17, 2012, American Conference Institute, Advanced Summit on Clinical Trials: Ensuring Safe and Compliant Domestic and International Clinical Trials, "Safely Conducting Biosimilars Clinical Trials: Understanding FDA's Requirements for Biosimilar Clinical Trials"

July 12, 2012, Q1 Productions, Regulatory Clearance & Commercialization of Generic Drugs & Biosimilars, "Preparing for the Evolution of the Generic Drug and Biosimilars Industry" and "Biobetters and Extending into the Marketplace Beyond Patent Expiration"

October 5, 2011, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles, "Exclusivities and Forfeitures: New Developments, Controversies and Concerns"

June 8, 2011, American Conference Institute, Biosimilars, "Ascertaining the Type and Volume of Clinical Data Necessary to Establish Biosimilarity"

May 2, 2011, American Conference Institute, Paragraph IV Disputes, "Exploring Patent Term Adjustment and Patent Term Extensions and Understanding their Applicability to Drugs and Biologics"

April 5, 2011, Food and Drug Law Institute, Annual Conference, "Development and Regulation of Tobacco Products, Nicotine, and Alternative Tobacco Products under the Family Smoking Prevention and Tobacco Control Act and Beyond"

January 27, 2011, American Conference Institute, Life Science Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions, " Patent Term Extension: Laying the Groundwork for Patent Term Restoration"

August 25, 2010, American Conference Institute, FDA Boot Camp, Conference Chair and "Non-patent Exclusivity"

June 21, 2010, American Conference Institute, Follow-on Biologics, "Defining Biosimilars: Proving (or Disproving) Interchangeability and Biosimilarity"

April 26, 2010, American Conference Institute Paragraph IV Disputes, "Patent and Intellectual Property Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More"

April 21, 2010, American Conference Institute Risk Evaluation and Mitigation Strategies ("REMS"), "Post-Conference Workshop Manufactures' Working Session - Preparing for and Implementing a REMS" (half-day program)