Brian J. Malkin

Brian J. Malkin

McGuireWoods LLP
  • Health Care Law, Gov & Administrative Law, Appeals & Appellate ...
  • District of Columbia, Maryland, New York
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Brian leads the firm’s FDA regulatory teams. He has more than 20 years of food and drug law practice and over nine 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. Immediately prior to law school, Brian worked as a legislative correspondent in the U.S. Senate Committee on Labor and Human Resources. He 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 lifecycle 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 McGuireWoods, he 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.

University of Maryland Francis King Carey School of Law
B.S. (2004)
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The George Washington University Law School
J.D. (1991)
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The George Washington University Law School
B.A. (1988)
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Professional Experience
Senior Counsel
McGuireWoods LLP
- Current
Frommer Lawrence & Haug
Professional Associations
District of Columbia Bar
- Current
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Jurisdictions Admitted to Practice
District of Columbia
District of Columbia Bar
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New York
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Practice Areas
  • Health Care Law

  • Gov & Administrative Law

    Administrative Law, Election Law, Government Contracts, Government Finance, Legislative & Government Affairs

  • Appeals & Appellate

    Civil Appeals, Federal Appeals

  • Business Law

    Business Contracts, Business Dissolution, Business Finance, Business Formation, Business Litigation, Franchising, Mergers & Acquisitions, Partnership & Shareholder Disputes

  • Intellectual Property

  • Patents

    Patent Appeals, Patent Litigation, Patent Prosecution

Websites & Blogs
FDA Life
Contact & Map
McGuireWoods LLP
2001 K Street NW
Washington, DC 20006
Telephone: (202) 857-1700