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Brian J. Malkin

Brian J. Malkin

FDA and IP Partner at McDermott Will & Emery LLP
  • Health Care Law, Gov & Administrative Law, Intellectual Property ...
  • District of Columbia, Maryland, New York
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Biography

Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.

Brian’s regulatory experience includes all types of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, cannabis, foods and dietary supplements, cosmetics and tobacco products. He is a key advisor to pharmaceutical and biologic clients in the premarket, regulatory review, and marketing, enforcement and lifecycle management phases of product development. Brian works alongside his clients on drug development strategies and patent strategies across a variety of areas, including:
Pre-Investigational new drug applications (INDs), new drug applications (NDAs), orphan /specialty drug designations, biologic license applications (BLAs) and abbreviated new drug applications (ANDAs)
505(b)(2) NDAs, including new indications, dosage forms or regiments, strengths or combination products, Risk Evaluation and Mitigation Strategies (REMS), including some with elements to assure safe use (ETASU), BLAs and biosimilars (351(k) applications), Medical Devices, including 510(k) clearances and premarket approval applications (PMAs), Laboratory Developed Tests (LDTs), and combination drug/device products, Cannabis and cannabis-derived products including cannabidiol (CBD) products.

Education
University of Maryland - College Park
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
Partner
McDermott Will & Emery LLP
- Current
Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.
Senior Counsel
McGuireWoods LLP
- Current
Partner
Frommer Lawrence & Haug
-
Professional Associations
New York State Bar Association
- Current
Activities: Executive Committee Member, Food, Drug and Cosmetic Law Section (former Chair (2014-2020)) Member, Committee on Cannabis Law (former Co-Chair 2017-2020) Member, Committees on Legislative Policy, CLE
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District of Columbia Bar
Member
- Current
Activities: Co-Chair, IP Community (Section) 2020-current
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Jurisdictions Admitted to Practice
District of Columbia
District of Columbia Bar
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Maryland
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New York
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Fees
  • Free Consultation
Practice Areas
    Health Care Law
    Gov & Administrative Law
    Administrative Law, Election Law, Government Contracts, Government Finance, Legislative & Government Affairs
    Intellectual Property
    Patents
    Patent Appeals, Patent Litigation, Patent Prosecution
    Cannabis & Marijuana Law
    Marijuana Business Formation, Medical Marijuana
    Appeals & Appellate
    Civil Appeals, Federal Appeals
    Business Law
    Business Contracts, Business Dissolution, Business Finance, Business Formation, Business Litigation, Franchising, Mergers & Acquisitions, Partnership & Shareholder Disputes
Websites & Blogs
Website
Website
Blog
FDA Life
Contact & Map
McGuireWoods LLP
2001 K Street NW
Washington, DC 20006
Telephone: (202) 857-1700