Brian J. Malkin
FDA and IP Partner at McDermott Will & Emery LLP
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.
- 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
- Free Consultation
- District of Columbia
- District of Columbia Bar
-
- Maryland
-
- New York
-
- 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
- -
- University of Maryland - College Park
- B.S. (2004)
-
- The George Washington University Law School
- J.D. (1991)
-
- The George Washington University Law School
- B.A. (1988)
-
- 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
-
- District of Columbia Bar
- Member
- - Current
- Activities: Co-Chair, IP Community (Section) 2020-current
-
