Sara W. Koblitz Director 202-737-9623
Sara W. Koblitz

Overview

Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Ms. Koblitz also counsels cosmetics, food, and dietary supplement clients, with experience regarding genetically-modified foods, medical foods, food labeling, and dietary supplement claims and substantiation.

Ms. Koblitz has authored several Citizen Petitions and has worked extensively with litigators and experts in preparation for depositions and trial. She has worked with companies of all sizes, from start-ups to fortune 500 companies. Ms. Koblitz also has experience in export control and other areas of regulatory law.

Prior to joining Hyman Phelps & McNamara, Ms. Koblitz practiced at a major intellectual property firm, where she counseled clients on the Hatch-Waxman Act and other areas of FDA regulation. Prior to that she worked on general FDA regulatory matters at an AmLaw 100 firm. While in law school, Ms. Koblitz clerked at the FDA Office of Policy and the Humane Society of the United States.

Education & Admissions

Education

BA, Johns Hopkins University
Political Science with honors

JD, Duke University School of Law
Special Projects Editor, Duke Journal of Constitutional Law & Public Policy

Admissions

Maryland
District of Columbia

Speaking Engagements

  • Webinar, Panel Member, Biologics and Biosimilars:  FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation, February 15, 2024
  • Webinar, Panel Member, Biosimilars and Interchangeable Biologics: New FDA Draft Guidance, November 28, 2023
  • Panel Moderator, Food and Drug Law Journal’s 2023 Symposium: Regulating on Shifting Sands: Analyzing the Impact of Recent and Upcoming Federal Court Decisions on FDA’s Authority, Orphan Drug Exclusivity: From Depomed to Jazz, a Review of Key Case Law and Themes in FDA’s Interpretation of ODD and ODE, November 8, 2023
    ACI’s Paragraph IV Disputes Master Symposium, Best Practices for Utilizing FDA’s Citizen Petition Process: Brand and Generic Recommendations for Achieving Market Access and Petitions for Reconsideration, October 24-25, 2023
  • ACI’s Virtual Course: Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA, Panel  “Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics”, October 12, 2023
  • GRx+Biosims 2023 – Generics and Biosimiliars Conference, Impact of Omnibus Bill on Generics Industry, October 2-4,2023
  • GRx+Biosims 2022 – Generics and Biosimilars Conference, Generic and Biosimilar Patent Landscape, November 7-9, 2022
  • Moderator, Food and Drug Law Journal 2022 Symposium – “The Interconnected Regulatory Landscape: Exploring FDA’s Relationship with Other Domestic Regulators”, November 3-4, 2022
  • ACI Virtual Series: Hatch-Waxman and BPCIA Passport to Proficiency Series: Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions; An In-Depth Look at 180-Day Exclusivity, October 25, 2022
  • TOPRA Virtual Masterclass:  Module Regulatory Strategy for Established Active Substances, Patent and Exclusivity Considerations for Abridged Drug and Biologic Applications in the USA, October 12-14, 2022
  • FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law; The Future of Skinny Labeling and Its Impact on Generics and Biosimilars, June 14-15, 2022
  • ACI Virtual Event, Hatch-Waxman and BPCIA Proficiency Series, The Hatch-Waxman Landscape: ANDAs and Exclusivities, October 5-12, 2021
  • District of Columbia Bar Virtual Program, FDA Law for IP Lawyers – Tips for Effectively Integrating FDA Regulatory Law Into an IP Law Practice, April 29, 2020
  • FDLI Introduction to Biologics and Biosimilars Law and Regulation Conference, Biologics License Applications (BLA’s), March 31-April 1, 2020
  • Webinar, Strafford Publications, Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation, February 13, 2020
  • RAPS Regulatory Convergence, Regulatory and Legal Implications for Orphan Drug Exclusivity in the US and Europe, October 1-4, 2018
Education

BA, Johns Hopkins University
Political Science with honors

JD, Duke University School of Law
Special Projects Editor, Duke Journal of Constitutional Law & Public Policy

Admissions

Maryland
District of Columbia

Practice Areas
Industries
FDA Regulatory Categories