June 15, 2023

FDA Lifecycle Management Webinar Series: Listing Patents in FDA's Orange Book


Join Mayer Brown FDA regulatory partner George O’Brien for the June installment of our FDA Lifecycle Management webinar series. In this webinar, George will discuss the listing of patents in the FDA’s Orange Book.

New drug application (NDA) holders are required to submit information to FDA regarding all patents that cover their approved drug, or a method of using their approved drug. FDA lists these patents in the Orange Book, based on the information provided by the NDA holder on FDA Forms 3542a and 3542. The submission of patent information to FDA is an important step in protecting innovator drug products, but is becoming increasingly fraught with uncertainty and risk, due to uncertainty regarding the scope of patents that can be listed. He will discuss how NDA holders can best comply with the patent listing obligations, while minimizing risk.

In this installment, George will:

  • Explain the statutory and regulatory criteria for determining which patents can and must be listed;
  • Discuss best practices and identify common pitfalls in filling out forms 3542a and 3542; and
  • Review recent cases and controversies regarding Use Codes and labeling carve outs, as well as eligibility for the listing of patents claiming REMS and/or medical devices. 

For additional information, please contact Hilda Macauley at hmacauley@mayerbrown.com or +1 202 263 3047.

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