April 10. 2024

FDA Lifecycle Management Webinar Series:Successfully Navigating the Patent Term Extension Process for FDA-Approved Products


Join Mayer Brown partners George O’Brien (FDA Regulatory) and Vera Nackovic (Intellectual Property) for our FDA Lifecycle Management webinar series. In this installment, George and Vera will discuss the operation of the Hatch-Waxman Act’s patent term extension provisions as they relate to patents covering FDA-approved drugs, biological products, and medical devices.

Patent term extension (PTE), available for certain patents covering novel, FDA-regulated products, and is designed to restore the portion of a patent’s term used up during the product’s development phase and the FDA’s review of the product’s marketing application.

The US Patent and Trademark Office (PTO) is tasked with reviewing PTE applications and making final determinations on the length of any extension. However, the PTO relies on the FDA to assist with questions of eligibility, and to provide other information found in the FDA’s product files. As a result, a PTE application often requires both patent and FDA regulatory expertise. Unfortunately, the mandatory exchange of information between the two agencies can also lead to significant delays before a PTE is awarded—many straightforward applications have been pending for more than three years.

George and Vera will discuss how patent owners and FDA application holders can maximize the PTE award for their innovative products, while minimizing the risk of unreasonable delay and other substantive pitfalls. Specifically, we will:

  • review the statutory and regulatory criteria for determining eligibility for PTE;
  • share best practices for drafting submitting a PTE application;
  • summarize the procedural aspects of the PTO/FDA information exchange, including the recent uptick in lengthy delays; and
  • examine recent developments and policy shifts that may impact eligibility for PTE and the length of any extensions. 

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