FDA Approval is Coming: Part 1 – Securing Exclusivities and Maximizing Patent Term

As the first part of a multi-part series, this panel will address strategic considerations for companies to consider following FDA approval a of a new drug product in order to maximize the value of available regulatory and patent exclusivities. Brian Burgess and Alex Varond, co-chairs of Goodwin’s FDA Litigation practice, will address how and when to pursue regulatory exclusivities, as well as to defend their scope before the FDA. Olivia Uitto, a co-chair of Goodwin’s Late-Stage Drug Development Practice, will discuss key steps to take to protect and maximize a company’s patent estate, including applying for patent-term extensions and patent-term adjustments and solidifying issues related to patent ownership in preparation for possible infringement litigation.