Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

October 30, 2025 2:30pm

Michelle O’Brien
Partner
Marbury Law Group, PLLC

  • Extension of patent term under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
  • Exploring the viability of extension applications to:  
    • Basic and combination compounds; secondary patents
  • Important benchmarks in the drug’s development and patent timelines
  • Eligibility for patent term extension
  • Regulatory review period determinations
  • How to calculate the patent term restored
    • Respective roles of the FDA and PTO in granting patent extensions
    • Third-party challenges — “diligence”
  • Patent term extensions outside the U.S.
  • Examining patent term adjustment due to delays in prosecution before the USPTO   
    • Strategies for:  
      • Diligence in prosecution by the patent applicant
      • Calculating the adjustment period
  • Understanding the link between patent extensions and exclusivity  
    • Extensions obtained through FDA Pediatric Exclusivity and Orphan Drug Exclusivity
  • Obtaining patent coverage for pharmaceuticals using second-generation patents, e.g.,  
    • Maintaining patent position for second-generation products
    • Approaches taken by pharmaceutical companies in obtaining second-generation patents
    • Enforcement of second-generation patents