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

ACI’s Hatch-Waxman and BPCIA Passport to Proficiency Series

April Abele Isaacson's presentation will include the following topics:

•  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:
          ƒ  Diligence in prosecution by the patent applicant
          ƒ  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 through the use of second-generation patents, e.g.,
     »  Approaches taken by pharmaceutical companies in obtaining second-generation patents
     »  Enforcement of second-generation patents

Event Details

Thursday, October 21, 2021


2:30 p.m. - 4:00 p.m

CLE Credit

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
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