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:
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 through the use of second-generation patents, e.g.,
» Approaches taken by pharmaceutical companies in obtaining second-generation patents
» Enforcement of second-generation patents
Thursday, October 21, 2021
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