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Thought Leadership

Speaker, "Paragraph IV Disputes and Litigation," 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

 
Speaking Engagements

Don Mizerk will present, “Paragraph IV Disputes and Litigation,” at the 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA on Tuesday, October 15, 2024.

Topics: 

  • Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
  • Pre-suit considerations
    • Initial pleadings
    • Multiple ANDA filers
    • Declaratory judgments
  • Typical Paragraph IV litigation scenarios -hypotheticals
    • 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
  • Preparing for parallel litigation before the PTAB
    • IPR overview
  • Hot buttons in Hatch-Waxman litigation
    • Settlements
    • Damages
    • Double-patenting

For more information, visit the event website.

Professional:

Don J. Mizerk

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