12:00 AM
  • Presented by: American Conference Institute
  • Speakers: Stephen R. Auten
  • Location: InterContinental Chicago Magnificent Mile, 505 N. Michigan Ave., Chicago, IL

5th Annual Paragraph IV Disputes Master Symposium

Stephen R. Auten will present “Paragraph IV Litigation Trends, Analysis and Future Predictions,” at American Conference Institute’s 5th Annual Paragraph IP Disputes Master Symposium on October 1 in Chicago. The session will cover the following topics:

  • Overview of PIV filing trends and analysis of litigation decline in the last year
  • Understanding the correlation between Paragraph IV filings and the speed of ANDA approvals
  • Exploring the relationship between PDUFA, GDUFA and Paragraph IV filings
  • Analyzing how recent proposed amendments to these User Fee Acts may influence future filings and impact future ANDA litigation
    • Schrader Amendment
  • Survey of proposed legislation that may impact Hatch-Waxman Act, exclusivities and ANDA litigation
    • Improving Access to Affordable Prescription Drugs Act
  • Examining how changes in the judiciary and Judges shortages in key jurisdictions have affected in Paragraph IV litigation

More information and registration here.

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