Institute for International Research

Strategies for Filing Successful Paragraph IV Certifications

Under Hatch-Waxman, companies can seek approval to market a generic version of a patented brand drug before the patent covering the brand drug expires. The first company to file an ANDA with the FDA gains the exclusive right to market the generic drug for 180 days - an important financial advantage in a tremendously competitive marketplace. The generic applicant must certify that either the product described in its ANDA does not infringe, or that the patent is invalid.

This is known as "Paragraph IV Certification.” Our legal expert takes you through the nuts and bolts of Paragraph IV certifications in an interactive workshop format.

What You Will Learn:

Purpose of Paragraph IV certifications and Notice Letters

• Background of Hatch-Waxman
  
• Orange Book listings
  
• Types of Certification Letters
  
• Benefits of First to File
  
• 30-month stays and 180-day exclusivity period

Requirements and Strategies for Paragraph IV certifications and Notice Letters

• Minimum Statutory Requirements
  
• Timing of Submissions and Notice
  
• Offering Additional Information to Patent Holder
  

Effect of Certification and Notice Letters on Litigation

• Use of Certification and Notice Letters at Trial
  
• Difference between opinion letters and notice letters
  
• Willful Infringement and Privilege issues
  
• Pre-Launch Litigation v. Post Launch Litigation Recent developments in the Law

Workshop Leader:
Richard J. Basile
ST. ONGE STEWARD JOHNSTON & REENS

Understanding How to Submit Quality ANDAs based on QbR to Reduce Approval Time

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. This updated workshop provides an overview of the ANDA process including the components of an ANDA, as well as potentially problematic issues sometimes raised by FDA reviewers. Understand FDA expectations and learn why FDA submission approvals and corporate quality go hand in hand. Learn how quality submissions can reduce approval time and favorably impact your company's bottom line.

What You Will Learn:

• Tips for communicating with FDA
  
• The role preparation plays in beating the clock
  
• Common mistakes made during an ANDA submission
  
• Strategies for eSubmissions

Workshop Leader:
Candis Edwards
Senior Vice President, Regulatory Affairs & Compliance
INTERPHARM