Abbreviated New Drug Application (ANDA) with Paragraph IV Certification: Critical Insights in 2015

Overview:

When a pharmaceutical company wants to sell a generic version of a branded product, it usually files an Abbreviated New Drug Application (“ANDA“) with the FDA showing that its generic product will meet certain bioequivalence standards as compared to the branded drug.

As part of its ANDA, a generic drug maker may certify that one or more patents covering the branded drug are invalid, not infringed or unenforceable (a “Paragraph IV Certification”).  The Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”) governs the patent litigation that follows. The Hatch-Waxman Act is designed to encourage a balance between incentives promoting technological innovation and market competition. If the patent owner sues within 45 days of receiving notice of a Paragraph IV Certification, the FDA will delay approving the ANDA at issue for 30 months in order to resolve the patent dispute.  At the same time, the first successful filer of a Paragraph IV Certification receives generic marketing exclusivity from FDA for 180 days.

The basic framework of Hatch-Waxman litigation has been made more complicated by recent changes to the Patent Act, pending legislation in Congress, and recent case law.  The Knowledge Group has assembled a panel of key thought leaders to provide the audience with a review and in-depth analysis of these “hot topics” affecting Hatch-Waxman litigation strategy.   

Key issues include that will be covered in this two-hour CLE course are:

• An Overview Of Hatch-Waxman Litigation
• Challenges To Personal Jurisdiction In Hatch-Waxman Litigation
• The Use Of IPRs And Post-Grant Review Strategy In Hatch-Waxman Litigation
• The Impact Of Pending Patent Reform Legislation On Hatch-Waxman Litigation

Agenda:

Who Should Attend:

• Patent Attorneys
• Patent Consultants
• Patent Licensing Attorneys
• Patent Litigators
• Pharma Industry Lawyers
• Pharmaceutical Company Executives
• Professionals coming from Biotech and Pharmaceutical Firms
• Professionals coming from Food and Drug Industries
• FDA Attorneys
• Drug Manufacturing Executives
• Other Related/Interested Professionals