Develop Strategies for PIV Litigation in the Evolving Regulatory and Enforcement Landscape
Navigate Enforcement Trends and Increase Preparedness for PIV Litigation
Paragraph IV is largely regarded as the most significant and contentious certification within the Hatch-Waxman legal framework. With the advent of the patent cliff and the industry’s continued shift to niche therapies and biologics, it is clear that PIV litigation is becoming more aggressive and frequent than ever before. As the regulatory and legislative environment continues to change, PIV litigators face new and evolving challenges inside and outside the courtroom.
Topics being Researched for 2012:
•Inner Workings of the FDA’s Biosimilars Pathway
•Supreme Court’s Ruling for Patent Use Codes
•New Provisions and Procedures of the America Invents Act
•Impact of the Changing Bio/Pharma Business Model on Paragraph IV Litigation
•Defining Inequitable Conduct in Today’s PIV Suits
•The New Era of Label Carve-Outs
Richard Ruzich, Kerry McTigue, and Blake Coblentz