Under the new Obama administration, analysts believe that Congressional legislation on follow-on biologics will pass in 2009. President Obama has high ambitions for health-care reform and follow-on biologics is clearly part of that agenda. What key factors will help shape this framework for competition and continued innovation? This session will look at the interplay of data exclusivity, patient safety and patents as the Congressional bills begin to be re-circulated and debated.

• Explore the debate around data protection and what constitutes an effective period of market exclusivity so as to provide certainty to innovator companies and investors, particularly in light of unique patent issues under a follow-on biologics pathway
• Educate as to how Congress is evaluating interchangeability between follow-on biologics and the innovator drugs, and the scientific testing and data that will be required prior to FDA approval, in light of patient safety concerns
• Discuss the legal challenges that patents covering innovator biologics are expected to face from manufacturers of follow-on biologics, and the appropriate mechanisms for challenging and defending these patents in the courtroom