Clinical Trials, Marketing and Labeling: Strategies for Proving and Defending Induced Infringement of Biosimilars

This webinar will discuss strategies and considerations on proving and defending patent infringement for developers of branded and follow-on biologics (biosimilars and interchangeables), including how the induced infringement analysis may be impacted by the selection; and, conduct of clinical trials and biosimilar marketing strategy. We will discuss the following issues:

• Overview of standard for proving induced infringement
• The relevance of ANDA experience and caselaw on biologics
• How prescribing biosimilars differs from prescribing interchangeables
• Developing caselaw on how labeling may affect the induced infringement analysis
• Impact on induced infringement based on clinical trial and marketing strategies