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
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