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The Next Chapter for Bolar Exemptions and Safe Harbor: Understanding Legislative Reform and Emerging Transatlantic Litigation Trends
With the EU Pharma Package poised to broaden and reshape Bolar exemptions across Europe and U.S. courts continuing to refine the scope of ' 271(e)(1), the life science industry is reassessing how regulatory carve-outs interact with patent enforcement and litigation strategy across global markets. Panellists in this session will examine the latest legislative developments and litigation trends influencing how Bolar exemptions and safe harbor defences are asserted, challenged and interpreted in practice across Europe and the United States.
- Review the latest Bolar case law and discuss jurisdictional differences relating to evidence gathering and preliminary injunction thresholds.
- Examine how expansions to Bolar provisions under the EU Pharma Package will impact launch planning and litigation strategy, and whether greater harmonisation around the boundaries of exempt activity will be achieved in practice across Europe.
- Learn how § 271(e)(1) interpretation for pharmaceutical and biotechnology products is evolving in U.S. safe harbor litigation.
- Assess emerging litigation trends surrounding the limits of exempt activity across major jurisdictions.
