The EU Pharma Package’s controversial expansion of the Bolar exemption has the potential to recalibrate launch timing, litigation leverage and competitive dynamics across the originator-generic divide. The reform directly challenges traditional assumptions about the protective scope of patent rights and the practical meaning of exclusivities in Europe, while inviting direct comparison with the U.S. Hatch-Waxman safe harbor framework.
This session will explore the expanded Bolar exemption and its broad implications across the sector, addressing how national courts are likely to interpret the legislation and how the new provisions compare with established U.S. safe harbor frameworks. Gain an enhanced understanding of how this landmark shift at the interface of IP and regulatory strategy will impact your life science legal work, and receive exclusive advice to help you adjust to the new provisions with confidence.
- What is the scope of the expanded Bolar exemption under the EU Pharma Package, and how does it compare with the U.S. Hatch-Waxman safe harbor?
- Will the expanded provisions actually enable day one generic entry in practice?
- How will expansions to the Bolar exemption play out in the national courts?
- How will incorporating aspects of pricing, public tender and reimbursement into the new provisions interplay with existing IP rules?
- Where do the core risks now lie for innovators, biosimilars and generics? How can they be minimised?
- What are the downstream implications of these legislative changes for patent litigation strategies?
Filipe Pedro
