Regulatory exclusivity frameworks are evolving at pace, with profound implications for how life sciences companies approach legal strategy across jurisdictions. In Europe, the EU Pharma Package is replacing the long-standing certainty of fixed-term regulatory data protection (RDP) and market exclusivity with a more involved system of conditional incentives linked to product characteristics, launch strategy and public health priorities. Set against this, the regulatory exclusivities landscape in the U.S continues to be shaped by litigation and judicial interpretation, creating new EU-U.S. divergences in how regulatory exclusivities are secured and leveraged.
This session will examine the Pharma Package’s changes to RDP and market exclusivity, and explore how evolving exclusivity frameworks in Europe and the U.S. are reshaping the complex interplay between IP, regulatory and broader business strategy.
- How feasible will it be for companies to meet the Pharma Package’s criteria for beyond-baseline extensions to regulatory exclusivities on pharmaceuticals?
- What does “unmet medical need” mean in a legal context? How will this be evaluated in practice across the EU?
- How are EU exclusivities and incentives changing for paediatric medicines, priority antimicrobials and orphan medicinal products?
- How feasible are the criteria for SPC extensions under the EU Biotech Act? How will they be assessed?
- What are the latest developments in U.S. regulatory exclusivity frameworks? How do they compare against evolving approaches in Europe?
- How should companies align lifecycle management and their regulatory exclusivity strategy across European and U.S. frameworks?
Alexander Natz
Andrew Williams
