Regulatory Exclusivities and Litigation: Preparing Your Life Science Strategy in a Changing EU Framework

The EU pharmaceutical package is set to reshape the European life sciences landscape, with reforms covering data exclusivity, compulsory licences, and SPCs. At the same time, high-profile disputes such as Tecfidera have exposed the litigation risks around exclusivity calculations. This session combines a regulatory overview with a litigation focus to help in-house teams anticipate challenges and adapt their exclusivity strategies.

• Assess proposed reforms to data exclusivity periods and their implications for generic market entry and incentives for innovation.
• Analyse the Tecfidera litigation at the CJEU and national level as a case study in exclusivity disputes and portfolio risk management.
• Examine the introduction of compulsory licences in emergency situations and the resulting litigation risks for originators.
• Evaluate the EU’s push for a centralised unitary SPC system and how it may alter enforcement and harmonisation.
• Debate how exclusivity reforms will influence competition law, supply chain security, and environmental requirements.