Global Regulatory Exclusivities and Litigation for the Pharma and Biotech Sector

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.
• Understand China’s evolving regulatory and enforcement landscape for the life science sector.
• Discuss China’s reliance on invalidation proceedings and administrative routes and understands how global life science companies plan parallel patent and regulatory strategies.