Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?
The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.
The CJEU Provides Further Clarity on the Application of the Global Marketing Authorisation Concept
On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment[1] for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.
