Key Legal Issues
- Scope of the Bolar exemption clarified under EU law.
- Supply of patented active ingredients covered under exemption.
- Strengthened alignment with Malta’s Patents and Designs Act (Chapter 417).
- Increased legal certainty for generics manufacturers and suppliers operating in Malta.
Executive Summary
In its landmark judgment in Case C-661/13 Arne Forsgren v. Österreichisches Patentamt, the European Court of Justice (ECJ) delivered decisive guidance on the application of the Bolar exemption within the EU. The ruling confirms that the supply of patented active ingredients for studies necessary for marketing authorisation falls within the exemption, even when supplied by third parties. This clarification fortifies Malta’s progressive interpretation under its national legislation, enhancing the country’s attractiveness as a jurisdiction for pharmaceutical development and regulatory operations.
ECJ Clarifies Scope of Bolar Exemption
On 15 January 2015, the ECJ ruled that activities involving the supply of patented active pharmaceutical ingredients to entities carrying out clinical trials or regulatory studies qualify under the Bolar exemption as explained in Case C-661/13.
Importantly, the Court specified that the exemption is not confined to activities directly carried out by marketing authorisation applicants, provided the use remains objectively linked to regulatory approval processes.
Reinforcement of Malta’s Legal Framework
Malta has long adopted an innovation-friendly approach to the Bolar exemption under the Patents and Designs Act. The judgment validates Malta’s broader interpretation, ensuring the country remains aligned with EU law while offering a supportive environment for pharmaceutical companies engaged in early-stage development and regulatory testing.
Implications for the Pharmaceutical Sector
The ECJ’s clarification creates regulatory certainty for companies operating in Malta and across the EU. In particular:
- Generic manufacturers can proceed with necessary studies without infringing patent rights.
- Suppliers of active pharmaceutical ingredients can lawfully support regulatory testing activities.
- Malta strengthens its competitive position as a preferred jurisdiction for pharmaceutical research and development.
Strategic Advantages for Malta
As pharmaceutical companies seek jurisdictions with reliable, innovation-friendly legal frameworks, Malta's legislative environment offers clear strategic advantages:
- Early access to European markets post-patent expiry.
- Reduced litigation risks for generic producers.
- Enhanced investment climate for pharmaceutical research and manufacturing projects.
Malta at the Forefront of EU Pharmaceutical Innovation
By aligning closely with the EU’s most progressive interpretations of the Bolar exemption, Malta positions itself as a leading jurisdiction for pharmaceutical innovation and regulatory excellence within the European Union. As industries continue to evolve, jurisdictions offering a balance between intellectual property rights and market accessibility will play a critical role in shaping the future of healthcare.
