## Facts

- The case concerns the application of state liability under EU law in the context of supplementary protection certificates (SPCs) for patented products.
- Synthon BV challenged the granting of an SPC by a national authority to Smithkline Beecham plc, which was later found to be invalid.
- The dispute centered on whether the grant of the invalid SPC, which extended patent protection, caused damage to parties such as generic pharmaceutical companies.
- The judgment examined the conditions under which a Member State could be held liable for such damages under EU law, referencing the Francovich case.
- The Court of Justice of the European Union (CJEU) considered the decision-making process of national courts and authorities in granting SPCs and the direct economic consequences for affected parties.

## Issues

1. Whether state liability arises under EU law when a national authority grants an SPC later found to be invalid.
2. What constitutes a "sufficiently serious breach" by a national court or authority in the context of SPC regulation.
3. How to establish a direct causal link between the grant of an invalid SPC and the damage suffered by affected parties.
4. Whether the mere invalidation of an SPC automatically triggers state liability.

## Decision

- The CJEU held that a manifest error of assessment by a national authority regarding the application of the SPC Regulation can constitute a sufficiently serious breach, potentially triggering state liability.
- The mere fact that an SPC is later found invalid does not automatically establish a sufficiently serious breach.
- State liability depends on whether the national authority's conduct was manifestly contrary to the provisions of the SPC Regulation at the time of the grant.
- The injured party must demonstrate a direct causal link between the grant of the invalid SPC and measurable damages, such as lost profits.
- National courts possess a margin of appreciation in technical matters but may be liable if they exceed this discretion by making manifest errors.

## Legal Principles

- State liability for breaches of EU law applies where the rule infringed confers rights on individuals, the breach is sufficiently serious, and there is a direct causal link between the breach and the damage.
- A "sufficiently serious breach" in the context of SPCs requires a manifest error of assessment by the national authority.
- The mere invalidation of an SPC is not enough to trigger state liability; the conduct of the authority at the time of the grant is decisive.
- National courts must balance their autonomy in interpreting patent law with the uniform application of EU law and the SPC Regulation.

## Conclusion

The CJEU clarified that state liability in the context of erroneously granted SPCs requires a manifest error of assessment by a national authority, not just subsequent invalidation of an SPC. Claimants must prove both a sufficiently serious breach and a direct causal link to damages suffered, thus reinforcing consistent application of EU law and legal certainty in pharmaceutical patent protection.


Synthon BV v Smithkline Beecham plc (Case C-452/06) [2008] ECR I-7681