## Facts

- Boehringer Ingelheim KG and related companies owned trade marks for pharmaceutical products sold in EEA Member States.
- Swingward Ltd and Dowelhurst Ltd acquired genuine Boehringer medicines in other EEA States and imported them into the United Kingdom without Boehringer’s consent (parallel imports).
- Before resale, the importers either:
  - added an external label to the original packaging (“overstickering”) to meet UK requirements; or
  - replaced the external packaging (“reboxing/repackaging”) and re-affixed Boehringer’s trade mark.
- Boehringer alleged that certain overstickering and repackaging infringed its trade mark rights despite exhaustion, invoking the proprietor’s ability to oppose further commercialization where there are “legitimate reasons,” including changed or impaired condition of goods.
- Following an earlier ECJ ruling in related proceedings, the UK Court of Appeal sought further guidance on application of the repackaging conditions and the burden of proof.

## Issues

1. When may a trade mark proprietor oppose further commercialization of parallel-imported pharmaceuticals that remain in original packaging but bear an additional external label applied by the importer?
2. Under what conditions may a parallel importer lawfully rebox pharmaceuticals and re-affix the original trade mark, including the meaning of “objective necessity” and the standard for harm to trade mark reputation?
3. Which party bears the burden of proving compliance (or noncompliance) with the repackaging/overstickering conditions?
4. What is the effect of failing to provide the proprietor with advance notice and, on request, a specimen of the product as marketed?

## Decision

- The ECJ held that a proprietor may oppose marketing of an overstickered pharmaceutical product unless five cumulative conditions are met: no artificial market partitioning, no effect on product condition, clear identification of the overstickerer and manufacturer, non-damaging presentation, and advance notice with specimen on request.
- The ECJ reaffirmed that a proprietor may oppose marketing of repackaged/reboxed products unless the parallel importer satisfies the established five cumulative conditions governing repackaging and re-affixing the mark.
- The ECJ allocated the burden of proof primarily to the parallel importer to show objective necessity and satisfaction of the conditions; the proprietor must substantiate allegations that presentation is liable to damage reputation.
- The ECJ confirmed that failure to give required advance notice (and specimen on request) permits the proprietor to oppose further marketing, while remedies remain subject to national procedural rules constrained by EU-law proportionality and effectiveness.

## Legal Principles

- Exhaustion limits a proprietor’s control over goods first placed on the EEA market by or with its consent, but the proprietor may oppose further commercialization where legitimate reasons exist, including altered presentation that risks impairment or reputational harm.
- Overstickering is permissible only if cumulative safeguards (modeled on repackaging case law) are met, including that the label is not defective, poor quality, or untidy and does not jeopardize the mark’s reputation.
- Reboxing with re-affixing the mark is permitted only if repackaging is objectively necessary for effective market access and the importer satisfies all cumulative safeguards (product condition preserved; proper attribution of repackager and manufacturer; non-damaging presentation; advance notice and specimen on request).
- “Objective necessity” can be shown where, absent repackaging, effective access to the market would be hindered, including due to strong resistance by a significant portion of consumers to relabelled products.
- The parallel importer bears the burden to justify interference with the proprietor’s rights by proving objective necessity and compliance with the cumulative conditions; the proprietor bears an evidentiary burden when asserting that presentation is liable to damage reputation.
- Noncompliance with the advance-notice/specimen requirement allows opposition to marketing, but sanctions must be proportionate under national law as constrained by EU-law principles.

## Conclusion

The ECJ extended the established repackaging safeguards to overstickering of parallel-imported medicines, required objective necessity for lawful reboxing, clarified that importers generally carry the burden to prove compliance, and treated advance notice (and specimen on request) as a condition whose breach permits the proprietor to block further marketing subject to proportionate remedies.


Boehringer Ingelheim KG v. Swingward Ltd, Case C-348/04, 2007 E.T.M.R. 71 (E.C.J. 2007)