Bristol-Myers Squibb v Paranova: the five conditions every repackaged parallel import still has to meet

What was decided

Paranova bought medicines of Bristol-Myers Squibb, Boehringer Ingelheim and Bayer in Greece, the United Kingdom, Spain and Portugal, where they were cheaper, and sold them in Denmark. To do so it put them into new outer boxes of its own uniform design, carrying the manufacturer’s trade mark and the words “imported and repackaged by Paranova”; changed pack sizes to match Danish prescribing, selling Adalat for instance as ten blister strips of ten tablets; took vials and ampoules out of their padding and relabelled them; stuck its own labels over the originals on bottles and inhalers; added Danish patient information; and, in one case, replaced the spray in a Mycostatin pack with one from another supplier. The three owners sued for trade-mark infringement, and the Copenhagen Maritime and Commercial Court and the Danish Supreme Court asked the Court of Justice how the new Trade Marks Directive’s exhaustion rule, Article 7, fitted with the Court’s older case law on repackaging under the Treaty.

The Court (sitting as the full court, Judge Gulmann as rapporteur, Advocate General Jacobs) held that the two are one. A trade mark cannot be used to keep national markets apart once the owner has put the goods on the market in the Community, and Article 7 of the Directive says what the Treaty had already said. The mark’s function is to guarantee origin, and repackaging that respects that function and is needed to get the product to market does not infringe. From its 1978 Hoffmann-La Roche judgment the Court then drew up the list that has been applied ever since. The owner may oppose a repackaged parallel import unless:

1. Necessity. Opposing the repackaging would contribute to the artificial partitioning of the market, which is the case where the repackaging is necessary to market the product in the importing state, as where pack sizes there differ; the owner’s intent does not matter.
2. Original condition. The repackaging cannot affect the original condition of the product inside the packaging. Taking blisters out of one box and putting them in another, adding labels, patient information or an extra item does not in itself do so; inaccurate information or a non-compliant added article might, and that is for the national court.
3. Identification. The new packaging states clearly who repackaged the product and who manufactured it.
4. Reputation. The presentation of the repackaged product is not such as to damage the reputation of the mark or its owner: no defective, poor-quality or untidy packaging.
5. Notice. The importer gives the owner notice before the repackaged product is put on sale and, on request, supplies a specimen.

The case name has become the name of the rule. In Europe the conditions are now written into the trade-mark legislation as the “legitimate reasons” on which an owner may resist exhaustion, and they were carried into UK law unchanged when the UK left the EU.

Timeline

Date	Event
31 October 1974	Centrafarm v Winthrop: the Court holds that a trade mark is exhausted once the owner puts the goods on the market in a member state
23 May 1978	Hoffmann-La Roche v Centrafarm (Valium): repackaging may be opposed, but not where it partitions the market and the product is untouched, the owner is notified and the pack says who repackaged it
1989	The Trade Marks Directive codifies exhaustion in Article 7
1993	Three Danish references on Paranova’s repackaging reach the Court
14 December 1995	Advocate General Jacobs’s opinion
11 July 1996	Judgment: the five conditions
16 July 1998	Silhouette: exhaustion is EEA-wide only; goods first sold outside the EEA can be kept out
12 October 1999	Pharmacia & Upjohn v Paranova: replacing the mark with the one used in the importing state is judged by the same necessity test
23 April 2002	Boehringer Ingelheim v Swingward I: the conditions apply to overstickering as well as reboxing; notice is mandatory, about fifteen working days being reasonable
26 April 2007	Boehringer Ingelheim v Swingward II: the importer bears the burden on the conditions, except that the owner must raise reputation damage; necessity is tested for whether to repackage, not how; de-branding and co-branding can damage reputation
17 November 2022	The anti-tampering rulings: a new box is necessary only where a relabelled, resealed pack would be refused by a significant part of the market
6 February 2026	Denmark applies the 2022 rulings in ten joined cases

What it means if you are…

A parallel trader. The five conditions are the checklist for every repackaged import, and they have not moved in thirty years. The one that generates most disputes is the first: since 2022, relabelling the original pack and resealing it is the default, and reboxing has to be justified pack by pack. The one that generates most lost cases is the last: notice before sale, with a specimen if asked, is a condition in its own right, and an importer who skips it infringes even if everything else is in order.

A generics or launch planner. This is trade-mark law and does not touch generic entry; its relevance is the 1999 and 2022 rebranding rulings, under which a generic may be sold in the importing state under the originator’s brand only where the two products are identical and the rebranding is objectively necessary. In practice that door is almost always shut.

A wholesaler or buyer. A repackaged parallel import that meets the five conditions is lawful stock; the box should name the repackager and the manufacturer, and the product inside should be the original. Where a national authority pushes importers towards new boxes, as Denmark’s did, the trade-mark position still governs, and stock in boxes that were not necessary can be the subject of infringement claims against the importer.

Status and what to watch

Still good law, and the root of everything on this site about repackaging. What has changed is the detail: necessity, notice and burden of proof were refined in the two Boehringer v Swingward rulings, the anti-tampering seal was fitted into the framework in the 2022 rulings, and Denmark and Belgium have applied them. The next refinement is the pending German reference on whether importers must relabel inner containers in the national language. In the UK the conditions apply as retained law, with no divergence so far; the UK’s exhaustion regime decides which imports they reach. This note is a summary for commercial readers and is not legal advice.