MEDICAL DEVICES: when medical device "repackaging" complies with legal rules

Court of Milan - Sez specialized Ordinance no. 30014/2014

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The Court Of Milan (Italy) has just issued an interesting judgement regarding  the "repackaging" of some medical devices which were subjected to parallel importation.

Litigation object:

An Italian company imported some medical devices aimed at the measure of the blood glucose (One Touch Ultra test strips) from other European markets: the  purpose was to repack and sell them in the Italian territory. 
To be  more precise,  it bought packs of 50 strips and repacked  for the Italian market in sizes from 25 to 100 strips.

The manufacturer of the original medical device took legal action to ban such repackaging operation before the Court of Milan.

Legal rules
Referring to the leading case of the European Court of Justice (Case C-379/97 Upjohn and C-348/04 Boehringer), the judges establish that the repackaging is allowed when:

1.     it is established that the repackaging carried out by the importer is necessary in order to market the product in the Member State of importation,

2.     it is shown that the new label cannot affect the original condition of the product inside the packaging;

3.     the packaging clearly states who overstickered the product and the name of the manufacturer;

4.     the presentation of the overstickered product is not such as to be liable to damage the reputation of the trade mark and of its proprietor; thus, the label must not be defective, of poor quality, or untidy;

5.     the importer gives notice to the trade mark proprietor before the overstickered product is put on sale, and, on demand, supplies him with a specimen of that product/

If the above mentioned conditions are not met, the manufacturer (trade mark proprietor) is entitled to oppose the repackaging.

Ruling

In this dispute, the judges established that the italian company had not proved the “objective necessity” to repackage the devices in order to  market them in Italy (see point 1 above).
The judges also noted that other foreign distribution companies already sell these medical devices in several European markets without any repacking operations.

Consequently the italian company repackaging has been evaluated as not in compliance with the legal rules, since just aimed at commercial advantage and not at  “objective necessity”.