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Curing rules on parallel import of pharmaceuticals?

Estimated time to read this article
2 min
Date of publication
23 December 2016
Eric De Gryse, Fernand De Visscher
Intellectual Property

On 7 November 2016 the Belgian Supreme Court (Cour de cassation – Hof van cassatie) gave judgment in two cases regarding the repackaging of pharmaceuticals, wherein it ruled in favour of the parallel importer with respect to the exhaustion of trademark rights principle. Simont Braun represented with success the defendant in these two cases.

Just three days later, on November 10, 2016, the CJEU gave a preliminary ruling on a question submitted by a Danish court in a similar case.

All three cases dealt with the issue of whether a trademark owner can oppose the parallel import of trademarked pharmaceuticals of which the packaging format has been modified.

The Belgian proceedings concerned the medicine ‘Cozaar’, containing the active component ‘Losartan’ in a dose of 50 milligrams in one case and a dose of 100 milligrams in the other case, both manufactured by Merck and imported by Pi Pharma into Belgium from Poland. In both proceedings, Pi Pharma bought the most common Polish packaging format of 28 tablets and repackaged these in formats of 98 tablets for the Belgian market.

In the Danish case, the parallel importer Orifarm imported the medicine ‘Klyx’ from Norway to Denmark, after having repackaged it from boxes containing 10 doses into boxes containing 1 dose. In the Danish case, just like in the Belgian 50-milligram case, both packaging formats at stake (i.e. the formats before and after repackaging) were available in the importing as well as in the exporting State. In the Belgian 50 milligram case, the 28 tablets packaging represented only 2% of the market, while in the 100-milligram case, the 28 tablets packaging was absent in the Belgian market.

Both the CJEU and the Belgian Supreme Court start their judgments by recalling the previous CJEU case law on the interaction between the principle of free movement of goods and the trademark rights. According to this case law, a trademark owner can only oppose importation of previously marketed and repackaged products within the EU or EEA if such opposition does not contribute to the artificial partitioning of the single market. Such partitioning occurs when the repackaging is objectively necessary to allow the importer to sell the repackaged products in the importing State. This may be the case when the product cannot be marketed in the importing State because of, in particular, a rule authorizing packaging only of (a) certain size(s) or a national practice to the same effect, sickness insurance rules making the reimbursement of medical expenses depend on the size of the packaging, or well-established medical prescription practices based, inter alia, on standard sizes recommended by professional groups and sickness insurance institutions. Then, where, in accordance with the rules and practices in force in the importing State, the proprietor uses several different sizes of packaging in that importing State, the finding that one of those sizes is also marketed in the exporting State is not enough to justify the conclusion that repackaging is unnecessary. Partitioning of the markets would exist if the importer were able to sell the product only in a limited part of the market.

The Belgian Supreme Court applied this case law by ruling that a trademark owner cannot oppose the repackaging and parallel import if the importer proves that without repackaging he would have access only to a limited part of the market in the importing State. In order to assess this, the Brussels Court of appeal had taken into account the whole Belgian market (all packaging formats) of the active component in their doses of 50 and 100 milligram respectively. The Court of appeal noted that the sale of 28 tablets packaging formats of the 50 milligram Cozaar in that market was marginal (2%) due to the Belgian popularity of the 98 tablets version. This was considered sufficient to prove that the pharmaceuticals in the 28 tablets format could be marketed in a limited part of the Belgian market only, thereby depriving the importer of effective access to the market as a whole. In the proceedings regarding the 100-milligram doses, the 28 tablets format was even inexistent in Belgium, so that the repackaging was also considered necessary. This analysis of the Brussels Court of appeal was explicitly confirmed by the Belgian Supreme Court in the 50-milligram case (in the 100-milligram case, the appeal was dismissed by the Supreme Court for mere procedural reasons). In both cases, repackaging has been objectively determined by the Court of appeal as necessary in order to enable entering the Belgian market. Allowing a trademark holder to oppose the repackaging in such circumstances would lead to the creation of artificial barriers to national markets and would undermine the EU/EEA single market.

A couple of days later, the CJEU went on to apply the same rules in the Danish case. The referring court asked whether the contested repackaging (from packets of 10 doses to packets of 1 dose) could be considered as “necessary” given that the products were available in both formats in the importing and exporting States, while the parallel importer argued that the partitioning of markets is an inherent consequence of the opposition to the repackaging, because the importer could then penetrate the Danish sub-market of packets of one dose of Klyx solely by importing the product in the same packaging from Norway.

On this specific point, the CJEU stated that it was not apparent from the court bundle that the market for Klyx in packets of 10 doses represents only a limited part of the market of the importing State, namely Denmark, and that it is for the referring national court to determine if such a condition is met in the main proceedings.

This led the CJEU to conclude that trademark owners may object to parallel import of repackaged pharmaceuticals when (i) the medicinal product at issue can be marketed in the importing State in the same packaging as that in which it is marketed in the exporting State and (ii) the importer has not demonstrated that the imported product can be marketed only in a limited part of the importing State’s market.

Whether these judgments in any way “cure” (or clarify) the rules on the parallel import of pharmaceuticals is doubtful. As it appears from this case law, the central question is : what is a “limited part” of a market? The Belgian cases confirm that 0% or 2% of a market are limited parts of that market, which seems rather obvious. However, the question whether, under what circumstances and to what extent a part of a market will be determined as a “limited” part of that market, is a very factual question that remains open and will need to be clarified on a case-by-case basis.

Fernand de Visscher, Eric De Gryse