On 17 November 2022, the ECJ in its cases C-253/20 and C-254/20 [1] addressed the question of whether and under what conditions a parallel importer may import and market under the trademark of the reference drug a generic drug that is identical in all respects to the reference drug. Put another way: can a parallel importer purchase a generic drug that is identical in all respects, but offered at a lower price compared to the reference drug, in order to then sell it, after appropriate repackaging, as the more expensive “original” product?
The ECJ ruled that repackaging one pharmaceutical product, e.g., by replacing the outer packaging with another (known as reboxing or relabeling) is only permissible if the following conditions are met cumulatively:
1. the two drugs are identical in every respect (bioidentity is not sufficient) and
2. repacking meets the so-called BMS criteria [2], in particular that of objective necessity.
According to the ECJ, the requirement of identity “in all respects” is based above all on the fact that under certain circumstances the law considers reference medicinal products and generic medicinal products to be equivalent, although they may in fact exhibit minor differences. Since this could lead to healthcare professionals and patients being misled, repackaging is only permissible if both medicines are identical to each other in all respects.
Such identity exists in particular if the generic product and the original product are manufactured – as is the case here – by the same company or commercially affiliated companies, and if the product is in fact the same product but is merely marketed differently.
With regard to the second requirement, the ECJ emphasizes that objective necessity for repackaging only exists if, due to factual circumstances there is an obstacle to the import of the drug if it is not repackaged, evidence for which must be provided by the parallel importer.
There is no obstacle to the importation of the generic product if a reference product has already been approved in the importing Member State, since approval of the generic product may then only be refused on grounds of public health protection or the protection of human life.
So if the sale of the generic drug (as a generic drug) is legally permissible in the corresponding Member State, i.e. if there is no market impediment, the name of the reference drug/original product may not be printed on it, even if the generic drug and the original are wholly identical to each other.
The ECJ concludes by refusing to allow a generic product to be repackaged in a higher-priced brand category if this merely serves the purpose of conferring economic advantages on the parallel importer by exploiting the reputation of the original brand. In this respect, it prioritizes trademark protection over the rights of parallel importers. However, parallel importers still have the option of marketing generics either under their trademark name or under their “own brand” name.
[1] ECJ, Judgment of 17 November 2022, Case Nos. C-253/20 and C-254/20 – GRUR-RS 2022, 31815.
[2] Repackaging generally constitutes an interference with the exclusive rights of the trademark owner. In the Bristol-Myers Squibb case – ECJ Judgment of 11 July 1996, Case Nos. 427/93, C-429/93 and C-436 – the ECJ set out five criteria for permitting repackaging.
