Several judgments from the CJEU on the parallel import of pharmaceutical products are good news for brand owners in the pharmaceutical industry. Egon Engin-Deniz, member of the MARQUES Council and Anti-Counterfeiting and Parallel Trade Team, discusses them in the second of two blog posts.

A previous post on the Class 46 blog discussed recent CJEU case law on repackaging and relabelling of parallel-imported pharmaceutical products. The CJEU addressed a slightly different issue in Joined Cases Impexeco v Novartis and PI Pharma v Novartis (C-253/20 and C-254/20).

Here, parallel importers planned to import and sell the trade mark owner’s pharmaceutical product into Belgium under its original name (Femara) after purchasing the generic product from a Novartis group company in the Netherlands under a different name.

They then repackaged the generic product and applied the trade mark owner’s name Femara to the outer package, which Novartis sought to oppose.

The parallel importers claimed that the generic products sold in the export country were in fact the same as the original products – as both were produced by a Novartis group company – and therefore Novartis only attempted to partition the market by prohibiting the import and rebranding of the generic product with the trade mark of the original product.

The CJEU clarified that a trade mark owner has the right to object to the parallel import of a generic product that is being introduced to the import market under the trade mark of the reference product. However, such rebranding is only acceptable when the products are indistinguishable and relabelling is objectively necessary. This would be the case if the medicinal product cannot be marketed in the importing country under the generic name.

The pharmaceutical industry has received these judgments and the key directives on the parallel import and repackaging of generic products positively.

Austrian case law

In 2020 a similar case was brought before the Commercial Court in Vienna, Austria. In this case F. Hoffmann-La Roche AG objected to the parallel import of their products in Austria by EurimPharm Vertriebs GmbH & Co KG, which sold the imported pharmaceutical products that were repackaged by EurimPharma Produktions GmbH beforehand.

In particular the trade mark owner claimed that the adhesive label (Anti-Tampering Device) bore the name of the parallel importer (EURIMPHARM) very prominently written in white on a green background. Furthermore, its company logo was placed next to the written information about the repackager, which could be understood as an indication of the product’s origin. Moreover, the sign EURIMPHARM was found more often on the outer packaging than the trade mark Roche.

In essence, the trade mark owner argued that the packaging used in the course of the repackaging had a misleading effect on the public and was therefore an infringement of the trade mark owner’s exclusive rights, since the trade mark was not yet exhausted.

The Commercial Court Vienna (Handelsgericht Wien) and subsequently the Higher Regional Court Vienna (Oberlandesgericht Wien) stated in the immediate injunctive relief proceedings that the Delegated Regulation (EU) 2016/161 does not require the parallel importer to affix its own trade mark or other company identification on the anti-tampering device.

Furthermore, the regulation does not intend to harm the rights of the trade mark owner and cannot be used by the parallel importer to attract the attention of the relevant public and impair the origin function of the medicine manufacturer’s trade mark. The information that none of the defendants are the manufacturer, but the first defendant is only a parallel importer, and the second defendant is only a re-packager of the respective medicine, is only found on the back of the packaging, which the relevant public hardly notices. The defendants thereby cause a deception regarding the origin and impair the origin function of the plaintiff’s trade mark.

Since the anti-tampering device with the sign EURIMPHARM is located on a narrow side of the outer packaging in close proximity to the plaintiff’s trade mark, the defendants furthermore gives the incorrect impression of a business relationship between the parties.

The plaintiff and the two defending parties reached a settlement in the main proceedings in which the first defendant agreed not to sell or distribute repackaged medicinal products in packaging that bears the plaintiff’s EU trade mark or similar marks, and on which the sign EURIMPHARM or similar signs are affixed to the anti-tampering device or appear more frequently than the plaintiff’s EU trade mark.

They must also indicate clearly on all sides that they are the parallel importer and that the second defendant is the repackager. The parallel importer had to render his books to calculate and pay damages. The Court settlement had to be published at the costs of the parallel importer in a pharmaceutical newspaper.

Legal certainty

These decisions have contributed to legal certainty by empowering brand owners’ rights against parallel importers through these significant rulings of the CJEU.

Nevertheless, it is advisable for brand owners/originators to always ask for a sample from parallel importers and to check the contents as well as (altered) leaflets inside. This checklist should also include an examination of the outside packaging and to make a note of the deadline to object distribution in case of a reasoned contradiction. If doubts remain whether a parallel importer will distribute products different than the supplied sample, organise test purchasing as well.

Egon Engin-Deniz is a partner of CMS Reich-Rohrwig Hainz in Vienna, a member of the MARQUES Council and a member of the Anti-Counterfeiting and Parallel Trade Team.

Image of pills taken from MARQUES photo library. The picture of the Commercial Court of Vienna is by Otto Normalverbraucher and licensed under Creative Commons