The European Commission Delegated Regulation (EU) 2016/161 introduced the Unique Identifier (UI) and the Anti-Tampering-Device as anti-counterfeiting protection mechanisms and to ensure that the product can be traced at any point in the supply chain. Within a trademark law context, the previous case law of the Court of Justice of the European Union (CJEU) on parallel imports has not been called into question by the European Commission Delegated Regulation (EU) 2016/161: The trademark proprietor continues to have the right to object on trade-mark reasons to the repackaging or to a trademark infringing anti-tampering device – arguably even if repackaging has not taken place – if there is unlawful co-branding, exploitation of reputation or a likelihood of confusion between the manufacturer and trademark proprietor on the one hand and the parallel importer on the other.
1. Unique Identifier (UI) & Anti-Tampering-Device (ATD)
The Unique Identifier (UI) and the Anti-Tampering-Device (ATD) were novelties implemented by the European Commission Delegated Regulation (EU) 2016/161, which supplements the Directive 2001/83/EC (amended by the Directive 2011/62/EU) and serve as counterfeiting measures primary to ensure that the concerned medicinal product can be traced back at any point of the supply chain. The Unique Identifier is an alphanumeric code which has to include, inter alia, the expiry date and a national reimbursement number, and must be applied on all packaging of medicinal products.
The Anti-Tampering-Device must also be applied on the packaging and is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, and by this means ensures that the content of the packaging is authentic. As no European harmonization regarding the exact structure of the ATD was implemented, the manufacturer can in principle choose an appropriate device. Examples for effective Anti-Tampering-Devices may be tamper verification labels (seal, void label) or tamper verification cartons (e.g. glued carton). Member states may – by national law – stipulate that the application of an ATD is obligatory on all pharmaceuticals. If the parallel importer repackages medicinal products, he must install a new Anti-Tampering Device.
2. The Anti-tampering device & Co-Branding
If the parallel importer or repackager repackages the product and thus is obliged to install a new anti-tampering device, an examination of design and trademark law is highly recommended for the trademark owner, as especially inadmissible co-branding may be given if the parallel importer also affixes his trademark on the product in addition to the manufacturer's trademark.
As far as trademark law is concerned, in principle, an EU-trademark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the European Economic Area under that trademark by the proprietor or with his consent. However, this shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialization of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market [Article 15 of the European Union Trademark Regulation (EUTMR)].
The CJEU has well-established case law on these legitimate reasons and on co-branding, and has also recognized the importance of protecting the reputation of the owner of a pharmaceutical trademark. Accordingly, pharmaceutical trademarks are a sensitive area in which the public is particularly demanding as to the quality and integrity of the product, and the presentation of the product may indeed be capable of inspiring public confidence in that regard. Consequently, a trademark owner can oppose repackaging if the carton or the label are “defective, of poor quality or untidy” (CJEU 23.05.1978, C-102/77 - Hoffmann-La Roche v Centrafram, para 76). The already established case law by the CJEU on the legitimate reasons according to Article 15 (2) EUTMR and on co-branding also applies to the Anti-Tampering-Device.
Accordingly, the trademark owner may first request a sample including the packaging of the concerned product. He then is entitled to examine the trademark admissibility of the product on the grounds of the case “Bristol-Myers Squibb” (CJEU 11.07.1996, joined cases C-427/93, C-429/93 and C-436/93), which means, particularly, to determine whether there has been an infringement according to Article 15 (2) of the European Union Trademark Regulation. Any potential co-branding must be assessed on a case-by-case basis.
In this assessment, particular attention must be paid to whether the trademarks of the parallel importer are too strongly accentuated compared to those of the trademark owner. After there-fore identifying the trademark names which were attached to the products in the course of the repackaging by the parallel importer, the trademark owner should further check whether there are any reasons to assume that a dilution of the trademark or an inadmissible co-branding come about, if the reputation of the trademark is impaired or if there is a confusion of origin caused by the repackaging, whereby the overall context must be taken into account.
After reviewing the sample and checking for these stated issues, the permission to distribute the repackaged products can eventually be given by the trademark owner. If the packaging does not correspond to the conceptions of the trademark owner, he has the right to object un-der Article 15(2) of the European Union Trademark Regulation.
3. Recent Austrian Case Law: Vienna Higher Regional Court, 20.12.2019, 5 R 137/19g
This approach is also confirmed by the most recent Austrian case law, in which the F. Hoffmann-La Roche Ltd. as the producer and trademark owner of several medicinal products initiated proceedings against the EurimPharm Vertriebs-GmbH & Co KG and its sister company EurimPharm Produktions GmbH as parallel importers and repackagers. The subject of the (at first provisional) proceedings were repackaged medicinal products on which the anti-tampering devices and the imprints of the EurimPharm’s own trademarks appeared in greater numbers and more prominently than those of the F. Hoffmann-La Roche Ltd. In such a case, there usually is a high risk of inadmissible co-branding, dilution and/or exploitation of the trademarks of the manufacturer. This decision currently constitutes the most important case law on this issue in Austria.
The Vienna Higher Regional Court decided that the design of the packaging infringed the trademark rights of the F. Hoffmann-La Roche Ltd. in the form of a tampering with origin (Vienna Higher Regional Court, 20.12.2019, 5 R 137/19g). According to the Vienna Higher Regional Court, EurimPharm designed the anti-tampering device in an eye-catching colour and provided it with their company slogan without it being apparent what function EurimPharm had. Moreover, the company logo was shown more often and more clearly on the pack-aging than the trademark of F. Hoffmann-La Roche Ltd. There was no indication that the EurimPharm companies were not the manufacturer of the product in close proximity to the anti-tampering device. The relevant public would therefore assume an economic link between EurimPharm and F. Hoffmann-La Roche Ltd.
The decision of the Vienna Higher Regional Court was followed by an injunction settlement in the main proceedings, in which the EurimPharm Vertriebs-GmbH & Co KG and its sister company Eurim-Pharm Produktions GmbH undertook to refrain from offering for sale, distributing in Austria, possessing for the purpose of offering or placing on the market as well as repackaging medicinal products in packaging printed with the manufacturer's trademarks or with signs similar to the trademarks of the manufacturer,
- on which the EurimPharm's trademark or a similar trademark is directly affixed to the anti-tampering device
- and/or on which the sign of EurimPharm appears more often than the trademark of the manufacturer F. Hoffmann-La Roche Ltd, in particular in the form of a figurative line or as a company slogan, on which the trademark of F. Hoffmann-La Roche Ltd is affixed in a com-parable form of co-branding with third-party trademarks and without any visible indication on all sides that the EurimPharm was the importer of the goods and/or the repackager.
The injunction settlement also included settlement publication, compensation for damages and removal.
4. Conclusion
This decision shows that permissible parallel importation should not consist in placing the parallel importer's trademark or sign more prominently on the packaging than the trademark of the actual manufacturer, so that there is an inadmissible co-branding, the trademark owner's trademark is diluted, or the reputation of the trademark is exploited.
This approach represents an acceptable compromise between the manufacturer and trademark proprietor on the one hand and the parallel importer on the other and shows where the limits of repackaging should be within the new safety features introduced by Regulation (EU) 2016/161, such as in particular the anti-tampering device.
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