INTA Committees Collaborate on Amicus Brief on Parallel Imports of Pharmaceutical Products

INTA filed an amicus curia brief with the Court of Justice of the European Union (CJEU) in October for two joint cases involving parallel imports of repackaged pharmaceutical products, and trademark exhaustion.

Both cases are requests for preliminary rulings. C-147/20, Novartis Pharma GmbH v. Abacus Medicine A/S was referred from the Regional Court, Hamburg, Germany, and C-224/20, Merck Sharp & Dohme B.V. et al. v. Abacus Medicine A/S et al. was referred from the Maritime and Commercial Court, Copenhagen, Denmark.

The cases emerged after the entry into force of Directive 2001/83/EC  on the Community code relating to medicinal products for human use, amended by Directive 2011/62/EU (Falsified Medicine Directive—FMD) and the respective Commission Delegated Regulation (EU) 2016/161 (Delegated Regulation).

At issue is whether manufacturers of pharmaceutical products maintain the right to object to repackaging in new, external packaging even under the new requirements of the obligatory anti-tampering device.

The International Amicus Committee—Europe Amicus Subcommittee and Parallel Imports Committee collaborated in the preparation of the brief.

Background

The cases involve parallel imports of pharmaceuticals into Germany and Denmark, respectively. The claimants are manufacturers of medicinal products and proprietors of the trademarks for the medicinal products. The defendants carry out parallel imports of medicinal products that the claimants have placed on the market in other EU countries. The defendants repackage the medicinal products in new, external packaging to which they either reaffix the claimants’ respective trademarks or give a new product name before marketing the medicinal products in the country of import.

The defendants claim that, prior to further distribution, the claimant’s original packaging must be opened, including the anti-tampering device, to be able to create a packet suited for distribution in the country of import.

INTA’s Position

INTA argued that repackaging is not the only possibility nor a legal requirement under the new requirements of the FMD and the Delegated Regulation. It is therefore not “objectively necessary” within the meaning of the five conditions for exhaustion with respect to the repackaging (see judgments of July 11, 1996, Bristol-Myers Squibb and Others, C-427/93, C-429/93, and C-436/93). Given that repackaging is not a legal obligation under the FMD and Delegated Regulation, it follows that repackaging is permissible to the extent it conforms with the established rules of the CJEU.

Following these rules, brand owners may object to the continued marketing of a medicinal product which a parallel importer has repacked in a new, outer packaging and to which it has reaffixed the trademark. That is the case if the medicinal product can be marketed in the importing member state in the packaging that was used for marketing the product in the exporting state. Brand owners can require parallel importers to reuse the original package, accommodated with new labels and leaflets in the language of the importing state.

Brand owners may oppose repackaging if it is due solely to the parallel importer’s attempt to secure a commercial advantage. In this case, this does not fulfill the condition of necessity to market the product in the importing state.

The relabeled product must have effective access to the relevant market for opposition to the use of repackaging to be conditional. National courts assess whether instances of strong resistance on (substantial parts of) markets from a significant proportion of consumers to relabeled products constitutes an obstacle to effective market access.

INTA submitted that FMD Article 47a and point (o) of Article 54 must be interpreted as meaning that a new anti-tampering device, affixed to the original packaging of the medicinal products (in connection with additional labeling after the packaging has been opened in such a way that the original anti-tampering device has been fully or partially covered and/or removed) may be “equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering [with] the medicinal product.” This is within the meaning of Article 47a(1)(b) of the FMD and may be “equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products,” within the meaning of Article 47a(1)(b)(ii) of the FMD.

Whether the new anti-tampering device affixed to the original packaging would indeed be equivalent in a particular given case, and equally effective, shall depend on the factual circumstances of the case. The removal of the brand cannot be accepted without considering the alternative solution of leaving the brand on the product while indicating the interference of a third party through the placement of additional labels or stickers.

The most recent cases on parallel importation of repackaged pharmaceuticals indicates the need for the courts to further clarify the relationship between the established jurisprudence on the requirements for repackaging under exhaustion principles (the so-called BMS conditions, referring to the Bristol-Myers Squibb judgments) and the provisions of the new FMD. INTA will continue to follow the cases closely.

Parallel Imports Committee members Mary Bagnall (Charles Russell Speechlys, UK), Charlotte Boddum (Patrade Legal ApS, Denmark), Nikolas Gregor (CMS, Germany), and Philipp Henrichs (HENRICHS IP, Germany) also contributed to this article.

Although every effort has been made to verify the accuracy of this article, readers are urged to check independently on matters of specific concern or interest. 

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