Mindaugas Zalepūga, Agnė Širinskienė

Abstract

The goal of the article is to analyze the evaluation of the affect of repackaging on the original condition of parallelly imported medicinal products in the jurisprudence of the Court of Justice of the European Union (CJEU).

The article observes that the criteria existing in the jurisprudence of CJEU for the above mentioned evaluation are rather fragmented and more confined to the determination of presumptions, when the possibility of the affect on the original condition of repackaged medicinal product is unlikely (cases Hoffmann-La Roche and Bristol-Myers Squibb). However, in comparison with the other goods, the CJEU clearly creates higher criteria for the repackaging and procedural requirements for the evaluation of the affect of repackaging on the original condition of medicinal products. The Court even establishes a duty for importer to supply the trade mark proprietor with a specimen of the repackaged product in order to enable him to evaluate the affect of repackaging on the original condition (cases Bristol-Myers Squibb and Boehringer II). While evaluating the national legal system, the article concludes that national law of the Republic of Lithuania does not define a duty for importer to give a notice to the trade mark proprietor before the repacked product is put on sale and, on his demand, to supply him with a specimen of the repackaged medicinal product. Accordingly, national law does not establishes any terms (as stated by the CJEU – notice must be given 15 working days before the repacked product is put on sale) or adequate and proportionate sanctions, as it was required by Boehringer II. Therefore, the possibility for the infrindgement of intellectual property rights exists.

 

Keyword(s): Parallel import, medicinal product, repackaging, intellectual property, quality of pharmaceutical product
DOI: 10.5200/11
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