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Supreme Court of Denmark

Relabelling of pharmaceutical product – unauthorised use of trade mark 

Case no 354/2011

Judgment delivered on 2 July 2014

Orifarm A/S

Orifarm Supply A/S
Sharp & Dohme Corp. (formerly Merck & Co. Inc.)
Merck Sharp & Dohme B.V.

Use of trade mark when relabelling a pharmaceutical product was unauthorised

The case concerned the question of whether Orifarm A/S and Orifarm Supply A/S had made unauthorised use of Merck Sharp & Dohme Corp. and Merck Sharp & Dohme B.V.'s trade mark by parallel importing the anti-hypertensive pharmaceutical product LORTAAN from Italy and distributing and marketing it in Denmark after having relabelled it to COZAAR. The main issue was whether Orifarm's relabelling from LORTAAN to COZAAR was authorised as there was an objective need in order for Orifarm to gain effective access to the Danish market, cf. the case law of the European Court of Justice.

It was undisputed that there were no legal impediments for Orifarm's marketing of the pharmaceutical product in Denmark under the LORTAAN trade mark. Before the Supreme Court, Orifarm had withdrawn its submission that relabelling was necessary due to the fact that doctors were reluctant to use substitutes. The question was then whether there was an objective need for relabelling due to resistance from the consumers. 

The Supreme Court held that Orifarm had not proven that its relabelling was necessary in order for Orifarm to gain effective access to the Danish market. Ori­farm had, thus, not been authorised to use Merck Sharp & Dohme's CO­ZAAR trade mark.     

The Danish Maritime and Commercial Court had reached the same conclusion.

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