INTA Files Amicus Brief Before Court of Justice of the EU

Published: November 11, 2020

INTA has filed an amicus brief before the Court of Justice of the European Union (CJEU), arguing that an original trademark is not exhausted when a brand owner makes generic versions of its pharmaceuticals that later appear as branded in parallel importation.

INTA filed the amicus brief with the CJEU on September 28, 2020, for Joint Cases C-253/20 Novartis AG v. Impexeco NV and C-254/20 Novartis AG v. PI Pharma NV. The last time INTA filed an amicus brief in a preliminary ruling case was in 2012, in case C-252/12 Specsavers International Healthcare Limited v. Asda Stores Limited.

The cases pending before the CJEU concern generic pharmaceuticals which in the course of parallel importation have been de-branded with the generic name and re-branded with the original trademark. The Brussels Court of Appeal referred questions to the CJEU to assess whether use of the original pharmaceutical names on the generic products is legitimate.

Novartis group company Sandoz markets generic products, which are chemically identical to their “original” counterpart and are manufactured in the same facility by the same entity. The products are, however, marketed through different distribution channels and follow distinct regulatory procedures. The referred cases concern the pharmaceuticals Letrozole Sandoz and Methylphenidate Sandoz. The parallel traders purchased the generics under these names and sold them in Belgium under the original product names, FEMARA and RILATINE, respectively. Neither the owner of the original trademarks concerned, Novartis, nor the manufacturer of the generics, Sandoz, consented to these activities.

In its brief, INTA maintained that the trademark rights in relation to the trademark of the original product are not exhausted when use of that trademark is made on the generic product. It further argued that paragraph 1 of Article 15 of the EU Trade Mark (EUTM) Regulation does not apply. As the rights are not exhausted in the cases at issue, there would be no reason to examine its exception (paragraph 2), the interpretation of Articles 34–36 of the Treaty on the Functioning of the European Union (TFEU), and the five Bristol-Myers Squibb conditions, which, if not fulfilled by a parallel importer, determine the non-exhaustion of the trademark owner’s rights and its consequent ability to prevent parallel imports.

INTA’s Key Arguments

Regarding Exhaustion of the FEMARA, RILATINE, and SANDOZ Marks

INTA stressed that, under parallel import provisions as interpreted by the CJEU, a parallel importer of a generic medicine shall, as a starting point, not have the right to use on this product the name/trademark of the original product, without the consent of the trademark owner. FEMARA and RILATINE are inter alia protected as EUTMs. Novartis, as their owner, has the sole right of putting these marks on products and putting the marked products on the market.

INTA supported the view that the generic product and the original product are different goods from the point of view of parallel trade and exhaustion. They are also different from a factual point of view, since generic products have different history and regulatory procedures. Therefore, the goods for which the trademarks are used are not the ones which were put on the market by the trademark owner or with its consent. INTA proposed that the trademark rights on FEMARA and RILATINE are not exhausted in the cases at issue. Exhaustion is a matter of the very mark on the very product. C-173/98 Sebago Inc. and Ancienne Maison Dubois et Fils SA v. GB-Unic SA, July 1, 1999, ¶¶ 19, 20.

With regards to exhaustion of the SANDOZ mark, INTA submitted that because the goods in question are not marketed by the trademark owner or with its consent under that specific trademark, it cannot be supported that the trademark rights in the case at issue are exhausted.


INTA submitted that de-branding in the context of parallel imports has been found by the CJEU to be potentially detrimental to the functions of the trademark and, therefore, prohibited. C-129/17 Mitsubishi Shoji Kaisha Ltd and Mitsubishi Caterpillar Forklift Europe BV v. Duma Forklifts NV and G.S. International BVBA, July 25, 2018, ¶¶ 42, 43, 46). INTA supported that all arguments brought forward in the Mitsubishi/Duma case against a deletion of the mark prior to first marketing the product also apply after first marketing it. Such a de-branding interferes in the cases at issue with the legitimate interests of Sandoz, as can be concluded from the CJEU-Mitsubishi/Duma judgment. C-129/17.

Regarding Articles 34 to 36 TFEU

INTA submitted that these articles would only be examined if Letrozol and Femara/Methylphenidate and Rilatine were treated as identical products. It holds the view that they are different in the public’s perception, the way they are marketed, and in the pricing.

The brief authors were Marina Perraki (Tsibanoulis & Partners, Greece) and Andreas Lubberger (Lubberger Lehment, Germany), with the participation of the International Amicus Committee—Europe Amicus Subcommittee.

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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