The European Court has ruled in joined cases C‑253/20 and C‑254/20 Impexeco NV v Novartis AG which target the issue of pharmaceutical products rebranding and parallel importation. The cases have the following background:
Case C‑253/20
Novartis developed a medicinal product with the active substance letrozole, marketed in Belgium and the Netherlands under the EU trademark ‘Femara’, of which Novartis is the proprietor.
That medicinal product is sold on the market in packages of 30 and 100 film-coated tablets of 2.5 mg in Belgium, and in packages of 30 film-coated tablets of 2.5 mg in the Netherlands.
Sandoz BV and Sandoz NV, respectively in the Netherlands and in Belgium, market the generic medicinal product ‘Letrozol Sandoz 2.5 mg’, in packages of 30 film-coated tablets in the Netherlands, and 30 and 100 film-coated tablets in Belgium.
According to the referring court, the medicinal products marketed under the names ‘Femara’ and ‘Letrozol Sandoz’ are identical.
By letter of 28 October 2014, Impexeco informed Novartis of its intention to import from the Netherlands and to place on the Belgian market, from 1 December 2014, the medicinal product ‘Femara 2.5 mg x 100 tablets (letrozol)’. It is apparent from the order for reference that that medicinal product was, in actual fact, the medicinal product ‘Letrozol Sandoz 2.5 mg’, repackaged in new outer packaging to which Impexeco intended to affix the trade mark ‘Femara’.
By letter of 17 November 2014, Novartis opposed the parallel import planned by Impexeco, claiming that a new marking of that product with the trade mark of the reference medicinal product produced by Novartis, that is to say, the trade mark ‘Femara’, constituted a manifest infringement of its rights in that mark and was likely to mislead the public.
In July 2016, Impexeco marketed in Belgium the medicinal product ‘Letrozol Sandoz 2.5 mg’, repackaged in new packaging bearing the trade mark ‘Femara’.
According to the referring court, the public price of the medicinal products ‘Femara (Novartis) 2.5 mg’, ‘Letrozol Sandoz 2.5 mg’ and ‘Femara (Impexeco) 2.5 mg’ are identical in Belgium. By contrast, the public price of ‘Letrozol Sandoz 2.5 mg’ is significantly lower in the Netherlands.
Claiming that the marketing referred to in paragraph 19 above infringed its trade mark rights, on 16 November 2016, Novartis brought an action against Impexeco before the Court of Cessations, Brussels, Belgium.
By letter of 10 April 2017, Impexeco also informed Novartis of its intention to market in Belgium the medicinal product ‘Femara 2.5 mg’ in packaging of 30 film-coated tablets imported from the Netherlands and re-labelled. It is apparent from the order for reference that that medicinal product was the medicinal product ‘Letrozol Sandoz 2.5 mg’ and that Impexeco intended to re-label that product and to affix the trade mark ‘Femara’ to it.
Case C‑254/20
Novartis developed a medicinal product with the active substance methylphenidate. Novartis Pharma NV markets that medicinal product in Belgium under the Benelux word mark ‘Rilatine’, of which it is the proprietor, inter alia in packs of 20 tablets of 10 mg. In the Netherlands, that medicinal product is marketed by Novartis Pharma BV under the trade mark ‘Ritalin’, inter alia in packs of 30 tablets of 10 mg.
Sandoz BV places on the market in the Netherlands the generic medicinal product ‘Methylphenidate HC1 Sandoz 10 mg’ in packaging of 30 tablets.
According to the referring court, the medicinal products marketed under the names ‘Methylphenidate HC1 Sandoz 10 mg tablet’ and ‘Ritalin 10 mg tablet’ are identical.
By letter of 30 June 2015, PI Pharma informed Novartis Pharma NV of its intention to import from the Netherlands and to place on the Belgian market the medicinal product ‘Rilatine 10 mg x 20 tablets’. It is apparent from the order for reference that that medicinal product was, in actual fact, the medicinal product ‘Methylphenidate HC1 Sandoz 10 mg’, in new outer packaging on which PI Pharma intended to affix the trade mark ‘Rilatine’.
In a letter of 22 July 2015, Novartis stated its opposition to the parallel import planned by PI Pharma, claiming that a new marking of the medicinal product ‘Methylphenidate HC1 Sandoz 10 mg’ with the trade mark of the reference medicinal product of Novartis, that is to say, the trade mark ‘Rilatine’, manifestly infringed its rights in that trade mark and was likely to mislead the public.
In October 2016, PI Pharma marketed that repackaged medicinal product in Belgium in new packaging bearing the trade mark ‘Rilatine’.
The referring court states that, in Belgium, the public price of the medicinal product ‘Rilatine 10 mg x 20 tablets Novartis’ is EUR 8.10 (EUR 0.405 per tablet) and the price of the medicinal product ‘Rilatine 10 mg x 20 tablets PI Pharma’ is EUR 7.95 (EUR 0.398 per tablet), while in the Netherlands the public price of the medicinal product ‘Methylphenidate HC1 Sandoz 10 mg’ is EUR 0.055 per tablet.
Claiming that the marketing referred to in paragraph 28 above infringed its trade mark rights, on 28 July 2017, Novartis brought an action against PI Pharma before the Court of Cessations, Brussels.
Factors common to the disputes in the main proceedings
By two judgments of 12 April 2018, the Court of Cessations, Brussels held that the two actions referred to in paragraphs 21 and 30 above were well founded on the ground, inter alia, that the practice of affixing the trade marks ‘Femara’ and ‘Rilatine’ respectively to the repackaged generic medicinal products ‘Letrozol Sandoz 2.5 mg’ and ‘Methylphenidate HC1 Sandoz 10 mg’, imported from the Netherlands, infringed the trade mark rights of Novartis, for the purposes, respectively, of Article 9(2)(a) of Regulation No 207/2009 and of Article 2.20(1)(a) of the Benelux Convention. Consequently, the Court of Cessations, Brussels ordered that that practice be discontinued.
Impexeco and PI Pharma, respectively, appealed against those two judgments before the referring court.
Before that court, they argue that the practices of using different packaging and different trade marks for the same product both contribute to the partitioning of Member States’ markets and, therefore, have the same adverse effect on trade within the European Union.
Relying on paragraphs 38 to 40 of the judgment of 12 October 1999, Upjohn (C‑379/97, EU:C:1999:494), Impexeco and PI Pharma submit that the opposition of the proprietor of a trade mark to the reaffixing of a trade mark by a parallel importer constitutes an obstacle to intra-Community trade creating artificial partitioning of the markets between Member States, where such reaffixing is necessary in order for the products concerned to be marketed by that importer in the importing Member State. That case-law can be applied to a situation in which a generic medicinal product is given a new marking by affixing the trade mark of the reference medicinal product, where those medicinal products have been placed on the market in the EEA by economically linked undertakings.
Novartis submits that, under Article 13(1) of Regulation No 207/2009 and Article 2.23(3) of the Benelux Convention, the rights conferred by a trade mark may be exhausted only in respect of goods which have been placed on the market in the EEA ‘under that trade mark’ by the proprietor or with its consent, and not where a parallel importer gives the goods concerned a new marking.
Taking the view, in those circumstances, that the disputes pending before it raise questions of interpretation of EU law, the hof van beroep te Brussel (Court of Appeal, Brussels, Belgium) decided to stay the proceedings and to refer the following questions, which are worded identically in Cases C‑253/20 and C‑254/20, to the Court of Justice for a preliminary ruling:
(1) Must Articles 34 to 36 TFEU be interpreted as meaning that, where a branded medicine (reference medicine) and a generic medicine have been put on the market in the EEA by economically linked undertakings, a trade mark proprietor’s opposition to the further commercialisation of the generic medicine by a parallel importer after the repackaging of that generic medicine by the affixing to it of the trade mark of the branded medicine (reference medicine) in the country of importation may lead to an artificial partitioning of the markets of the Member States?
(2) If the answer to that question is in the affirmative, must the trade mark proprietor’s opposition to that [new marking] be assessed by reference to the … conditions [set out in paragraph 79 of the judgment of 11 July 1996, Bristol-Myers Squibb and Others (C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282)]?
(3) Is it relevant to the answer to those questions that the generic medicine and the branded medicine (reference medicine) are identical or have the same therapeutic effect as referred to in Article 3(2) of the … Royal Decree of 19 April 2001 on parallel imports [of medicinal products for human use and the parallel distribution of medicinal products for human and veterinary use, as amended by the Royal Decree of 21 January 2011]?’
The EU Court decision:
Article 9(2) and Article 13 of Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark, as amended by Regulation (EU) 2015/2424 of the European Parliament and of the Council of 16 December 2015, and Article 5(1) and Article 7 of Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks, read in the light of Articles 34 and 36 TFEU,
must be interpreted as meaning that the proprietor of the trade mark of a reference medicinal product and the trade mark of a generic medicinal product may oppose the placing on the market of a Member State, by a parallel importer, of that generic medicinal product imported from another Member State, where that medicinal product has been repackaged in new outer packaging to which the trade mark of the corresponding reference medicinal product has been affixed, unless, first, the two medicinal products are identical in all respects and, second, the replacement of the trade mark satisfies the conditions laid down in paragraph 79 of the judgment of 11 July 1996, Bristol-Myers Squibb and Others (C‑427/93, C‑429/93 and C‑436/93, EU:C:1996:282); in paragraph 32 of the judgment of 26 April 2007, Boehringer Ingelheim and Others (C‑348/04, EU:C:2007:249); and in paragraph 28 of the judgment of 17 May 2018, Junek Europ-Vertrieb (C‑642/16, EU:C:2018:322).
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