Last updated: 14 September 2023
See updates at the end of the post.
This post is an attempt to facilitate an understanding of some of the complexities associated with the affixing of proprietary trademarks to repackaged generic medicinal products, for parallel trade. This is done by presenting information on two European court cases, C-253/20 and C-254/20.
The information provided below is by no means exhaustive. To develop a more thorough understanding of these cases, it is important to read the judgement in full as well as comments on the cases provided by e.g. law firms (see links provided below).
Parties to the main proceedings
| Case | Applicant | Defendant |
|---|---|---|
| C-253/20 | Impexeco NV (Parallel trader) | Novartis AG |
| C-254/20 | PI Pharma NV (Parallel trader) | Novartis AG, Novartis Pharma NV |
Background to the cases
1. Impexeco NV v Novartis AG (Case C-253/20) detailed in Tables 1 and 2 below
Table 1
| Date | Event |
|---|---|
| Novartis developed and is the proprietor of a medicinal product with the active substance letrozole, marketed in Belgium and the Netherlands under the EU trade mark ‘Femara’. Novartis sells the product on the market in packs of 30 and 100 film-coated (f/c) tablets of 2.5 mg in Belgium, and in packs of 30 f/c tablets of 2.5 mg in the Netherlands. Sandoz BV and Sandoz NV (part of the Novartis group), market the identical generic of the above medicinal product ‘Letrozol Sandoz 2.5 mg’, in identical pack sizes in Belgium and the Netherlands. The information above has been tabulated in Table 2 below. | |
| 28 Oct 2014 | Impexeco (a parallel trader) informed Novartis of its intention to import from the Netherlands and to place on the Belgian market, from December 2014, the medicinal product ‘Femara 2.5 mg x 100 tablets (letrozol)’. The latter 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’. |
| 17 Nov 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, i.e. the trade mark ‘Femara’, constituted a manifest infringement of its rights in that mark and was likely to mislead the public. |
| July 2016 | Impexeco marketed in Belgium the medicinal product ‘Letrozol Sandoz 2.5 mg (imported from The Netherlands) 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. |
| 16 Nov 2016 | Novartis brought an action against Impexeco before the Court of Cessations, Brussels, Belgium claiming that the marketing (of Letrozol Sandoz 2.5 mg repackaged in new packaging bearing the trade mark ‘Femara’) infringed its trade mark rights. |
| 10 Apr 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. That 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. |
Table 2
| Company | Active substance | Product | Belgium | The Netherlands | Notes |
|---|---|---|---|---|---|
| Novartis developed the medicinal product and is proprietor of the trademark ‘Femara’ | letrozole | Femara 2.5 mg x 100 tablets (letrozol)* | Sells packs of 30 and 100 f/c tabs 2.5 mg | Sells packs of 30 and 100 f/c tabs 2.5 mg | *According to the referring court, the medicinal products marketed under the names ‘Femara’ and ‘Letrozol Sandoz’ are identical. |
| Sandoz BV and Sandoz NV (part of the Novartis group) | letrozole | Letrozol Sandoz 2.5 mg* (generic) | Sandoz NV Markets identical pack sizes as above, of the generic | Sandoz BV Markets identical pack size as above, of the generic. | |
| Impexeco (PI Trader) | letrozole | In July 2016, Impexeco marketed in Belgium. the medicinal product Femara 2.5 mg x 100 tablets (letrozol). The latter was, in actual fact, the medicinal product ‘Letrozol Sandoz 2.5 mg’ (imported from The Netherlands) and repackaged in new outer packaging to which Impexeco affixed the trade mark ‘Femara’. |
2. PI Pharma NV v Novartis AG, Novartis Pharma NV (Case C‑254/20) detailed in Tables 3 and 4 below
Table 3
| Date | Event |
|---|---|
| Novartis developed a medicinal product with the active substance methylphenidate. Novartis Pharma NV markets that medicinal product in Belgium under the Benelux trade mark ‘Rilatine’, of which it is the proprietor, 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 HCl Sandoz 10 mg’ in packs 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. The information above has been presented in Table 4 below. | |
| 30 Jun 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’. 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’. |
| 22 Jul 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 i.e. ‘Rilatine’, manifestly infringed its rights in that trade mark and was likely to mislead the public. |
| Oct 2016 | PI Pharma marketed that repackaged medicinal product (Rilatine 10 mg x 20 tablets) 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. |
| 28 Jul 2017 | Claiming that the marketing in Belgium (of the repackaged medicinal product in Belgium in new packaging bearing the trade mark ‘Rilatine’) infringed its trade mark rights, Novartis brought an action against PI Pharma before the (Court of Cessations, Brussels. |
Table 4
| Company | Active substance | Belgium | The Netherlands | Notes |
|---|---|---|---|---|
| Novartis developed the medicinal product | methylphenidate | Novartis Pharma NV , proprietor of the trademark ‘Rilatine’ markets product in packs of 20 x 10mg tabs | Novartis Pharma BV markets under the trademark ‘Ritalin’, in packs of 30 x 10mg tabs* | *According to the referring court, the medicinal products marketed under the names ‘Methylphenidate HCl Sandoz 10 mg tablet’ and ‘Ritalin 10 mg tablet’ are identical. |
| Sandoz BV (part of the Novartis group) | methylphenidate | Places on the market, the generic medicinal product ‘Methylphenidate HCl Sandoz 10 mg’ in packs of 30 tabs* | ||
| PI Pharma | methylphenidate | In October 2016, PI Pharma marketed in Belgium, the medicinal product Rilatine 10 mg x 20 tablets. This was, in actual fact, the medicinal product ‘Methylphenidate HC1 Sandoz 10 mg’ x 30 (imported from The Netherlands) and repackaged in new outer packaging on which PI Pharma affixed the trade mark ‘Rilatine’. |
Factors common to the disputes in both cases and the ruling of the court of cessations, Brussels
By two judgments of 12 April 2018, the Court of Cessations, Brussels held that the two actions referred to above (i.e Novartis cases against were well founded on the ground 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 and the Court ordered that that practice be discontinued.
Impexeco and PI Pharma appeal
Impexeco and PI Pharma respectively, appealed against those two judgments (of 12 April 2018) before the referring court.
The appeal arguments from Impexeco and PI Pharma
Before the referring court, both Impexeco and PI Pharma argued 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.
Impexeco and PI Pharma submitted 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.
What was the the Novartis counter argument to the appeal from Impexeco and PI Pharma?
Novartis submitted that, under certain Articles 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.
What action did Court of Appeal, Brussels take following the appeal from Impexeco and PI Pharma?
The court of Appeal 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 European Court of Justice (CJEU) for a preliminary ruling:
Q1 Is it true 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?
Q2. If the answer to point 1 above is true, 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)]?
Q3. Is it relevant to the answer to those questions (i.e. Q1 and Q2 above) 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 cases C-253/20 and C-254/20 were joined on 14 July 2020.
Judgment of the joint cases C-253/20 and C-254/20 by the European Court of Justice (CJEU)
Here you can view the judgment (of 17 Nov 2022) of the joined cases C/253/20 and C254/20 in brief and in full.
The judgement is summarised below:
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).**
* Note that the generic product and the reference product had already been found to be identical by the referring court.
**These conditions are also known as the ‘BMS conditions’ (the well-established body of case law surrounding repackaging of products by parallel importers – see Bristol-Myers Squibb at paragraph 79; Boehringer Ingelheim at paragraph 32; Junek at paragraph 28).
Conditions stipulated
The ‘conditions’ stipulated in bullet point 2 above are as follows:
According to settled case-law, the proprietor of a trade mark may legitimately oppose the further commercialisation in one Member State of a pharmaceutical product bearing its trade mark and imported from another Member State, where the importer of that product has repackaged it and reaffixed that trade mark to it, unless:
- it is established that the use of the trade mark rights by the proprietor thereof to oppose the marketing of the relabelled products under that trade mark would contribute to the artificial partitioning of the markets between Member States*
- it is shown that the repackaging cannot affect the original condition of the product inside the packaging
- the new packaging states clearly who repackaged the product and the name of the manufacturer
- the presentation of the repackaged product is not such as to be liable to damage the reputation of the trade mark and of its proprietor and
- the importer gives notice to the trade mark proprietor before the repackaged product is put on sale, and, on demand, supplies it with a specimen of the repackaged product.
* The Court has held that a trade mark proprietor’s opposition to repackaging of pharmaceutical products contributes to artificial partitioning of the markets between Member States where the repackaging is necessary in order to enable the product imported in parallel to be marketed in the importing Member State.
That condition of necessity is satisfied, in particular, where the circumstances prevailing at the time of marketing in the importing Member State preclude the medicinal product from being placed on the market in the same packaging as that in which it is marketed in the exporting Member State, thereby making repackaging objectively necessary in order for the medicinal product concerned to be marketed in that Member State by the parallel importer.
By contrast, that condition is not fulfilled if repackaging of the product is explicable solely by the parallel importer’s attempt to secure a commercial advantage
Further information
To develop a better understanding of the finer points of the judgement, it is well worth reading the following two posts:
- Parallel imports: identicality of products when repackaging, Dr Beatriz San Martin et al 31 Jan 2023 Bioslice
- EU ruling loosens pharma companies’ control over brands, Emily Swithenbank, 5 Jan 2023 Pinsent Masons
- Understanding parallel import of pharmaceuticals in the EU – a quick guide to repackaging and relabelling of parallel imports for brand owners, Emily Sullivan, 31 August 2023 Mewburn Ellis
Updates
| Date | Update |
|---|---|
| 14 Sept 2023 | Item no 3 added under the section Further Information |