Judgment;Summary — ECLI:EU:C:2022:894
Date: 2022-11-17
Language of the case: Dutch
Court formation: Fifth Chamber
Subject matter: Free movement of goods;Measures having equivalent effect;Quantitative restrictions
Procedure: Reference for a preliminary ruling
Origin: Belgium

Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged:  
9 June 2020 
Referring court:  
Hof van beroep Brussel (Belgium) 
Date of the decision to refer:  
25 May 2020 
Appellant:  
IMPEXECO NV 
Respondent:  
NOVARTIS AG 
  
Subject matter of the main proceedings 
Appeal brought by Impexeco before the Hof van beroep Brussel (Court of Appeal, 
Brussels, Belgium) against the judgment of 12 April 2018 of the President of the 
Nederlandstalige rechtbank van koophandel Brussel (Brussels Commercial Court 
(Dutch-speaking), Belgium), hearing an application for interim relief, upholding 
the action brought by Novartis for infringement of its trade mark rights, and 
ordering, on pain of a financial penalty, the cessation of the trade mark 
infringement which Impexeco was found to have committed under Article 9(1)(a) 
of Regulation No 207/2009 by rebranding the Sandoz generic medicine Letrozol 
with the Novartis trade mark Femara and subsequently marketing that medicine in 
Belgium. 
Subject matter and legal basis of the request for a preliminary ruling 
Interpretation, pursuant to Article 267 TFEU, of Articles 34 and 36 TFEU and of 
the ‘BMS’ conditions, as developed in the judgments of the Court of Justice of 
11 July 1996, Bristol-Myers Squibb and Others (C-427/93, C-429/93 and 
EN 
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C-436/93, EU:C:1996:282), and of 12 October 1999, Upjohn (C-379/97, 
EU:C:1999:494). 
Questions referred 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 rebranding be assessed by reference to the BMS 
conditions? 
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 Koninklijk besluit van 19 
april 2001 inzake parallelinvoer (Royal Decree of 19 April 2001 on parallel 
imports)?  
Provisions of EU law and case-law of the Court of Justice relied on 
Articles 34 and 36 TFEU 
Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community 
trade mark (‘the Trade Mark Regulation’) (Article 9(1)(a) and Article 13) 
Judgments of the Court of Justice of 11 July 1996, Bristol-Myers Squibb and 
Others (C-427/93, C-429/93 and C-436/93, EU:C:1996:282), and of 12 October 
1999, Upjohn (C-379/97, EU:C:1999:494) 
Provisions of national law relied on 
Article 3(2) of the Koninklijk besluit van 19 april 2001 inzake parallelinvoer van 
geneesmiddelen voor menselijk gebruik en de parallelle distributie van 
geneesmiddelen voor menselijk en diergeneeskundig gebruik (Royal Decree of 
19 April 2001 on the parallel import of medicines for human use and parallel 
distribution of medicines for human and veterinary use (‘the Royal Decree of 
19 April 2001’): ‘… a person who wishes to import a medicine in parallel may 
obtain an authorisation to do so, provided that the medicine in question is one: (1) 
for which authorisation to put it on the market has been issued by the competent 
authorities in the Member State of origin; (2) for which a reference medicine 
 IMPEXECO 
 
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exists; (3) which, while not being identical in all respects, in comparison to the 
reference medicine at least (a) has the same qualitative and quantitative 
composition as regards its active ingredients; (b) has the same therapeutic 
indications; (c) is therapeutically equivalent; (d) has the same pharmaceutical 
form.’  
Brief summary of the facts and procedure in the main proceedings 
1 Novartis AG is the Swiss parent company of the Novartis Group, to which the 
Novartis Division (sale of patented branded medicines) and the Sandoz Division 
(sale of generic medicines) belong. In Belgium, Novartis Pharma NV puts the 
branded medicines on the market and Sandoz NV puts the generic medicines on 
the market; in the Netherlands, this is done by Novartis Pharma BV and Sandoz 
BV respectively.  
2 Sandoz is an EU trade mark (No 003070422) of which Novartis AG is the 
proprietor.  
3 Novartis has developed a prescription medicine containing the active ingredient 
letrozol for the treatment of breast cancer. That medicine is sold in Belgium 
(packs of 30 and 100 film-coated tablets of 2.5 mg under the marketing 
authorisation VHB No BE0182926) and in the Netherlands (packs of 30 film-
coated tablets of 2.5 mg under marketing authorisation number RVG 20755) 
under the EU trade mark No 00838417 Femara, of which Novartis AG is the 
proprietor.  
4 Since letrozol is no longer patent-protected, Sandoz BV puts the generic medicine 
Letrozol Sandoz 2.5 mg on the market in the Netherlands in packs of 30 film-
coated tablets under marketing authorisation number RVG 106321. In Belgium, 
that generic medicine is sold by Sandoz NV in packs of 30 and 100 film-coated 
tablets under marketing authorisation VHB BE382383.  
5 Femara and Letrozol Sandoz are identical medicines. 
6 Impexeco is a Belgian undertaking engaged in the parallel import of medicines. It 
imports the generic medicine Letrozol Sandoz 2.5 mg from the Netherlands into 
Belgium after (1) repackaging (the packs of 100 tablets are given a new outer 
packaging and the packs of 30 tablets are relabelled), and (2) rebranding with the 
Femara trade mark. To that end, on 22 September 2014 Impexeco obtained a 
Belgian parallel import licence No. 1549 PI 187 F3, with Femara 2.5 mg film-
coated tablets as reference medicine.  
7 By letter of 28 October 2014, Impexeco notified Novartis that it had obtained 
authorisation to put on the market in Belgium the medicine ‘Femara 2.5 mg x 100 
tablets (letrozol)’, imported from the Netherlands, with effect from 1 December 
2014. It appears from the annexes to that letter (draft package insert and mock-up 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-253/20 
 
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of the packaging) that this involved the repackaging and rebranding of Letrozol 
Sandoz 2.5 mg, imported from the Netherlands.  
8 By letter of 17 November 2014, Novartis opposed the planned parallel import on 
the ground that its trade mark rights had not been exhausted, so that the 
rebranding of the generic medicine imported from the Netherlands as Novartis’s 
original branded medicine manifestly infringed its trade mark rights and amounted 
to misleading the public.  
9 Impexeco proceeded with the commercialisation of the repackaged and rebranded 
medicine in Belgium in July 2016. 
10 By letter of 10 April 2017, Impexeco notified Novartis that it also intended to sell 
Letrozol Sandoz 2.5 mg, imported from the Netherlands, in Belgium, as rebranded 
Femara 2.5 mg in relabelled packs of 30 film-coated tablets. That letter was 
accompanied by a finished sample of the relabelled packaging.  
11 The respective Belgian and Netherlands markets for branded and generic 
medicines have the following characteristics:  
– Prices: Due to the fact that Impexeco applied to the Rijksinstituut voor ziekte- 
en invaliditeitsverzekering (National Institute for Health and Disability 
Insurance) for reimbursements in respect of the medicines it sells, and due to 
the application of the reference reimbursement system (reduction of the 
reimbursements in respect of the branded medicine), the price of the branded 
medicine decreases as a result of a generic medicine (with reimbursement) 
coming on the market. In Belgium, the retail price for Femara 2.5 mg 
(Novartis) is the same as for Letrozol Sandoz 2.5 mg (Sandoz) and for Femara 
2.5 mg (Impexeco). In the Netherlands, the retail price for Letrozol Sandoz 2.5 
mg is significantly lower.  
– Reimbursement via health insurance: in Belgium, since 1 August 2018, 
reimbursement in respect of medicines containing letrozol is no longer subject 
to prior authorisation. 
– Letrozol-based medicines are ‘no switch’ (it is not possible to switch to another 
medicine during treatment).  
– Market share: in Belgium, in the period 2015-2018, Femara 2.5 mg had a 
market share of 80% (compared with the generic Letrozol 2.5 mg), whereas in 
the Netherlands, Femara’s market share in 2018 was 21.58%. 
Main submissions of the parties to the main proceedings 
Regarding the exhaustion of the trade mark rights of Novaris:  
 IMPEXECO 
 
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12 Novartis submits that, under Article 13(1) of the Trade Mark Regulation, trade 
mark rights are only exhausted in relation to goods which have been put on the 
market in the EEA ‘under that trade mark’ by the proprietor or with his consent.  
13 In the present case, the medicines imported in parallel into Belgium were put on 
the market in the Netherlands by Sandoz BV under the International Non-
proprietary Name (INN) Letrozol, followed by the Sandoz trade mark, thus not 
under the Femara trade mark by Novartis or an economically linked undertaking 
such as Sandoz BV. Article 13(1) does not apply in the case of a rebranding, that 
is to say, where Impexeco imports into Belgium Letrozol Sandoz, which was put 
on the market in the Netherlands, and for the first time applies to those medicines 
a sign identical to another trade mark (Femara). The rights which Novartis derives 
from its EU trade mark Femara are therefore not exhausted for the purposes of 
Article 13(1) of the Trade Mark Regulation. 
14 Impexeco contends that that statement does not make any difference. The trade 
mark rights of Novartis in the event of the rebranding of a medicine by Impexeco 
as a parallel importer must be assessed on the basis of Articles 34 and 36 TFEU 
and on the basis of the BMS conditions concerning trade mark exhaustion in the 
case of repackaging of parallel imported medicines. One of those conditions, 
under which the trade mark proprietor cannot prohibit a parallel importer from 
putting a product on the market after repackaging and under the trade mark, is that 
it has been established that the trade mark proprietor is using its trade mark right 
to artificially partition markets, in particular where repackaging is necessary in 
order to put the product on the market in the Member State of importation. The 
opposition of the trade mark proprietor to rebranding by a parallel importer where 
rebranding is necessary in order to sell the products in the Member State of 
importation constitutes a barrier to trade between Member States which leads to 
an artificial partitioning of the markets of the Member States.  
15 According to Impexeco, that case-law should also be applied to the rebranding of 
a generic medicine as a branded medicine when both have been placed on the 
market in the EEA by economically linked undertakings. Moreover, Letrozol 
Sandoz and Femara are identical products (the composition of the medicines is 
identical and the imported Letrozol Sandoz was authorised through a decentralised 
procedure with the Netherlands as reference Member State and without a 
bioequivalence study because Novartis confirmed that Letrozol Sandoz is 
identical to Femara, the so-called bio-waiver).  
Regarding the artificial partitioning of markets 
16 Novartis submits that there is no question of artificial partitioning of the markets 
because generic medicines and branded medicines are different products that 
operate in different market segments. They are distinct from a regulatory point of 
view (requirement of separate market authorisations and different names), from a 
medical point of view (substitution by the pharmacist is prohibited in Belgium and 
they are ‘no switch’ medicines), from the point of view of the pricing and 
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reimbursement policy, and in terms of public perception. Since branded medicines 
and generic medicines are sold in different markets, prohibiting a parallel importer 
from rebranding a generic medicine as a branded medicine cannot be said to 
partition the market. The principle of the free movement of goods cannot be 
invoked to permit rebranding; assessment against the BMS conditions is not at 
issue and the identical composition of the medicines and the fact that they are 
placed on the market by economically linked undertakings is irrelevant. 
17 Impexeco argues that the question whether the markets have been artificially 
partitioned should not be assessed on the basis of product markets (as Novartis 
does) but on the basis of territorial markets (the EEA Member States). If there is 
no possibility of normal parallel trade between the Member States, then there is an 
artificial partitioning of the (territorial) markets. In fact, there is but a single 
pharmaceutical market, driven by the prescribing practices of doctors (using their 
therapeutic freedom). Once patent protection for the active ingredient has been 
lifted, there are fully fledged alternatives that are interchangeable, and that 
interchangeability is not affected by the other distinctions cited by Novartis. The 
only relevant criterion when examining interchangeability of medicines is 
therapeutic efficacy, which is assessed in practice by the prescribing doctor. 
Irrespective of whether the product is a branded medicine or a generic medicine, 
when a trade mark proprietor starts to use different brand names for the same 
product in the EEA, a parallel trader is entitled to rebrand if the BMS conditions 
are fulfilled. Furthermore, the imported medicine does not have to be 100% 
identical to the Belgian reference medicine (pursuant to Article 3(2) of the Royal 
Decree of 19 April 2001). Moreover, the medicines at issue in the present case are 
totally identical (Letrozol Sandoz is identical to Femara), despite the fact that 
Novartis presents Letrozol Sandoz 2.5 mg as a generic medicine.  
Brief summary of the reasons for the reference for a preliminary ruling 
18 The Brussels Court of Appeal finds that there is controversy and uncertainty as to 
whether the trade mark proprietor’s opposition to the further commercialisation of 
a generic medicine by a parallel importer who has repackaged that generic 
medicine in the country of importation by affixing to it the trade mark of the 
branded medicine (the reference medicine) is liable to lead to an artificial 
partitioning of the markets of the Member States for the purposes of Articles 34 
and 36 TFEU.  
19 Various court cases are pending in Belgium in which trade mark proprietors and 
parallel importers disagree on this question. The question is answered in different 
ways by the courts.  
20 Those disputes are characterised by the fact that they all concern the rebranding of 
a generic medicine as a branded medicine by a parallel importer, where both 
medicines have been put on the market in the EEA by economically linked 
undertakings.