Summary;Judgment — ECLI:EU:C:2022:892
Date: 2022-11-17
Language of the case: German
Court formation: Fifth Chamber
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling;Reference for a preliminary ruling - inadmissible
Origin: Germany

Translation  C-204/20 — 1 
Case C-204/20 
Request for a preliminary ruling 
Date lodged: 
13 May 2020 
Referring court: 
Landgericht Hamburg (Germany) 
Date of the decision to refer: 
2 April 2020 
Applicant: 
Bayer Intellectual Property GmbH 
Defendant: 
kohlpharma GmbH 
  
Landgericht Hamburg (Regional Court of Hamburg, Germany) 
[…] 
Order 
In the matter of 
Bayer Intellectual Property GmbH, […] Monheim 
– Applicant – 
[…] 
v 
kohlpharma GmbH, […] Merzig 
– Defendant – 
[…] 
EN 
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the Landgericht Hamburg (Regional Court, Hamburg) […] ordered as follows on 
2 April 2020: 
I. The proceedings are stayed. 
II. The following questions on the interpretation of Article 47a of Directive 
2001/83/EC (‘Community Code relating to medicinal products for human 
use’) and Article 15 of Directive 2015/2436 (‘Trade Mark Directive’) are 
referred to the Court of Justice of the European Union for a preliminary 
ruling under Article 267 of the Treaty on the Functioning of the European 
Union: 
Question 1: 
Is Article 47a of Directive 2001/83/EC to be interpreted as meaning that, in 
the case of parallel imported products, the measures for the removal and 
reaffixing of the safety features pursuant to point (o) of Article 54 of 
Directive 2001/83/EC, which are carried out by the [Or. 2] parallel importer 
either by means of relabelling (use of adhesive labels on the original 
secondary packaging) or by means of reboxing (production of new 
secondary packaging for the medicinal product), can be considered 
equivalent if both measures otherwise comply with all the requirements set 
out in Directive 2011/62/EU (‘Falsified Medicines Directive’) and 
Delegated Regulation (EU) 2016/161 (‘Delegated Regulation’) and are 
equally effective in enabling the verification of authenticity and 
identification of medicinal products and in providing evidence of tampering 
with medicinal products? 
Question 2: 
If the first question is to be answered in the affirmative: In the light of the 
new anti-falsification rules, can a trade mark owner oppose the repackaging 
of the product in new external packaging (‘reboxing’) by a parallel importer 
where the parallel importer is also able to achieve packaging which may be 
marketed in the Member State of importation by merely affixing new 
adhesive labels to the original secondary packaging (‘relabelling’)? 
Question 3: 
If the second question is to be answered in the affirmative, is it the case that 
no harm is done if, in the case of relabelling, it is apparent to the relevant 
public that a safety feature of the original supplier has been damaged, as 
long as it is ensured that the parallel importer is responsible for this and has 
affixed a new safety feature to the original secondary packaging? Does it 
make any difference whether the signs of opening become visible only when 
the secondary packaging of a medicinal product is opened? 
BAYER INTELLECTUAL PROPERTY 
 
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Question 4: 
If Question 2 and/or 3 is to be answered in the affirmative, must repackaging 
by means of ‘reboxing’ nevertheless be deemed to be objectively necessary 
within the meaning of the five conditions for exhaustion in respect of the 
repackaging (see […] judgments of 11 July 1996, Bristol-Myers Squibb and 
Others, C-427/93, C-429/93 and C-436/93, EU:C:1996:282, paragraph 79, 
and of 26 April 2007, Boehringer Ingelheim and Others, C-348/04, 
EU:C:2007:249, paragraph 21) if the national authorities state, in their 
current guidelines for implementing the requirements of the Falsified 
Medicines Directive or other such announcements of the authorities, that the 
resealing of opened packaging is not normally accepted or, at least, is 
accepted only on an exceptional basis and under strict conditions? [Or. 3] 
Grounds: 
I. 
The applicant opposes the parallel import of a medicinal product for which new 
packaging (‘reboxing’) is to be produced even though — according to the 
applicant — the affixing of a new label (‘relabelling’) is less of an encroachment 
on its trade mark rights. The parties to the present proceedings are ultimately in 
dispute as to the extent to which the new provisions of Directive 2011/62/EU 
(‘Falsified Medicines Directive’) and Delegated Regulation (EU) 2016/161 
(‘Delegated Regulation’) affect the requirements imposed on parallel imports. 
1. The relevant facts: 
The applicant is the owner of the German trade mark ANDROCUR and is part of 
the Bayer Group. ANDROCUR (active ingredient: cyproterone acetate) is a 
hormone preparation that is sold, inter alia, in Germany. The trade mark 
ANDROCUR is protected in respect of ‘medicines, chemical preparations for 
healing purposes and health care, pharmaceutical drugs’. The trade mark was 
originally registered in the name of Schering Aktiengesellschaft on 2 November 
1956. After several changes to the company name, the trade mark was assigned to 
the applicant in 2012 […]. 
The defendant is the largest German importer of medicinal products. By letter of 
28 January 2019, it announced to the applicant that it would be importing the 
medicinal product ANDROCUR 50 mg from the Netherlands in packs of 50 film-
coated tablets and distributing it in Germany in packs of 50 and 100 tablets. In 
subsequent correspondence, the defendant stated that the imported outer 
packaging of the medicinal product was sealed in accordance with the 
requirements of the Falsified Medicines Directive and that the seal would have to 
be broken for the purposes of parallel importation, meaning that relabelling was 
not possible and reboxing was necessary. 
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The applicant expressly objected to the planned reboxing, referring to the 
possibility of less invasive repackaging methods in the form of relabelling, and 
requested that the defendant give a legally binding assurance that it would refrain 
from carrying out the reboxing that had been announced. The defendant refused to 
do so. 
[…] 
2. Applicant’s arguments 
The applicant submits that it is possible and legally sufficient for the side flaps (or 
one of the side flaps) of the packaging for the medicinal product to be sealed with 
a type of adhesive seal after being opened by the parallel importer. This would 
generally be a round or rectangular transparent or coloured adhesive label. Even 
when [Or. 4] removed, it leaves clear traces on the packaging, meaning that any 
tampering by an unauthorised party would be immediately visible. Legally, both 
variants of the ‘anti-tampering device’ (‘ATD’) are regarded by the legislature as 
being equally effective (see DIN EN 16679). The applicant takes the view that 
there is no principle, of any kind, according to which repackaged medicinal 
products must always be marketed with (unopened) perforated packaging. The 
assessment as to whether reboxing is actually necessary is subject to strict 
requirements. In particular, one condition is that relabelling would prove to be a 
barrier that would hinder the parallel importer’s access to the market to a not 
insignificant extent. The prevailing view is that purely economic considerations 
do not justify such reboxing […]. Nor would a possible consumer preference — 
which does not actually exist — for newly manufactured outer packaging by way 
of reboxing be legally sufficient to justify an infringement of the applicant’s trade 
mark rights. 
The applicant takes the view that, in the context of parallel imports, sufficient 
protection against falsification can be fundamentally ensured by means of 
relabelling using the ATD and ‘unique identifier’ (‘UI’) features. The Community 
legislature had therefore made further provision for the possibility of relabelling 
specifically in the case of parallel imports. Article 47a of Directive 2001/83/EC 
expressly regulates the circumstances as to when existing safety features may be 
covered. Points (a) to (d) of paragraph 1 list the conditions that have to be fulfilled 
in order for such covering to be permitted. There is nothing in any part of the 
legislation to indicate that completely new packaging must necessarily be 
manufactured and that the new safety features cannot simply be affixed to the 
original packaging even though they provide equivalent protection against 
tampering. The Community legislature has therefore proceeded on the basis that 
relabelling is possible in the case of parallel imports, even in the light of the 
Falsified Medicines Directive. Nor are there such restrictions in any part of the 
Delegated Regulation. Rather, the reference to Article 47a of Directive 
2001/83/EC in Article 33(1) of the Delegated Regulation once again makes clear 
that the legislature also had in mind the possibility of safety features being 
BAYER INTELLECTUAL PROPERTY 
 
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covered. The reference also makes clear that Article 47a of Directive 2001/83/EC 
relates specifically to the case of parallel imports and also provides for the 
possibility of relabelling in that context. It is, moreover, assumed in point 4 of 
Article 34 and point 4 of Article 35 of the Delegated Regulation that relabelling is 
possible. Those articles contain the words ‘before and after the repackaging or re-
labelling operations’ and ‘repackaged or relabelled packs of a medicinal 
product’, respectively. From the perspective of protection against falsification, 
reboxing and relabelling have therefore been established, in principle, as 
alternatives. The recitals regarding Article 12 of the Falsified Medicines Directive 
also suggest that the European legislature continued to consider relabelling to be 
permissible and possible. This understanding is also confirmed by the Q&A 
documents of the ‘Co-ordination Group for Mutual Recognition and Decentralised 
Procedures — Human’ (‘CMDh’). [Or. 5] 
Finally, the applicant argues that the two variants, relabelling and reboxing, are at 
least equivalent in terms of safety in the case of parallel imports. In the case of 
perforated packaging also, adequate protection against tampering is ensured by the 
affixing to that point of breakage of a new ATD that complies with the 
requirements of the Falsified Medicines Directive. Each time packaging is opened, 
the parallel importer has to cover the signs of opening by affixing a new, intact 
adhesive seal, thus ensuring complete protection against falsification, which is 
also visible to the public. 
3. Forms of order sought by the parties 
The applicant requests that: 
I. the defendant be ordered to desist, immediately, on pain of incurring 
statutory penalties, from 
repackaging, in the course of trade, the pharmaceutical product 
ANDROCUR 50 mg, 50 film-coated tablets, originating in the 
Netherlands for marketing in the Federal Republic of Germany, in new 
external packaging and affixing the trade mark ANDROCUR to that 
packaging and/or displaying for sale, marketing and/or advertising new 
packaging bearing that indication, where the medicinal product was 
marketed in the country of origin in packets of 50 film-coated tablets; 
II. the defendant be ordered to inform the applicant in writing of the 
nature, scope, dates and duration of the act referred to in point I; 
III. it be declared that the defendant be obliged to compensate the 
applicant for all the damage which it has already suffered and will 
suffer in the future as a result of the act described in point I above. 
The defendant requests that 
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the action be dismissed. 
4. Defendant’s arguments: 
The defendant takes the view that it can rely on the trade-mark-law principle of 
exhaustion pursuant to Paragraph 24 of the Markengesetz (Law on trade marks, 
‘MarkenG’) (corresponding to Article 15 of Directive (EU) 2015/2436, ‘Trade 
Marks Directive’; Article 15 of Regulation (EU) 2017/1001, ‘EUTMR’), since the 
previous repackaging [Or. 6] practice is obsolete due to the higher level of 
protection against falsification that has to be guaranteed. The rule/exception 
relationship between relabelling and reboxing has now, it contends, been reversed. 
The defendant submits that, when opening the ANDROCUR 50 mg packaging, 
the perforated parts of the front side panel are opened, leaving visible signs of 
damage in the previously directly connected areas on the sides. It is also not 
possible for the packaging to be opened from the side and glued back together 
without any traces being left, as the paper/cardboard would be torn or worn down 
and an additional layer of adhesive would have to be applied when gluing it back 
together. Wholesalers are obliged to check packaging for tampering, meaning that 
ultimately only a new foldable carton could prevent rejection by wholesalers and 
pharmacists. Noticeable damage is also a warning sign for patients/consumers, 
however. Resealing is therefore not sufficient, especially since counterfeiters 
could also use such seals. 
In addition, a survey carried out by the Institut Pflüger Rechtsforschung GmbH 
[…] showed that 73.5% of the pharmacists/pharmaceutical assistants questioned 
were of the opinion that it would be better for the acceptance of parallel imported 
medicinal products if they were repackaged by the importer in a new foldable 
carton. Large stickers also raised suspicions. On the whole, therefore, it has to be 
assumed that the use of original adhesive packaging significantly inhibits market 
entry in the pharmacy/wholesale sector. The claim that relabelling is just as safe 
and cheaper is also incorrect. Reboxing is 25% [more] expensive. 
In the current 16th version of the Q&As (September 2019 […]), points 1.20 and 
1.21 clarify that the marketing of repackaged products with visible signs of 
opening is permitted only under very strict conditions. According to point 1.20, 
relabelling is generally subject to the approval of the authorities, which is not the 
case with reboxing. The pharmaceutical authorities of various EU Member States 
also affirm the objective necessity of a new folding carton, and refer to reboxing, 
if it is not possible for the original packaging to be sealed […]. 
The defendant contends that, as a result of the changed legal situation, relabelling 
is no longer a less severe method; on the contrary, it is now completely unsuitable. 
II. 
BAYER INTELLECTUAL PROPERTY 
 
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The success of the action depends on how Article 47a of Directive 2001/83/EC, 
introduced by Directive 2011/62/EU (‘Falsified Medicines Directive’), is to be 
interpreted against the background of the trade-mark-law defence of exhaustion 
under Article 15 of Directive (EU) 2015/2436 (with effect from 15 January 2019), 
in the light of Articles 34 and 36 TFEU (formerly Articles 28 and 30 of the EC 
Treaty). [Or. 7] 
1. Background in the context of trade mark law 
In the context of parallel imports of medicinal products, it is generally necessary, 
for regulatory reasons, to make physical alterations to the original outer 
packaging, for example in order to insert an information leaflet in the national 
language or to replace inscriptions in the national language. According to the 
case-law of the Court of Justice, it is the repackaging in itself which is prejudicial 
to the specific subject matter of the medicinal product’s trade mark as applied to 
the packaging (see, for example, […] judgment of 26 April 2007, Boehringer 
Ingelheim and Others, C-348/04, EU:C:2007:249). In this case, however, the 
parallel importer must meet five conditions for exhaustion in respect of 
repackaging for pharmaceutical/medical products (see […] judgments of 11 
July1996, Bristol-Myers Squibb and Others, C-427/93, C-429/93 and C-436/93, 
EU:C:1996:282, paragraph 79, and of 26 April 2007, Boehringer Ingelheim and 
Others, C-348/04, EU:C:2007:249, paragraph 21): 
[…] a) the repackaging is necessary in order to enable the medicinal product to be 
marketed in the Member State of importation; 
[…] b) the repackaging cannot affect the original condition of the product inside 
the packaging; 
[…] c) the new packaging clearly states who repackaged the product and the name 
of the manufacturer; 
[…] d) the presentation of the repackaged product is not such as to be liable to 
damage the reputation of the trade mark and of its owner; thus, the 
packaging must not be defective, of poor quality, or untidy; 
[…] e) the importer gives notice to the trade mark owner before the repackaged 
product is put on sale, and, on demand, supplies him with a specimen of the 
repackaged product. 
The first of these conditions is affected in the present case. 
2. The new regulatory background: Directive 2011/62/EU (‘Falsified Medicines 
Directive’) and Delegated Regulation (EU) 2016/161 (‘Delegated Regulation’) 
First of all, the Directive on the Community code relating to medicinal products 
for human use was adopted in 2001. It served primarily to harmonise the general 
legislation of the individual Member […] States of the EU in the field of 
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medicinal products. The Community code relating to medicinal products for 
human use was transposed accordingly by the German legislature in the 
Arzneimittelgesetz (Law on medicinal products, ‘AMG’). 
Ten years later, there was an ‘alarming’ increase of medicinal products detected 
in the EU which were falsified in relation to their identity, history or source (see 
recital 2 of Directive 2011/6[2]/EU). This increase was connected, in particular, to 
the purchase [Or. 8] of medicinal products via the internet. For this reason, 
Directive 2001/83/EC was amended and supplemented. Directive 2011/62/EU and 
Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC on the 
Community code relating to medicinal products for human use have been in force 
since 9 February 2019. According to recital 33 of Directive 2011/62/EU, the 
objective of the directive is ‘to safeguard the functioning of the internal market 
for medicinal products, whilst ensuring a high level of protection of public health 
against falsified medicinal products’. It is emphasised in recital 12 that the safety 
features should be replaced in the case of repackaging ‘by equivalent safety 
features’. Through the provisions of the Falsified Medicines Directive and the 
Delegated Regulation, the European legislature has implemented further 
regulations that are intended to improve the prevention of falsification of 
medicines. It provides for two main means of doing so, which are to be affixed to 
the outer packaging of (prescription) medicines: a ‘unique identifier’ (‘UI’) and an 
‘anti-tampering device’ (‘ATD’). A UI is a two-dimensional barcode or QR code 
that conceals a unique number allowing each medicine to be uniquely identified. 
The code is created by the manufacturer himself and notified by him to the 
system. Falsified medicines bearing a QR code can therefore be immediately 
identified as such by those involved in the supply chain. Via a simple system 
query, they can immediately determine whether a corresponding medicine with 
the correct QR code has actually been manufactured and marketed by the original 
supplier. This can be done in every pharmacy within a few seconds by means of a 
simple system verification. 
In addition to this IT-supported protection against falsification, it is also possible 
to carry out a physical check by inspecting the ATD. The purpose of the ATD is 
to make it possible to see whether unauthorised persons have opened or tampered 
with the packaging. The ATD can be designed in various ways. It is possible for 
packaging to be firmly glued at both side flaps and/or have a perforation at the 
point where the outer packaging is opened, as is the case with the original 
packaging at issue here, that of the medicinal product ANDROCUR 50 mg, 50 
film-coated tablets. Third parties are able to see if the packaging has been opened 
via the perforated area or the glued side flap. 
The German legislature transposed these requirements, inter alia, in 
Paragraph 10(1)(c) AMG: ‘In the case of medicinal products for human use, 
safety features and a device for detecting possible tampering with the outer 
packaging must be affixed to the outer packaging, where this is required by 
Article 54a of Directive 2001/83/EC of the European Parliament and of the 
Council of 6 November 2001 on the Community code relating to medicinal 
BAYER INTELLECTUAL PROPERTY 
 
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products for human use (OJ L 311, 28.11.2001, p. 67), last amended by Directive 
2011/62/EU (OJ L 174, 1.7.2011, p. 74), or laid down by virtue of Article 54a of 
Directive 2001/83/EC.’ [Or. 9] 
Therefore, the question is how the parallel importer can implement these new 
requirements if repackaging is necessary in order to be able to market the product 
in the Member State of importation. 
The Oberlandesgericht Köln (Higher Regional Court of Cologne) takes the view 
that the Falsified Medicines Directive (Directive 2011/62/EU), which introduced 
Article 54a of Directive 2001/83/EC, does not mean that a re-importer who has to 
open the packaging of a medicinal product in order to insert a German-language 
information leaflet cannot continue to use that packaging, even if it remains 
apparent to the patient that it has been opened […]. 
The SVEA HOVRÄTT (Svea Court of Appeal, Sweden) takes the view that the 
conditions on the national market play a decisive role when it comes to answering 
the question whether it is objectively necessary for medicinal products to be 
repackaged. As the Swedish Medical Products Agency took the view that 
repackaging in a new carton appeared to be necessary, the court, setting aside the 
judgment under appeal in that case, refused the trade mark proprietor’s application 
for interim measures […]. 
The success of the action therefore crucially depends on how Article 47a of 
Directive 2001/83/EC is to be interpreted against the background of the trade-
mark-law defence of exhaustion under Article 15 of Directive (EU) 2015/2436, in 
the light of Articles 34 and 36 TFEU (formerly Articles 28 and 30 of the EC 
Treaty). 
In that context, the first question addresses the defendant’s argument that, as a 
result of the new rules, reboxing and relabelling are now subject to a 
rule/exception principle in the sense that, as a general rule, reboxing is preferable. 
The second question addresses a new direction developing in the German case-
law, according to which, where repackaging is necessary, it is ultimately for the 
parallel importer to decide how to implement the national requirements in order to 
be able to market the medicinal product in the Member State of importation, 
provided that he complies with the other requirements established by the Court of 
Justice (see above). Accordingly, the Oberlandesgericht Frankfurt a. M. (Higher 
Regional Court of Frankfurt am Main) […] and the Hanseatisches 
Oberlandesgericht Hamburg (Hanseatic Higher Regional Court, Hamburg) […] 
have recently ruled that the requirement of necessity relates only to the 
repackaging as such and not to the manner in which the repackaging has been 
carried out. However, this involved the affixing of the ‘Pharmazentralnummer’ 
(central pharmaceutical product number) and a new barcode, and the reaffixing of 
the batch number, expiry date and manufacturer’s trade mark. The referring court 
also takes the view that, given the large number of inscriptions and safety features 
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that the parallel importer has to affix to pharmaceutical containers nowadays, 
which, in practice, often leads to extensive overstickering, it is not entirely 
understandable why the production of new packaging to which there can be no 
objection and which cannot be falsified constitutes an unacceptable and greater 
encroachment on trade mark rights. [Or. 10] 
The third question addresses the objection raised by the defendant that 
professionals and end users may be deterred or unsettled by signs of opening. 
The fourth question takes account of the arguments of the SVEA HOVRÄTT (Svea 
Court of Appeal), which considered statements made by the national authorities 
on the interpretation of provisions of EU law for the question of the necessity of 
reboxing. According to the defendant, the national medicines authorities in other 
Member [[…]] States also appear to interpret the new anti-falsification rules as 
meaning that, as a general rule, a new foldable carton must be produced after the 
anti-tampering device has been broken […]. 
[…]