Tenor:
On appeal by the defendant, the judgment of the 10th Chamber for Commercial Matters of the Regional Court of Frankfurt am Main delivered on February 2, 2018 is amended.
The action is dismissed.
Orders the plaintiff to pay the costs.
The judgment is provisionally enforceable without the provision of security. The plaintiff may avert enforcement by providing security in the amount of 120% of the amount enforceable on the basis of the judgment, unless the defendant provides security in the amount of 120% of the amount to be enforced in each case prior to enforcement.
Reasons
A.
The parties are in dispute over trademark claims in connection with the parallel import of medical products.
The plaintiff sells wound care products in Germany under the brand name “X”. Among other things, it sells the product “X1 …”. This is a medical product that bears a CE mark and is sold through pharmacies.
The European Union word mark X with priority dated 13.11.1998 is registered, inter alia, for pharmaceutical products, preparations for health care, plasters and dressings (Annex K 1). The national word mark X1 with priority dated 02.10.1999 is registered for dressing material (Annex K 1). By agreement dated 7 September 2016, the trademark owner authorized the plaintiff, as the exclusive licensee of the X trademarks in the Federal Republic of Germany, to assert and enforce claims arising from the trademarks in the federal territory (Annex K 2).
On November 19, 2015, the defendant sent a sample of the product “X1 … Lipid colloid wound dressing” to announce how it intends to distribute this product imported in parallel from Spain (Annex K 3, K 4). Accordingly, it provides the products with instructions for use in German. It removes the information provided by the plaintiff on the outer packaging regarding shelf life and batch and replaces it with a sticker with its own information. The label also contains the defendant’s central pharmaceutical number (PZN) and barcode.
The trademark owner objected to the distribution in a lawyer’s letter dated January 13, 2016 (Annex K 5). In a letter dated January 25, 2016, the defendant stated that it was refraining from distribution until further notice (Annex K 6). On December 1, 2016, it sent a new preliminary information (Annex K 7). The plaintiff objected to the distribution in a lawyer’s letter dated 14.12.2016 (Annex K 8).
Reference is made to the contested judgment for further details of the facts of the case and the applications made at first instance (Section 540 I, 1 ZPO).
The Regional Court sentenced the defendant,
1. to refrain from selling or placing on the market in the course of trade packaging of wound dressings which are marked with the marks “X1” and/or “X” and which have been modified as reproduced below (stickers) without the consent of the trademark proprietor, on pain of a statutory penalty:
The picture is not shown (- the ed.).
2. to inform the plaintiff in writing about the origin and the distribution channel of the relabeled products pursuant to para. 1, namely
a) by submitting a list stating the names and addresses of the commercial customers and sales outlets for whom they were intended and the quantity of products manufactured, delivered, received or ordered in accordance with para. 1 as well as the prices paid for the products concerned and
b) Supporting documents for the information pursuant to no. 2 lit. a in the form of clearly legible copies of all order letters, order confirmations, delivery bills and invoices.
3. it is established that the defendant is obliged to compensate the plaintiff for any damage that the plaintiff has suffered and/or will suffer as a result of the acts referred to in paragraph 1.
The Regional Court stated that a trademark owner could, in principle, prevent a third party from relabeling products it had placed on the market and distributing them in this form. Any relabeling or other change to the packaging is in principle an infringement of trademark rights. The claims under trademark law were not precluded by the objection of exhaustion. It was not sufficiently demonstrated that a ban on the distribution of repackaged goods with their own PZN and barcode would lead to an artificial partitioning of the markets. It could not be assumed that the defendant was excluded from distribution to wholesalers without affixing its PZN. The plaintiff’s claim for injunctive relief was also not forfeited.
The defendant contests this assessment with its appeal in which it continues to pursue its claim for dismissal. On appeal, the parties repeat and deepen their arguments. The defendant claims that the new framework agreement pursuant to § 131 SGB V explicitly states that medical devices that can be prescribed at the expense of the statutory health insurance funds must be labeled with a PZN (Annex BK1).
The defendant requests,
set aside the judgment of the Regional Court of Frankfurt am Main of February 2, 2018, Ref. 3 – 10 O 50/17 be set aside.
The applicant claims that the Court should,
dismiss the appeal, with the proviso that “in the Federal Republic of Germany” is inserted after “in the course of trade” in the operative part to 1. of the judgment under appeal and that “and in which a new instruction leaflet in German has been inserted and on which the existing label with the marks X and X1l has been replaced by a label in German – either by affixing it or by removing and affixing a new label” is inserted after “(sticker)” in the operative part to 1. of the judgment under appeal.
With regard to the further submissions of the parties, reference is made to the exchanged written submissions and their annexes.
B.
The admissible appeal is also successful on the merits.
I. The appellant’s formal motion to set aside the judgment of the Regional Court was to be interpreted to mean that it was pursuing its motion to dismiss filed at first instance. This follows from the context of the grounds of appeal, in which the appellant denies any trademark infringement.
II. The plaintiff has no claim against the defendant under Art. 9 II lit. a, 130 I UMV, § 14 V, II No. 1 MarkenG to refrain from using the challenged designations.
1. the plaintiff is the exclusive licensee of the European Union word mark “X” and the national word mark “X1”. It was authorized by the trademark owner to assert trademark claims in Germany (Annex K2).
2. there is a case of double identity. The trademarks in suit are registered for “dressing material”, among other things. The defendant imports and sells wound dressings under identical names from Spain. The contested embodiment is shown in Annex K4 and in the operative part of the judgment under appeal.
3. however, the defendant can successfully invoke the exhaustion (Art. 15 I UMV = Art. 13 I UMV old version, § 24 MarkenG) of the prohibition right from the trademarks. The products were first placed on the market in the European Union with the consent of the trademark owner. The plaintiff cannot oppose further distribution due to the changes made by the defendant. There are no “legitimate reasons” within the meaning of Art. 15 II EUTMR = Art. 13 II EUTMR old version, § 24 II MarkenG.
a) This would be the case if the alteration of the original product would create actual risks for the guarantee of origin of the branded goods. Such an impairment can be assumed if the parallel importer either repackages the branded goods and reaffixes the trademark to them or affixes a label to the packaging of the goods. Nevertheless, the trademark owner cannot oppose the distribution of the modified product if the special exhaustion requirements developed for the parallel import of medicinal products and medical devices – listed in detail by the Regional Court – are fulfilled. Whether the obligation to notify and provide samples can be waived for medical devices (BGH GRUR 2017, 71 para. 18 – Debrisoft; left open in ECJ GRUR 2018, 736 – Debrisoft) can be left open, as the defendant has fulfilled these requirements. Moreover, it must be proven in particular that the assertion of the trade mark against the distribution of the repackaged goods would contribute to an artificial partitioning of the markets between Member States and thus to a disguised restriction of trade between Member States within the meaning of the second sentence of Article 36 TFEU (ECJ GRUR 2007, 586 para. 37 Boehringer Ingelheim/Swingward II; ECJ, Urt. v. 17.5.2018, C-642/16, para. 25; BGH GRUR 2017, 71 [BGH 06.10.2016 – I ZR 165/15] para. 15 – Debrisoft). The specific type of repackaging must also take into account the legitimate interests of the trade mark proprietor. This presupposes that the repackaging does not impair the original condition of the medicinal product and does not damage the reputation of the trade mark (ECJ GRUR 2007, 586 [OLG Naumburg 26.06.2006 – 10 U 11/06] para. 17 Boehringer Ingelheim/Swingward II; ECJ, judgment v. 17.5.2018, C-642/16, para. 26).
b) In the case in dispute, a “repackaging” must be assumed (see aa below), but the exercise of the right of opposition would lead to a disguised restriction of trade between the Member States (see bb below). The specific type of packaging design does not conflict with any legitimate interests of the trademark proprietor (cf. cc below).
aa) The changes made by the defendant to the plaintiff’s original product constitute “repackaging” within the meaning of the pharmaceutical exhaustion jurisdiction. The defendant not only provided the original product with a sticker bearing a barcode, its own PZN and a note “Umpackung, Import und Vertrieb: A GmbH” (Annex K4), but also replaced the original package insert with one (only) in German. The packaging had to be opened for this purpose. This is therefore a classic “repackaging case”, not just a so-called “repackaging by relabeling”. By opening the packaging and replacing the package insert, risks were created for the guarantee of origin of the manufacturer’s brand (cf. BGH GRUR 2010, 756 [BGH 12.05.2010 – I ZR 185/07] para. 20 – One Touch Ultra).
bb) Nevertheless, the plaintiff cannot oppose the further distribution of the original packaging modified in this way because the assertion of the rights from the trademark leads to an artificial partitioning of the national markets.
(1) Artificial market foreclosure can be assumed if regulations or practices in the importing country prevent the distribution of the product in the unchanged original packaging; on the other hand, the necessity for repackaging or relabeling is not given if the parallel importer merely wants to gain an economic advantage (Senate, PharmR 2017, 304, para. 6; ECJ GRUR 2007, 586, para. 36, 37 – Boehringer Ingelheim-Swingward II). The requirements for an objective predicament in this sense must not be overstretched. They do not only exist if distribution on all domestic distribution channels is excluded without repackaging. It is sufficient if the parallel importer is only excluded from a sub-market in the importing Member State (BGH MarkenR 2014, 265, para. 15 – Micardis, with further references). This is already assumed if the importer cannot offer one of two common pack sizes without repackaging (BGH loc. cit.). Nothing else can apply if the importer is excluded from a certain important distribution channel, such as the wholesale trade.
(2) In the case in dispute, the necessity for repackaging already results from the fact that the product would not be marketable in Germany without instructions for use in German. The other changes (indication of own PZN, barcode, reapplication of LOT no. and expiry date) relate to the specific manner of repackaging. In this respect, it is not a question of necessity. The requirement of necessity only concerns the repackaging as such (ECJ GRUR 2007, 586 [OLG Naumburg 26.06.2006 – 10 U 11/06] para. 38 – Boehringer Ingelheim/Swingward II). In the present case, it does not matter whether the defendant cannot place the imported products in the wholesale trade without affixing its own PZN and whether there is also a fear of market foreclosure from this point of view.
cc) The specific nature of the defendant’s packaging design does not conflict with any legitimate interests of the trade mark proprietor.
(1) The plaintiff unsuccessfully objects to the affixing of a sticker with the importer’s own PZN and a corresponding barcode. According to the case law of the ECJ, corresponding stickers on the outer packaging – in themselves – do not constitute a modification of the original product within the meaning of Art. 15 II EUTMR / Sec. 24 II MarkenG (ECJ GRUR 2018, 736 – Debrisoft). Accordingly, no justification can be required for this (see Senate, GRUR 2018, 1151 para. 36 – Urgo Tül). The plaintiff unsuccessfully argues that the ECJ’s decision only relates to small stickers (see ECJ GRUR 2018, 736 para. 34 – Debrisoft). The packaging at issue is also a small sticker (Annex K4). The fact that in the present case, in contrast to the case decided by the ECJ, a “repackaging” is to be assumed for other reasons does not lead to a different assessment with regard to the indication of the PZN and the barcode. This change only concerns the method of repackaging. In this respect, it is only necessary to examine whether the original condition of the medicinal product is impaired or the good reputation of the brand is damaged. There are no indications of this.
(2) The good reputation of the brand is also not damaged by the fact that the defendant’s sticker contains the indication of a batch number (LOT) and an expiry date (2017.11) at the bottom right next to the barcode (Annex K4). Contrary to the plaintiff’s view, the public will not assume that this information was applied by the manufacturer. The sticker clearly indicates that it originates from the repackaging company. However, the public will assume that the information corresponds to the manufacturer’s instructions on the original packaging. The plaintiff complains that it has no control over whether errors occur in this respect. In fact, the guarantee of origin of the brand could be impaired if the defendant makes mistakes in the safety-relevant area of shelf life. In terms of content, the information on the stickers, insofar as it is required by law, is attributed by the public to the plaintiff as the manufacturer (cf. BGH GRUR 2013, 739 [BGH 22.11.2012 – I ZR 72/11] para. 43 – Barilla). However, this – purely abstract – risk must be accepted.
(a) If repackaging is necessary in order to make the re-imported products marketable in Germany, it may even be permissible to repackage the medicinal product or medical device in completely newly manufactured boxes (see ECJ GRUR 2018, 736 para. 32 – Debrisoft). The expiration date and the batch number must also necessarily be transferred to the new packaging in this case. In the present case, the plaintiff’s original sticker was written in Spanish, had a barcode and indicated a contact address in Barcelona (response to the appeal p. 11, 40; pp. 392, 421 of the file). It could not be left on the packaging to avoid misunderstandings.
(b) It is not apparent that in the specific case the expiration date does not correspond to the manufacturer’s specification. The plaintiff doubts this without demonstrating concrete circumstances for her doubts. She has therefore not satisfied her secondary burden of proof. In principle, the parallel importer must prove that the presentation of the goods cannot damage the reputation of the trademark and its owner. However, it is sufficient for the parallel importer to present circumstances that reasonably suggest that this requirement is met. It is then up to the trade mark proprietor to prove specific circumstances according to which the repackaging may damage its reputation and that of the trade mark (ECJ GRUR 2007, 586 [OLG Naumburg 26.06.2006 – 10 U 11/06] para. 54 Boehringer Ingelheim/Swingward II). The defendant has argued that the batch number (LOT) and the expiry date were adopted identically (BB p. 7). This is sufficient. Concrete circumstances suggesting otherwise have not been presented.
(3) Contrary to the plaintiff’s view, the affixing of the expiration date and the batch number also does not require a new conformity assessment procedure. A parallel importer of a medical device that bears a CE marking and has been subject to a conformity assessment within the meaning of Article 11 of Directive 93/42/EEC is, in principle, not obliged to carry out a new assessment in order to certify the conformity of the information enabling its determination, which it adds to the product labeling with a view to placing it on the market in the Member State of importation (ECJ GRUR 2017, 102 para. 39 – Lohmann & Rauscher/BIOS Medical Services). The obligation to carry out the conformity assessment pursuant to Art. 11 of Directive 93/42 only applies to manufacturers. If an importer purchases medical devices in a Member State after they have been placed on the market in the Union by their manufacturer and then resells them in another Member State under the manufacturer’s name, he is not to be considered a manufacturer. According to Art. 1 para. 2(f) of the Directive, the manufacturer is the natural or legal person who is responsible for the design, manufacture, packaging and labeling of a product with a view to placing it on the market in his own name. According to the decision of the ECJ, it is not sufficient if the packaging is merely modified by affixing a sticker that identifies the importer as the person responsible for placing the product on the market, stating his coordinates and a product identification code (ECJ loc. cit. para. 32). Nothing else can apply if further information from an original manufacturer’s sticker is merely transferred to the new sticker. The information to be provided by the manufacturer in accordance with the Medical Devices Directive includes the batch number and the expiration date (Annex I No. 13.3 d, e Directive 93/42/EEC). If the importer does not use his own information in this respect, but merely transfers the manufacturer’s information to his own label, he is not to be regarded as the manufacturer himself.
(4) Finally, the legitimate interests of the trade mark proprietor are not infringed by the contested presentation because the original packaging sticker in Spanish contained the signs “X” and “X1” (see p. 11 of the response to the appeal, p. 392). These signs are not present on the defendant’s sticker. However, the trademarks are also only reproduced on the original sticker in the continuous text, partly as part of the company name of the Spanish distribution company. They have no significant meaning for the labeling of the product. The trademarks are still prominently displayed on all sides of the packaging. The defendant has not changed these markings. In this situation, there is in particular no case in which “the trade mark is obscured” within the meaning of the “Debrisoft” decision of the ECJ (loc. cit. para. 35).
III In the absence of a trademark infringement, the subsequent claims for disclosure and damages awarded by the Regional Court also do not exist.
IV. There was no need for a preliminary ruling by the ECJ. There can be no doubt that the exhaustion requirements established by the ECJ for the parallel import of medicinal products apply in any case to medical devices that have been repackaged by replacing the instructions for use (cf. BGH GRUR 2010, 756 [BGH 12.05.2010 – I ZR 185/07] para. 20 – One Touch Ultra). Contrary to the plaintiff’s view, the ECJ’s “Debrisoft” decision also means that it is no longer necessary to clarify whether the trademark owner can oppose distribution if, in addition to replacing the package leaflet, a label with a barcode and PZN of the repackaging company is affixed to the outer packaging. In this respect, reference can be made to the above statements.
V. The reduction in the pleading requested by the plaintiff for the pleading of the opposing party dated 28.2.2019 was not to be granted, as this pleading did not contain any new arguments relevant to the decision.
VI. The requirements for admission of the appeal are not met. In particular, the appeal did not have to be admitted in order to ensure uniform case law with regard to the decision of the Higher Regional Court of Stuttgart of 28.6.2018 (2 U 105/17, Annex K52). Should it emerge from this that the Higher Regional Court of Stuttgart assesses the scope of the ECJ decision “Debrisoft” differently than the deciding Senate, it must in any case be taken into account that the decision was issued in summary proceedings and is therefore of a provisional nature. It also referred to the particularities and prima facie evidence of the facts of the case.