# C_2020279EN.01003101.xml

| 24.8.2020 | EN | Official Journal of the European Union | C 279/31 |
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24.8.2020

EN

Official Journal of the European Union

C 279/31

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Request for a preliminary ruling from the Sø- og Handelsretten (Denmark) lodged on 29 May 2020 — Merck Sharp & Dohme B.V., Merck Sharp & Dohme Corp., MSD DANMARK ApS, MSD Sharp & Dohme GmbH, Novartis AG, FERRING LÆGEMIDLER A/S and H. Lundbeck A/S v Abacus Medicine A/S, Paranova Danmark A/S, 2CARE4 ApS

(Case C-224/20)

(2020/C 279/43)

Language of the case: Danish

Referring court

Sø- og Handelsretten

Parties to the main proceedings

Applicants: Merck Sharp & Dohme BV, Merck Sharp & Dohme Corp., MSD DANMARK ApS, MSD Sharp & Dohme GmbH, Novartis AG, FERRING LÆGEMIDLER A/S and H. Lundbeck A/S

Defendants: Abacus Medicine A/S, Paranova Danmark A/S and 2CARE4 ApS

Questions referred

| 1. | Must Article 15(2) of Directive 2015/2436/EU (1) of the European Parliament and of the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU (2) of the European Parliament and of the Council on the EU trade mark be interpreted as meaning that a trade mark proprietor may oppose further commercialisation of a medicinal product which a parallel importer has repackaged in new external packaging to which the trade mark has been reaffixed, where






  (i) | the importer is able to achieve packaging which may be marketed and gain effective access to the market of the Member State of importation by breaking the original external packaging in order to affix new labels to the inner packaging and/or replace the package leaflet and then reseal the original external packaging with a new device to verify whether the packaging has been tampered with, in accordance with Article 47a of Directive 2001/83/EC (3) of the European Parliament and of the Council of 6 November 2001 on medicinal products (as amended by Directive 2011/62/EU (4) of the European Parliament and of the Council) and Article 16 of Commission Delegated Regulation (EU) 2016/161 (5) on safety features appearing on the packaging of medicinal products? |
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1.

Must Article 15(2) of Directive 2015/2436/EU (1) of the European Parliament and of the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU (2) of the European Parliament and of the Council on the EU trade mark be interpreted as meaning that a trade mark proprietor may oppose further commercialisation of a medicinal product which a parallel importer has repackaged in new external packaging to which the trade mark has been reaffixed, where

(i)

the importer is able to achieve packaging which may be marketed and gain effective access to the market of the Member State of importation by breaking the original external packaging in order to affix new labels to the inner packaging and/or replace the package leaflet and then reseal the original external packaging with a new device to verify whether the packaging has been tampered with, in accordance with Article 47a of Directive 2001/83/EC (3) of the European Parliament and of the Council of 6 November 2001 on medicinal products (as amended by Directive 2011/62/EU (4) of the European Parliament and of the Council) and Article 16 of Commission Delegated Regulation (EU) 2016/161 (5) on safety features appearing on the packaging of medicinal products?

| (ii) | the importer is not able to achieve packaging which may be marketed and gain effective access to the market of the Member State of importation by breaking the original external packaging in order to affix new labels to the inner packaging and/or replace the package leaflet and then reseal the original external packaging with a new device to verify whether the packaging has been tampered with, in accordance with Article 47a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on medicinal products (as amended by Directive 2011/62/EU of the European Parliament and of the Council) and Article 16 of Commission Delegated Regulation (EU) 2016/161 on safety features appearing on the packaging of medicinal products? |
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(ii)

the importer is not able to achieve packaging which may be marketed and gain effective access to the market of the Member State of importation by breaking the original external packaging in order to affix new labels to the inner packaging and/or replace the package leaflet and then reseal the original external packaging with a new device to verify whether the packaging has been tampered with, in accordance with Article 47a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on medicinal products (as amended by Directive 2011/62/EU of the European Parliament and of the Council) and Article 16 of Commission Delegated Regulation (EU) 2016/161 on safety features appearing on the packaging of medicinal products?

| 2. | Must Directive 2001/83/EC of the European Parliament and of the Council on medicinal products (as amended by Directive 2011/62/EU), including, in particular, Articles 47a and point (o) of Article 54, be interpreted as meaning that a new device to verify whether the packaging has been tampered with (anti-tampering device), affixed to the original packaging of the medicinal products (in connection with additional labelling after the packaging has been opened in such a way that the original anti-tampering device has been fully or partially covered and/or removed), within the meaning of Article 47a(1)(b), ‘[is] equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering [with] the medicinal product’ and, within the meaning of Article 47a(1)(b)(ii), ‘‘[is] equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products’, where the packaging of the medicinal products (a) displays visible signs that the original anti-tampering device has been tampered with, or (b) that can be established by touching the product, including






  (i) | through mandatory verification of the integrity of the anti-tampering device carried out by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public (see Directive 2011/62/EU of the European Parliament and of the Council, Article 54a(2)(d) and Commission Delegated Regulation 2016/161, Article 10(b) and Articles 25 and 30), or |
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2.

Must Directive 2001/83/EC of the European Parliament and of the Council on medicinal products (as amended by Directive 2011/62/EU), including, in particular, Articles 47a and point (o) of Article 54, be interpreted as meaning that a new device to verify whether the packaging has been tampered with (anti-tampering device), affixed to the original packaging of the medicinal products (in connection with additional labelling after the packaging has been opened in such a way that the original anti-tampering device has been fully or partially covered and/or removed), within the meaning of Article 47a(1)(b), ‘[is] equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering [with] the medicinal product’ and, within the meaning of Article 47a(1)(b)(ii), ‘‘[is] equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products’, where the packaging of the medicinal products (a) displays visible signs that the original anti-tampering device has been tampered with, or (b) that can be established by touching the product, including

(i)

through mandatory verification of the integrity of the anti-tampering device carried out by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public (see Directive 2011/62/EU of the European Parliament and of the Council, Article 54a(2)(d) and Commission Delegated Regulation 2016/161, Article 10(b) and Articles 25 and 30), or

| (ii) | after the packaging of the medicinal products has been opened, for example by a patient? |
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(ii)

after the packaging of the medicinal products has been opened, for example by a patient?

| 3. | If the answer to Question 2 is in the negative:
  Must Article 15 of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks, Article 15 of Regulation 2017/1001/EU of the European Parliament and Council on EU trade marks, and Articles 36 and 34 TFEU, then be interpreted as meaning that repackaging in new external packaging is objectively necessary for effective access to the market of the State of importation, where it is not possible for the parallel importer to affix additional labelling and reseal the original packaging in accordance with Article 47a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on medicinal products (as amended by Directive 2011/62/EU of the European Parliament and of the Council), that is to say without the packaging of the medicinal products (a) displaying visible signs that the original anti-tampering device has been tampered with, or (b) that can be established by touching the product, as described in Question 2, in a manner which is not in accordance with Article 47a? |
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3.

If the answer to Question 2 is in the negative:

Must Article 15 of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks, Article 15 of Regulation 2017/1001/EU of the European Parliament and Council on EU trade marks, and Articles 36 and 34 TFEU, then be interpreted as meaning that repackaging in new external packaging is objectively necessary for effective access to the market of the State of importation, where it is not possible for the parallel importer to affix additional labelling and reseal the original packaging in accordance with Article 47a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on medicinal products (as amended by Directive 2011/62/EU of the European Parliament and of the Council), that is to say without the packaging of the medicinal products (a) displaying visible signs that the original anti-tampering device has been tampered with, or (b) that can be established by touching the product, as described in Question 2, in a manner which is not in accordance with Article 47a?

| 4. | Must Directive 2001/83/EC of the European Parliament and of the Council on medicinal products (as amended by Directive 2011/62/EU of the European Parliament and of the Council) and Commission Delegated Regulation (EU) 2016/161, in conjunction with Articles 34 and 36 TFEU and Article 15(2) of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks, be interpreted as meaning that a Member State (in Denmark: the Lægemiddelstyrelsen (Danish Medicines Agency)) is entitled to lay down guidelines, in accordance with which, in general, repackaging in new external packaging is to be carried out and it is only on application, in exceptional cases (for example where there is a risk to the supply of the medicinal product), that additional labelling and resealing may be permitted to be carried out by attaching new security features to the original external packaging, or is the Member State’s issuing and observance of such guidelines incompatible with Articles 34 and 36 TFEU and/or Article 47a of Directive 2001/83/EC of the European Parliament and of the Council on medicinal products and Article 16 of Commission Delegated Regulation (EU) 2016/161? |
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4.

Must Directive 2001/83/EC of the European Parliament and of the Council on medicinal products (as amended by Directive 2011/62/EU of the European Parliament and of the Council) and Commission Delegated Regulation (EU) 2016/161, in conjunction with Articles 34 and 36 TFEU and Article 15(2) of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks, be interpreted as meaning that a Member State (in Denmark: the Lægemiddelstyrelsen (Danish Medicines Agency)) is entitled to lay down guidelines, in accordance with which, in general, repackaging in new external packaging is to be carried out and it is only on application, in exceptional cases (for example where there is a risk to the supply of the medicinal product), that additional labelling and resealing may be permitted to be carried out by attaching new security features to the original external packaging, or is the Member State’s issuing and observance of such guidelines incompatible with Articles 34 and 36 TFEU and/or Article 47a of Directive 2001/83/EC of the European Parliament and of the Council on medicinal products and Article 16 of Commission Delegated Regulation (EU) 2016/161?

| 5. | Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the European Parliament and of the Council on trade marks, in conjunction with Articles 34 and 36 TFEU, be interpreted as meaning that repackaging in new external packaging carried out by a parallel importer in accordance with the guidelines laid down by a Member State, as referred to in Question 4, must be regarded as necessary for the purposes of the case-law of the Court of Justice of the European Union,






  (i) | where such guidelines are compatible with Articles 34 and 36 TFEU and the case-law of the Court of Justice of the European Union on parallel imports of medicinal products? |
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5.

Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the European Parliament and of the Council on trade marks, in conjunction with Articles 34 and 36 TFEU, be interpreted as meaning that repackaging in new external packaging carried out by a parallel importer in accordance with the guidelines laid down by a Member State, as referred to in Question 4, must be regarded as necessary for the purposes of the case-law of the Court of Justice of the European Union,

(i)

where such guidelines are compatible with Articles 34 and 36 TFEU and the case-law of the Court of Justice of the European Union on parallel imports of medicinal products?

| (ii) | where such guidelines are incompatible with Articles 34 and 36 TFEU and the case-law of the Court of Justice of the European Union on parallel imports of medicinal products? |
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(ii)

where such guidelines are incompatible with Articles 34 and 36 TFEU and the case-law of the Court of Justice of the European Union on parallel imports of medicinal products?

| 6. | Must Articles 34 and 36 TFEU be interpreted as meaning that the repackaging of a medicinal product in new external packaging must be objectively necessary for effective access to the market of the importing State, even if the parallel importer has not reaffixed the original trade mark (product name), but instead given the new external packaging a product name which does not contain the trade mark proprietor’s product trade mark (‘de-branding’)? |
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6.

Must Articles 34 and 36 TFEU be interpreted as meaning that the repackaging of a medicinal product in new external packaging must be objectively necessary for effective access to the market of the importing State, even if the parallel importer has not reaffixed the original trade mark (product name), but instead given the new external packaging a product name which does not contain the trade mark proprietor’s product trade mark (‘de-branding’)?

| 7. | Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the European Parliament and of the Council on EU trade marks be interpreted as meaning that a trade mark proprietor may oppose further commercialisation of a medicinal product which a parallel importer has repackaged in a new external packaging, in so far as the parallel importer has reaffixed only the trade mark proprietor’s product-specific trade mark, but has not reaffixed the other trade marks and/or commercial indications which the trade mark proprietor had affixed to the original external packaging? |
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7.

Must Article 15(2) of Directive 2015/2436/EU of the European Parliament and of the Council on trade marks and Article 15(2) of Regulation 2017/1001/EU of the European Parliament and of the Council on EU trade marks be interpreted as meaning that a trade mark proprietor may oppose further commercialisation of a medicinal product which a parallel importer has repackaged in a new external packaging, in so far as the parallel importer has reaffixed only the trade mark proprietor’s product-specific trade mark, but has not reaffixed the other trade marks and/or commercial indications which the trade mark proprietor had affixed to the original external packaging?

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(1)  Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (OJ 2015 L 336, p. 1).

(2)  Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ 2017 L 154, p. 1).

(3)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

(4)  Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ 2011 L 174, p. 74).

(5)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ 2016 L 32, p. 1).

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