Merck Canada Inc. and Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc.

• Jurisdiction: European Union
• Celex Number: 62013CC0539
• ECLI: ECLI:EU:C:2014:2322
• Date: 23 October 2014
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Docket Number: C-539/13

OPINION OF ADVOCATE GENERAL

JÄÄSKINEN

delivered on 23 October 2014 (1 )

Case C‑539/13

Merck Canada Inc.

and

Merck Sharp & Dohme Ltd

v

Sigma Pharmaceuticals PLC

(Request for a preliminary ruling from the

Court of Appeal (England and Wales) (Civil Division) (United Kingdom))

‛Intellectual Property — Trade marks — Parallel imports from Poland into the United Kingdom of a pharmaceutical product — Interpretation of the Specific Mechanism provided for in Chapter 2 of Annex IV to the Act of Accession of 2003 — Requirement to notify holders and beneficiaries of patents or supplementary protection certificates of an intention to import certain medicinal products from an acceding Member State where patent protection has been unavailable — Effect of the patent owner’s failure to respond to notification — Entity bound to make notification and entity to whom the notification is to be addressed’

I – Introduction

1. In this order for reference the Court of Appeal (England and Wales) seeks guidance on the interpretation of the Specific Mechanism in Chapter 2 of Annex IV to the Act of Accession of 2003 (‘the Specific Mechanism’). (2) This provision sets out a derogation from the principle of the free movement of goods, and is designed to protect the interests of holders and beneficiaries of patents and supplementary protection certificates (in the following ‘patent owner’) in the old Member States with respect to certain pharmaceutical products, in situations in which the product concerned could not have been effectively protected in the new Member State before its accession to the European Union.

2. In a nutshell, the Specific Mechanism allows patent owners to rely on their rights with respect to imports from the new Member States, even after their accession, and even if the product in question was put on the market in that new Member State for the first time by a patent owner or with his consent. However, this can occur in only a narrow set of circumstances. That is, when at the time of filing of the application for the patent or supplementary protection certificate in question in an old Member State (Member State A), such protection could not be obtained in the relevant new Member State (Member State B), and importation of the pharmaceutical product concerned is intended from Member State B into Member State A.

3. This is exactly the situation that has arisen in the main proceedings. Merck Canada Inc., a company incorporated under the laws of Canada, and Merck Sharp & Dohme Limited, a company incorporated under the laws of the United Kingdom (in the following jointly ‘Merck’), have brought proceedings in the United Kingdom in reliance on the Specific Mechanism. Merck seek, inter alia, damages and destruction of stock, due to the alleged unlawful parallel importation by Sigma Pharmaceuticals PLC (‘Sigma’) into the United Kingdom from Poland of quantities of a Merck drug called ‘Singulair’, the generic name of which is ‘Montelukast’, even though Sigma purports to have provided prior notification as required by the Specific Mechanism.

4. After the United Kingdom Patents County Court found in favour of Merck, Sigma appealed to the Court of Appeal. It sent questions for a preliminary ruling seeking guidance concerning the consequences of the patent owner not responding to a notification made pursuant to the Specific Mechanism, the entities who may give the notification, and to whom the notification must be given.

II – Legal framework, facts and the question referred

A – Applicable provisions

5. The Specific Mechanism in Chapter 2 of Annex IV to the Act of Accession of 2003 is formulated as follows: ‘With regard to the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia, the holder, or his beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at a time when such protection could not be obtained in one of the abovementioned new Member States for that product, may rely on the rights granted by that patent or supplementary protection certificate in order to prevent the import and marketing (3) of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection, even if the product was put on the market in that new Member State for the first time by him or with his consent. Any person intending to import or market a pharmaceutical product covered by the above paragraph in a Member State where the product enjoys patent or supplementary protection shall demonstrate to the competent authorities in the application regarding that import that one month’s prior notification has been given to the holder or beneficiary of such protection.’

B – Facts and questions referred

6. A commercial version of Montelukast, namely Singulair, protected by Supplementary Protection Certificate in favour of Merck, (4) was placed on the market in the European Union in Finland on 25 August 1997 under a first Community medicinal product authorisation. It received its medical product authorisations in the United Kingdom on 15 January 1998.

7. On 22 June 2009, Pharma XL Limited, an associated company of Sigma, sent a letter addressed to the ‘Manager, Regulatory Affairs’ of Merck Sharp & Dohme Limited at its address in the United Kingdom giving notice of its intention to import Singulair from Poland to the United Kingdom and to apply for the necessary authorisation therein. There was no reference to Sigma in the letter, and nor did it refer to any potential importer other than Pharma XL. (5)

8. The letter was received by Merck Sharp & Dohme Limited, but no reply was sent as a result of an administrative oversight, and even though it was in accordance with Merck’s policy to reply to letters objecting to importations of this kind. In addition, Pharma XL Ltd wrote four subsequent letters to the Manager, Regulatory Affairs, Merck, Sharpe & Dome Limited, stating their intention to import Singulair from Poland, enclosing copies of the intended presentation of the repackaged product, and asking whether Merck had any objection. None of these letters received a response.

9. On 14 September 2009, Pharma XL Ltd filed two applications with the competent United Kingdom government agency for parallel import licences of Singulair. Parallel import licences were granted for different dosages of Singulair in May and September of 2010. Thereafter Sigma began importing Singulair from Poland, which was repackaged by Pharma XL Ltd and sold in the United Kingdom market by Sigma.

10. However, on 14 December 2010 Merck informed Pharma XL Ltd, by letter, of their objection to the importation of Singulair from Poland under the Specific Mechanism. On 16 December 2010 the letter was received at Pharma XL Ltd’s registered office, and Sigma immediately ceased further sales of Singulair from Poland. However, prior to receiving that letter, Sigma had already imported and sold in excess of £2 million of Singulair and was left in possession of over £2 million worth of stocks, the majority irreversibly repackaged for the United Kingdom market.

11. Merck instituted proceedings in the Patent County Court which found in its favour. On Sigma’s appeal to the Court of Appeal, an order for reference, dated 18 April 2013 and received at the Court on 14 October 2013, was sent with the following preliminary questions: ‘(1) May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so? (2) If the answer to Question 1 is yes: (a) How must that intention be demonstrated? (b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights? (3) Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular: (a) Must the prior notification be given by the person intending to import or market the pharmaceutical product? or (b) Where, as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant’s regulatory approval?; and (i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product? (ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product? (4) To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular: (a) Is the beneficiary of a...