Opinion of Advocate General Tanchev delivered on 7 February 2018.

• Jurisdiction: European Union
• Celex Number: 62016CC0681
• ECLI: ECLI:EU:C:2018:69
• Date: 07 February 2018
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Docket Number: C-681/16

Provisional text

OPINION OF ADVOCATE GENERAL

TANCHEV

delivered on 7 February 2018(1)

Case C‑681/16

Pfizer Ireland Pharmaceuticals, Operations Support Group

v

Orifarm GmbH

(Request for a preliminary ruling from the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany))

(Preliminary ruling — Accession of new Member States — Acts of Accession — Specific Mechanism — Patent law — Medicine protected by a supplementary protection certificate — Regulation No 469/2009 — Paediatric prolongation of the protection — Regulation No 1901/2006 — Product protected in an old Member State and marketed in a new Member State without protection by the holder of the patent— Parallel imports — Exhaustion of intellectual property rights)

1. This request for a preliminary ruling from the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) deals with parallel imports of medicine from new Member States into Germany. When comparable patent protection for pharmaceutical products was not available in those States, the Acts of Accession provide for an exception to the free movement of goods. The scope of that exception is at issue here.

2. In the main proceedings, the holder of a ‘supplementary protection certificate for medicinal products’ (‘SPC’) in Germany sought an injunction prohibiting such parallel imports from Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia (‘the new Member States concerned’), and consequently seeks remedies. The referring court therefore asks for an interpretation of the exception clauses, known as the ‘Specific Mechanism’, that are contained in these Member States’ Acts of Accession of 2003, 2005 and 2012.

I. Legal framework

A. Acts of Accession to the European Union

3. Sentence 1 of Annex IV No 2 to the Act of Accession 2003 (2) states in the first paragraph:

‘SPECIFIC MECHANISM 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 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.’

4. Sentence 1 of Annex V No 1 to the Act of Accession 2005 (3) in the first paragraph provides:

‘SPECIFIC MECHANISM With regard to Bulgaria or Romania, 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 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.’

5. Sentence 1 of Annex IV No 1 first paragraph to the Act of Accession 2012 (4) is worded as follows:

‘SPECIFIC MECHANISM With regard to Croatia, the holder, or the holder’s beneficiary, of a patent or Supplementary Protection Certificate (SPC) for a medicinal product filed in a Member State at the time when such protection could not be obtained in Croatia for that product, may rely on the rights granted by that patent or SPC in order to prevent the import and marketing of that product in the Member State or Member States where the product in question enjoys patent or SPC protection, even if this product was put on the market in Croatia for the first time by the holder or with the holder’s consent.’

B. Regulation No 469/2009 on the SPC

6.Article 3 of Regulation No 469/2009 (5) reads as follows:

‘A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;

…’

7.Article 7(1) of Regulation No 469/2009 states:

‘The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted.’

8.Article 13(1) to (3) of Regulation No 469/2009 reads:

‘1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.

2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.

3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.’

C. Regulation No 1901/2006 on the paediatric extension

9. The first subparagraph of Article 36(1) of Regulation No 1901/2006 (6)states:

‘Where an application under Article 7 or 8 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92.’

II. The facts in the main proceedings and the questions referred for a preliminary ruling

10. Pfizer Ireland Pharmaceuticals, Operations Support Group, the plaintiff in the main proceedings, is an Irish-based pharmaceutical company in the Pfizer Group, and was the registered holder of an SPC (7) protecting the protein Etanercept. (8) Etanercept is an active substance of the drug Enbrel® that the plaintiff produces and markets in Germany and many other countries and is authorised for the treatment of arthritis in adults and in children. (9)

11. Orifarm GmbH, the defendant in the main proceedings, is a company in the Danish Orifarm Group and operates as a so-called parallel importer of medical products into Germany from countries with lower price levels.

12. An SPC grants a supplementary protection for a medicinal product that was protected by a basic patent and extends the rights under that patent for a certain period after its expiry. (10) The plaintiff’s SPC was issued on the basis of a European basic patent (11)that had effect for the Federal Republic of Germany.

13. This patent had been filed on 31 August 1990 by the pharmaceutical company Roche, (12) which had developed the product and which was also able to utilise Swiss priorities of 12 September 1989, 8 March 1990 and 20 April 1990.

14. On 31 August 1990, none of the 11 new Member States concerned, which would join the EU in 2004, 2007 and 2013, provided for comparable rules for the protection of pharmaceutical products or specific therapeutic indications.

15. On 1 February 2000, the pharmaceutical company Wyeth Pharma, obtained an authorisation for Enbrel®, which allowed the marketing of that product. This authorisation was first issued in Switzerland and was also valid for the European Community.

16. On 26 June 2003, Wyeth Pharma applied for an SPC that was issued on 11 January 2006. (13) In 2009, the plaintiff acquired Wyeth Pharma, with all its assets, including the SPC. (14)

17. Upon expiration of the basic patent on 1 September 2010, the SPC entered into effect for a period which lasted until 1 February 2015.

18. In view of the authorisation of Enbrel® for the paediatric population and as a reward for the research undertaken for this population, on 15 October 2012, the German Patent and Trade Mark Office granted to the plaintiff a ‘paediatric extension’ of the SPC (15) by which the protection was extended for another six months and thus expired only on 1 August 2015.

19. Since 2012, the defendant had informed the plaintiff of its intention to carry out parallel imports from Estonia and Latvia and - from February 2015 - also from Bulgaria, the Czech Republic, Hungary, Poland, Rumania, Slovakia and Slovenia. The plaintiff repeatedly objected to this and an ongoing correspondence ensued.

20. In April 2015, the plaintiff finally discovered that packages of Enbrel®, which had been produced for Poland, Slovenia and Lithuania (for which an identical packaging is used) and also packages that had been produced for Croatia, all of which identified the defendant as the parallel importer, were available on the German market.

21. Therefore, on 1 June 2015, the plaintiff filed suit with the referring court, the Landgericht Düsseldorf (Regional Court, Düsseldorf), for infringement of its SPC, also taking into account its paediatric extension. The plaintiff requested (i) an injunction prohibiting the import, possession, offering for sale and placing on the market of Enbrel®, (16) and (ii) orders to disclose information about these activities for the period of 1 September 2010 to 1 August 2015, including the submission of copies of invoices, and to recall and destroy the products, and (iii) a declaration of a right to damages.

22. In the context of these proceedings, the defendant argues that it had lawfully...