Source: EURLEX
Language: en
Format: md

Case C‑471/14

Seattle Genetics Inc.

v

Österreichisches Patentamt

(Request for a preliminary ruling from the Oberlandesgericht Wien)

‛Reference for a preliminary ruling — Intellectual and industrial property — Proprietary medicinal products — Regulation (EC) No 469/2009 — Article 13(1) — Supplementary protection certificate — Duration — Concept of the ‘date of the first authorisation to place the product on the market in the European Union’ — Whether account is to be taken of the date of the decision granting authorisation or the date on which notification was given of that decision’

Summary — Judgment of the Court (Eighth Chamber), 6 October 2015

1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Duration of the certificate — 85658 / Date of the first authorisation to place the product on the market in the European Union — Concept — Independent and uniform interpretation

   (European Parliament and Council Regulation No 469/2009, Recitals 7 and 8 and Art. 13(1))
2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Aim

   (European Parliament and Council Regulation No 469/2009, Recitals 3 to 5, 8 and 9)
3. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Duration of the certificate — Date of the first authorisation to place the product on the market in the European Union — Concept — Date on which notification of the decision granting authorisation was given to the addressee — Included

   (Art. 297(2), third subpara., TFEU; European Parliament and Council Regulation No 469/2009, Art. 13(1))

1. Article 13(1) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.

   As is apparent from recitals 7 and 8 in the preamble thereto, Regulation No 469/2009 establishes a uniform solution at EU level by creating a supplementary protection certificate which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and the functioning of the internal market. While Article 13 of Regulation No 469/2009 does not define ‘the date of the first authorisation to place the product on the market in the [European Union]’, to which that provision refers for the purpose of determining the date of expiry of a certificate, nor does it contain any reference to national laws as regards the meaning to be applied to those words. It therefore follows that that provision must be regarded, for the purposes of the application of that regulation, as containing an autonomous concept of EU law which must be interpreted in a uniform manner throughout the territory of the European Union.

   (see paras 24, 26, 28, operative part 1)
2. See the text of the decision.

   (see paras 32, 33)
3. Article 13(1) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

   Since the EU legislature’s intention was to give the holder of a supplementary protection certificate adequate effective protection, the calculation of the duration of supplementary protection cannot be carried out without taking into account the determination of the date from which the recipient of a certificate is in fact able to enjoy the benefit of his marketing authorisation by marketing his product. The holder of a supplementary protection certificate is entitled to market a product only from the date on which he is given notification of the decision granting the marketing authorisation in question, not from the date on which that decision was adopted.

   Accordingly, it cannot be accepted that procedural steps carried out between the decision granting marketing authorisation and the notification of that decision — the duration of which is not within the control of the supplementary protection certificate holder — reduce the period of validity of the certificate.

   That interpretation is all the more appropriate since decisions granting marketing authorisations issued by the Commission are subject to the requirements laid down in the third subparagraph of Article 297(2) TFEU, which provides that decisions which specify to whom they are addressed are to be notified to those to whom they are addressed and take effect upon such notification. That requirement to give notification cannot be disregarded when calculating the period of supplementary protection under Article 13(1) of Regulation No 469/2009.

   (see paras 34-37, 39, 40, operative part 2)

[Top](#document1)