Case C‑492/16

Incyte Corporation

v

Szellemi Tulajdon Nemzeti Hivatala

(Request for a preliminary ruling from the Fővárosi Törvényszék)

(Reference for a preliminary ruling — Intellectual and industrial property — Patents — Medicinal products for human use — Regulation (EC) No 469/2009 — Article 18 — Plant-protection products — Regulation (EC) No 1610/96 — Article 17(2) — Supplementary protection certificate — Duration — Fixing the date of expiry — Consequences of a judgment of the Court — Possibility or requirement to rectify the date of expiry)

Summary — Judgment of the Court (Second Chamber), 20 December 2017

1. 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 for placing the product on the market in the European Union—Meaning—Date of notification of the decision of authorisation for placing the product on the market to its addressee—Indication, in the application for the award of a certificate, of another date leading to a method for calculating the duration of the certificate which does not comply with Regulation No 469/2009—Incorrect entry

   (European Parliament and Council Regulations No 1610/96, Art. 17(2) and No 469/2009, Arts 13(1) and 18)

2. Approximation of laws—Uniform legislation—Industrial and commercial property—Patent right—Supplementary protection certificate for medicinal products—Duration of the certificate—Erroneous calculation by the competent authority due to an incorrect entry, in the request for the grant of the certificate, of the date of the first authorisation for placing the product on the market in the European Union—Possibility for the holder of the certificate to bring an appeal to rectify the duration

   (European Parliament and Council Regulations No 1610/96, Recital 17 and Art. 17(2) and No 469/2009, Art. 18)

1.  Article 18 du Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, read in the light of Article 17(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, must be interpreted as meaning that the date of the first authorisation to place the product on the market, as stated in an application for a supplementary protection certificate, on the basis of which the national authority competent for granting such a certificate calculated the duration of the certificate, is incorrect in a situation, such as that at issue in the main proceedings, where the date led to a method for calculating the duration of the certificate which does not comply with the requirements of Article 13(1) of Regulation No 469/2009, as interpreted by a subsequent judgment of the Court.

   In paragraph 40 of the judgment of 6 October 2015, Seattle Genetics (C‑471/14, EU:C:2015:659), the Court held that Article 13(1) of Regulation No 469/2009 must be interpreted as meaning that the ‘date of the first [MA] in the [European Union]’, within the meaning of that provision, is the date on which notification of the decision granting MA was given to the addressee of the decision. Accordingly, the interpretation adopted by the Court, in the judgment of 6 October 2015, Seattle Genetics (C‑471/14, EU:C:2015:659), in relation to the concept of ‘date of the first [MA] in the [European Union]’, as it appears in Article 13(1) of Regulation No 469/2009, clarifies and defines the meaning and scope of that rule as it must be, or ought to have been, understood and applied from the date of its entry into force.

   (see paras 40, 42, 44, operative part 1)

2.  Article 18 of Regulation No 469/2009, read in the light of recital 17 and of Article 17(2) of Regulation No 1610/96, must be interpreted as meaning that, in a situation such as that set out in point 1 of this operative part, the holder of a supplementary protection certificate may, under Article 18 of Regulation No 469/2009, bring an appeal for rectification of the duration stated in the certificate, provided that that certificate has not expired.

   (see para. 60, operative part 2)