Date of the first MA, as stated in an application for the SPC, on the basis of which the duration of the certificate is calculated, is incorrect when the incorrect date led to a method for calculating the durating of the certificate which does not comply with the requirements of Article 13(1) of SPC Regulation for Medicinal Products, as interpreted by a subsequent judgment of the Court. When the date of the first MA is incorrect, the holder of an SPC may, under Article 18 of SPC Regulation for Medicinal Products, bring an appeal for ectification of the duration stated in the SPC, provided that the SPC has not expired.
PATENT LAW - SPC
Incyte is the owner of European patent No E013235 (‘the basic patent’). On 24 January 2013, Incyte submitted an application for an SPC to the Office, by reference to the basic patent and to a marketing authorisation (‘MA’) granted by the European Commission for the whole of the European Union, dated 23 August 2012 in respect of the pharmaceutical product ‘Jakavi’, used in the treatment of myelofibrosis. By decision of 7 October 2014, the Office granted the SPC applied for. That decision contained the date on which that authorisation was granted, namely on 23 August 2012, and the date of expiry of the SPC, namely on 24 August 2027. On 18 November 2015, Incyte requested rectification of the SPC at issue in the main proceedings to the effect that the expiry date of the certificate be changed to 28 August 2027. According to Incyte, the Office made a miscalculation by using, as the basis for calculating the duration of the SPC, not the date on which the addressee was given notification of the decision on the MA, but the date on which it was granted, which disregards the interpretation adopted in the ‘Seattle Genetics’ judgment of 6 October 2015 (IPPT20151006). The referring court harbours doubts as to whether the present case concerns a date which is ‘incorrect’ within the meaning of SPC Regulation for Medicinal Products (Regulation No 1610/96), given that it was on the basis of a preliminary ruling delivered after the application for the SPC at issue was lodged that it appeared that the relevant date was stated on the basis of an incorrect interpretation of the law.
The Court of Justice of the EU answers the questions as follows:
1. Article 18 of 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.
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.