Case C‑617/12

Astrazeneca AB

v

Comptroller General of Patents, Designs and Trade Marks

(Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court))

‛Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 13(1) — Concept of ‘first authorisation to place [a product] on the market in the Community’ — Authorisation issued by the Swiss Institute for Medicinal Products (Swissmedic) — Automatic recognition in Liechtenstein — Authorisation issued by the European Medicines Agency — Period of validity of a certificate’

Summary — Order of the Court (Eighth Chamber), 14 November 2013

1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Marketing authorisation — Automatic recognition by a State forming part of the European Economic Area of a Swiss marketing authorisation — Whether such an authorisation should be regarded as the first marketing authorisation in the Community — Conditions

   (Annex II to the EEA Agreement, as amended by Annex 2 to Decision No 1/95 of the EEA Council; European Parliament and Council Regulation No 469/2009, Art. 13(1))

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Marketing authorisation — Automatic recognition by a State forming part of the European Economic Area of a Swiss marketing authorisation — Whether such an authorisation should be regarded as the first marketing authorisation in the Community— Decision of the European Medicines Agency refusing to grant a marketing authorisation for the same medicinal product on the base of similar clinical data — Initial authorisation subsequently suspended until additional data submitted — No effect

   (Annex II to the EEA Agreement, as amended by Annex 2 to Decision No 1/95 of the EEA Council; European Parliament and Council Regulation No 469/2009, Art. 13(1))

1.  Article 13 of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products is to be construed, for the purposes of the application of the Agreement on the European Economic Area (EEA), as providing that such a certificate is to 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 territory of one of the States covered by the EEA Agreement, reduced by a period of five years. That first authorisation to place the product on the market in the EEA is not intended to take the place of the marketing authorisation provided for in Article 3(b) of Regulation No 469/2009; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the EEA. The first marketing authorisation in the European Union therefore serves a purely temporal purpose.

   The EEA Agreement — Annex II of which, as amended by Annex 2 to Decision No 1/95 on the entry into force of the Agreement on the European Economic Area for the Principality of Liechtenstein, permits that principality to apply, in parallel with Community legislation, Swiss technical regulations and standards deriving from its regional union with the Swiss Confederation — recognises that two types of marketing authorisation may co-exist in the Principality of Liechtenstein, namely marketing authorisations issued by the Swiss authorities, which are automatically recognised in Liechtenstein, and marketing authorisations issued in Liechtenstein in accordance with Community legislation.

   A marketing authorisation issued by the Swiss authorities and automatically recognised in Liechtenstein in the context of its regional union with the Swiss Confederation may be regarded as a first marketing authorisation for the purpose of Article 13 of Regulation No 469/2009 if it was issued before the marketing authorisation granted by the European Medicines Agency pursuant to Regulation No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency or before the marketing authorisations granted by the competent intellectual property authorities of an EU Member State in accordance with Directive 2001/83 on the Community code relating to medicinal products for human use, or by the competent authorities of the Republic of Iceland or the Kingdom of Norway.

   In the context of the EEA, Article 13(1) of Regulation No 469/2009 must be interpreted as meaning that a Swiss administrative marketing authorisation, which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place the medicinal product in question on the market within the meaning of that provision in the EEA where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency, or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83 and the authorities of the Republic of Iceland and the Kingdom of Norway.

   (see paras 38-41, 60, operative part)

2.  For the purposes of the application of Article 13(1) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products, the fact that the European Medicines Agency refused to grant a European Union marketing authorisation, in the light of the requirements laid down in Directive 2001/83 on the Community code relating to medicinal products for human use, on the basis of similar clinical data to those on the basis of which the Swiss marketing authorisation was issued, does not prevent the Swiss authorisation, as a result of its automatic recognition in Liechtenstein, from being treated as an authorisation granted in conformity with Directive 2001/83 and it must be regarded as the first marketing authorisation in the territory of the European Economic Area. Moreover, the fact that the initial Swiss marketing authorisation was subsequently suspended does not alter the fact that the operator concerned has in fact already placed his product on the market by obtaining an authorisation for that purpose. The requirement to obtain a marketing authorisation laid down in Articles 3 and 13 of Regulation No 469/2009 is not contingent upon whether the holder of the authorisation has actually been able to market the medicinal product in question.

   Accordingly, the fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant.

   (see paras 54, 56, 60, operative part)

Case C‑617/12

Astrazeneca AB

v

Comptroller General of Patents, Designs and Trade Marks

(Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court))

‛Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 13(1) — Concept of ‘first authorisation to place [a product] on the market in the Community’ — Authorisation issued by the Swiss Institute for Medicinal Products (Swissmedic) — Automatic recognition in Liechtenstein — Authorisation issued by the European Medicines Agency — Period of validity of a certificate’

Summary — Order of the Court (Eighth Chamber), 14 November 2013

1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Marketing authorisation — Automatic recognition by a State forming part of the European Economic Area of a Swiss marketing authorisation — Whether such an authorisation should be regarded as the first marketing authorisation in the Community — Conditions

   (Annex II to the EEA Agreement, as amended by Annex 2 to Decision No 1/95 of the EEA Council; European Parliament and Council Regulation No 469/2009, Art. 13(1))

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Marketing authorisation — Automatic recognition by a State forming part of the European Economic Area of a Swiss marketing authorisation — Whether such an authorisation should be regarded as the first marketing authorisation in the Community— Decision of the European Medicines Agency refusing to grant a marketing authorisation for the same medicinal product on the base of similar clinical data — Initial authorisation subsequently suspended until additional data submitted — No effect

   (Annex II to the EEA Agreement, as amended by Annex 2 to Decision No 1/95 of the EEA Council; European Parliament and Council Regulation No 469/2009, Art. 13(1))

1.  Article 13 of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products is to be construed, for the purposes of the application of the Agreement on the European Economic Area (EEA), as providing that such a certificate is to 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 territory of one of the States covered by the EEA Agreement, reduced by a period of five years. That first authorisation to place the product on the market in the EEA is not intended to take the place of the marketing authorisation provided for in Article 3(b) of Regulation No 469/2009; instead, it constitutes a further condition applying in the event that the latter authorisation is not the first authorisation to place the product on the market as a medicinal product in the EEA. The first marketing authorisation in the European Union therefore serves a purely temporal purpose.

   The EEA Agreement — Annex II of which, as amended by Annex 2 to Decision No 1/95 on the entry into force of the Agreement on the European Economic Area for the Principality of Liechtenstein, permits that principality to apply, in parallel with Community legislation, Swiss technical regulations and standards deriving from its regional union with the Swiss Confederation — recognises that two types of marketing authorisation may co-exist in the Principality of Liechtenstein, namely marketing authorisations issued by the Swiss authorities, which are automatically recognised in Liechtenstein, and marketing authorisations issued in Liechtenstein in accordance with Community legislation.

   A marketing authorisation issued by the Swiss authorities and automatically recognised in Liechtenstein in the context of its regional union with the Swiss Confederation may be regarded as a first marketing authorisation for the purpose of Article 13 of Regulation No 469/2009 if it was issued before the marketing authorisation granted by the European Medicines Agency pursuant to Regulation No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency or before the marketing authorisations granted by the competent intellectual property authorities of an EU Member State in accordance with Directive 2001/83 on the Community code relating to medicinal products for human use, or by the competent authorities of the Republic of Iceland or the Kingdom of Norway.

   In the context of the EEA, Article 13(1) of Regulation No 469/2009 must be interpreted as meaning that a Swiss administrative marketing authorisation, which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place the medicinal product in question on the market within the meaning of that provision in the EEA where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency, or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83 and the authorities of the Republic of Iceland and the Kingdom of Norway.

   (see paras 38-41, 60, operative part)

2.  For the purposes of the application of Article 13(1) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products, the fact that the European Medicines Agency refused to grant a European Union marketing authorisation, in the light of the requirements laid down in Directive 2001/83 on the Community code relating to medicinal products for human use, on the basis of similar clinical data to those on the basis of which the Swiss marketing authorisation was issued, does not prevent the Swiss authorisation, as a result of its automatic recognition in Liechtenstein, from being treated as an authorisation granted in conformity with Directive 2001/83 and it must be regarded as the first marketing authorisation in the territory of the European Economic Area. Moreover, the fact that the initial Swiss marketing authorisation was subsequently suspended does not alter the fact that the operator concerned has in fact already placed his product on the market by obtaining an authorisation for that purpose. The requirement to obtain a marketing authorisation laid down in Articles 3 and 13 of Regulation No 469/2009 is not contingent upon whether the holder of the authorisation has actually been able to market the medicinal product in question.

   Accordingly, the fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant.

   (see paras 54, 56, 60, operative part)