Case C‑577/13

Actavis Group PTC EHF

and

Actavis UK Ltd

v

Boehringer Ingelheim Pharma GmbH & Co. KG

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

‛Reference for a preliminary ruling — Medicinal products for human use — Regulation (EC) No 469/2009 — Article 3 — Supplementary protection certificate — Conditions for obtaining such a certificate — Medicinal products containing in whole or in part the same active ingredient — Medicinal products placed on the market in succession — Combination of active ingredients — Active ingredient previously marketed in the form of a medicinal product with a single active ingredient — Conditions for obtaining several certificates on the basis of the same patent — Modification of the active ingredients of a basic patent’

Summary — Judgment of the Court (Eighth Chamber), 12 March 2015

1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for granting — A patent protecting a combination of several active ingredients — Marketing authorisation and supplementary protection certificate granted for a medicinal product containing such a combination of active ingredients — Application for a certificate in respect of one of those active ingredients individually protected by that patent — Lawfulness

   (European Parliament and Council Regulation No 469/2009, Arts 1(b) and (c) and 3(a))

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Objective

   (European Parliament and Council Regulation No 469/2009, Recitals 4, 5, 9 and 10)

3. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for granting — Patent protecting a single innovative active ingredient — Two medicinal products containing in whole or in part that active ingredient placed on the market in succession — Supplementary protection certificate granted for the medicinal product containing only that active ingredient — Application for a second certificate for the medicinal product containing that active ingredient in combination with another substance that is not protected by the patent — Not permissible

   (European Parliament and Council Regulation No 469/2009, Arts 1(c) and 3(a) and (c))

1.  See the text of the decision.

   (see para. 33)

2.  See the text of the decision.

   (see paras 34-36)

3.  Article 3(a) and (c) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination.

   It cannot be accepted that the holder of a basic patent in force may obtain a new supplementary protection certificate, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, an active ingredient, protected as such by the holder’s basic patent and constituting the subject-matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject-matter of the invention covered by the basic patent It follows that, in order for a basic patent to protect as such an active ingredient within the meaning of Articles 1(c) and 3(a) of Regulation No 469/2009, that active ingredient must constitute the subject-matter of the invention covered by that patent.

   (see paras 37-39, operative part)

Case C‑577/13

Actavis Group PTC EHF

and

Actavis UK Ltd

v

Boehringer Ingelheim Pharma GmbH & Co. KG

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

‛Reference for a preliminary ruling — Medicinal products for human use — Regulation (EC) No 469/2009 — Article 3 — Supplementary protection certificate — Conditions for obtaining such a certificate — Medicinal products containing in whole or in part the same active ingredient — Medicinal products placed on the market in succession — Combination of active ingredients — Active ingredient previously marketed in the form of a medicinal product with a single active ingredient — Conditions for obtaining several certificates on the basis of the same patent — Modification of the active ingredients of a basic patent’

Summary — Judgment of the Court (Eighth Chamber), 12 March 2015

1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for granting — A patent protecting a combination of several active ingredients — Marketing authorisation and supplementary protection certificate granted for a medicinal product containing such a combination of active ingredients — Application for a certificate in respect of one of those active ingredients individually protected by that patent — Lawfulness

   (European Parliament and Council Regulation No 469/2009, Arts 1(b) and (c) and 3(a))

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Objective

   (European Parliament and Council Regulation No 469/2009, Recitals 4, 5, 9 and 10)

3. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for granting — Patent protecting a single innovative active ingredient — Two medicinal products containing in whole or in part that active ingredient placed on the market in succession — Supplementary protection certificate granted for the medicinal product containing only that active ingredient — Application for a second certificate for the medicinal product containing that active ingredient in combination with another substance that is not protected by the patent — Not permissible

   (European Parliament and Council Regulation No 469/2009, Arts 1(c) and 3(a) and (c))

1.  See the text of the decision.

   (see para. 33)

2.  See the text of the decision.

   (see paras 34-36)

3.  Article 3(a) and (c) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination.

   It cannot be accepted that the holder of a basic patent in force may obtain a new supplementary protection certificate, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, an active ingredient, protected as such by the holder’s basic patent and constituting the subject-matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject-matter of the invention covered by the basic patent It follows that, in order for a basic patent to protect as such an active ingredient within the meaning of Articles 1(c) and 3(a) of Regulation No 469/2009, that active ingredient must constitute the subject-matter of the invention covered by that patent.

   (see paras 37-39, operative part)