Case C‑210/13

Glaxosmithkline Biologicals SA and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG

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)

‛Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Concepts of ‘active ingredient’ and ‘combination of active ingredients’ — Adjuvant’

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 — Concept of ‘active ingredient’ of a medicinal product — Interpretation — Context in which the terms are used and their usual meaning to be taken into consideration

   (European Parliament and Council Regulation No 1049/2009)

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Concept of ‘combination of active ingredients of a medicinal product’ — Combination of a substance having therapeutic effects and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own — Not included

   (European Parliament and Council Regulation No 469/2009, Art. 1(b))

1.  In the absence of any definition of the concept of ‘active ingredient’ in Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products, the meaning and scope of those terms must be determined by considering the general context in which they are used and their usual meaning in everyday language. In this case, it is generally accepted in pharmacology that the term active ‘ingredient’ does not include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body.

   (see paras 27, 28)

2.  Article 1(b) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, just as an adjuvant does not fall within the definition of ‘active ingredient’, so a combination of two substances, namely an active ingredient having therapeutic effects on its own, and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of ‘combination of active ingredients’.

   (see para. 45, operative part)

Case C‑210/13

Glaxosmithkline Biologicals SA and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG

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)

‛Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Concepts of ‘active ingredient’ and ‘combination of active ingredients’ — Adjuvant’

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 — Concept of ‘active ingredient’ of a medicinal product — Interpretation — Context in which the terms are used and their usual meaning to be taken into consideration

   (European Parliament and Council Regulation No 1049/2009)

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Concept of ‘combination of active ingredients of a medicinal product’ — Combination of a substance having therapeutic effects and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own — Not included

   (European Parliament and Council Regulation No 469/2009, Art. 1(b))

1.  In the absence of any definition of the concept of ‘active ingredient’ in Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products, the meaning and scope of those terms must be determined by considering the general context in which they are used and their usual meaning in everyday language. In this case, it is generally accepted in pharmacology that the term active ‘ingredient’ does not include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body.

   (see paras 27, 28)

2.  Article 1(b) of Regulation No 469/2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, just as an adjuvant does not fall within the definition of ‘active ingredient’, so a combination of two substances, namely an active ingredient having therapeutic effects on its own, and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of ‘combination of active ingredients’.

   (see para. 45, operative part)