Arne Forsgren v Österreichisches Patentamt.
Date: 2015-01-15
18. The referring court is uncertain whether, as a carrier protein, Protein D can give rise to the grant of an SPC. On the basis of the judgment in Massachusetts Institute of Technology (C‑431/04, EU:C:2006:291), the referring court is of the opinion that the grant of an SPC is all the more unlikely since Protein D permits only the administration of an active ingredient.
23. ‘[P]roduct’ is defined in Article 1(b) of Regulation No 469/2009 as ‘the active ingredient or combination of active ingredients of a medicinal product’. However, the term ‘active ingredient’ is not defined in that regulation. That term also appeared in Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1), which was repealed by Regulation No 469/2009, and a question relating to that provision has already been referred to the Court. The Court held on that occasion that it is generally accepted in pharmacology that the term ‘active ingredient’ does not cover substances forming part of a medicinal product which do not have an effect of their own on the human or animal body (see judgment in Massachusetts Institute of Technology , EU:C:2006:291, paragraph 18).
24. That interpretation was subsequently reproduced, in essence, by the EU legislature. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) amended Article 1 of Directive 2001/83 to the effect that the term ‘active substance’ — which must be understood as meaning ‘active ingredient’ (judgment in Massachusetts Institute of Technology , EU:C:2006:291, paragraph 21) — is defined therein as ‘any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis’.
25. It follows that the term ‘active ingredient’, for the purposes of applying Regulation No 469/2009, concerns substances producing a pharmacological, immunological or metabolic action of their own. Since Regulation No 469/2009 does not draw any distinction according to whether an active ingredient is covalently bound with other substances, it is not appropriate to exclude, on that ground, the grant of an SPC for such an active ingredient.
26. On the other hand, the Court has held that a substance which has no therapeutic effect of its own and which is used to obtain a certain pharmaceutical form of the medicinal product is not covered by the term ‘active ingredient’ and, consequently, cannot give rise to the grant of an SPC (judgment in Massachusetts Institute of Technology , EU:C:2006:291, paragraph 25).
32. In that regard, it should be borne in mind that the grant of an SPC requires fulfilment of the four cumulative conditions set out in Article 3 of Regulation No 469/2009. That provision provides, in essence, that an SPC can be granted only if, at the date of the application, the product is protected by a basic patent in force and has not already been the subject of a certificate. In addition, that product must have been granted a marketing authorisation as a medicinal product which is still valid, in accordance with Directive 2001/83 or Directive 2001/82, as appropriate; and, lastly, that authorisation must be the first in relation to that product as a medicinal product.
33. It is also important to note that the SPC is designed to re-establish an adequate period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first marketing authorisation in the European Union was granted (judgment in Eli Lilly and Company , C‑493/12, EU:C:2013:835, paragraph 41 and the case-law cited).
34. It follows from the foregoing that, unless it has been granted a marketing authorisation as a medicinal product, a patented product may not give rise to the grant of an SPC.
35. In addition, Article 4 of Regulation No 469/2009 provides that the protection conferred by the certificate is to extend only to the product covered by the marketing authorisation ‘for any use of the product as a medicinal product that has been authorised before the expiry of the certificate’. That provision implies that the use of a product which has not been authorised, as a medicinal product, by the marketing authorisation may not be covered by an SPC (see, to that effect, judgment in Medeva , EU:C:2011:773, paragraph 37). Consequently, an active ingredient whose therapeutic effects do not fall within the therapeutic indications for which a marketing authorisation was granted may not give rise to the grant of an SPC.
51. It is appropriate, consequently, to refer to the fundamental objective of Regulation No 469/2009, which is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health (judgment in Georgetown University and Others , EU:C:2011:776, paragraph 24 and the case-law cited).