Forsgren v Österreichisches Patentamt (CJEU, C-631/13, 2015)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Oberster Patent- und Markensenat (Austria), the Court held that the covalent binding of an active ingredient to other active ingredients in a medicinal product does not, in principle, preclude the grant of an SPC for that active ingredient (para 28). It nonetheless confined the certificate in two respects: Article 3(b) of Regulation 469/2009 precludes an SPC for an active ingredient whose effect falls outside the therapeutic indications of the marketing authorisation (para 39), and a carrier protein conjugated to a polysaccharide is an active ingredient only if it has its own pharmacological, immunological or metabolic action covered by those indications (para 54). The ruling matters for SPC applications directed to a component of a conjugate vaccine and, more generally, to any substance whose own activity does not appear in the authorised indications.

Facts and procedure

Mr Forsgren holds European patent EP 0 594 610 B1 on Protein D, an IgD-binding protein of Haemophilus influenzae. Protein D is a component of Synflorix, a paediatric pneumococcal vaccine authorised by the Commission on 30 March 2009, in which it acts as the carrier protein for eight of the ten serotypes. On 24 September 2009 Mr Forsgren applied for an SPC for Protein D. The Austrian Patent Office refused it on the ground that Protein D was merely an excipient; its Board of Appeal upheld the refusal, finding that a protein covalently bound to other active ingredients could not be a medicinal product within the meaning of the Regulation. On appeal, the Oberster Patent- und Markensenat identified two possible effects of Protein D in its own right (protection against otitis media caused by non-typeable H. influenzae, and an adjuvant effect on the pneumococcal polysaccharides) and referred two questions by decision of 28 August 2013.

The applicable law

The dispute concerns Articles 1(b) and 3(a) and (b) of Regulation 469/2009. Since the Regulation does not define « active ingredient », the Court relied on Massachusetts Institute of Technology (C-431/04), which excludes substances having no effect of their own on the body (para 23), and noted that the definition of « active substance » inserted into Directive 2001/83 by Directive 2011/62 turns on pharmacological, immunological or metabolic action (para 24). It recalled that Article 3 lays down four cumulative conditions (para 32) and that Article 4 limits protection to uses authorised before the certificate expires (para 35).

Question

Can an active ingredient covalently bound to other active ingredients be the subject of an SPC and, if so, is that still the case where its own effect is not covered by the marketing authorisation, or where the authorisation describes it only as a carrier protein?

Decision

« Active ingredient » covers substances producing a pharmacological, immunological or metabolic action of their own; the Regulation draws no distinction according to whether a substance is covalently bound, so that binding cannot by itself rule out a certificate (paras 25 to 28). By contrast, no SPC may be granted for an active ingredient whose effects fall outside the therapeutic indications of the authorisation: the Synflorix authorisation is limited to pneumococcal disease, the public assessment report confirms that no clinical data on protection against H. influenzae were submitted, and the authorisation procedure therefore did not delay the commercial exploitation of the patent in that respect (paras 35 to 39). On the second limb, the Court found that the order in GlaxoSmithKline Biologicals (C-210/13) did not settle the point, since the authorisation and the report identify aluminium phosphate as the adjuvant (paras 42 and 43), nor did Bayer CropScience (C-11/13), decided under a different regulation (para 50). In light of the aim of encouraging research (paras 51 and 52), a conjugated carrier protein is an active ingredient only if it has an effect of its own within the authorised indications, which is for the referring court to determine (paras 53 and 54).

Key points for practice

• Covalent binding is irrelevant: what matters is whether the substance has an effect of its own (paras 25 and 27).
• The therapeutic indications of the authorisation set the limits of the certificate: an effect they do not cover, for want of clinical data assessed in the procedure, cannot support an SPC (paras 37 to 39).
• A carrier protein is not excluded as such, provided it has its own action within the authorised indications (para 54).
• Practical point: before applying for an SPC for a component of a conjugate or combination product, check that its own effect is reflected in the indications of the authorisation and in the public assessment report, which are the documents on which the Court based its analysis (paras 37 and 42).

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 2, 3 and 4

Directive 2001/83/EC

Art. 1, as amended by Directive 2011/62/EU

Case law cited

Massachusetts Institute of Technology (C-431/04); Medeva (C-322/10); Georgetown University and Others (C-422/10); GlaxoSmithKline Biologicals (C-210/13, order); Eli Lilly and Company (C-493/12); Bayer CropScience (C-11/13); Novartis (C-442/11 and C-574/11, orders)

Related decisions

• Eli Lilly, CJEU, 12 December 2013, cited on the compensatory function of the certificate (para 33).
• Medeva, CJEU, 24 November 2011, among the case law cited by the Court.

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.