Eli Lilly v Human Genome Sciences (CJEU, C-493/12, 2013)

Date	12 December 2013
Jurisdiction	European Union
Court	Court of Justice of the European Union (Third Chamber)
Case number	C-493/12
ECLI	ECLI:EU:C:2013:835
Parties	Eli Lilly and Company Ltd v Human Genome Sciences Inc.
Language of the decision	EN

Text of the decision · Texte officiel, EUR-Lex (CELEX 62012CJ0493), version anglaise ; langue de procédure : anglais

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the High Court (Patents Court), the Court held that Article 3(a) does not require the active ingredient to be identified in the claims by a structural formula. An active ingredient covered by a functional definition in the claims of a patent granted by the EPO may be protected by the basic patent, provided that the claims, interpreted in particular in the light of the description, relate implicitly but necessarily and specifically to that ingredient, which is for the national court to determine. The judgment refines the Medeva test for functional claims, which are common for antibodies.

Facts and procedure

Human Genome Sciences (HGS) holds European Patent (UK) EP 0 939 804, applied for on 25 October 1996 and expiring on 25 October 2016, relating to the protein Neutrokine-alpha; claim 13 covers an isolated antibody binding specifically to that protein, defined by function rather than structure (paras 12, 13 and 19). Eli Lilly, which plans to market a composition containing the antibody LY2127399 (tabalumab), accepts that marketing it before the patent expires would infringe claim 13 (paras 14 and 15). It sought a declaration that any SPC granted on the basis of that patent and an MA for that product would be invalid (para 16). The patent had been upheld by the EPO Board of Appeal (T 18/09, 21 October 2009), the UK Supreme Court on 2 November 2011 and the Court of Appeal on 5 September 2012 (para 20). Three questions were referred by decision of 24 October 2012 (para 23).

The applicable law

The case concerns Articles 1(b) and (c) and 3(a) of Regulation 469/2009. The Court held that protection under Article 3(a) is governed by the rules on the extent of protection conferred by the patent, not by the rules on infringement; for a patent granted by the EPO, those are Article 69 EPC and its Protocol on Interpretation (paras 32 and 33). The claims play a decisive role in that respect (paras 34 and 35). The Court recalled that it has no jurisdiction to interpret the EPC (para 40).

Question

Can an active ingredient defined in the claims by a functional formula, without a structural formula, be regarded as protected by the basic patent within the meaning of Article 3(a)?

Decision

The fact that marketing the active ingredient would infringe the patent is not decisive (para 37). It was common ground that tabalumab was not expressly named in the claims or identified in the description (para 36). An active ingredient identified in the claims by neither a structural nor a functional formula cannot be regarded as protected (para 38). Article 3(a) does not, however, in principle preclude an active ingredient corresponding to a functional definition in the claims of an EPO-granted patent from being regarded as protected, provided that those claims, interpreted in particular in the light of the description as Article 69 EPC and its Protocol require, relate implicitly but necessarily and specifically to the active ingredient in question (para 39). That is for the referring court to determine (paras 40 and 44). The Court added, having regard to the aim of the Regulation, which is to ensure that research investment is recouped (para 42), that refusing a certificate may be justified where the proprietor has taken no steps to carry out more in-depth research to identify the active ingredient specifically: a certificate granted in that case would undermine that aim (para 43).

Key points for practice

A functional definition in the claims may suffice for Article 3(a); a structural formula is not required (paras 39 and 44).
The test is whether the claims, read in the light of the description, relate implicitly but necessarily and specifically to the active ingredient (para 39).
Infringement of the patent by the product does not by itself show that the product is protected under Article 3(a) (para 37).
Practical point: against an SPC based on a functional claim to a product the patent does not identify, the proprietor’s failure to carry out research to identify the active ingredient specifically is an argument the Court expressly accepts (para 43).

Provisions applied

Regulation (EC) No 469/2009: Arts 1 and 3
European Patent Convention: Art. 69; Protocol on the Interpretation of Article 69
National law: Patents Act 1977 (UK), sections 60, 125 and 130(7), set out in the legal context
Case law cited: Medeva (C-322/10); University of Queensland and CSL (C-630/10, order); Daiichi Sankyo (C-6/11, order); Hogan Lovells International (C-229/09); Actavis Group PTC and Actavis UK (C-443/12); Georgetown University (C-484/12); EPO Board of Appeal, T 18/09, 21 October 2009; UK Supreme Court, 2 November 2011; Court of Appeal, 5 September 2012

Related decisions

Human Genome Sciences v Eli Lilly, UK Supreme Court, 2 November 2011, ruling on the validity of the same patent, mentioned at para 20.
Medeva, CJEU, 24 November 2011, the test refined by the Court (paras 34 and 35).
Actavis v Sanofi, CJEU, 12 December 2013, delivered the same day, cited (para 41).
Georgetown University, CJEU, 12 December 2013, delivered the same day, cited (para 41).

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.