Human Genome Sciences v Eli Lilly (UKSC, [2011] UKSC 51, 2011)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The UK Supreme Court held that Human Genome Sciences’ patent for the sequence encoding a novel protein, Neutrokine-α, was susceptible of industrial application under Article 57 EPC, although the High Court and the Court of Appeal had revoked it. It is enough that, in the light of common general knowledge, the patent makes a use of the protein plausible, here derived from its membership of the TNF ligand superfamily, all known members of which shared common activities. The Court expressly aligned English law with the settled case law of the EPO Boards of Appeal.

Facts and procedure

European Patent (UK) 0 939 804, filed on 25 October 1996 and granted on 17 August 2005, discloses Neutrokine-α, its sequence and tissue distribution, with no experimental data (paras 3, 4 and 8). On Eli Lilly’s opposition, the Opposition Division revoked it in June 2008, but the Technical Board of Appeal allowed the appeal on 21 October 2009 (T 18/09) (paras 29 and 30). In parallel, Kitchin J revoked it on 31 July 2008 for lack of industrial application and insufficiency, and the Court of Appeal dismissed the appeal on 9 February 2010 (paras 31, 32 and 132).

The applicable law

Articles 52 and 57 EPC, implemented by sections 1(1)(c) and 4 of the Patents Act 1977, require the invention to be susceptible of industrial application (paras 28 and 142). Article 5 of Directive 98/44 was of no help, as it cannot alter Article 57 (paras 35 and 36). National courts should normally follow the established case law of the Boards; only very unusual facts justify departing from a consistent approach (paras 83 to 87).

Question

Is disclosure of a novel protein, its sequence and its membership of a superfamily with known but pleiotropic functions enough, without experimental data, to satisfy the requirement of industrial application?

Decision

Lord Neuberger summarised the Boards’ case law in fifteen points: a vague and speculative indication will not do, but the absence of experimental evidence is not fatal and a plausible use or an educated guess can suffice, later evidence being able to confirm it without being the sole basis (para 107, citing in particular T 870/04, T 898/05 and T 1329/04). Kitchin J had not followed that approach (para 106). Disclosure of the existence and structure of Neutrokine-α, its sequence and its membership of the superfamily should have sufficed (para 109). The pleiotropic nature of the superfamily’s members is no obstacle where all of them share sufficient common activities (paras 112 and 113). The courts below gave insufficient weight to plausibility, the Court of Appeal having rejected a use it accepted was plausible (para 122), and to the protein’s functions at the cellular level (para 124). For Lord Hope, the test is a question of law: it is enough that the molecule was plausibly shown to be usable (paras 161 and 165). Lilly’s cross-appeal on insufficiency was dismissed, claim 1 being directed to the sequence only (paras 135 to 139), and the case was remitted to the Court of Appeal for the outstanding issues (para 140).

Key points for practice

• Industrial application of a sequence may follow from its plausible membership of a protein family all known members of which share a useful activity (paras 107 and 109).
• The line between plausibility and speculation remains delicate, but the Boards’ approach is held to be tolerably clear (para 123).
• Practical point: for a sequence without experimental data, defending validity rests on showing, through common general knowledge at the filing date, the functions shared by the family to which it belongs.

Relevance before the UPC

Since the UPC assesses validity against Article 138(1) EPC, the reading of Article 57 adopted here, aligned with the Boards’ case law (para 91), carries over to revocation actions concerning sequence patents.

Provisions applied

European Patent Convention

Art. 52; Art. 57; Art. 83

Directive 98/44/EC

Art. 5

National law

Patents Act 1977, sections 1(1)(c) and 4

Case law cited

T 870/04 (BDP1 Phosphatase/Max-Planck); T 1329/04; T 604/04; T 898/05 (ZymoGenetics); T 1452/06; T 1165/06; T 18/09 (Neutrokine/Human Genome Sciences); Generics (UK) v H Lundbeck [2009] UKHL 12; Conor Medsystems v Angiotech [2008] UKHL 49; Biogen v Medeva [1997] RPC 1

Related decisions

• Johns Hopkins University, GDF-9, EPO, 28 June 2005, cited on plausibility and post-published evidence (paras 48 to 50 and 107).

Prepared by Dhenne Avocats from the text of the decision (National Archives, Find Case Law), consulted on 11 October 2026. Only the official text is authoritative.