Human Genome Sciences Inc v Eli Lilly and Company

A patent for a newly identified protein and its encoding gene satisfies industrial applicability where the specification, read with common general knowledge, discloses a plausible, specific and readily identifiable use. The benefit may arise at the biochemical, cellular or biological level. Experimental confirmation and identification of a particular therapeutic treatment are not invariably required.

Membership of a known protein family may establish industrial applicability where known members share a significant function and the new protein can plausibly be assigned that function. Later evidence may confirm an initially plausible use but cannot supply the sole basis for it. The skilled person must be able to exploit the disclosed invention without undue burden or a research programme to discover its function.

Human Genome Sciences Inc held a patent disclosing the nucleotide sequence encoding Neutrokine-α, a previously unknown protein identified as a member of the TNF ligand superfamily. Eli Lilly and Company sought revocation. The patent contained broad predictions about possible uses but no experimental evidence supporting them.

Kitchin J revoked the patent in [2008] EWHC 1903 (Pat), holding that its predicted functions were too general and speculative to establish industrial applicability. The Court of Appeal dismissed the appeal in [2010] EWCA Civ 33. In parallel proceedings, the Technical Board of Appeal of the European Patent Office held that the patent disclosed sufficient industrial applicability.

The principal question was whether the disclosure, read with the common general knowledge at the priority date, satisfied articles 52 and 57 of the European Patent Convention. A further question concerned whether claim 1 was insufficient because it implicitly required proof of Neutrokine-α activity.

1. The appeal was allowed unanimously. The patent satisfied article 57 of the European Patent Convention. Eli Lilly's cross-appeal on insufficiency was dismissed, and the outstanding issues were remitted to the Court of Appeal.

2. Lord Neuberger and Lord Hope held that the courts below had applied a more exacting legal standard than the consistent jurisprudence of the Technical Board of Appeal. A patent must disclose a practical application and a concrete benefit directly derivable from the description and common general knowledge. A merely vague or speculative objective is insufficient. The disclosed use must nevertheless only be plausible or reasonably credible, rather than experimentally proved, and may exist at a biochemical, cellular or biological level.

3. Where a newly identified protein is plausibly assigned to a known family, shared functions of that family may establish industrial applicability. This remains possible where family members have additional pleiotropic or differing effects, provided they also share significant relevant functions. The absence of wet-laboratory evidence is not fatal. Later evidence may confirm a use already made plausible by the application, but cannot provide the sole foundation for patentability.

4. The patent disclosed Neutrokine-α's structure, encoding sequence, tissue distribution and membership of the TNF ligand superfamily. All known members were expressed on activated T-cells and could co-stimulate T-cell proliferation. The skilled person would therefore expect Neutrokine-α to possess that function. Its reported expression in B-cell and T-cell lymphomas reinforced a plausible basis for developing diagnostic and therapeutic methods. The extravagant breadth and poor drafting of other predictions did not divert the skilled reader from that positive technical information.

5. Further work needed to determine precise therapeutic benefits did not defeat industrial applicability. Once an appropriately plausible function had been disclosed, the undue-burden inquiry concerned the skilled person's ability to make and exploit the claimed product, rather than whether further research was needed to develop a marketable therapy.

6. Claim 1 covered the specified isolated nucleic acid sequences encoding the identified polypeptide. It did not implicitly require the polypeptide to display an additional, imprecisely defined “Neutrokine-α activity”. There was no express language or commercial or technical reason supporting that construction. The insufficiency challenge therefore failed.

1. United Kingdom Supreme Court: Allowed HGS's appeal on industrial applicability, dismissed Eli Lilly's cross-appeal on insufficiency, and remitted outstanding issues to the Court of Appeal: [2011] UKSC 51 .
2. Court of Appeal: Dismissed HGS's appeal and approved the High Court's reasoning: [2010] EWCA Civ 33 ; [2010] RPC 14 .
3. High Court: Kitchin J ordered revocation because the patent lacked industrial applicability and was insufficient: [2008] EWHC 1903 (Pat) ; [2008] RPC 29 .
4. European Patent Office: In parallel opposition proceedings, the Opposition Division revoked the patent. The Technical Board of Appeal allowed HGS's appeal in T 0018/09 and directed that the patent be maintained.