## Facts

- Human Genome Sciences, Inc. (HGS) obtained a European patent (UK designation) claiming a newly identified human protein (Neutrokine‑α), its encoding nucleotide sequence, and related antibodies.
- The application (filed 1996; granted 2005) described predicted biological properties and therapeutic uses primarily from Neutrokine‑α’s membership in the TNF ligand superfamily, without in vitro or in vivo experimental data.
- Eli Lilly & Co. sought revocation in the UK, arguing the patent failed the European Patent Convention (EPC) requirement that an invention be “susceptible of industrial application” (Art. 57).
- In EPO opposition proceedings, the Opposition Division revoked the patent, but the Technical Board of Appeal later allowed HGS’s appeal and directed maintenance of the patent.
- In the UK, the High Court revoked the patent as speculative and as merely setting the skilled person a research program; the Court of Appeal affirmed, treating EPO Board decisions as persuasive on law but not controlling on fact and degree.
- HGS appealed to the UK Supreme Court.

## Issues

1. Whether the patent disclosed a sufficiently plausible industrial application for Neutrokine‑α to satisfy EPC Article 57 at the filing date.
2. What weight UK courts should give to established EPO Technical Board of Appeal jurisprudence when interpreting and applying EPC requirements.

## Decision

- The Supreme Court unanimously allowed HGS’s appeal and held the patent satisfied EPC Article 57’s industrial applicability requirement.
- The Court held that industrial applicability does not require clinical efficacy or experimental proof at filing; a specific use that is credible on the face of the specification and common general knowledge can suffice.
- The Court accepted that, in biotechnology, bioinformatics and family-homology reasoning may provide a sound basis for plausibility without “wet lab” data.
- The Court held that UK courts are not formally bound by EPO Board decisions, but should generally follow the EPO’s settled line of authority to promote consistent EPC interpretation, absent strong reasons to depart.
- The revocation judgments of the High Court and Court of Appeal were reversed on the industrial applicability ground.

## Legal Principles

- EPC Article 57 requires disclosure of a “specific, substantial and credible” (plausible) industrial use; it is not satisfied by purely speculative or wholly general assertions.
- Plausibility may be established by credible scientific reasoning, including sequence similarity, functional homology, and membership in a well-characterized protein superfamily, even without experimental confirmation at filing.
- The industrial applicability inquiry focuses on whether the skilled person, reading the patent with common general knowledge, would recognize a concrete practical use, not whether the invention’s medical benefit is proven.
- National courts applying the EPC should normally align with consistent EPO Technical Board of Appeal jurisprudence on EPC interpretation and application, while remaining free to depart for strong reasons.

## Conclusion

The UK Supreme Court upheld a biotechnology patent where the specification, grounded in accepted superfamily-based reasoning, made the claimed therapeutic uses plausible at filing, and it endorsed a strong default of harmonization with established EPO Board jurisprudence when applying EPC validity standards.


Human Genome Scis., Inc. v. Eli Lilly & Co., [2011] UKSC 51 (U.K. 2011)