Eli Lilly & Company v Human Genome Sciences Inc

Industrial applicability requires more than identifying and reproducing a biological sequence. The patent must disclose, directly or through the common general knowledge, a practical use for the invention and a sound and concrete basis for exploiting it. A speculative list of possible functions, diseases or treatments is insufficient, particularly where discovering the function requires a research programme. Subsequent research cannot supply the missing disclosure. The same principles inform sufficiency and obviousness: a patent cannot reserve an unexplored technical field or operate as a hunting licence for a useful application. Claims to products may be sufficiently defined as products yet remain invalid for lack of industrial application, insufficiency, or lack of inventive step.

Eli Lilly sought revocation of a patent held by Human Genome Sciences concerning Neutrokine-α, a newly identified member of the TNF ligand superfamily. HGS applied to amend the patent by narrowing the claims principally to specified full-length and extracellular-domain sequences. Lilly alleged lack of industrial applicability, insufficiency, obviousness, added matter and impermissible extension of protection.

The patent disclosed sequence information and attributed a very wide range of biological activities and therapeutic and diagnostic uses to Neutrokine-α, but supplied no experimental data establishing its function. The central issues were whether the disclosure identified a practical industrial application, whether the amended claims were enabled across their scope, and whether the claimed subject matter involved an inventive step.

1. Industrial applicability. The requirement under Patents Act 1977 s 1 and arts 52 and 57 EPC must be interpreted consistently with the EPC. Industry is construed broadly, but the specification must disclose a practical way of exploiting the invention. The skilled person must be able to derive a real prospect of exploitation directly from the specification, the nature of the invention or the background art. A speculative indication of possible objectives requiring further research is insufficient.
2. The disclosure of Neutrokine-α established only that it was a member of the TNF ligand superfamily. The common general knowledge suggested possible involvement in immune regulation and B- and T-cell activity, but did not identify a particular disease, condition or technical problem which the protein could solve. The extensive research undertaken after the priority date confirmed that the patent presented a research programme rather than a practical application. The claims were therefore not susceptible of industrial application.
3. Insufficiency. Sufficiency is assessed by construing the claims and considering the specification as a whole, supplemented by the skilled person’s common general knowledge. The invention must be performable across the whole scope of the claims without undue burden. The sequence claims were sufficiently defined after amendment, and identifying specific antibodies was routine. However, the pharmaceutical and diagnostic composition claims required a substantial research programme with an uncertain outcome and were far too broad to be enabled.
4. Obviousness. The structured approach in Pozzoli v BDMO SA was applied. The amended sequence claims were not obvious over the Fujiwara EST or Image clone. The skilled person was not required to select an uncharacterised sequence from hundreds of thousands of alternatives without a reason to do so, and mass database screening was not an obvious strategy. However, the claims made no technical contribution because the specification supplied only speculation as to useful function. That objection succeeded.
5. The amendment deleting the functional limitation from proposed claim 10 would extend the scope of protection to denatured polypeptides that previously fell outside the claim. It was therefore impermissible. Other objections to the amendments failed or were misconceived.
6. The patent was invalid for lack of industrial applicability, insufficiency and obviousness. The proposed amendments were not allowable to the extent identified above.