On 31 July 2008 a decision of the English High Court was handed down by Mr Justice Kitchen in the case of Eli Lilly v Human Genome Sciences Inc (HGS). In it the court addressed for the first time the criteria to be applied for the industrial applicability of biological molecules to be recognised.

Lilly had applied for revocation of HGS Euro(UK) patent EP-B 0939804, which related to a nucleic acid sequence and the protein it encoded which was identified as a novel member of the TNF ligand superfamily of molecules. This new molecule was given the name Neutrokine-a. The nucleic acid and protein were claimed as well as antibodies specifically binding to the protein and pharmaceutical and diagnostic compositions containing the protein or antibodies. HGS had found the new molecule, not by any wet lab technique but purely using bioinformatic tools. The patent attributed to the molecule all the functional properties of other known TNF family members and provided a considerable list of possible pharmaceutical and diagnostic uses on that basis. However, these were mere predictions not supported by any experimental data obtained from in vitro or in vivo studies. Lilly contended that these predictions were wholly speculative and that HGS did not know the biological activity or function of Neutokine-a, the identity of any diseases with which it might be associated and hence the diseases it might be able to treat, at the time it filed the patent application. No utility existed for the invention claimed at the filing date and hence all the claims were invalid for failing to be capable of an industrial application. 

In a very detailed judgement Mr Justice Kitchen agreed with Lilly and found all the claims invalid for lack of industrial applicability. In reaching his decision, great weight was placed on the decisions of the EPO on this point,  as well as the application of the Utility Requirement in the US. Specifically, the Judge held that the application did not provide any sound or concrete basis for recognising that Neutrokine-a could lead to a practical application in industry. Rather it provided sound and concrete basis only for a research project to find out what the molecule actually did and what it could be used for. Its use as a tool to investigate its own activities did not constitute a relevant industrial application.