5 August 2008
In a significant judgment on Thursday 31 July, Mr. Justice Kitchin of the UK High Court revoked a UK patent held by US pharmaceutical company Human Genome Science (HGS) over neutrokine alpha, a member of the ‘tumour necrosis factor’ (TNF) superfamily of proteins found to trigger inflammation in the body (reported by Financial Times). The patent was one of many such patents in relation to genes, proteins and human stem cells issued to biotech companies during the rush to map the human genome that began in the 1990s.
Proteins in the TNF superfamily are involved in a number of cellular activities including immune response, and given that a number of widespread diseases, such as arthritis, asthma and chronic pulmonary disease, are associated with inflammation, the discovery of neutrokine alpha holds valuable potential for pharmaceutical companies. Indeed, HGS had been collaborating with Glaxo-Wellcome to produce lymphostat, an antibody to neutrokine alpha, for the potential treatment of rheumatoid arthritis and lupus, and it was competitor Eli Lilly, also heavily invested in the development of such antibodies, who initiated the challenge against the HGS patent. Subsequent experimental evidence enabled Eli Lilly to demonstrate that the HGS patent had been granted in the absence of sufficient detail regarding the biological function of neutrokine alpha, the conditions it caused or its therapeutic applications, and that it had been based on knowledge of other members of the TNF group of proteins. Mr. Justice Kitchin invalidated the UK patent, ruling that HGS had failed to identify an industrial application for the protein at the time the patent filing was made. The case raises the threshold for intellectual property protection for biotechnological inventions.