In what appears to be the end of a long running legal saga, a ruling by the UK's Supreme Court has found in favour of a patent for a gene and the protein sequence it encodes. Lawyers say that the ruling will make it easier to patent discoveries which do not have a clear demonstrated application, a result that will largely please the private bioscience industry but may alarm many who believe that human genes should not be patentable.
In a case described as 'difficult and troublesome' by Lord Hope, one of the five presiding judges, the patent was found to be valid, quashing two earlier verdicts in lower courts.
In 2005 Human Genome Sciences patented the gene and protein sequence of what they called neutrokine-α after identifying it as a member of the tumour necrosis factor (TNF) ligand superfamily. They also patented antibodies that they produced against the protein. However, it is a requirement of patents that the technology be 'capable of industrial application', meaning that it has to be useful.
The company believed that like other members of the TNF superfamily, neutrokine-α might be involved in cancer, inflammation and the immune system. They therefore suggested these as possible future uses of the product of their research when applying for the patent.
The patent was challenged by pharmaceutical company Eli Lilly on the ground that mere speculation of use was not sufficient. Cases in the High Court and the Court of Appeal both found in favour of Eli Lilly. The case then went to the highest court in England and Wales – the Supreme Court.
In his judgment Lord Neuberger ruled that a 'plausible' or 'reasonably credible' claimed use, or an 'educated guess', is enough to satisfy the need to show 'industrial applicability'. The European Patent Office (EPO) has already made similar judgments and so, Lord Neuberger said, previous judges should have followed earlier EPO guidance on the issue.
During the trial the UK's BioIndustry Association (BIA) warned the judges of the consequences of ruling the patent invalid. They argued this would cause 'great difficulty in attracting investment at an early stage in the research and development process' because it would make it harder to patent their discoveries.
'Just as it would be undesirable to let someone have a monopoly over a particular biological molecule too early, because it risks closing down competition, so it would be wrong to set the hurdle for patentability too high', said Lord Neuberger.
Lord Walker said there were 'two strong policy arguments' for accepting the patent: 'The first is to reduce the risk of a chilling effect on investment in bioscience (though here the arguments are certainly not all one way). The other is to align this country’s interpretation of the European Patent Convention more closely with that of other [European] states'.
The ruling, which sets a precedent for future cases, is considered to favour the UK's private bioscience industry. Commenting on the case, Will James, lawyer at Marks and Clerk solicitors, who was not involved in the case, said: 'The Supreme Court has recognised that patents are the foundation on which research based companies attract funding for further research, and for the development of the fruits of this research into useful technologies and products'.
Human Genome Sciences and GlaxoSmithKline already have a drug on the market based on the patent. Benylysta is a monoclonal antibody against neutrokine-α and is used to treat the autoimmune disease, lupus.