Out-Law News | 09 Nov 2011 | 10:58 am | 2 min. read
The European Patent Convention says that an invention is only patentable if it is "susceptible of industrial application". The EU's Biotech Directive states that an element isolated from the human body can be protected by a patent, but only if its industrial application is disclosed in the patent.
The High Court ruled in 2008 that the functions of the protein were not clearly defined enough to merit a patent. That ruling said that the functions were "at best a matter of expectation and then at far too high a level of generality to constitute a sound or concrete basis for anything except a research project".
The patent application was made by Human Genome Sciences (HGS) and it was opposed in the UK courts and at the European Patent Office (EPO) by pharmaceutical giant Eli Lilly.
The EPO's Technical Board of Appeal ruled in 2009 that the patent did give enough information about its industrial use to qualify for protection, but the Court of Appeal did not take the same view, ruling in 2010 that the patent was not susceptible of industrial application and so should not be granted protection.
The Supreme Court ruled this month that UK courts should normally follow rulings of the EPO, especially where it has adopted a consistent approach in a number of decisions, as it has done in relation to biological material and industrial applications.
It said that the protein should be patentable based on its "industrial application." Though that was not the only issue before the Supreme Court is was the main focus.
When the patent application for Neutrokine-alpha was filed, the exact function of the protein could only have been predicted by reference to its membership of a family of substances with an established use, the TNF ligand superfamily.
The patent claimed that the protein is potentially useful for the diagnosis, prevention or treatment of a large number of categories of disorders of the immune system. This was based, though, not on evidence but on its membership of that family.
The Supreme Court said that its membership of that family was enough to justify patentability, and that the Court of Appeal had focused too much on the 'speculative' nature of some of the therapeutic uses of the Neutrokine-alpha.
Patent law expert Camilla Balleny of Pinsent Masons, the law firm behind Out-Law.com, said that the ruling would assist legal certainty in the area and underlined the need for consistency of approach between UK courts and the EPO.
"The Supreme Court's approach to this issue focuses on the bringing together of the EPO jurisprudence on this topic and points towards the need for a more general policy decision," she said. "It stops short of making that broader policy suggestion, though, as it did not receive submissions on such wider policy decisions."
"The decision will be of particular assistance in helping companies understand when they should be applying for a patent following research and the discovery of a new protein or gene, though uncertainty will still surround patent applications in relation to material that is not a member of a family with defined qualities or indeed where the qualities of a particular family are not sufficiently predictable." said Balleny.
"The question around the distinction between a discovery and what is capable of being patented remains partially unanswered but this decision does at least give some certainty for circumstances where the discovery is of something that is a member of a family of substances with an established use, at least at a general level," she said.