Can Human Proteins be Patented?

The starting point for considering this question is the European Patent Convention, which states, amongst other things, that an invention must be capable of use within an industrial setting in order to attract patent protection. The European Biotech Directive goes further and states that “an element isolated from the human body or otherwise produced is not excluded from patentability”. This is subject to the details of its industrial application being disclosed in the patent application.

In 2008, the High Court ruled that the industrial application of the protein Neutrokine-alpha was not defined in enough detail to merit the award of a patent in favour of Human Genome Sciences. It stated that it would not be of much use beyond a research project. Pharmaceutical company had Eli Lilly opposed the grant.

Neutrokine-alpha belongs to a group of substances known as the TNF ligand superfamily. Human Genome Sciences claimed it would be useful in diagnosing, treating and preventing numerous disorders affecting the immune system. This was based on its inclusion within the TNF ligand superfamily and not because its use had been conclusively demonstrated.

The Technical Board of the European Patent Office ruled a year later that the protein was capable of patent protection, although the Court of Appeal did not share this view and upheld the earlier decision of the High Court. The Supreme Court then ruled in November 2011 that English courts should follow the rulings of the European Patent Office and stressed the importance of doing so where it had ruled consistently across numerous rulings. It stated that the approach to the industrial use of biological material had been consistent and overturned the earlier decision of the Court of Appeal. In particular, it also stated that Neutrokine-alpha’s membership within the TNF ligand superfamily was enough to attract patent protection.

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