UK - Eli Lilly v. Human Genome Sciences: Industrial Applicability

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Supreme Court decides that plausible use of a gene sequence meets UK patent law crietria.

The Court delivered its judgement in Eli Lilly v. Human Genome Sciences on gene sequence patenting on 2 November 2011 and has reversed the decisions of the lower courts regarding industrial applicability of a gene sequence.  The decision appears to have been essentially a political one, with a submission by the BioIndustry Association having been influential.

The disputed patent relates to a novel protein, neutrokine-α, identified through the generation of human genome sequence data.  Putative functions for neutrokine-α were ascribed on the basis of its similarity to members of the tumour necrosis factor family of proteins.  However, the members of this family have diverse functions, although they are all involved in the immune system.  The original patent application therefore could not assign a specific function to the protein, and much work was required after filing to determine its precise role.

It was decided that a plausible claimed use, later confirmed by evidence, was enough for industial applicability to be acknowledged in this case.  The decision of the Supreme Court is therefore in line with the earlier findings of the Boards of Appeal at the European Patent Office.  The case is likely now to return to the Court of Appeal for consideration of obviousness and insufficiency.

 
Tagged in: biotech
Katherine is a British and European Patent Attorney. She obtained a BSc in Molecular Biology with French from the University of Manchester. Katherine works on, amongst other things, the patenting of nucleic acid arrays and their use in hybridisation assays, methods of oligonucleotide synthesis, diagnostic tests and treatments for several important diseases, and medical devices.