In a case of first impression, the UK Supreme Court held that the requirement of “Industrial Application” was met for a bioinformatics patent claiming the encoding nucleotide and amino acid sequences of the novel human protein Neutrokine-a, overturning the rulings of the Court of Appeal and Patents Court.
In HGS v. Eli Lilly (2011) UKSC 51, the patent at issue claimed sequences for the Neutrokine-a protein, which had been discovered using bioinformatics. Bioinformatics, in general, uses computer programs to compare “unknown” sequences with sequences of previously characterized genes, in order to predict the function of the unknown sequence. Thus, the patent application at issue listed many possible, and sometimes conflicting, activities of the Neutrokine-a protein, but provided no clinical data to support these predictions.
Similar to the “utility” requirement under US law, the UK “Industrial Application” provision requires that an invention be able to be “made or used in any kind of industry, including agriculture”. Due to the lack of substantiating data, the lower courts had found that the industrial application provision was not satisfied, and rather the application could only form the basis for a further research program.
In a stunning reversal, the UK Supreme Court upheld the validity of the patent, holding that disclosure of the existence and structure of Neutrokine-α and its gene sequence, and its membership of the TNF ligand superfamily, taking into account the common general knowledge in the art, was sufficient to satisfy the requirement of industrial applicability. The court was particularly influenced by two factors in its decision. First, the BioIndustry Association intervened and submitted evidence that the UK biotech industry would be negatively impacted if the court set the industrial application bar too high, and followed the decision of the Court of Appeal. Second, the Supreme Court found that the lower courts’ decisions were inconsistent with the EPO Technical Board of Appeal (“Board”), which had previously found the industrial applicability requirement met in a parallel proceeding in the EPO. Although the court indicated that the reasoning of the Board is not binding, they stressed the importance “UK patent law aligning itself, so far as possible, with the jurisprudence of the EPO”. Experts predict that the HGS decision will have a positive impact on the EP biotech industry.
