The Court of Appeal has upheld a decision of the Patents Court (reported in IP News, September 2008) that a patent for a protein identified using bioinformatics techniques and the DNA sequence encoding it, was invalid on the grounds that it lacked industrial application (Eli Lilly v HGS [2010] EWCA Civ 33, 9 February 2010). In doing so, the Court has come to a different decision from the European Patent Office Technical Board of Appeal. However, the Court distinguished the Board’s decision as based on a view of the facts that did not benefit from the level of evidential scrutiny available to the Patents Court. While the decisions of the Board are of key importance to the extent that they concerned legal principles, the courts are not required to respect the application by the Board of the principles to particular facts, which invariably involve questions of degree.
HGS used bioinformatics techniques to identify the nucleotide and amino acid sequences of a new member of the TNF ligand superfamily, which it named Neutrokine-α. The TNF ligand superfamily comprises a group of proteins which act as inter-cellular mediators in a range of immune and cellular responses. The proteins have been identified as potential targets in new treatments for inflammatory diseases. HGS’ patent claimed the protein Neutrokine-α, antibodies to it and the polynucleotide sequence encoding it. The patent taught that Neutrokine-α was structurally similar to TNF and related cytokines, and was believed to have similar biological effects and activities.
An invention is patentable only if it is capable of industrial application (Article 52(1) European Patent Convention). The Court of Appeal endorsed the Patents Court’s test under this rule which required amongst other things that the invention present a sound and concrete basis on which the skilled person could recognise that the invention’s contribution could have a practical application in industry. While the Board had previously held that the invention must be “plausibly shown to be useful” (see ZymoGenetics T-0898/05), this did not lower the test adopted by the Patents Court—‘plausible’ in this context meant that there must be a real likelihood that the invention would be useful; it was not enough that the patent merely made a credible or educated guess as to a real use.
On the evidence before the Court of Appeal, the teaching of the patent failed the Patents Court’s test. Although the postulated uses of Neutrokine-α were scientifically possible, they could not be said to be reasonably plausible; the skilled reader would need to embark on a research programme to identify which, if any, of the protein’s possible uses would work.
According to the Court of Appeal, the Board’s decision resulted from a different view of the facts. The Board’s analysis is questionable. It held that the skilled person would identify Neutrokine-α as useful since they would realise that the description of Neutrokine-α and reports about certain of its characteristics (amongst other things) were the “first essential steps at the onset of research work on the newly found TNF ligand superfamily member”. This seems to fall short of the requirement of ‘sound and concrete basis’.
Under the Patents Court’s approach, it is no bar to patentability that an invention has been found by homology studies using bioinformatics techniques (ZymoGenetics). However, the decision highlights the difficulties that remain for developers seeking to be the first to monopolise specific gene sequences using such techniques.
For further information on this subject or any other IP issues please contact:
Ian Karet, Partner, on +44 20 7456 5800 (ian.karet@linklaters.com)
Alex Batteson, Solicitor-Advocate, on +44 20 7456 5808 (alex.batteson@linklaters.com)
