Case Comment: Human Genome Sciences v Eli Lilly  UKSC 51
15 Thursday Dec 2011
In order to be patented, an invention must be “susceptible of industrial application”; this is provided by Art 52(1) of the European Patent Convention (EPC) in relation to a European patent. It requires merely that it can be made or used, in any kind of industry: Art 57 EPC. This provision has rarely given rise to many issues of patentability; the standard example of an invention that would fall foul of this provision is a perpetual motion machine. It all sounds pretty clear-cut.
This case was a rare one that turned on Art 52(1); specifically, it dealt with the industrial applicability in the context of a patent for biological matter. HGS, the appellants, own a European patent describing the amino-acid sequence for a protein called Neutrokine-a, along with the nucleotide sequence coding for it, and some of its antibodies. Neutrokine-a is the member of a particular class of proteins which are generally found to have certain biological and medicinal properties. By extension, the patent made similar assertions about the properties of Neutrokine-a in particular.
An opposition and appeal within the European Patent Office (EPO) led to its Technical Board of Appeal (TBA – last three-letter abbreviation for now!) maintaining the patent. But Eli Lilly simultaneously pursued parallel proceedings in the UK, seeking revocation of the patent on the basis that the assertions as to the effects and functions of Neutrokine-a were speculative, and merely presented the reader of the patent with a research project to go and try out. The High Court agreed: the assertions about the properties of the protein and its antibodies were at “for too high a level of generality to constitute a sound or concrete basis” for their use. The Court of Appeal, in a judgment written by Lord Justice Jacob shortly before his retirement from the bench, upheld Kitchin J’s first instance judgment. Lord Justice Jacob found that the English courts would tend to follow any principle of law laid down by the TBA, but need not accord such considerable respect to its findings on matters of fact and degree. He found that a judge who had the benefit of fuller, cross-examined expert evidence before him might well accord greater weight to his own evaluation than that of the TBA in such factual matters. Accordingly, the Court of Appeal held that there was no difficulty in the fact that the High Court’s finding was at variance with that of the TBA.
The Supreme Court (see Lord Neuberger MR at §§83—95) agreed that the UK court was not bound by the Board, and should not uncritically accept its conclusions. However, in cases where the TBA had followed a consistent approach to an issue in several decisions, then that approach should ordinarily be adopted by the national court (§87). The approach that the TBA had taken in cases relevant to the facts at issue here was distilled into a series of statements listed by Lord Neuberger at §§106ff. The Supreme Court held that Kitchin J, and by extension the Court of Appeal, hadn’t been sufficiently faithful to the considered and consistent approach the TBA had taken, leading to their finding that there was industrial applicability in HGS’s patent. Instead, Kitchin J had applied too stringent a standard in seeking a confirmed use for the matter of the patent, rather than true plausibility.
A further aspect of interest is the role of the interest groups who intervened. The policy reasons seem to have been very important in the Supreme Court’s decision. The BioIndustry Association intervened to the effect that the bioscience industry needed clarity, and needed to know exactly at what stage in the research process they should file their patents. The BIA did not formally attach to either party in the case, but made clear the outcome it desired (Lord Neuberger at §100). It seems that the BIA’s submissions persuaded the Supreme Court, and at the very least they were granted considerable respect. It will be interesting to see if such interventions by interest groups become more common in IP cases of principle.
Stuart is the pupil at Three New Square, the specialist intellectual property chambers of Simon Thorley QC. He is the chair of the Oxford International Intellectual Property Moot and Conversazione.