UK: Healthcare: Supreme Court lowers bar for bioinformatics patents

The Supreme Court has unanimously allowed an appeal against a decision of the Court of Appeal 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. The Supreme Court held that the Court of Appeal and the Patents Court had applied too exacting a test in the assessment of this ground of patentability.  While observing that the case was “difficult and troublesome”, Lord Walker explained that there were two strong policy arguments for lowering the bar: to reduce the chilling effect on bioscience investment and to align the UK’s interpretation of the European Patent Convention (‘EPC’) with that of other EPC Contracting States (HGS v Eli Lilly, [2011] UKSC 51, 2 November 2011).

The Court of Appeal’s decision

The appellant 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) EPC). In upholding the decision of the Patents Court that the patent was invalid on the grounds that it lacked industrial application, the Court of Appeal came to a different decision from the European Patent Office Technical Board of Appeal. It 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 were of key importance to the extent that they concerned legal principles, the courts were not required to respect the application by the Board of the principles to particular facts, which invariably involved questions of degree.

The Court of Appeal endorsed the Patents Court’s test under Article 52 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 usable” (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.

The Court of Appeal held that 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.  

The Supreme Court’s ruling

Lord Neuberger and Lord Hope (with whom Lord Walker, Lord Clarke and Lord Collins agreed) rejected the Court of Appeal’s view that the differences between the conclusions reached by the Patents Court and the Board were attributable to the fact that the Board was working on different evidence and was using a different procedure; the trial judge had applied a test which was inconsistent with the principles applied by the Board.

Lord Neuberger set out in detail the general principles to be extracted from the Boards’ jurisprudence on industrial application.  In particular and contrary to the finding of Jacob LJ, he considered that a reasonably credible or educated guess as to a claimed use could satisfy the requirement.

While in some cases it would be obvious that a new member of a superfamily possessed an ‘immediate concrete benefit’ sufficient to support an industrial application because the superfamily was closely knit, there would be other cases where the superfamily consisted of less homologous compounds, so that no effects could be attributed to a new member without experimental data.  This was not the case with the TNF ligand superfamily which lay between the two extremes so that a detailed examination of the facts (without further experiments) was all that was required before it could be concluded that a specific effect could be assigned to a new member.

The Supreme Court endorsed the Board’s conclusion that Neutrokine-α satisfied the test of being “plausibly shown to be usable”, since it was a research tool which could be used to develop methods for the diagnosis and treatment of certain lymphomas; it was not necessary in light of the common general knowledge for a skilled person to undertake a research programme to determine this. Lord Neuberger considered that it was irrelevant that the superfamily members might possess additional differing qualities provided that they had sufficient common features.

The Supreme Court thus also rejected the Patents Court’s finding that the skilled reader would need to embark on a research programme to identify which, if any, of the claimed protein’s possible uses would work.  Provided that the patent advanced a plausible function for the protein, the question of undue burden had to be considered in relation to the making of the protein, adequate instructions for which were, according to the Board, to be found in the specification.

The Patents Court and the Court of Appeal had also wrongly held that it was necessary for the skilled person to be able to identify the role of the ligand in the biology of a particular cell type before the newly discovered molecule could be said to be susceptible of industrial application.  This was inconsistent with the Board’s analysis which identified Neutrokine-α’s role at the broader level of cellular function - a valid basis for an industrial application.

Eli Lilly’s cross appeal that the patent was insufficient failed.  There remain some issues decided by the Patents Court but not considered by the Court of Appeal which the Supreme Court remitted to the Court of Appeal. However, since they went hand-in-hand with the industrial application question, their resolution is unlikely to affect the overall result.

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)