Infringement - Validity of patent - Industrial application

Eli Lilly and Company v Human Genome Sciences Inc: SC (Justices of the Supreme Court, Lords Hope, Walker, Neuberger, Clarke and Collins): 2 November 2011

The patent in suit was European Patent (UK) 0,939,804 (the patent). The patent described the encoding nucleotide, the amino acid sequence, and certain antibodies of a new human protein called Neutrokine-α (Neutrokine), and included contentions as to its biological properties and therapeutic activities, as well as those of its antibodies.

Those contentions were predications substantially based on the proposition that Neutrokine was a member of the THF ligand superfamily. An application for the patent was filed by the defendant in October 1996, and it was granted by the Examining Division of the European Patent Office (the EPO) to the defendant in August 2005. In 2008, the patent was declared invalid by the High Court (see [2008] EWHC 1903 (Pat)).

The central issue had been whether, in light of the common general knowledge at October 1996, the patent satisfied articles 52 and 57 of the European Patent Convention (EPC) so as to enable the defendant to claim the encoding gene for Neutrokine. Article 52 of the EPC provided that an invention could not be patented unless it was ‘susceptible of industrial application’. Article 57 of the EPC went on to state that an invention was susceptible of industrial application ‘if it could be made or used in any kind of industry, including agriculture’.

The judge held that all the claims of the patent were invalid on the grounds, inter alia, that they were not susceptible of industrial application as required by article 57 of the EPC and section 1 of the Patents Act 1977. He found that describing the existence of a protein and its structure was not enough. The function of that protein had to be specified. At the time of the decision the Opposition Division of the EPO had also held the patent invalid, however the Technical Board of Appeal (TBA) of the EPO had since allowed the defendant’s appeal based on certain claims.

It gave its reasons in December 2009, doing so as part of accelerated proceedings in co-operative effort with the national proceedings. The defendant appealed on the basis of the claim as allowed by the TBA. The decision was upheld by the Court of Appeal. The defendant appealed and the claimant cross-appealed.

An issue arose as to whether the judge was right, or at least entitled, to conclude that the inferences which would have been drawn from the patent specification in 1996 would not have been enough to satisfy article 57 of the EPC. The claimant contended that, even if the patent satisfied article 57 of the EPC, it was invalid on the ground of insufficiency. The appeal would be allowed. The cross-appeal would be dismissed.

There had been little helpful domestic guidance as to the application of article 57 of the EPC to patents for biological material. In the light of established authority, the UK patent law should normally follow the jurisprudence of the EPO. Further, while the national courts should normally follow the established jurisprudence of the EPO, that did not mean that the national courts should regard the reasoning in each decision of the TBA as effectively binding.

There would no doubt sometimes be a TBA decision which a national court considered might take the law in an inappropriate direction, misapplied previous EPO jurisprudence, or failed to take a relevant argument into account. In such cases, the court might well think it right not to apply the reasoning in the particular decision. While consistency of approach was important, there had to be room for dialogue between a national court and the EPO. Nonetheless, where the TBA had adopted a consistent approach to an issue in a number of decisions, it would require very unusual facts to justify a national court not following that approach (see [84], [87]-[88] of the judgment).

Despite the very wide-ranging and generalised suggestions in the patent as to the uses which Neutrokine and its antibodies might be put, over and above revealing the existence and structure of the new protein and its encoding gene, the only relevant guidance in the patent ultimately arose from its teaching as to the tissue distribution of Neutrokine, its expression in T-cell and B-cell lymphomas, and the fact that it was a member of the TNF ligand superfamily.

The judge’s conclusion had been based on fact that the patent had neither revealed how Neutrokine could be used to solve any particular problem nor had identified any disease or condition which it could be used to diagnose or treat was fatal to the patent’s validity. The basis upon which the judge had decided the issue had not been consistent with the approach adopted by the TBA from which a number of general and specific principles could be drawn.

In light of those principles, the disclosure of the existence and structure of Neutrokine and its gene sequence, and its membership of the TNF ligand superfamily should have been sufficient, taking into account the common general knowledge, to satisfy the requirements of article 57. That was because all known members of the TNF ligand superfamily were expressed as T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine would be expected to have a similar function (see [97], [103]-[104], [106]-[107], [109], [111] of the judgment).

The patent had satisfied article 57 of the EPC (see [129] of the judgment).

(2) The insufficiency argument went hand-in-hand with article 57. The reason why the judge and the Court of Appeal were wrong to hold that article 57 was not satisfied was the same reason for holding the claim to be sufficient. Accordingly, the patent was not invalid on the ground of insufficiency (see [133] of the judgment). The case would be remitted to the Court of Appeal to deal with the outstanding issues (see [140] of the judgment).

Per curiam: Just as it would be undesirable to let someone have a monopoly over a particular biological molecule too early, because it risks closing down competition, so it would be wrong to set the hurdle for patentability too high. Quite where the line should be drawn in the light of commercial reality and the public interest can no doubt be a matter of different opinions and debate (see [130] of the judgment).

Andrew Waugh QC and Thomas Mitcheson (instructed by Field Fisher Waterhouse) for the claimant; Simon Thorley QC and Michael Tappin QC (instructed by Gilbert) for the defendant.