Rejecting an appeal by Human Genome Sciences Inc (HGS), the Court of Appeal of England and Wales in Eli Lilly and Co v Human Genome Sciences Inc [2010] EWCA Civ 33 upheld the finding that HGS' patent (as amended) was invalid for lack of industrial applicability. Although consistent with first instance decisions of both the High Court and, in concurrent opposition proceedings, the European Patent Office (EPO), the Court of Appeal's decision was inconsistent with that of the EPO's Technical Board of Appeal (TBA), which had found the amended patent valid. Giving the lead judgment, Jacob LJ stated that on the basis that the assessment of industrial applicability was necessarily a fact-dependent exercise, there was no reason for the higher level of scrutiny in the English system to defer to the EPO. Nonetheless, the principles were the same and, in reviewing the relevant EPO case law, Jacob LJ stressed that the industrial applicability must be plausible and sufficiently precise and that merely stating something has a use as a pharmaceutical without specifying what that use might be was not enough.

THE TECHNOLOGY HGS elucidated the nucleotide sequence of a previously unknown protein, "neutrokine-α". This protein seemed to be part of a known family (the TNF family) of proteins, a group of proteins known to affect the immune system. HGS obtained a patent for neutrokine-α, which was subsequently challenged by Eli Lilly on a number of grounds, including that the patent lacked an industrial applicability.

THE LAW ON INDUSTRIAL APPLICABILITY

In order to be patentable, an invention must be new, involve an inventive step and be capable of industrial applicability (Section 1(1) of the Patents Act 1977, Article 52(1) of the European Patents Convention (EPC)). An invention shall be considered as capable of industrial application "if it can be made or used in any kind of industry, including agriculture" (Section 4 of the 1977 Act; Article 57 EPC), so the requirement for industrial applicability is assessed broadly. Further, the Biotech Directive (Directive 98/44/EC on the legal protection of biotechnological inventions) requires that "The industrial application of sequence or a partial sequence of a gene must be disclosed in the patent application" (R 29(3) EPC; Article 5(3) Biotech Directive).

EPO case law has provided guidance as to what must be disclosed in order to meet this requirement of industrial applicability. In essence, the disclosure must provide an "immediate, concrete benefit" (T 0898/05), be more than a speculative indication of possible objectives that might or might not be achievable by carrying out further research (T 1452/06), and not be so vaguely defined that no practical application or profitable use can be envisaged (T 0898/05). This is assessed as of the filing date of the patent (T 0898/05) and is considered in light of the common general knowledge (T 0604/04).

THE DECISION

The HGS patent disclosed that neutrokine-α could be used to treat a very large number of specific diseases; in some cases these treatments were contradictory in nature. An irony of the case is that HGS has gone on to develop a product based on neutrokine-α for the treatment of lupus, one of the few diseases not mentioned in the patent.

In assessing whether this disclosure was sufficient for HGS' patent to meet the requirement of industrial applicability, the Court of Appeal was first faced with the fact that the TBA had already found the patent valid. Jacob LJ, giving the leading judgment in the case, noted that the UK courts would follow any principle of law clearly set out by the EPO, unless it was clear that "the commodore is steering the fleet on to the rocks". However, the application of those principles to a particular case would often be a question of degree. Where the issue is a matter of degree, courts will disagree, and the English Court could differ legitimately from a decision of the EPO.

In addition, the assessment of industrial applicability was necessarily a fact-dependent exercise and the facts before the different tribunals may well differ. Whereas the English courts adopted an intense fact-finding process, this was not the case in the EPO, where there is generally no disclosure and no crossexamination of witnesses. Again, Jacob LJ saw no reason for the higher level of scrutiny in the English system to defer to that of the EPO.

In reviewing EPO case law to determine those relevant principles, Jacob LJ held that the disclosed industrial applicability must be plausible. This was described as meaning "having a significant degree of likelihood to be true", "having some real reason for supposing the statement is true" and being "reasonably credible", meaning something more than merely not incredible. Jacob LJ also held that the industrial applicability must be sufficiently precise that it would not be enough to state merely that something has a use as a pharmaceutical without doing more to specify what that pharmaceutical use might be.

The Court of Appeal was required to apply these principles to the facts as found by the first instance judge, which included that, the inventors had no idea as to the activity of neutrokine- α, and that it was hard to believe, on the basis of no experimental data, that, neutrokine-α could treat such a diverse range of conditions. The first instance judge further found that the skilled person would have known not only that TNF proteins were involved in immune regulation and an extensive range of diseases, but also that TNF proteins had a wide range of different actions, with there being no disease related to all TNF proteins; and in reality, one was faced with a research programme to see which of the possible uses was real. In light of these findings the Court of Appeal therefore held that there was no disclosure of an industrial applicability which was both specific and plausible. Consequently, the ruling that the patent was invalid for lack of an industrial applicability was upheld.

COMMENT

This is the first case in the United Kingdom to address properly the question of industrial applicability. In doing so, the English courts have adopted the principles drawn from EPO case law; Jacob LJ referred to the need for an industrial application to be specific and plausible, similar to the requirements of the EPO that the industrial applicability not be vague and be more than speculative.

Nevertheless, even though the principles applied were the same, the Court of Appeal reached a different conclusion from that of the EPO. Whilst this might be explained by the different facts placed before the tribunals, Jacob LJ nevertheless commented that he found the finding of the TBA surprising even on the facts as the TBA found them. It therefore seems that even though the United Kingdom and the EPO are applying the same principles, the manner in which they apply them can and sometimes will differ, at least with regard to industrial applicability