Human Genome Sciences Inc v Eli Lilly & Co1 is the first patent decision to issue from the Supreme Court. The decision overturned the previous findings of the lower courts that Human Genome Science Inc (HGS)'s patent to Neutrokine-α lacked industrial application, and is in line with the European Patent Office (EPO) Board of Appeal's findings in respect of Eli Lilly & Co's attempt to revoke the patent at the European level.
Background
In 1996 HGS filed a patent application directed to a newly identified polypeptide called Neutrokine-α. The EPO granted a patent in 2005 with claims to the protein, antibodies against the protein and genes encoding the protein. Importantly, although HGS had identified the Neutrokine-α sequences, they had performed very little experimental work as to its role and function, or possible uses. The patent application contained information concerning the sequence of the gene and the protein, identified Neutrokine-α (on the basis of its sequence) as being a member of the TNF superfamily of cytokines and described its expression pattern in various tissues, including T-cell and B-cell lymphomas. As noted by Lord Neuberger, the patent also contained a description of the claimed invention as "potentially useful for the diagnosis, prevention, or treatment of an extraordinarily large and disparate number of, sometimes widely expressed, categories of disorders of the immune system, and other conditions and actions, either through Neutrokine-α itself or through its antagonists"2. This description was based on what was already known about the other members of the TNF superfamily. There was no direct experimental evidence to support these uses.
Eli Lilly sought to revoke the patent and in the High Court3 the patent was found to be invalid as it lacked industrial application and inventive step and was insufficient. Kitchen J commented in the decision that "simply identifying a protein is not necessarily sufficient to confer industrial utility upon it. … It may be sufficient if the identification of the protein will immediately suggest a practical application, such as was the case with insulin, human growth hormone and erythropoietin. But if the function of the protein is not known or is incompletely understood and if no disease has been attributed to a deficiency or excess of it, then the position may well be different. In these cases the industrial utility must be identified in some other way."4 The decision was appealed.
The revocation proceedings in the UK continued in parallel with opposition proceedings against the patent at the EPO, in which Lilly was an opponent. Notably, the EPO Board of Appeal ultimately found the patent (in amended form) to be valid5 and its decision was available to the UK Court of Appeal when they decided on the UK appeal. The Court of Appeal, however, declined to follow the EPO's approach, and commented that the different evidence available to the UK courts was responsible for the different outcomes6.
Relevant Law
The provisions of the European Patent Convention (EPC) were referred to throughout the proceedings. Article 52 EPC indicates that to be patentable an invention must be "susceptible of industrial application". Article 57 of the EPC clarifies that an invention is susceptible of industrial application "if it can be made or used in any kind of industry, including agriculture".
The Judgment
It is made very clear that it is in principle undesirable to overturn decisions of the lower courts and that this had been done only with reluctance. It is also made clear that in this case it had been appropriate to follow the jurisprudence of the EPO Boards of Appeal, but that this might not be appropriate in all cases.
Having set this out at the outset, Lord Neuberger provides a detailed analysis of the Boards of Appeal of the EPO's approach to the determination of industrial application of biological materials, noting that there was very little UK case law on this point and also that he believes the approach adopted by the Boards of the EPO to be consistent. In such a case, he advocates following the EPO case law, stating that "it would require very unusual facts to justify a national court not following that approach"7. He further notes that the lower courts had also considered this case law but had reached a different conclusion.
From this detailed analysis Lord Neuberger derives 15 principles which are to be used in the assessment of industrial application in relation to biological material, including the general principles that:
(i) The patent must disclose a practical application and some profitable use for the claimed substance, so that the ensuing monopoly can be expected to lead to some commercial benefit;
(ii) A concrete benefit, namely the invention's use in industrial practice must be derivable directly from the description, coupled with common general knowledge;
(iii) A merely speculative use will not suffice; and
(iv) The patent and common general knowledge must enable the skilled person to reproduce or exploit the claimed invention without undue burden, or having to carry out a research programme.
Further principles are also set out which apply to the specific cases where a patent discloses a new protein and its encoding gene, and where the protein is said to be a new member of a known family or superfamily.
He indicates that it was necessary to determine whether Kitchen J had followed these principles. Whilst he notes that his initial reaction had been that it was inappropriate to interfere with the original judgment, he determines ultimately that Kitchen J had not reached a decision in a manner consistent with these principles.
On the basis of his 15 principles he notes that (subject to dealing with the specific arguments to the contrary, which he duly did) the "disclosure of the existence and structure of Neutrokine-α 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"8. He explicitly refers to some of the principles, including that a plausible or reasonably credible claimed use, or an educated guess, can suffice for Article 57 to be satisfied, and that plausibility can be assisted by being confirmed by later evidence, although later evidence on its own will not do. He comments also that the requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level and that where the protein is a member of a family, as in this case, if all known members have a common role, assigning a similar role to the new protein may suffice to satisfy Article 57.
The specific arguments that had been put to the contrary included the fact that the TNF superfamily had pleiotropic effects, the unsatisfactory drafting of the patent and the fact that the uses of Neutrokine-α were speculative, with no immediate concrete benefit. These arguments were all disposed of, Lord Neuberger noting in particular that neither the Patents Court nor the EPO Technical Board of Appeal had found that the content of the patent was such that it would have actually diverted the addressee of the patent from what they would otherwise have understood from the patent, in the context of both the common general knowledge and the relevant literature. He further notes that this finding was consistent with the evidence that had been presented to him.
Also mentioned by Lord Neuberger was the somewhat unusual intervention filed by the Bioindustry Association (BIA). The BIA had commented that there should be clarity and certainty in this area of law in order for bioscience companies to be able to decide at what stage to file for patent protection, filing too early resulting in disclosure of the invention to competitors, without necessarily obtaining protection, but filing late risking competitors filing an application first. They had submitted that a finding in line with the Court of Appeal would result in a risk that it would be "harder for patentees to satisfy the requirements of Industrial Application in future cases" which would "cause UK bioscience companies great difficulty in attracting investment at an early stage in the research and development process".
Finally, Lord Neuberger considers the Article 83 EPC (sufficiency) point, which he rejects, commenting that the issues of Industrial Application and sufficiency were overlapping and that the claims were directed only to a polypeptide and did not incorporate a provision that the polypeptide had certain activities.
In the other leading speech, Lord Hope again acknowledges the undesirability of overturning the lower courts' findings and comments on the relevance of the BIA intervention. He provides a comparison of some of the findings of the EPO Board and the Court of Appeal and notes that while the Court of Appeal had been working on different evidence and was using a different procedure to the EPO Board, the tests that had been applied in making the UK decisions and the EPO decision were "materially different". In particular he focuses on the apparently different standards used by the EPO Board and the Court of Appeal, the EPO Board requiring Neutrokine-α to have been plausibly shown to be "usable", whereas the Court of Appeal had applied a more exacting standard, in seeking that a specific use for Neutrokine-α had been demonstrated. Specifically in relation to the patent in issue he notes that the EPO Board had found that the technical data in the patent supported a use for Neutrokine-α, whereas the Court of Appeal believed that the patent was "just too speculative to provide anything of practical value other than information upon which a research programme could be based"9. His view is that the differences between the conclusions reached by the UK courts and the EPO Board are attributable to "differences of principle about the amount of information that was needed to show that the invention was susceptible of industrial application"10 and that the correct principles are those laid down by the EPO Board.
Summary and Conclusions
This judgment sets out a clear indication that the UK courts are prepared to follow the EPO case law, and will do so when this is appropriate. In relation to the industrial application of biological material, a summary of the relevant legal principles that should be applied, as derived from the EPO Boards of Appeal case law is set out. As noted at the outset by Lord Neuberger, this case may be of limited wider application, but these principles indicate that the standard for industrial application is not as exacting as had previously been indicated by the Court of Appeal. This should result in a somewhat lower threshold for industrial application being applied in future cases than was indicated in the lower courts and will be welcomed at least by the BIA, whose intervention clearly had an influence on the thinking of the judges. The judges' willingness to consider the issues raised by the BIA intervention, and desire to align the UK's interpretation of the EPC with that of the EPO indicates that policy issues such as these can have a bearing on the outcome of patent cases.
The case has now been remitted to the Court of Appeal, in order for the outstanding issues to be decided on.
Footnotes
1. [2011] UKSC 51
2. paragraph 8 [2011] UKSC 51
3. [2008] EWHC 1903 (Pat), [2008] RPC 29
4. paragraph 230 [2008] EWHC 1903 (Pat), [2008] RPC 29
5. T0018/90
6. [2010] EWCA Civ 33
7. paragraph 87 [2011] UKSC 51
8. paragraph 109 [2011] UKSC 51
9. paragraph 145 [2010] EWCA Civ 33
10. paragraph 165 [2011] UKSC 51
Anna Leathley, Associate
First published in Intellectual Property Magazine, December 2011
