The Supreme Court of the United Kingdom has handed down its first patent decision, over-turning the Court of Appeal's decision to revoke a patent owned by Human Genome Sciences Inc (HGS) covering a nucleotide gene sequence encoding a novel protein, called Neutrokine-α (the Patent). The decision has clarified the 'industrial application' requirement for patentability under English law and has emphasised that it should be interpreted in line with decisions of the European Patent Office (the EPO).
Background to the case
HGS filed the underlying patent application with the EPO in October 1996 and was granted the Patent in August 2005. The claimed invention covers the existence and structure of Neutrokine-α, its amino acid sequence, antibodies to the protein and its membership of the TNF ligand superfamily. The invention was identified using 'bioinformatics' techniques - a computational process which enables researchers to identify genes and proteins by comparing their sequences with previously identified genes. HGS was unable to identify precise activities of Neutrokine-α using this process. However, HGS used existing information about other members of the TNF superfamily to predict the biological properties and therapeutic activities of Neutrokine-α. This led HGS to disclose in the Patent a long list of potential uses of Neutrokine-α in the diagnosis, prevention or treatment of a large number of disorders and conditions.
Eli Lilly and Company (Eli Lilly) commenced opposition proceedings against the Patent in the EPO in June 2008. The EPO revoked the Patent on the basis that the claimed invention constituted a claim to an 'arbitrary member of the TNF ligand superfamily' without a known function (ie. the claims were too general and there was no experimental evidence in the Patent to support any of the contentions). HGS appealed to the Board of the EPO, which subsequently reversed the decision and directed that the Patent be maintained.
Around the same time, Eli Lilly also commenced proceedings in the High Court of England and Wales to revoke the Patent. The trial judge (Kitchin J) revoked the Patent on the basis that HGS had provided no evidence of potential uses for the invention. The trial judge found that the 'functions' of the nucleotide were 'at best, a matter of expectation and then at far too high a level of generality to constitute ... anything except a research project'. Accordingly, it did not amount to sufficient disclosure of an industrial application.
On appeal, the Court of Appeal agreed with the trial judge. Lord Justice Jacob's decision is of particular interest, as he rationalised the reasons for the different outcomes (at that time) in the English Court and the EPO. He noted that the EPO and Courts serve different roles, with the EPO having a more administrative function and the Court proceedings being of a final nature. Additionally, the EPO and Courts have different approaches to evidence and, in this case, they considered different evidence when reaching their decisions.
Supreme Court findings
The central issue for the Supreme Court was whether, in light of the common general knowledge at October 1996, the Patent satisfied the requirement for 'industrial application'. Under Article 57 of the European Patent Convention, an invention is capable of industrial application 'if it can be made or used in any kind of industry, including agriculture'.
The Supreme Court acknowledged that the relevant law to be applied were the principles developed in prior EPO Board decisions. Lord Neuberger, giving the leading judgment, undertook a detailed analysis of the case law in relation to industrial application, which he concluded was consistent on the following principles:
(i) the term 'industry' is to be interpreted broadly, as referring to activities which provide any kind of commercial gain;
(ii) the patent must disclose a 'practical application' and 'some profitable use' for the claimed invention (ie. a 'concrete benefit' to be expected in order for the monopoly to be granted);
(iii) this benefit must be derivable directly from the patent description combined with the common general knowledge;
(iv) a vague and speculative indication as to potential applications that may or may not be achievable will not be sufficient; and
(v) the patent and common general knowledge must enable the skilled person to reproduce or exploit the claimed invention without undue burden.
The Supreme Court was mindful of the strong tension faced by inventors when deciding whether to file a patent application. On the one hand, if an inventor files a patent application early without sufficient evidential data to support the claimed invention, they risk not obtaining the patent and have then disclosed their invention to the public. On the other hand, if an inventor waits until they have further experimental data at hand, they risk a competitor beating them to the patent.
The Supreme Court acknowledged two strong policy arguments in favour of finding that the Patent satisfied the 'industrially applicable' test. They were:
(i) to reduce the risk of a 'chilling effect' on investment in bioscience; ie. a high threshold to satisfy the requirement of industrial application may discourage innovators from investing in research and development; and
(ii) to harmonise the UK's interpretation of the European Patent Convention with that of other European states.
The Supreme Court also noted that where an appellate court is called to consider a case where there are two or more preceding lower court decisions in favour of one party, it is only in rare cases that the appellate court will interfere with their findings. On balance they considered that this was a case where the lower courts' findings should be overturned.
Significantly, the Supreme Court also reconfirmed that, in the interests of harmonisation, European patent law should be followed unless there are strong reasons to differ. That said, the English Courts need not unquestioningly follow EPO decisions, as the Supreme Court acknowledged that 'there has to be room for dialogue between a national court and the EPO'.
Applying these principles, the Supreme Court found that the lower courts had set too strict a standard for 'industrial application' and found that there was sufficient disclosure in the Patent. The Supreme Court therefore (i) allowed HGS's appeal; (ii) held that the Patent satisfied the requirements of Article 57; (iii) dismissed Eli Lilly's cross-appeal on the insufficiency argument; and (iv) remitted the case to the Court of Appeal to deal with outstanding issues.
Impact of the decision
The case has significant implications on the bioscience industry generally and, in the author's view, is likely to receive a mixed reaction. For those patentees owning patents based on bioinformatics techniques and predicted therapeutic uses, the Supreme Court's decision endorsing the lower 'plausible' test for industrial applicability will clearly be welcomed. However, many may view the decision as going too far and potentially opening the floodgates for unduly speculative patents. Lord Justice Jacob, in the Court of Appeal decision, succinctly characterised this concern when he observed that '[you] cannot have a patent for an invention when only years later you or someone else finds out what it is for'.
This is not, however, the end of the case and it remains to be seen how the Court of Appeal determines the other grounds that have been remitted to it by the Supreme Court.
Senior Associate: Dennis Schubauer
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