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Eli vs HGS
25/02/2010
Industrial Applicability: UK Court of Appeal disagrees with EPO
Eli Lilly and Company (Lilly) v Human Genome Sciences (HGS)
Introduction
In 2005 the EPO granted HGS a European patent (EP0939804) relating to the protein Neutrokine.
The patent contained the correct nucleotide and amino acid sequences for Neutrokine-? but the sequences had been obtained only by prediction based on other members of the TNF ligand superfamily using bioinformatic techniques. The patent listed a wide range of activities and uses for the novel protein (and antibodies to the protein) but, again, these activities and uses were pure prediction, based on the properties of other TNF ligand proteins.
EPO proceedings (T0018/09)
EP0939804 was revoked by the EPO's Opposition Division. In contrast, the Technical Board of Appeal (TBA) maintained that an amended form of the patent was valid.
The TBA held that the standard of proof for determining whether or not an invention is industrially applicable is the same as that for sufficiency of disclosure for a patent i.e. that a lack of industrial applicability can only be maintained if there are serious doubts, substantiated by verifiable facts. The TBA concluded that verifiable facts to substantiate the allegations of lack of industrial applicability had not been provided and that, furthermore, post-published evidence on file confirmed the plausability of the uses disclosed in the patent. Thus, the TBA felt that the patent provided a "technical basis for the skilled person to recognise a practical exploitation of the claimed invention in industry".
UK Court of Appeal proceedings
In contrast, the UK Court of Appeal, led by Jacob LJ, recently upheld the UK High Court's finding that EP0939804 was invalid because the claimed invention lacked industrial applicability.
Jacob LJ held that the English Courts should follow legal principles of the TBAs but that the Courts can differ on determination of facts and on questions of degree. Jacob LJ discussed the fact that the EPO "….cannot, need not and does not investigate matters affecting validity as profoundly as a national court can". In the present case, Jacob LJ felt that at least some of the conclusions reached by the TBA were reached because the TBA did not have access to the same level of detailed information that was available to the UK Courts (including the possibility of cross-examining witnesses).
In terms of guidance for assessing whether an invention is industrially applicable, Jacob LJ set out that the disclosure of industrial application in a patent must be "plausible" (meaning there must be some reason for supposing the statement is true) and "sufficiently precise" (meaning you are not left to find out what the use is). On the facts, Jacob LJ did not consider that these requirements had been met in EP0939804.
Jacob LJ also stated that post-published evidence should not be allowed as evidence to establish for the first time or to add to potential industrial application of an invention. Furthermore, Jacob LJ felt that post-published evidence can in fact be a powerful indication that the information in the patent is not itself enough to establish industrial applicability (and it appears that he felt this applied in EP0939804).
Conclusion
This UK judgment makes it clear that patentees must ensure that their EPO and UK patents include clear, non-contradictory industrial applications of an invention in order to ensure validity in the UK. In the life science and chemical fields at least, it is also advisable that the industrial applicability of the claimed invention is supported by data.
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