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8 November 2011
UK Supreme Court endorses EPO approach to industrial applicability of biological inventions
The UK Supreme Court has liberalised the approach to be used by UK courts when assessing the industrial applicability requirement for biological patents under Art. 57 EPC.
In Human Genome Sciences v Eli Lilly, a decision handed down on November 2, 2011, the UK Supreme Court ruled that Human Genome Science's ("HGS") patent EP 0 939 804 did meet the industrial applicability requirement, thereby not only overturning the decisions of the lower Courts, but also providing clearer guidance for future cases as to what should suffice in a biological patent to meet this patentability standard.
Background
Since the use of bioinformatics became popular in the 1990s, the question of "how early can a patent application be filed?", that is always foremost in the minds of biological companies, became that much more difficult. Bioinformatics provides a method for allowing researchers to identify genes (and the proteins for which they encode), by comparing their sequences with previously identified and characterised genes, usually long before any functionality has been identified or proven. The present case involved such an invention, particularly concerning the requirement of Art. 57 EPC that the invention must be capable of industrial application.
In 1996, HGS applied for the patent in question, which related to a novel cytokine, Neutrokine-α. The patent included bioinformatics data on Neutrokine-α, including:
(i) sequence homology, enabling HGS to propose the novel cytokine as a new member of the tumour necrosis factor (TNF) superfamily;
(ii) the tissue distribution of Neutrokine-α; and
(iii) the expression of Neutrokine-α in T-cell and B-cell lymphomas.
Based on this data, the patent described numerous potential functions for Neutrokine-α. However, importantly, the patent included no "wet lab" evidence of any actual functionality.
Litigation History
The patent was granted by the EPO in 2005 and, although revoked during opposition proceedings brought by Eli Lilly, was subsequently held to be valid by the EPO Board of Appeal. The EPO considered that the patent did disclose sufficient functionality for the claimed invention, essentially because Neutrokine-a would be expected to have a similar function to the known members of the TNF superfamily.
Meanwhile, Eli Lilly had brought parallel proceedings against HGS in the UK. In the High Court, Kitchin J revoked the patent, stating that a skilled person would consider the functions of Neutrokine-α as included in the patent to be "..at best a matter of expectation and then at far too high a level of generality to constitute a sound or concrete basis for anything except a research project." HGS appealed this decision to the Court of Appeal, but the Court of Appeal diverged from the previously issued EPO Board of Appeal decision, dismissing the appeal by essentially following and approving the reasoning given by Kitchin J.
The Supreme Court Decision
In the Supreme Court judgment, Lord Neuberger gave the leading judgment and stated that "the question which needs to be decided is whether, as the Court of Appeal held, Kitchin J followed the principles laid down by the [EPO] Board's jurisprudence. If he did, then it seems to me that it would be inappropriate to interfere with his conclusion that the patent did not satisfy the requirements of Article 57, unless the conclusion was one which he could not reasonably have reached. If he did not, then things would stand on a very different footing".
Interestingly, Lord Neuberger then discussed the submissions of the BioIndustry Association ("BIA") who had intervened in the Supreme Court case. The BIA had submitted that if the Supreme Court were to agree with the reasoning of the Court of Appeal, there would be at least a risk that it would "make it appreciably harder for patentees to satisfy the requirement of industrial applicability in future cases" and that this "would cause UK bioscience companies great difficulty in attracting investment at an early stage in the research and development process".
Lord Neuberger also looked closely at the case law of the EPO Board of Appeal on the topic of industrial applicability. He summarised the approach of the EPO in this area in a list of 15 points. This summary is a particularly useful guide for any patent practitioner in the biological field, as it first covers the general principles under Art. 57, then the specific situation where a patent discloses a new protein and its encoding gene, and then the even more specific situation where the protein is said to be a member of a family or superfamily.
Lord Neuberger concluded that the lower Courts had incorrectly applied the principles of the EPO as to industrial applicability. In particular, Lord Neuberger considered that the EPO principle that a "plausible" or "reasonably credible" claimed use, or an "educated guess" can suffice, had not been approached consistently with the jurisprudence of the EPO Board of Appeal. Lord Neuberger also appears to have taken significant cognisance of the BIA submissions, as he stated "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, essentially for the reasons advanced by the BIA".
The next judgment, delivered by Lord Hope, also referred to the intervention from the BIA, suggesting that this Supreme Court decision took into account policy arguments rather than limiting the decision to the specific facts. Lord Walker further stated that "There is nothing that I can usefully add to the reasoning except to repeat that there are two strong policy arguments for allowing the appeal. The first is to reduce the risk of a chilling effect on investment in bioscience (though here the arguments are certainly not all one way). The other is to align this country's interpretation of the European Patent Convention more closely with that of other contracting states. To my mind these considerations justify this Court in taking what would otherwise be a questionable course". Lord Hope also approved the general principle, expressed by Jacob LJ in the Court of Appeal, that "our practice is to follow any principle of law clearly laid down by the TBA", i.e. the EPO's Technical Boards of Appeal.
The remainder of the Court unanimously agreed and ordered that the case be returned to the Court of Appeal for consideration of the remaining issues, none of which are expected to affect the validity of the HGS patent.
Implications
This decision provides a great deal of clarity to biological companies, as it confirms that a plausible role for a claimed invention can suffice for the purposes of industrial applicability, as has previously been held by the EPO. This essentially "lowers the bar" for the requirement of industrial applicability compared to the more stringent requirements sought by the lower Courts. In this decision, the UK law on industrial applicability has been brought into line with that of the EPO.
Moreover, this decision has indicated that, in future, the UK Supreme Court will be inclined to follow the decisions of the EPO Board of Appeal, unless there are strong reasons to differ. Furthermore, the weight given to the policy considerations in this case suggests that such policy considerations may have increasing importance in the mindset of the UK Supreme Court in biological patent matters.
