In 1996, Human Genome Sciences (HGS) patented Neutrokine-a, a previously undiscovered member of the TNF ligand superfamily. HGSidentified Neutrokine-a using bioinformatics rather than wet lab techniques. When sequences are identified in this way, further work is required to elucidate the function and characteristics of the protein. HGS did not know the protein's precise function or characteristics at the priority date of the patent. It therefore set out a list of putative uses in the patent specification, based on known uses of other known members of the superfamily. This list was lengthy, varied and contradictory.
Eli Lilly applied to revoke HGS' patent for lack of industrial application, insufficiency and obviousness. This report focuses on the industrial application ground and touches on Mr Justice Kitchin's findings on obviousness.
Capable of industrial application
Kitchin J explained that an invention must be "capable of industrial application" to be patentable under the EPC and UK Patents Act 1977. If this were not so, the patent system could be used to reserve an unexplored field of research to the patentee. In Kitchin J's words, "A patent is not a hunting licence to find a use for the claimed product. It is a reward for the successful conclusion of the search".
Due to the lack of UK jurisprudence on this point, Kitchin J considered in detail the EPO's approach to "industrial application" and the US "specific" and "substantial" utility test. The requirements of Council Directive 98/44 on the legal protection of biotechnological inventions were also considered.
Kitchin J held that "industry" should be construed broadly. The term includes all manufacturing, extracting and processing activities of enterprises that are carried out continuously, independently and for commercial gain. It also includes those things not done for profit. However, the breadth is not limitless.
Kitchin J then set out the following guidelines which essentially summarise EPO jurisprudence:
- the capability of industrial exploitation must be deliverable by the skilled person from the description read with the benefit of the common general knowledge;
- the description, so read, must disclose a practical way of exploiting the invention in at least one field of industrial activity. That is to say, it must disclose in definite technical terms the purpose of the invention and how it can be used to solve a given technical problem;
- the requirement will not be satisfied if what is described is merely an interesting research result without any specified application. A speculative indication of possible objectives is not sufficient. The patent should not leave the skilled person with a research programme to carry out in order to exploit the invention;
- if a substance is disclosed and its function is essential for human health, the identification of the substance having that function will immediately suggest a practical application. If the function of that substance is not known or is incompletely understood and no disease has been identified which the substance is implicated in, and no other practical use is suggested for it, then the requirement of industrial applicability is not satisfied (even if there is a scientific achievement of considerable merit in the disclosure); and
- it is no bar to patentability that the invention has been found by homology studies using bioinformatics techniques but this may have a bearing on how the skilled person would understand the disclosure.
Kitchin J accepted that HGS's contribution was to find Neutrokine-a and identify it as a member of the superfamily. However, the "extraordinary" disclosure about its predicted function was entirely speculative. It was not possible to predict the function of the protein by looking at the function of the other members of the superfamily. While members of the family had some commonality, they also had disparate or pleiotropic actions. The disclosure, together with the common general knowledge, would not lead the skilled person to an industrial application of the invention without the skilled person undertaking a lengthy research programme. Kitchen J therefore found the patent invalid for lack of industrial application.
Eli Lilly argued that (i) Neutrokine-a was obvious over an Expressed Sequence Tag (EST) which contained part of the Neutrokine-a structure, and which would have allowed the skilled person to create the entire Neutrokine-a structure; and (ii) that the patent contributed nothing to the art.
Kitchen J held that Neutrokine-a was not obvious over the EST. The relevant EST was one of 390,000 ESTs in a database, and there was no reason why the skilled person would investigate that EST over any other. Not only must it be obvious what to do with the prior art,it must also be obvious that it should be done.
The allegation of obviousness over the common general knowledge did succeed. Kitchin J referred to the House of Lords' decision in Connor v Angiotech and its consideration of the AGREVO case before the EPO. Here, simply finding Neutrokine-a was not inventive and there was nothing inventive in the way it was produced. In the absence of any definite intended use the purported invention was obvious.
With most inventions (for example, mechanical inventions), satisfying the industrial applicability requirement for patentability is straightforward. This is not the case with biotech inventions where finding a particular gene sequence may be a scientific breakthrough but an industrial application for that sequence is required for the sequence to be patentable. This may take many further years of research with the possibility that the original scientific breakthrough is left with no protection. In this case, as it turned out, Neutrokine-a is an important therapeutic protein and Eli Lilly is itself investing vast sums of money in trying to bring an anti-Neutrokine-a antibody therapy to market. However, the fact that a prediction turns out to be correct cannot be used to remedy the deficiencies in the patent.
It is also interesting to see the House of Lords' decision in Angiotech being applied. There now appears to be a meeting of minds between the English Patent courts and other key European patent jurisdictions. The correct question to ask in determining whether an invention is obvious is not only whether the skilled person could do the things necessary to move from the prior art to the invention, but more importantly, assuming that he could, whether he would in fact decide to do so, given the other alternatives available to him.
Finally, we are now seeing an important trend in judgments from the English Courts in the life sciences sector. UK judges seem to be accepting the importance of EPO decisions much more. This should provide greater certainty and consistency for patentees across Europe.