UK Supreme Court clarifies EU ‘industrial applicability’ test for new gene patents
Human Genome Sciences, Inc. v Eli Lilly and Company  UKSC 51 (2 November 2011)
A recent decision of the UK Supreme Court has provided important guidance on the level of disclosure required in relation to the specific therapeutic role of a new gene or protein in order to satisfy the European industrial application threshold for patentability.
The court held that a patent for a new gene satisfies the industrial applicability threshold without including actual experimental evidence of a specific therapeutic role, if sufficient information is provided in the patent application, when common general knowledge is taken into account, to show that it is plausible that a profitable use could be identified. This decision brings the UK in line with Europe where it is accepted that “plausible” speculation is sufficient and provides clarity for applicants in the biological field operating in the UK market to be able to decide at what stage to file a patent application in order to secure funding.
The key issue for determination
The primary issue at hand was the interpretation of the requirement for industrial applicability under Article 57 of the European Patent Convention (EPC) (which requires that an invention must be ‘susceptible of industrial application’, i.e. it can be made or used in any kind of industry) in relation to patents for biological materials.
Lower courts: the patent disclosed no industrial applicability
The case was an appeal from the decision of the UK Patents Court1 and Court of Appeal2 which revoked the patent held by Human Genome Sciences (HGS). The patent describes a newly identified gene referred to as Neutrokine-α3 and the patent was revoked on the basis that it neither disclosed how Neutrokine-α could be used to solve any particular problem nor identified any disease or condition which it could be used to diagnose or treat and, therefore, did not satisfy the requirement of industrial applicability. This is despite The Technical Board of Appeal of the European Patent Office (EPO) finding that the European patent did satisfy the Article 57 requirements and upholding an appeal to the revocation of the patent which had occurred during EPO opposition proceedings4.
The patent did not provide experimental data demonstrating a particular medical use for the gene but described its tissue-distribution, expression in T-cell and B-cell lymphomas and listed a number of potential therapeutic applications based on bioinformatics data. This data placed the gene in the Tumour Necrosis Factor (TNF) ligand superfamily of cytokines, which have well understood effects as mediators of inflammation and the immune response.
In the UK High Court Justice Kitchin held that the applications suggested for Neutrokine-α were “at best, a matter of expectation and at far too high a level of generality to constitute a sound or concrete basis for anything except a research project”. He concluded that simply identifying a protein was not sufficient to confer industrial applicability.
UK Supreme Court upholds appeal
Focusing on Article 57 and using the Biotech Directive (99/44EPC) and relevant decisions of the EPO Technical Boards of Appeal (TBA) to interpret it, the five judges of the Supreme Court unanimously upheld the TBA ruling that Article 57 of the EPC does not require patent applications for new genes to provide evidence of clinical tests in order to show industrial application.
The Court concluded that the High Court had set too high a standard in looking for a description that showed a particular use of the gene had been demonstrated and that the High Court was wrong in focusing on the ‘speculative’ nature of the therapeutic uses of the gene when the well known and common activities of the superfamily were enough to justify patentability. This was particularly the case in view of the consistent approach to industrial applicability of biological materials taken by the TBA.
The Court noted that clarity and consistency of approach is especially important in the bioscience industry, which is particularly dependent on funding for long term research and development. Bioscience companies need to be able to decide at what stage to file for patent protection, and to be able to obtain funding based on patent protection.
- While decisions of the TBA are not binding on National courts, the jurisprudence of the EPO should be followed where the board has adopted a consistent approach to an issue.
- Lord Neuberger provided a useful summary on the general principles to consider in relation to the requirements of Article 57 with respect to biological materials, noting that5:
- 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. Such a benefit should be concrete, i.e. derivable directly from the description coupled with common general knowledge – speculative indications will not do. Together the patent and common general knowledge must enable the skilled person to reproduce the invention without undue burden or having to carry out additional research.
- Where a patent discloses a new protein and its encoding gene, the patent, taken with the common general knowledge, must demonstrate a real, as opposed to a purely theoretical, possibility of exploitation. Merely identifying a protein without suggesting a practical use for it, is not enough. Lack of experimental evidence is not fatal; a plausible or reasonably credible use can suffice, and can be assisted by being confirmed by later evidence (although later evidence on its own will not be sufficient).
- If the protein is a member of a family or superfamily where all known members have a known role, assigning a similar role to the protein may suffice; unless there is evidence which calls the claimed role into question and/or known members have different activities. The problem to be solved, may in some cases be isolating a particular member of a family.
- If the disclosure is important to the pharmaceutical industry, the disclosure of the sequences of the protein and its gene may suffice even if its role has not been clearly defined.
Implications for patentees
This decision has important implications for the biotechnology industry operating in the European market and particularly in the UK:
- If a new potentially biologically active protein is discovered a patent can be legitimately applied for at an early stage in the research process and need not be delayed until experimental data demonstrating its therapeutic utility is obtained, provided that the patent when taken with the common general knowledge, demonstrates a real as opposed to a purely theoretical possibility of exploitation.
- The decision also confirms that UK courts should generally follow well established EPO case law which has been previously applied consistently, thus providing greater certainty as to the tests that will be applied against a UK national phase application.
- It must be emphasised that as identified by Lord Hope in the decision – whether or not a known effect can be assigned to a particular new gene product on the basis of its ‘membership’ within a known family will be examined on a case-by-case basis6. Applicants must, therefore, ensure that there is at least sound basis for arguing a “potential” therapeutic application when choosing to file without specific experimental data.
-  EWHC 1903 (Pat)
-  EWCA Civ 33
- European Patent (UK) 0,939,804
- Human Genome Sciences, Inc. v Eli Lilly and Company  UKSC 51, para 107
-  UKSC 51, para 148.