On 2 November 2011, the UK Supreme Court (formerly the House of Lords) handed down its decision in Human Genome Sciences Inc (HGS) v Eli Lilly and Company (Lilly), which was primarily concerned with the issue of industrial applicability of claimed biological material. The judgment provides some welcome clarification of the level of disclosure required for industrial applicability in this field to be recognised. The full decision can be found at tiny.cc/neutrokine.
In general terms, the Supreme Court summarised that for an invention to be susceptible of industrial application,
- 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";
- a "concrete benefit", namely the invention's
"use ... in industrial practice" must be "derivable
directly from the description", coupled with common general
- a merely "speculative" use will not suffice, so "a vague and speculative indication of possible objectives that might or might not be achievable" will not do; and
- the patent and common general knowledge must enable the skilled person "to reproduce" or "exploit" the claimed invention without "undue burden", or having to carry out "a research programme".
Further more specific guidance on the requirements for industrial applicability where a patent discloses a new protein and its encoding gene, and where the protein is said to be a family or superfamily member, were also provided by the Supreme Court at paragraph 107 of the decision. In summary:
Where a patent discloses a new protein and its encoding
- The patent, when taken with common general knowledge, must demonstrate "a real as opposed to a purely theoretical possibility of exploitation";
- Merely identifying the structure of a protein, without attributing to it a "clear role", or "suggest[ing]" any "practical use" for it, or suggesting "a vague and speculative indication of possible objectives that might be achieved", is not enough;
- The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal;
- A "plausible" or "reasonably credible" claimed use, or an "educated guess", can suffice; Such plausibility can be assisted by being confirmed by "later evidence", although later evidence on its own will not do;
- The requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level.
Where the protein is said to be a family or superfamily
- If all known members have a "role in the proliferation, differentiation and/or activation of immune cells" or "function in controlling physiology, development and differentiation of mammalian cells", assigning a similar role to the protein may suffice;
- So "the problem to be solved" in such a case can be "isolating a further member of the [family]";
- If the disclosure is "important to the pharmaceutical industry", the disclosure of the sequences of the protein and its gene may suffice, even though its role has not "been clearly defined";
- The position may be different if there is evidence, either in the patent or elsewhere, which calls the claimed role or membership of the family into question;
- The position may also be different if the known members have different activities, although they need not always be "precisely interchangeable in terms of their biological action", and it may be acceptable if "most" of them have a common role.
The Supreme Court decision re-aligns the UK standard for industrial applicability with that of the European Patent Office (EPO) by overturning the first instance decision and appeal, which appeared to set a higher standard than at the EPO. The decision will provide reassurance for biotechnology companies and provides helpful guidance to assist those making the decision on when to file a new biotech patent application.
Additionally, the Supreme Court gave a clear direction that UK Courts, whilst not bound by the decisions of the EPO Technical Boards of Appeal (TBA), should align their interpretation of the European Patent Convention (EPC) with that of the TBA particularly in cases where the TBA have issued consistent decisions on an issue.
Unusually, the UK BioIndustry Association (BIA) filed written submissions to the Supreme Court as they were concerned that the first instance and appeal decisions could harm the biotech industry in the UK. The BIA emphasised the importance of patents to the biotech industry and highlighted the difficulty in timing correctly the filing of a biotech patent application: if it is filed too early, the patent application may fail for lack of industrial applicability, whereas if it is filed too late, the patent application may fail through being preempted by competitors' publications or patent applications. Biotech patent applications are often necessarily filed at an early stage when only provisional experimental data are available. These policy issues and the importance of patents to biotech companies were explicitly taken into account by the Supreme Court in reaching their decision. The Supreme Court may also have concluded that a decision that encouraged delays in filing would not have been helpful in the context of the move to a "first inventor to file" system in the US, which places greater emphasis on getting an early filing date.
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