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Wednesday, 2 November 2011

Human Genome Sciences v Eli Lilly - A Little More on the SC judgment

The story so far…

Perpetual motion?
That'll be a 'no' then...
The requirement for industrial application appears deceptively simple. The obligation is imposed by the European Patent Convention which, as many readers will be aware, states within Art 52(1) that an invention is only patentable if, among other things, it is “susceptible of industrial application”. Art 57 EPC (from which s4 of the Patents Act 1977 derives in the UK) further explains that “An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture.” For many years this provision had been used to weed out what might be described as some of the wackier products of the inventor’s imagination – the jurisprudence of patent law has been made all the richer by cases such as Thompson’s Application [2005] EWHC 3065, which deals with an invention described in the application as “A means for purveying energy for the future comprising an engine in the form of a contra-rotational drive plate and fan that serves to create a pressure differential above and below drive plate without consuming fuel in the process”. The applicant described it as a “flying saucer”. According to Patten J, the Examiner had rejected it as being “incapable of industrial application because, to put it bluntly, it did not work”, contravening, as it did, both Newton’s third law of motion and the first law of thermodynamics. Still, you can’t blame the inventor for trying…

The dispute in Human Genome Sciences v Eli Lilly is, by comparison, a whole other kettle of fish. As opposed to an application for an impossible invention, HGS were seeking protection for an isolated nucleic acid molecule comprising a polynucleotide sequence encoding a Neutrokine-α polypeptide. This was identifiable and isolatable. It also didn’t contravene the laws of nature - which, as readers will have gathered, is a big plus where patents are concerned. The problem was that having identified it (via a technique known as bioinformatics – described by Lord Neuberger in the Supreme Court’s decision as enabling “researchers to identify genes (and the proteins for which they encode) by comparing their sequences with previously identified and characterised genes”), the patentees were at a bit of a loss to know exactly what it did. They were sure that it was useful for something and, as with those little bits of string that one often finds lurking in desk drawers, they could speculate as to what this use might potentially be but they weren’t entirely sure their predictions would prove to be correct. So, keeping with the string analogy, they picked it up and put it in a special place ready to be pulled out when the state of knowledge caught up with events and a concrete use was revealed. In the meantime they drafted a patent.

The polypeptide in question was identified in the specification as a member of the Tumour Necrosis Factor (TNF) ligand superfamily (imagine a potentially homicidal version of the Waltons and you get the idea), and a long list of its activities and uses was speculated. Critically, there was no actual evidence provided to back this up – all predictions were based on knowledge of other members of the TNF superfamily. At first instance, Kitchin J described ([2008] EWHC 1903) the patent as “speculative” and noted that it contained “extravagant and sometimes contradictory claims”

Mr Justice Kitchin held that the invention failed to comply with Art 57. The Court of Appeal ([2010] EWCA Civ 33) agreed – although for those familiar with Jacob LJ’s oft-expressed irritation with the UK Parliamentary draftsman’s insistence on translating the perfectly intelligible provisions of the EPC into mere shadows of their former self when creating the Patents Act 1977, the comments in [52] are perhaps one of the most striking aspects of the case:
[52] “The British Parliamentary draftsman’s “translation” of “susceptible of industrial application” is “capable of industrial application” (see s.1 of the Patents Act 1977. Although this is “so framed as to have, as nearly as practicable, the same effect as Art 57 (see s.130(7) of the Act)”, “capable” does convey a flavour of concreteness about what the invention must be for. Of course the translation cannot be determinative but is it perhaps a straw in the wind as indicating what one of the parties to the EPC had in mind.”
Rare praise indeed!

However, the Kat digresses.

Taking note of the provisions of the Biotech Directive (99/44 EC), the Court of Appeal considered that:
[57] “The upshot, stated broadly, is that you can patent an isolated gene sequence but only if you disclose the industrial application of the protein for which it encodes. However clever and inventive you may have been in discovering a gene sequence, you cannot have a patent for it or for the protein for which it encodes if you do not disclose how it can be used.”
The information given in the patent concerning the potential effects and uses of Neutrokine-α was considered to be a “mass of mere speculation” ([121]). The Court noted (at [132]) that just because it was known how all members of the superfamily were expressed and that they all played a role in certain mediated immune responses:
[132] “…it by no means follows that any member of the superfamily has a practical use or that the skilled reader would envisage such a use (other than as a speculation) on being told that a new member of the superfamily had been found. You would have to investigate each of them to find out. It is not impossible they would have such a use of some sort, but no more. It is all too speculative to say, on the basis of the information in the patent and common general knowledge that a newly found member of the superfamily is “capable of industrial application.”
So enters the Supreme Court.
As noted by the IPKat earlier today, the Supreme Court handed down its judgment in the case this morning.  The main judgments were given by Lord Neuberger and Lord Hope, which whom the others agreed.

Lord Neuberger summarised the patent as disclosing the following:
[10] “...(i) the existence and amino acid sequence of Neutrokine-α, (ii) the nucleotide sequence of the gene encoding for Neutrokine-α, (iii) the tissue distribution of Neutrokine-α, (iv) the expression of Neutrokine-α by its mRNA (the encoding gene) in T-cell and B-cell lymphomas, and (v) the information that Neutrokine-α is a member of the TNF ligand superfamily."
Noting, as the Judge at first instance had done, that “[t]here is very little authority” on industrial applicability in this jurisdiction, His Lordship turned his attention briefly to the law of utility in the U.S. before focusing firmly on the jurisprudence of the EPO’s Boards of Appeal. Lord Neuberger also echoed the observations of Lord Hoffmann in Biogen v Medeva [1997] RPC 1 concerning the deference that should be made to the findings of those at first instance, explaining further that this:
[93] “…is all the more true of appeals to this court from the Court of Appeal, especially where, as here, there are concomitant findings (i.e. where the Court of Appeal has upheld the trial judge’s findings of fact and value judgments).”
Nevertheless, the Judge’s findings are not necessarily sacrosanct, as was soon made clear.

However, before diving into the issues raised on the facts, His Lordship first turned to what he labelled “Consistency and policy: the wider picture”. Under this heading, Lord Neuberger recounted the intervention of the BioIndustry Association (BIA), which was stated to represent members with an aggregate turnover in 2010 of £5.5 billion. The BIA had argued that if the Supreme Court were to agree with the lower courts’ reasoning on the issues then this would “make it appreciably harder for patentees to satisfy the requirement of industrial applicability in future cases.” Furthermore, that this would result in UK bioscience companies suffering “great difficulty in attracting investment at an early stage in the research and development process”.

BIA accordingly advocated a more relaxed standard of industrial applicability than had been required by the Court of Appeal and the Judge at first instance. However, Lord Neuberger noted that:
[102] “…BIA accepts that it would be wrong in principle to enable applications for patents to be made when the applicant can reveal no more than “a vague indication of possible objectives that might or might not be achievable by carrying out further research”. After all, as the BIA also states, the purpose of the patents system is not “to reserve an unexplored field of research for the applicant nor to give the patentee unjustified control over others who are actively investigating in that area and who might eventually find ways actually to exploit it.”
This aside concluded with, His Lordship then returned to the question of whether the lower courts’ approaches were consistent with the EPO Board of Appeal’s jurisprudence. Lord Neuberger extracted some 15 points which he considered summarised the Board’s approach under Art 57. The points are reproduced at [107] of the judgment: the Kat singles out one or two. Accordingly:
“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” (point iii)
“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” (point vi).
[Notes the Kat: this is slightly more concrete than point iii, but can be read in two ways, either:
Merely identifying the structure of a protein, without:
  1. attributing to it a “clear role”, or
  2. “suggest[ing]” any “practical use” for it, or
  3. suggesting “a vague and speculative indication of possible objectives that might be achieved”,
is not enough”



  1. identifying the structure of a protein, without attributing to it a “clear role”, or “suggest[ing]” any “practical use” for it, or
  2. suggesting “a vague and speculative indication of possible objectives that might be achieved”,
 is not enough”

Having read the judgment a couple of times now, the Kat is reasonably content that Lord Neuberger intended the latter, but elements of the judgment point the other way]
A “plausible” or “reasonably credible” claimed use, or an “educated guess”, can suffice. (point viii)
The Court of Appeal was considered to have erred in relation to its approach to the concept of plausibility:
[122] “…That is well demonstrated by Jacob LJ’s observation at [2010] RPC 14, para 112, that “[i]t is not good enough to say this protein or any antibody to it probably has a pharmaceutical use. Such a statement is indeed plausible, but is of no real practical use. You are left to find out what that use is.” If the statement “is indeed plausible”, then, in the absence of any reason to the contrary, it at least prima facie satisfies the requirements of Article 57 according to the Board.”
Advancing justification for the view that the patent was valid, Lord Neuberger explained that:
[130] “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 and discussed in paras 97-100 above. Quite where the line should be drawn in the light of commercial reality and the public interest can no doubt be a matter of different opinions and debate. However, in this case, apart from the fairly general submissions of the parties and of the BIA, we have not had any submissions on such wider policy considerations.”
Lord Hope, who provided a separate judgment, was in agreement. The issue, he said, was the plausibility of the claims made in the patent concerning the use of the substance in question. The standard adopted by the TBA was not considered to be as high as that which had been demanded by the Court of Appeal:
[151] “…the standard which Jacob LJ was setting for susceptibility to industrial application was a more exacting one than that used by the TBA. He appears to have been looking for a description that showed that a particular use for the product had actually been demonstrated rather than that the product had plausibly been shown to be “usable”.”
Lords Walker, Clarke and Collins agreed, and accordingly the Supreme Court allowed the appeal.

This Kat will inevitably be chewing over this decision for a number of days, but at present he is left pondering a couple of things:

Is Art 57 now effectively dead: A coarse filter for crackpot inventions that contravene the laws of physics, but little more? Surely plausibility is part of all research and development exercises.  If so, this is looking very much like the debate over whether something is obvious to try.

Is the economic argument advanced by the BIA a valid consideration? Surely even if the primary innovation is precluded from patentability because the inventor does not know with any degree of certainty what it may be used for then there is still a possibility for patenting downstream inventions.

Thoughts, as ever, are invited in the comments.


Anonymous said...

Why is the sequence of a naturally-occurring protein, and information pertaining to that naturally-occurring protein, not a discovery (and therefore unpatentable)? If the patent gave information as to its industrial applicability, I can see that it would go beyond being a mere discovery. Given that it doesn't, though, it is difficult for me to understand why it shouldn't be unpatentable.

Tevildo said...

As a non-professional reader, I don't see the issue as completely clear-cut - the invention _is_ "susceptible" of industrial application, it's just that the nature of that application isn't particularized. I can't help but feel that the judgements below were more criticisms of the drafting ("treating cancer to treating worms") than a serious attack on the substantive issue - if HGS had just put "The invention is potentially of use for the treatment or diagnosis of conditions involving the immune system", rather than a comprehensive list of all possible uses, would it have had a smoother ride?

Tevildo said...

Off-topic, but the major enormity of the Supreme Court recently is Rainy Sky v Kookmin, which has (a) definitively knocked contra proferentem on the head, (b) completed the apotheosis of Shoe Lane Parking and established the principle of "contracts mean what the courts think they ought to mean, rather than what they say". But this is irrelevant to the subject-matter of this blog.

SooraJ said...

To my best understanding this case deals with prospective application of "Capable of industrial application". which means that a disease has to be invented in the future else their monopoly is defeated. what is the whole point of it? please advice me.

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