Sufficient disclosure to satisfy requirements of article 57 EPC regarding “a practical application” and “some profitable use"

Print this page 06-12-2012
IPPT20111102, UKSC, Human Genome Sciences v Eli Lilly

PATENT LAW


Supremacy principles laid down by the Board’s jurisprudence.

 

"94. In these circumstances, the question which needs to be decided is whether, as the Court of Appeal held, Kitchin J followed the principles laid down by the 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."


Sufficient disclosure to satisfy requirements of article 57 EPC regarding “a practical application” and “some profitable use”

 

"109. In those circumstances, it seems to me that, subject to dealing with a number of specific arguments to the contrary, the disclosure of the existence and structure of Neutrokine-α and its gene sequence, and its membership of the TNF ligand superfamily should have been sufficient, taking into account the common general knowledge, to satisfy the requirements of Article 57, in the light of the principles which I have attempted to summarise in para 107 above. Points (viii), (ix) and (x) appear to apply so far as the plausibility of at least some of the claims are concerned, and points (xi), (xii) and (xiii) all appear to be satisfied, given the evidence in relation to the TNF ligand superfamily (and point (xiv) cannot be invoked by Eli Lilly).

 

111. As Lord Hope says at para 152 below, the Board’s conclusion was effectively this, that the disclosure of what was accepted to be a new member of the TNF ligand superfamily (coupled with details of its tissue distribution) satisfied Article 57, because all known members were expressed on T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be expected to have a similar function. This conclusion was supported, or reinforced, by the statement that Neutrokine-α was expressed in B-cell and T-cell lymphomas (referred to in T 0018/09, para 30), and indeed by the interest and effort in the pharmaceutical industry in finding a new member of the superfamily (as explained by Kitchin J at [2008] RPC 29, paras 72-74)."


No different assessment of evidence if one concludes that the disclosure satisfies article 57 in line with Board’s jurisprudence

 

"128. As the Court of Appeal rightly observed, such a conflict is entirely legitimate and understandable, in view of the different evidence, the benefit of cross-examination, and/or the room for difference of opinion between two tribunals. In another case, such a difference in assessment of the evidence could well justify a difference in outcome. But not in this case. Once one concludes that the effect of the Board’s jurisprudence is that, in the light of the common general knowledge, the disclosure of Neutrokine-α as a member of the TNF ligand superfamily (coupled with its amino acid and encoding gene sequences and the tissues in which it is expressed), the claims in relation to the invention’s potential satisfy Article 57. As a result, the relevance of the degree of effort needed in relation to any subsequent work falls away. (The same point undermines Eli Lilly’s reliance on a number of other small differences between the findings of the Judge and the Board on the expert evidence)."


Sufficient disclosure to satisfy article 57 goes hand in hand with sufficiently enabling disclosure

 

"133. Although the Court of Appeal did not consider this point, Jacob LJ did say at the end of his judgment, that he “rather suspect[ed]” that the insufficiency argument “would go hand-in-hand with Article 57” – [2010] RPC 29, para 159. Subject to one point, which turns on the meaning of Claim 1 (as well as some of the other claims), it seems to me that that must be correct. If Claim 1 is simply to the encoding gene of Neutrokine-α, then, subject to any other points which have yet to be decided by the Court of Appeal, the reason why I consider the Judge and the Court of Appeal were wrong to hold that Article 57 is not satisfied is the same reason for holding the claim to be sufficient."

 

General principles Board’s approach in relation to article 57 in relation to biological materials

 

"107. The essence of the Board’s approach in relation to the requirements of Article 57 in relation to biological material may, I think, be summarised in the following points:
The general principles are:
(i) 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” (T 0870/04, para 4, T 0898/05, paras 2 and 4);
(ii) A “concrete benefit”, namely the invention’s “use … in industrial practice” must be “derivable directly from the description”, coupled with common general knowledge (T 0898/05, para 6, T 0604/04, para 15);
(iii) 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 (T 0870/04, para 21 and T 0898/05, paras 6 and 21);
(iv) 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” (T 0604/04, para 22, T 0898/05, para 6); Where a patent discloses a new protein and its encoding gene:
(v) The patent, when taken with common general knowledge, must demonstrate “a real as opposed to a purely theoretical possibility of exploitation” (T 0604/04, para 15, T 0898/05, paras 6, 22 and 31) ;
(vi) 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 (T 0870/04, paras 6-7, 11, and 21; T 0898/05, paras 7, 10 and 31);
(vii) The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal (T 0898/05, paras 21 and 31, T 1452/06, para 5);
(viii) A “plausible” or “reasonably credible” claimed use, or an “educated guess”, can suffice (T 1329/04, paras 6 and 11, T 0640/04, para 6, T 0898/05, paras 8, 21, 27 and 31, T 1452/06, para 6, T 1165/06 para 25);
(ix) Such plausibility can be assisted by being confirmed by “later evidence”, although later evidence on its own will not do (T 1329/04, para 12, T 0898/05, para 24, T 1452/06, para 6, T 1165/06, para 25);
(x) The requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level (T 0898/05, paras 29-30);
Where the protein is said to be a family or superfamily member:
(xi) 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 (T 1329/04, para 13, T 0898/05, para 21, T 1165/06, paras 14 and 16, and T 0870/04, para 12);
(xii) So “the problem to be solved” in such a case can be “isolating a further member of the [family]” (T 1329/04, para 4, T 0604/04, para 22, T 1165/06, paras 14 and 16);
(xiii) 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” (T 0604/04, para 18);
(xiv) 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 (T 0898/05 para 24, T 1452/06, para 5);
(xv) 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 (T 0870/04, para 12, T 0604/04, para 16, T 0898/05, para 27)."

 

IPPT20111102, UKSC, Human Genome Sciences v Eli Lilly

 

[2011] UKSC 51