For the half-year to 31 December 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Rebecca Gulbul, Lucas Michels and Marie-Andrée Weiss.

Regular round-ups of the previous week's blogposts are kindly compiled by Alberto Bellan.

Wednesday, 2 November 2011

Neutrokine-α appeal allowed: why specify when you can speculate?

The Kat had this brilliant idea for what you get
when you cross 'Neutrokine-a' with 'genome'
Hot off the press and not yet digested, this morning's ruling of the United Kingdom's Supreme Court in Human Genome Sciences Inc. v Eli Lilly and Company [2011] UKSC 51, will be the subject of considerable analysis in the coming days and weeks.  The court, consisting of Lord Hope, Deputy President Lord Walker, Lord Neuberger (who gave the main judgment), Lord Clarke and Lord Collins, allowed HGS's appeal in a decision which has been helpfully summarised by the court's press release as follows:
"BACKGROUND TO THE APPEALS 
Article 52(1) of the European Patent Convention (“the EPC”) provides that, in order to obtain a
European patent, an invention must be “susceptible of industrial application”. Article 57 states that an invention is susceptible of industrial application if it can be made or used in any kind of industry. The primary issue in this case is the way in which the requirement of industrial applicability extends to a patent for biological material. 
The Appellant [HGS] is the proprietor of European Patent (UK) 0,939,804 .... It describes the
encoding nucleotide, the amino acid sequence, and certain antibodies of a new human protein called Neutrokine-α, and includes contentions as to its biological properties and therapeutic activities, as well as those of its antibodies. These contentions are predictions substantially based on the proposition that Neutrokine-α is a member of the THF ligand superfamily. 
The Patent was filed on 25 October 1996 and granted on 17 August 2005. The Respondent brought opposition proceedings in the Opposition Division of the European Patent Office (“the EPO”), following which the Patent was revoked. The Appellant appealed to the Technical Board of Appeal ... of the EPO, which allowed the appeal and ordered that the Patent be maintained.  
Meanwhile, the Respondent [Eli Lilly] brought parallel proceedings in the High Court for revocation of the Patent in the UK. The High Court revoked the Patent, on the basis that, in the light of the common general knowledge, the notional addressee of the Patent (a “person skilled in the art”) would have concluded that the “functions” of Neutrokine-α “were, at best, a matter of expectation and then at far too high a level of generality to constitute a sound or concrete basis for anything except a research project”. This decision was upheld by the Court of Appeal
JUDGMENT 

The Supreme Court unanimously allows the appeal, dismisses the cross-appeal, and remits the case to the Court of Appeal to deal with the outstanding issues. The leading judgments are given by Lord Neuberger [paragraphs 1 to 140] and Lord Hope [paragraphs 141-166], with whom the other justices agreed. 
REASONS FOR THE JUDGMENT 
There is very little UK authority on the topic of industrial applicability, particularly as regards
biological material [37] and [88], and the applicable principles are really to be found in the
jurisprudence of the EPO and the Board [42]. While the reasoning in each decision of the Board is not binding upon national courts, the courts should normally follow the jurisprudence of the EPO, particularly where the Board has adopted a consistent approach to an issue in a number of decisions [84] and [87], as is the case with regard to the application of Article 57 to patents for biological material [88]. [The Kat hopes that national courts might still have some say in whether the Board's decisions are consistent, since this has been a contentious question in the field of computer implemented inventions] Further, there are strong policy reasons for seeking consistency of approach to patents in the biological field, as it is import for bioscience companies to be able to decide at what stage to file for patent protection, and to be able to obtain funding based on patent protection [96-102] and [141-143]. 
Despite the very wide-ranging and generalised suggestions in the Patent as to the uses to which
Neutrokine-α and its antibodies might be put, over and above revealing the existence and structure of the new protein and its encoding gene, the only relevant guidance in the Patent ultimately arises from its teaching as to the tissue distribution of Neutrokine-α, its expression in T-cell and B-cell lymphomas, and the fact that it is a member of the TNF ligant superfamily. 
The question is whether the Judge in the High Court was right, or at least entitled, to conclude that the inferences which would have been drawn from the Patent specification in 1996 would not have been enough to satisfy Article 57 [103]. That conclusion was based on the fact that the Patent neither revealed 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 [104] and [161]. 
That reasoning was not consistent with the approach adopted by the Board, from which a number of general and specific principles may be drawn [106-107]. In light of those principles, the disclosure of the existence and structure of Neutrokine-α and its gene, 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 [109]. This is because all known members of the TNF ligand family 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 [111]. 
The fact that the members of that superfamily were known to have pleiotropic effects is irrelevant where the value of the new member relates to the common features manifested by all known members [112-115]. Neither the Judge nor the Board considered that the unsatisfactory drafting of the Patent would actually have diverted the person skilled in the art from what their search of the literature, coupled with common general knowledge, would otherwise have led them to understand represented the teaching of the Patent [116-118]. The lower courts were wrong to focus on the “speculative” nature of some of the therapeutic uses of Neutrokine-α as disclosed in the Patent, and the degree of extra effort required to determine those uses, when the known activities of the superfamily were enough in themselves to justify patentability for the disclosure of a novel molecule (and its encoding gene) [119-121], [124-128] and [161]. [This presumably gives the green light to speculative drafting]  For the same reason, the Respondent’s argument that the specification of the Patent is insufficient must fail [132-139]. 
The standard set by the Judge for susceptibility to industrial application was a more exacting one than that used by the Board. He was 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 for the purposes of research work [151] and [154], which the Board must be taken to have regarded as an industrial activity in itself [155-156]. 
Notwithstanding the importance of deference to the findings of fact and value judgments of a court of first instance, especially where that decision is confirmed on appeal [94-95], [166], [168-170 and 172], in this case it is evident that the Judge and Court of Appeal failed to follow the principles of law clearly set out by the Board in this and previous cases. The appeal must therefore be allowed".
It isn't over till it's over, notes this member of the IPKat team, who rather suspects that one or more of his colleagues will have something to say on the decision, since the matter has been remitted to the Court of Appeal for a spot of mopping-up.  While he's not quite fighting back the tears, he does rather feel that the High Court and the Court of Appeal were right and that it's the law that's wrong.

Reuters report here

5 comments:

Gentoo said...

"...does rather feel that the High Court and the Court of Appeal were right and that it's the law that's wrong"

I believe, but have not yet researched the archive here, that (degrees of) derision have been heaped on those of us who are unhappy with software patents from a technology perspective, using concepts such as "it's what the law says"

Further, once you start saying "it's the law that's wrong" it seems to me you are standing shoulder to shoulder with Jack Straw and his description of the Belmarsh decision, so undermining the institution of the rule of law.

Bingham might even be turning in his grave.

MaxDrei said...

Correct me if I'm wrong, but what seems to have swayed the noble lords is 1. a letter from the Biotech Industry Association 2.a bunch of T Decisions and 3. a desire to teach the BGH in Karlsruhe how to defer to the EPO.

To that I would add a meme: the thought going around, that it is wrong to give the same protective blanket to both biotech and computer-implemented business method stuff. The former is a baby that needs a warmer blanket, it is vaguely felt, while the latter green shoots will be hardier and more vigorous without a blanket at all. Here's the Supreme Court, conscientiously and considerately wrapping baby bio in a warmer protective blanket.

Mark said...

So they pull Neuberger back up to the Supreme Court (because there are no other chemistry graduates or ex-patents court judges there?), and against the instincts and usual approach of at least 2 of the regular crew of SC justices "as appellate judges", they are collectively persuaded by Neuberger to overturn Jacob and Kitchin.

Not sure whether this is the best way of deciding these cases. It seems to be concentrating judicial power in one man. But perhaps it wasn't too different when Hoffmann was around.

Norman said...

I wonder why the Kat has such a strong intuition that the decision was wrong. Surely the question of how far upstream is too far is an empirical question, on which we have no real empirical evidence; certainly the courts had none in this case, as Lord Neuberger pointed out at [130]. In the absence of evidence on this point, the UKSC turned to the very real if pedestrian virtues of certainty and harmony. That seems to me more sensible than pretending to know where the line should optimally be drawn.

Ron said...

While the UK courts are evidently placing weight on EPO precedents, the EPO itself does not consider itself to be bound by its own precedents [other than those of the Enlarged Board Of Appeal] as it is a code-based system.

Nor does it consider that it has any obligation to refer to precedents in decisions as in Anglo-Saxon jurispridence, see T0910/06 , point 2.6 of the decision [emphasis added]:

2.8 To the extent that the absence in the decision under appeal of any reference to the "established case law" referred to by the opposition division or even to decision T 615/95, invoked by the appellant (see section V, in particular subsections (b).(iii), (vi) and (vii) thereof and section XII.(a) above) is seen in itself by the appellant as a "substantial procedural violation" it must be recalled that unlike some Anglo-Saxon legal systems which are precedent driven, the instances of the European Patent Organisation work within a codified system of law, i.e. the European Patent Convention and its implementing regulations, and are constrained by case law only in the case of decisions handed down by the Enlarged Board of Appeal. Further the ratio decidendi of a decision of a Board of appeal is only binding, in the case of remittal, on the department whose decision was appealed in so far as the facts are the same (Art. 111(2) EPC). It is furthermore clear to the Board from the statement in part 2.3 of the reasons of the decision under appeal that a "more complete summing up of all other unsupported combinations of features claimed in the various requests is not necessary" that the opposition division did not see any reason to go into further detail, e.g. into particular case law in order to justify its refusal of the main request and the first to fourth auxiliary requests.

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