© Bird & Bird LLP 2011page 1 UK: Statutory Basis for and Judicial Application of a Utility Requirement Gerry Kamstra [email protected]

© Bird & Bird LLP 2011

UK: Statutory Basis for and Judicial Application of a Utility Requirement

Gerry Kamstra

[email protected]

© Bird & Bird LLP 2011 page 2

Statutory basis for requirement of utilityEPC and PA 1977

Basis for requirement of industrial application enshrined in Article

52(1) EPC:

“European patents shall be granted for any inventions, in all fields

of technology, provided that they are new, involve an inventive

step and are susceptible of industrial application”

Article 57 EPC (and s. 4 PA 1977) defines industrial application as:

“An invention shall be considered as susceptible of industrial

application if it can be made or used in any kind of industry,

including agriculture”

Section 1(c) UK Patents Act 1977:

…“capable of industrial application"


Chiron v Organon Teknika - Court of Appeal [1996] R.P.C. 535Claims 1 and 11 of the patent were as follows.

1. “A polypeptide in substantially isolated form comprising a contiguous sequence of at least 10 amino acids encoded by the genome of hepatitis C virus (HCV) and comprising an antigenic determinant, wherein HCV is characterised by:

(i) a positive stranded RNA genome;

(ii) said genome comprising an open reading frame (ORF) encoding a polyprotein; and

(iii) said polyprotein comprising an amino acid sequence having at least 40% homology to the 859 amino acid sequence in figure 14.

11. A polypeptide in substantially isolated form whose sequence is shown in any one of figures 1, 3 to 32, 36, 46 and 47, or whose sequence is encoded in a polynucleotide selectively hybridisable with the polynucleotide as shown in any one of figures 1, 3 to 32, 36, 46 or 47.”


Chiron v Organon Teknika - Court of Appeal"It was demonstrated at the trial that the polypeptide resulting from the second part of claim 11 might have nothing to do with HCV as a polynucleotide may selectively hybridise with the polynucleotide as shown in the specified figures without encoding either the virus protein or more importantly the antigenic determinant to the antibodies produced by exposure to HCV…… We accept that the polypeptides claimed in the second part of claim 11 can be made, for as will become apparent from the section of our judgment dealing with insufficiency, it is a routine task to see whether one polynucleotide will hybridise with another. But the sections require that the invention can be made or used “in any kind of industry” so as to be “capable” or “susceptible of industrial application”. The connotation is that of trade or manufacture in its widest sense and whether or not for profit. But industry does not exist in that sense to make or use that which is useless for any known purpose."

© Bird & Bird LLP 2011 page 5page 5

●Patents Court [2008] EWHC 1903 (July 2008)• Lacking in industrial application (Article 57 EPC)• Insufficient• Lacked Inventive Step on "no contribution to the art" basis

alone - Applying T-1329/04 Johns Hopkins University School of

Medicine

●EPO TBA T-0018/09 (OD hearing June 2008, TBA hearing October 2009)• Valid

●Court of Appeal [2010] EWCA 33 (February 2010)• Lacking in industrial applicability• Did not address other grounds

●Supreme Court [2011] UKSC 51 (November 2011)• Not lacking in industrial applicability• Not insufficient

Human Genome Sciences v Eli Lilly



Neutrokine α



EP (UK) 0 939 804

• Discloses full length nucleotide and polypeptide sequence of a novel protein, Neutrokine-α.

• Identified by HGS from proprietary databases using bioinformatics

• Characterised as a new member of the TNF ligand superfamily on the basis of distinct, conserved domains, sequence homology and structural features

• Proteins of this family share certain conserved structural features and have unique AND overlapping functions

• Tissue expression data included in the application

• Specification lists a number of possible applications for the protein, and antibodies raised against it, based on membership of the TNF ligand superfamily and known activities of other TNF ligands– i.e.involvement in immune and inflammatory disorders



Claims (as amended) include inter alia

(i) the nucleic acid sequence of Neutrokine-α

(ii) recombinant vectors containing the sequence

(iii) recombinant host cells containing the sequence

(iv) a process for making Neutrokine-α

(v) Neutrokine-α itself

(vi)antibodies to Neutrokine-α and portions thereof

(vii) pharmaceutical compositions comprising the Neutrokine-α nucleic or amino acid sequence or an antibody to Neutrokine-α or portion thereof and

(viii) diagnostic compositions

But no use claims



Claim 1

1. An isolated nucleic acid molecule comprising a polynucleotide

sequence encoding a Neutrokine-a polypeptide wherein said

polynucleotide sequence is selected from the group consisting of:

(a) a polynucleotide sequence encoding the full length Neutrokine-

a polypeptide having the amino acid sequence of residues 1 to

285 of SEQ ID NO: 2; and

(b) a polynucleotide sequence encoding the extracellular domain

of the Neutrokine-a polypeptide having the amino acid sequence

of residues 73 to 285 of SEQ ID NO: 2.



At the heart of the challenge by Eli Lilly was an assertion that the specification of the Patent fails to describe the activities of Neutrokine-α in a way that is anything more than speculative, in particular that the specification does not have any in vitro or in vivo data to support the predictions about the activities of Neutrokine-α.

Eli Lilly argued that its own independent work on Neutrokine-α (which it called LP-40) confirmed that the therapeutic applications in the patent were speculative; and HGS argued that its work confirmed the predictions in the specification were reasonable



Kitchin J reviewed the lengthy evidence and said that “the limited conclusions ultimately drawn and the amount of work that remains to be done point strongly to the conclusion that the therapeutic and diagnostic applications suggested in the Patent were indeed speculative”.

The UK implementation on 28/7/2000 of Directive 98/44/EC did not apply to the patent (which was applied for in 1996) - it was agreed this made no fundamental change to the applicable principles. Art. 5 (3) requires the industrial application of a sequence or partial sequence of a gene to be disclosed in the patent



The judge carried out a lengthy review of UK, EPO and US decisions on industrial applicability and summarised the relevant factors under 9 headings:●The notion of industry must be construed broadly ●The capability of industrial exploitation must be

derivable by the skilled person from the description read with the benefit of the common general knowledge

●The description, so read, must disclose a practical way of exploiting the invention in at least one field of industrial activity

●There must be a real prospect of exploitation which is derivable directly from the specification, if not already obvious from the nature of the invention or the background art


Human Genome Sciences v Eli Lilly●Conversely, the requirement will not be satisfied if what is

described is merely an interesting research result that might yield a yet to be identified industrial application

●The purpose of granting a patent is not to reserve an unexplored field of research for the applicant

●If the function of a substance is not known or is incompletely understood, and no disease has been identified which is attributable to an excess or a deficiency of it, and no other practical use is suggested for it, then the requirement of industrial applicability is not satisfied

● Using the claimed invention to find out more about its own activities is not in itself an industrial application

●It is no bar to patentability that the invention has been found, as here, by homology studies using bioinformatics techniques



Revoking the patent, the judge said that he was “quite satisfied that the skilled person would consider the Patent does not of itself identify any industrial application other than by way of speculation” and that it was “no answer to say that subsequent research has shown they [the claimed inventions] may be useful to treat diseases associated with particular B cell disorders”.

The claims to "pharmaceutical" and "diagnostic" compositions were also held to be invalid for insufficiency as any such functionalities were not disclosed in the patent.



• HGS appealed on industrial applicability and consequent insufficiency/ obviousness findings.

• Eli Lilly cross -appealed finding of non-obviousness over ESTs and finding of “classic” sufficiency.

• Court of Appeal adjourned UK appeal hearing and asked EPO TBA to expedite and produce a decision within 10 months of OD’s written decision – very fast timetable for EPO.

• TBA agreed to co-operate with English Court of Appeal timeline.

• Patent held valid by TBA and written decision given before the English Court of Appeal hearing.


Human Genome Sciences v Eli LillyTechnical Board of Appeal – T18/09

• Common feature of all members of TNF ligand superfamily is the expression on activated T cells and ability to co-stimulate T cell proliferation

• Skilled person would expect Neutrokine α, as a member of TNF ligand superfamily, to have such effects. No “serious doubts substantiated by verifiable facts”

• Further technical data disclosed in the patent are in line with the expected properties of TNF ligand superfamily members e.g. directing B cell proliferation

• Ample post publication evidence confirming ability to co-stimulate T cell proliferation

• Knowledge of activity of Neutrokine α may represent a valid basis for a possible industrial application in immune diseases

• “Boiler-plate” list of potential applications not detrimental to validity

“In view of the known broad application of possible activities of such a molecule, the skilled person is aware of the fact that the full elucidation of all properties required further investigations which will gradually reveal them”



Lord Justice Jacob said what is required is:

•“Sufficient specification of the function of the protein: Just describing the existence of a protein and its structure is not enough. Nor is it enough to describe the function at a high level of generality – e.g. that the compound must have a significant function biologically and so it ..may be useable to treat some sort of disease. You have to say what it is for with more particularity.” (Para 64)

• “It is not good enough to say this protein or any protein or any antibody to it probably has a pharmaceutical use. Such a statement is indeed plausible, but is of no real practical use” (Para 112)


Human Genome Sciences v Eli LillyLord Justice Jacob considered that TBA’s decision depended on its assessment of facts and was critical of EPO procedure for determining facts (“ a coarse filter”)

He also criticised the standard set by TBA on the agreed facts.

“I confess I do not really see why the mere fact of the T cell activity “may represent a valid basis for a possible industrial application” as the Board held. Nor do I consider that such a test is consistent with settled TBA authority, can fairly be said to provide either an “immediate” or “concrete” benefit or, fundamentally, amount to something which is “susceptible of industrial application”” (paragraph 155)


● Speeches in Supreme Court• Lords Hope, Walker and Neuberger

● Held that Patents Court and Court of Appeal, despite reciting the EPO TBA case law, had misapplied it to the evidence

● Lord Neuberger• [2] Whilst this issue can be said to raise an important question of

principle, its resolution is inevitably fact sensitive and therefore any answer may of limited value in other cases.’

● Provided 15 Propositions derived from EPO case law at [107] [see post]

● Referred to BIA Amicus Brief @ [96] to [102] suggesting at [100] that• "if we agree with the reasoning of the Court of Appeal there is at least a

risk that it will “make it appreciably harder for patentees to satisfy the requirement of industrial applicability in future cases.” If that were so, it is suggested that this “would cause UK bioscience companies great difficulty in attracting investment at an early stage in the research and development process”.



Human Genome Sciences v Eli LillyLord Neuberger summarised principles from the EPO Boards as follows:

(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) ;


Human Genome Sciences v Eli Lilly(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, T0640/04, 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);


Human Genome Sciences v Eli LillyWhere 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).


● Specific criticisms of the Court of Appeal approach: • Lord Neuberger @ [122] "… In particular … the Court of Appeal

did not approach the concept of plausibility consistently with the jurisprudence of the Board. That is well demonstrated by Jacob LJ’s observation … at 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."

• Lord Hope @ [151] "I think that there are indications in these passages that 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”.



●Grudging concurrence• Lord Walker @ [171]. "Nevertheless the powerful and

sustained analysis and reasoning in the judgments of Lord Hope and Lord Neuberger has persuaded me, against my inclination, that this appeal must be allowed. There is nothing that I can usefully add to their reasoning, except to repeat that there are two strong policy arguments for allowing the appeal. The first is to reduce the risk of a chilling effect on investment in bioscience (though here the arguments are certainly not all one way). The other is to align this country’s interpretation of the European Patent Convention more closely with that of other contracting states. To my mind these considerations justify this Court in taking what would otherwise be a questionable course."


Thank you

Documents

© Bird & Bird LLP 2011page 1 UK: Statutory Basis for and Judicial Application of a Utility Requirement Gerry Kamstra [email protected]