Download UK Statutory Basis for and Judicial Application of a Utility

UK: Statutory Basis for and
Judicial Application of a Utility
Requirement
Gerry Kamstra
[email protected]
© Bird & Bird LLP 2011
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Statutory basis for requirement of utility
EPC 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"
© Bird & Bird LLP 2011
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Chiron v Organon Teknika - Court of Appeal
[1996] R.P.C. 535
Claims 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.”
© Bird & Bird LLP 2011
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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
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Human Genome Sciences v Eli Lilly
● 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
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
Neutrokine α
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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 Neutrokinea 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.
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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
© Bird & Bird LLP 2011
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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
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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.
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
• 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.
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
Technical 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”
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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)
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
Lord 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)
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
● 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”.
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
Lord 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) ;
© Bird & Bird LLP 2011
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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);
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
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).
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
● 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”.
© Bird & Bird LLP 2011
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Human Genome Sciences v Eli Lilly
● 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."
© Bird & Bird LLP 2011
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Thank you