Utility or Not Utility? – Industrial Applicability in the UK
For an invention to be patentable in the UK, it must involve an inventive step that is
“susceptible” or “capable” of industrial application”.1 This requirement is designed to
ensure that the invention has a real practical application i.e. there must be some use
for which it can be employed. In the ordinary course, the use will be clear from the
invention but in the case of certain industries such as the biotech industry the
position is often not straightforward. The threshold for fulfilling the requirement of
disclosure of industrial applicability in the UK has recently been lowered by the
Supreme Court in Human Genome Sciences (“HGS”) v Eli Lilly2 to bring UK
jurisprudence into line with that of the European Patent Office (“EPO”). In this paper
we consider the UK position before HGS v Lilly as well as the decisions of the
European Technical Boards of Appeal which underpinned the Supreme Court’s
decision.
The UK legislation governing industrial applicability is the Patents Act 1977 which
provides at s.1(1)(c) that a patent may be granted only for an invention which is
“capable of industrial application.” However, the Courts in the key case of HGS v Lilly
applied the corresponding provisions of the European Patent Convention 1973
(“EPC”). Article 52 EPC states “European patents shall be granted for any
inventions, in all fields of technology, provided that they…are susceptible of
industrial application.” Article 57 EPC explains the nature of the Article 52
requirement in 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.”
UK and EPO case law concerning industrial applicability has focussed heavily on
cases involving the biotech sector.
The UK has recognised the possibility of patenting biological material, however, the
position was not harmonised across all Member States and as such, Directive
98/44/EC (the “Biotech Directive”) was adopted. Articles 1 to 11 of the Biotech
Directive were implemented in the UK and came into force on 28 July 2000.
The Biotech Directive recognises that patentability of sequences or partial sequences
of genes is controversial3 but that the grant of a patent for such sequences should be
subject to the same criteria of patentability as applied to all other areas of technology,
including in relation to industrial application. However, the industrial application of
Article 52 EPC 1973
[2011] UKSC 51
3 Recital 22
1
2
a sequence or partial sequence must be disclosed in the patent application as filed.4
The disclosure obligations in respect of industrial applicability and the requirement
of sufficiency of disclosure are inter-related as both provisions oblige the applicant to
provide a sufficient description of the invention.5,6 The way in which the invention is
industrially applicable should be set out explicitly where it is not obvious from the
description of the nature of the invention.7 The level of information required for a
sufficient disclosure will be fact specific and will depend on the nature of the
invention such as whether the invention falls within a well-known technical field and
is based on accepted principles. However, the Board of Appeal has stated that an
objection for lack of sufficiency of disclosure can only be properly founded if serious
doubts were raised substantiated by verifiable facts.8 Recent UK and EPO case law
has considered the level of disclosure which is acceptable to meet the requirement of
industrial application.
The Biotech Directive provides some guidance in relation to the level of disclosure of
industrial applicability that is required in an application but cannot alter the meaning
of Article 57 EPC as it came into force after the EPC. The Biotech Directive states that
“a mere DNA sequence without indication of a function does not contain any
technical information and is therefore not a patentable invention”9. Similarly, a
“simple discovery of an element of the human body including a sequence or partial
sequence of a gene, cannot constitute patentable inventions”.10 However, “an
element isolated from the human body or otherwise produced by means of a
technical process, including the sequence or partial sequence of a gene, may
constitute a patentable invention, even if the structure of that element is identical to
that of a natural element”. In addition, “in order to comply with the industrial
application criterion it is necessary in cases where a sequence or partial sequence of
a gene is used to produce a protein or a part of a protein, to specify which protein or
part of a protein is produced or what function it performs.”11 “The industrial
application of a sequence or a partial sequence of a gene must be disclosed in the
patent application.”12
Industrial Applicability in the UK pre- Lilly v HGS
Recital 22
Article 83 EPC 1973
6 T 18/09
7 Rule 42(1)(f) EPC
8 T19/90
9 Recital 23
10 Article 5(1) Directive 98/44/EC
11 Recital 24
12 Article 5(3) Directive 98/44/EC. Article 5 of the Biotech Directive is directly reflected in EPC Rule 29.
4
5
There is very little UK case law on the scope of the requirement of industrial
applicability. The Judge briefly considered the position in Chiron Corporation v
Murex and Ors13 where the patentee had discovered the HCV virus and had claimed
polypeptides which were useless for any known purpose. In considering the
requirement that the invention must be made or used in any kind of industry so as to
be capable or susceptible of industrial application, the Court held that “industry”
should be construed in its widest sense to include trade or manufacture whether or
not for profit. The Court of Appeal in Chiron distinguished between the first instance
decision where the judge had considered what can be made and used by industry
rather than what can be made and used in any kind of industry.
The question of industrial applicability was also considered pre. Lilly v HGS in
Aeomica’s Application14 by the Divisional Director acting for the Comptroller of
patents. The patent application related to the human ZZAP1 protein. The patent
described similarities between this protein and other known proteins and implied a
role in protein-protein interactions associated with the development of certain types
of cancer. The hearing officer applied the test applied by the United States Patent and
Trademark Office (USPTO) in relation to the requirement that the invention must
have some utility15 and rejected the application on the grounds that the proposed
industrial application was not substantial. The test as applied by the hearing officer
was a four step test:
1. There must be a specific disclosure of a particular condition that can be
diagnosed or treated. A general statement of diagnostic or therapeutic utility
will not be sufficient;
2. The disclosure must be substantial in that a real world use must be described.
Where further research is necessary to confirm a use, it is not substantial;
3. The utility asserted must be credible to the ordinary skilled person who would
accept that the invention is currently available for the described use;
4. The utility must be apparent from the specification alone or taken together
with the knowledge of the person skilled in the art.
Cases of the EPO Technical Boards of Appeal
The EPO Technical Boards of Appeal have considered in a number of decisions the
level of disclosure which is adequate to satisfy the Article 57 EPC requirement of
industrial applicability. The concept of “industry” in Article 57 is very broad and
[1996] RPC 535
BL O/286/05
15 s.101 of the United States Code, Title 35
13
14
extends to all activities carried out “for financial (commercial) gains”.16 The patent
application must disclose a “practical application” so that there is “some profitable
use for which the [claimed] substance can be employed.”17 “Profitable use” should be
construed as meaning “immediate concrete benefit”.18 The invention claimed must
have a “sound and concrete technical basis” such that the skilled person can
recognise that its contribution could lead to practical application in industry.19
The disclosure of a sequence identified by computer assisted studies does not
preclude a new polypeptide from meeting the requirements of industrial applicability
provided a “reasonably credible” suggested application is put forward and the prior
art does not cast significant or serious doubts on the suggested use.20 Provided such
an “educated guess” has been disclosed in the application, later evidence can be used
to confirm this position. Such an application can include uses extrapolated from the
wider family of which the polypeptide is a part. For such a disclosure to reach the
level of disclosure required to fulfil Article 57 EPC there must be:
1. sufficient information disclosed to show that the polypeptide is part of the
family identified. Where a significant structural feature is not identified as
identical in the polypeptide claimed to that of the wider class and no
functional characterisation of the polypeptide is set out, the application does
not sufficiently identify the polypeptide as part of the family. Supplementary
post published evidence can be taken into consideration but cannot be the
sole basis on which the application solves the problem it purports to solve.21
2. sufficient information known about the applications of the wider family.
Where an application claims that the polypeptide disclosed plays an important
role in for example cellular function but the prior art did not attribute clear
functions to the class to which the polypeptide is said to belong, only a vague
and speculative indication of possible industrial application can be gleaned.22
Using the basic scientific activities disclosed as a tool to find out more about
the natural functions about what is claimed itself does not fulfil the
requirement of industrial applicability. However, where it is common general
knowledge that a particular class or superfamily has a particular function, such
as use as mediators of inflammatory response and that the polypeptide as
T870/04
T870/04
18 T898/05
19 T898/05
20 T898/05
21 T1329/04
22 T870/04
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17
structurally characterised shows that it is a member of that superfamily,
industrial applicability may be acknowledged.23
There are a number of broad levels at which the biological function of a protein can
be seen including the biochemical activity of the protein, its function in cellular
processes or the influence of these cellular processes within an organism. Elucidation
of any one of these which may result in an industrial application is sufficient to fulfil
the requirements of Article 57, even where the other levels of function are unknown.24
Eli Lilly v Human Genome Sciences25
European patent (UK) 0,939,804 held by HGS disclosed a nucleotide and amino acid
sequence of a novel member of the TNF ligand superfamily which HGS called
Neutrokine-a. The patent claimed the polypeptide, the nucleotide which encodes it,
antibodies which specifically bind to it and corresponding claims to pharmaceutical
and diagnostic compositions. No in vitro or in vivo data was disclosed in the patent
to support the claims. The description of the activity and uses of Neutrokine-a were a
prediction based on the characteristics of other members of the TNF superfamily.
However, evidence post-dating the filing of the application showed these predictions
to be correct and that Neutrokine-a plays an important role in the development of
autoimmune disease and B-cell cancers. The patent disclosed the existence and
structure of Neutrokine-a, the sequence of encoding DNA, its tissue distribution, its
expression and its membership of the TNF ligand superfamily. The Court had to
decide if these disclosures were enough to satisfy Artiles 52 and 57 of the EPC.
Kitchin J at first instance held that the patent “teaches the skilled person nothing
useful about its [Neutrokine-a’s] activity other than that Neutrokine-a is another
member of the TNF ligand superfamily.” The Judge further held that the “astonishing
range of diseases and conditions” were disclosed and that there was “no data of any
kind to support the claims made.” the skilled person would not consider that
Neutrokine-a could be used in respect of all indications and as such, the disclosure
was speculative. The Judge distinguished between this kind of disclosure and the
disclosure of a gene or protein sequence where the practical application is selfevident, such as insulin.
T604/04
Para. 30 T898/05
25 [2008] EWHC 1903 (Pat)
23
24
The Court of Appeal in HGS v Lilly26 upheld the first instance decision. The Court
expanded on what would constitute “industry” for the purposes of Article 52 EPC and
held that it included all manufacturing, extracting and processing activities of
enterprises that were carried out continuously, independently and for commercial
gain but made clear that this did not have to be directed at making a profit.
The Supreme Court27 overturned the decisions of the Court of Appeal and First
Instance Court and, highlighted the importance of applying the principles of the EPC
in a consistent manner to the Board of Appeal where the Board has taken a consistent
approach to the issue under consideration. Following the EPO case law but not
mandating the decision of the Technical Board of Appeal in case T18/09, the
Supreme Court held that the disclosures of HGS’s patent were sufficient to fulfil the
industrial applicability requirement. The Supreme Court set out the general
principles that the Technical Boards of Appeal had adopted in relation to the
requirements for industrial application under Article 57:
1. There must be a disclosure of a practical application and some profitable use
for the claimed substance where it can be expected to lead to some
commercial benefit;
2. There must be a disclosure of a concrete benefit that can be derived directly
from the description together with the common general knowledge of the
skilled person;
3. A vague and speculative disclosure of possible uses that might or might not be
achievable will not be sufficient;
4. There must be an enabling disclosure such that the skilled person can
reproduce or exploit the invention without undue burden or having to conduct
a research programme. This requirement highlights the close interplay
between sufficiency of disclosure and industrial applicability and sets in
context the Board of Appeal’s position that the standard of proof in respect of
Article 57 EPC should not be a different standard to that for sufficiency.
The Court further summarised the factors to be taken into account where the
invention is a new protein and its encoding gene:28
1. the patent together with the common general knowledge must demonstrate a
real as opposed to a purely theoretical possibility of exploitation;
[2010] EWCA Civ 33
[2011] UKSC 51
28 Para. 102 [2011] UKSC 51
26
27
2. merely identifying the protein without attributing a clear role or suggesting a
practical use is not sufficient;
3. the absence of any experimental evidence is not fatal;
4. a plausible or reasonably credible claimed use can suffice;
5. the plausibility of a claim can be supported by later evidence;
6. the requirements of a plausible and specific possibility of exploitation can be
at the biochemical, cellular or biological level.
The Court also summarised the factors to take into account where the invention is a
new protein and is said to be part of a family or superfamily:
1. if all known members have a role in the proliferation, differentiation and/or
activation of immune cells or a function controlling physiology, development
and differentiation of mammalian cells, assigning a similar role to the new
protein may suffice;
2. if the disclosure is important to the pharmaceutical industry, the disclosure of
the protein sequence and encoding gene may suffice even where its role has
not been clearly identified;
3. if there is evidence which calls the claimed role or membership fo the family
into question, the requirement of industrial applicability on the basis of being
part of the superfamily will not be sufficient;
4. where known members of a superfamily have different activities the
requirement of industrial applicability on the basis of being part of the
superfamily will not be sufficient, although if most of them have a common
role this may be enough.
Although the decision in Lilly v HGS was made in the context of a biotech invention
and was influenced in some part by the submissions of the UK BioIndustry
Association, the policy issues which the Court addressed as to the timing of filing and
the need to incentivise innovation can equally be applied to any innovative industry.
The BioIndustry Association’s submissions to the Supreme Court highlighted the
tension between filing early without data but making an early disclosure of the
invention with waiting to file the application until data has been acquired with the
associated expense but with the risks of competitors filing first. Significant research
and development must be conducted before there can be a therapeutic benefit and as
such, the timing of filing a patent is of some importance. The level of disclosure
required by the Court of Appeal to meet the requirements of industrial applicability
would have required experimental data to be submitted. Such testing would be costly
and raising funding would be difficult without patent protection in place.
In Lilly v HGS the Supreme Court struck a balance between protecting the
investment made by industry with ensuring that sufficient disclosure of industrial
applicability was made to avoid reserving a field of research for an applicant who
discloses an interesting result but then precludes others who have found applications
for that result from obtaining patent protection or exploiting. The Court’s decision
can provide guidance as to the timing of filing in relation to the amount of supporting
data which must be incorporated for the application to have met the requirement of
industrial applicability and not being merely speculative.
Emily Peters
Bird & Bird LLP