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European Biopharmaceutical Review
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Eleanor Root and Patrick Kelleher of
Bird & Bird provide an analysis of the key issues that may arise in
future litigation concerning patents for stem cells
A feature of patent litigation in the English Courts is that it
often produces a wave of cases in a particular technological field
before another field takes over. This was the case with genetic
engineering, surgical stents and mobile telecoms. What field of
technology will feature in the next wave of patent litigation? Many
commentators have their eyes on stem cells where the race is on to
bring new clinical applications to the marketplace and the field is
awash with patents.
As with all of the fields of technology mentioned above, patent
disputes only tend to arise when they are commercially rational – in
other words, when money is to be made by third parties trying to grab a
piece of the lucrative market. We are not yet at this stage with stem
cell technologies but we are not far. For example, ReNeuron (a company
based in Guildford, UK) indicates on its website that it will soon be
recruiting for a Phase I clinical trial of its ReN001 stem cell therapy
for disabled stroke patients. If ReNeuron’s therapy shows promise in
the clinic, we can expect a flurry of activity in the marketplace.
So what are the key issues that may arise in future litigation
concerning patents for stem cells in research and therapies which are
necessarily filed at an early stage of research and development?
MORALITY
On 25 November 2008, the Enlarged Board of Appeal of the European
Patent Office (EBA) ruled on the issue of patentability of stem cell
cultures (1). The case involved a patent application filed by Wisconsin
Alumni Research Foundation (WARF) in 1995, which described a method for
obtaining embryonic stem cell cultures from primates, including humans.
The claims covered human embryonic stem cell (hESC) cultures and it was
accepted that at the filing date of the patent application the only
disclosed starting point for the creation of these hESC cultures was
the use (involving their destruction) of human embryos.
Under European patent law, patent protection is denied to
inventions, the commercial exploitation of which would be contrary to ‘ordre public’
or morality. A fair test is whether the public in general would regard
the invention as to be so abhorrent (rather than merely controversial)
that the grant of patent rights would be inconceivable. The relevant
law provides a specific example: “the use of human embryos for
industrial or commercial purposes”. However, there is nothing which
addresses the patentability of hESCs directly.
In its decision, the EBA held that an invention which necessarily
involves the use and destruction of human embryos cannot secure patent
protection. Such prohibition applies to the invention in the context of
its commercial exploitation rather than being limited to what an
applicant has chosen to explicitly write into the patent’s claims.
Significantly, the EBA clearly stated that its decision was “not
concerned with the patentability in general of inventions relating to
human stem cells or human stem cell cultures.”
In light of this decision, the UK Intellectual Property Office
reconsidered its patent examination practice in the area of stem cells,
which have been isolated from human embryos and processes involving
these cells. The practice note issued on 3 February 2009 indicates the
following:
- Processes for obtaining stem cells from human embryos are not patentable.
- Human totipotent cells (which have the potential to develop into an entire human body) are not patentable.
- Human
embryonic pluripotent stem cells (which do not have the potential to
develop into an entire human body, and which can be grown in culture
and the cell lines stored in cell banks) are patentable provided that
they satisfy the normal requirements for patentability and, at the
filing or priority date, the invention could be obtained by means other
than the destruction of human embryos.
Additionally, the German Federal Court of Justice has recently
referred questions to the Court of Justice of the EU (CJEU), including
one on the interpretation of the term ‘human embryos’ and whether it
includes all stages of development of human life beginning with the
fertilisation of the egg. It remains to be seen whether the CJEU will
take a similarly restricted approach as the EBA. In any event, the
ruling could be determinative of the validity of many applications
claiming the use of human stem cells.
INDUSTRIAL APPLICATION
It is a requirement of patentability under European patent law that
a claimed invention is susceptible to industrial application. For
example, a new chemical cannot be patented unless it has some use, for
example as a pharmaceutical or an intermediate, even though the utility
may not form part of the patent claim. Similarly in biotechnology,
attempts to patent gene or partial gene sequences of unknown or
speculative utility such as expressed sequence tags (ESTs) or single
nucleotide polymorphisms (SNPs) will fall foul of this principle.
The issue of industrial application often arises because of the
inherent tension that exists between, on the one hand, being the first
in the race to file patent applications, while on the other ensuring
that those patent applications contain enough explanatory information
to pass muster. File too late and you may be beaten to the punch by
your competitors. File too early and you may not be in a position to
describe a utility for your invention.
The UK case of Eli Lilly and Co v Human Genome Sciences Inc(HGS) did not relate to stem cell technology but rather to recombinant
DNA and proteins involved in mediating the inflammatory response (2).
Nevertheless, the principles which arose in that case are of direct
relevance to the UK stem cell industry.
The HGS patent application disclosed the nucleotide and amino acid
sequence of a novel member of the TNF ligand superfamily (named
Neutrokine-α). By analysing the nucleotide sequence of a cDNA clone
using bioinformatics, HGS identified the sequence as corresponding to a
new TNF ligand.
The English judge identified several important principles that can
be used to assess the industrial applicability of inventions:
- “‘Industry’ must be construed broadly. It includes all
manufacturing, extracting and processing activities of enterprises that
are carried out continuously, independently and for commercial gain. It
need not necessarily be conducted for profit, and a product which is
shown to be useful to cure a rare or orphan disease may be considered
capable of industrial application, even if it is not intended for use
in any trade at all.
- Industrial applicability must be
derivable by the skilled person from the patent specification read with
the benefit of the common general knowledge.
- The
specification must disclose a practical way of exploiting the invention
in at least one field of industrial activity. Is there a sound and
concrete basis for recognising that the contribution could lead to
practical application in industry? There remains a need to disclose in
definite technical terms the purpose of the invention and how it can be
used to solve a given technical problem.
- The
requirement will not be satisfied if what is described is merely an
interesting research result that might yield an industrial application
that is yet to be identified. A speculative indication of possible
objectives that might or might not be achievable by carrying out
research is not sufficient. Similarly, it should not be left to the
skilled reader to find out how to exploit the invention by carrying out
a research programme.
- The purpose of granting a patent
is not to reserve an unexplored field of research for the applicant,
nor to give the patentee unjustified control over others who are
actively investigating in that area and who might eventually find ways
to exploit it.
- If a substance is disclosed and its
function is essential for human health then the identification of the
substance having that function will immediately suggest a practical
application. But if the function of that substance is not known or is
understood incompletely, 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. This will be the case even though the
disclosure may be a scientific achievement of considerable merit.
- Using the claimed invention to find out more about its own activities is not in itself an industrial application.”
The above principles also highlight the overlap between the legal
requirement of industrial application and that of ‘inventive step’ and
‘sufficiency of description’ (an aspect of the test for inventive step
is that the disclosure in the patent should bring some contribution to
the stock of human knowledge; the test for sufficiency of description
is whether the specification discloses the invention clearly and
completely enough for it to be performed by a person skilled in the art
or in other words that the invention could be put to practical use
without undue effort by the skilled person). There needs to be at least
a real prospect of exploitation as opposed to a purely theoretical
possibility, and this should be derivable from the patent description –
if it is not already obvious from the nature of the invention or from
the background art. The requirements all reflect the basic principle of
the patent system that exclusive rights can only be granted in exchange
for a full disclosure of the invention.
The HGS specification contained mere speculation about how
Neutrokine-α might be useful; it did not teach the skilled person how
to solve any technical problem and its teaching as to the range of
applications of Neutrokine-α, although plausible, was “miles away from
being able to say that any particular use was plausible in the sense of
being taken, by the reader, to be reasonably so. In reality one was
faced with a research programme to see which, if any, of the possible
uses of Neutrokine-α or its antagonists was real.”
It was also noted that the application was filed at a time when the
field was very active and rapid advances were being made in terms of
the public availability of gene sequences and how they might be
searched. HGS had filed its application promptly, perhaps in
anticipation of the discovery of Neutrokine-α by others in the field.
In essence, HGS had “secured broad protection over an unexplored
technical field without providing an adequate compensating benefit to
the public.” It was not relevant that evidence published subsequently
confirmed some of the speculation stated within it (although this was
taken into account by the European Patent Office).
This case illustrates the fundamental drawback of filing broad and
speculative applications at an early stage in the development of a new
invention when it may not be possible to provide the full disclosure
required. It provides a cautionary tale for those looking to file
patents in the rapidly expanding field of stem cell technology where it
may take time to establish enough evidence to confirm any plausible
utility and advantages.
References
- WARF/Stem cells (G2/06)
- [2008] EWHC 1903 (Pat); upheld unanimously by the Court of
Appeal [2010] EWCA Civ 33 9 although conflicting with equivalent EPO
decision T 0018/09
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