Patenting Synthetic Life
21 November 2007
On 12 October 2006, The J. Craig Venter Institute filed an
international patent application seeking patent protection
for, among other things:
- various defined sets of genes required for growth and
replication of a free-living organism;
- various defined sets of genes which are in a free-living
organism;
- a method for determining the function of a gene by inserting
that gene into a free-living organism made from any of various
defined sets of genes;
- a free-living organism made from any of various defined sets of
genes;
- a method of hydrogen or ethanol production using a free-living
organism made from any of various defined sets of genes;
- a digital version of the various defined sets of genes.
The Venter application thus claims as inventive (and therefore a
monopoly in) synthetic organisms made from various defined sets of
genes, and further any free-living organism which contains various
defined sets of genes (which need not be synthetically
made).
For an invention to be patentable it must be new (i.e. not
previously publicly disclosed) and involve an inventive step as
judged by a ‘person skilled in the art’ (i.e. a person of ordinary
skill working in the field). It must also be capable of
industrial application and the specification must disclose the
invention in a manner which is clear enough and complete enough for
the invention to be performed by the person skilled in the art
(commonly referred to as the sufficiency test). Finally, the
invention must not be of a type that is excluded from
patentability.
The European Directive on the legal protection of
biotechnological inventions provides that just because an
invention concerns biological material, or concerns a process by
which biological material is produced, does not prevent that
invention from being patentable. Biological material which is
isolated from its natural environment or produced by means of a
technical process may be the subject of an invention even if it
previously occurred in nature.
In addition, the sequence or partial sequence of a gene may
constitute a patentable invention. The Directive excludes a
number of inventions from being patentable including, for example,
the cloning of human beings and the use of human embryos for
industrial or commercial purposes. Micro-organisms such as
bacteria and genes or genetic sequences are, however, patentable
(subject to meeting all the other requirements for
patentability).
In principle, therefore, the Venter application is not excluded
from being patentable in Europe merely because it concerns
synthetically made micro-organisms. There is, however, a
further exclusion from patentability: that commercial exploitation
would be contrary to public policy or morality. This
exclusion was considered by the European Patent Office in the
Oncomouse patent application concerning a genetically modified
mouse that was highly susceptible to cancer. They applied a
balancing test assessing the potential benefits against any
negative aspects and concluded that the usefulness of the invention
outweighed moral concerns. The ETC pressure group has lodged
a request to reject the Venter application on this ground citing a
concern about the potential environmental effect of such inventions
and that they could be used to create bio warfare agents. Dr
Craig Venter has, on the other hand, argued that artificial life
forms could produce solutions to global problems such as providing
bio fuels and reducing the levels of greenhouse gases.
At this stage no preliminary view has been expressed by the
patent examiner as to whether the Venter application meets the
requirements of patentability and whether it is excluded from being
patentable and it is impossible to provide a considered opinion as
to whether the patent is likely to be granted in Europe. One
example where the claims sought may prove problematic is the
inclusion of claims to “functional equivalents” to the sets of
genes identified. This may not satisfy the sufficiency test
if a person skilled in the art identifies a functional equivalent
which cannot be made to perform the invention. Even if a
patent is granted, it can still later face a validity challenge by
third parties often based on different prior art and/or different
arguments.
The Venter application may spur others to file further patent
applications covering similar inventions. The same principles
of patentability will apply to such applications, and anything
disclosed in the Venter application, and since the application was
filed, will be relevant for identifying the state of the art and
whether such patent applications are new and inventive.
If the Venter application is granted, those who want to use the
invention for commercial means will need to obtain appropriate
licences from The J. Craig Venter Institute or risk patent
infringement claims. This has led to the criticism that, if
granted, the patent will have a detrimental effect in the field of
synthetic biology by stifling research and development, but such a
criticism could be made of most patents (wrongly in the authors'
view) and the Venter application is no different in this
respect. There may, however, be ways to circumvent the patent
such that there is no infringement, for example by adding more
genes to take it outside the Venter claims.
There is no doubt that many people will be awaiting developments
on the Venter application with interest on what is proving to be a
highly charged and emotive issue.
For further information, please contact David Knight or Beatriz
San-Martin.