EASAC
Realising European potential in synthetic biology | December 2010 | 21
2008) that synthetic biology by encompassing entities
that are discrete and isolable is, in theory, well suited to
commodifi cation, at least by comparison with intellectual
property in systems biology.
In a report on IPR issues more generally, the Royal Society
(2003) also warned of the consequences if patents are
too broad in scope, deterring other researchers, and
recommended that public authorities should make
explicit to their patent offi ces their duty to examine
patent applications appropriately. In the fi eld of synthetic
biology, there is still a concern that groups may gain a
dominant, monopolistic, advantage from broad patents
that then act to deter translation into products of research
by other groups. For example, one US patent granted in
2003 covers ‘chemical synthesis and assembly of genes
and genomes’ that might be construed very broadly
30
.
EASAC reiterates the advice that patent offi ces should be
very careful when being asked to grant broad patents. As
science advances, patent offi ces must learn to apply more
stringent examination of claims for function, novelty and
inventive effort.
Assuming that appropriately delineated and focused
patents are granted, there is growing interest in new
routes to sharing patented information for collective
benefi t. One reduced-cost, approach to sharing patented
information, which is already being used within the
pharmaceutical industry, is the creation of patent pools.
However, there may be practical problems in synthetic
biology for contributors and users of patent pools to
agree on terms in joint agreements that do not exclude
competition and violate anti-trust laws (Henkel and
Maurer 2009).
There may be alternatives to patents, derived from the
models for ownership and open sharing of information
that are used in other industries. The BIOS initiative,
adopted initially for agricultural biotechnology R&D from
IT community practices, is one open source model for
sharing both patented and non-patented technologies
that might be employed as a collaborative mechanism
more widely in the biosciences. In synthetic biology, the
BioBricks Foundation makes its registered regulatory and
structural elements freely available for use. It would be
generally helpful if more researchers donated parts to the
common pool and if public funders linked their support
for research to the obligation to share. One problem with
the BioBricks-based approach, however, is that it is not
necessarily obvious if any of the parts already have rights
attached to them (POST 2008). It will be necessary to
become much clearer about the legal basis of all offerings
within an open source platform if commercialisation is to
proceed. The options for sharing standard biological parts
in synthetic biology based on lessons learned from other
industrial sectors are discussed in detail by Henkel and
Maurer (2009).
From the public policy perspective, it is also worth
noting that patenting is not the only way to control
Table 2 New approaches to collaborative activity in biosciences with features that may serve as models
for synthetic biology R&D
Initiative
Scope
EMBL: European Bioinformatics Institute, EU, 1998
(www.ebi.ac.uk/industry/ind-prog-index.html)
Bioinformatics forum for interaction with users in life
sciences industry, for research and training; aims to maximise
benefi ts from innovation.
Division of Signal Transduction Therapy, University of Dundee, UK,
1998 (www.ppu.mrc.ac.uk/technologies/dstt.php)
Collaboration with pharmaceutical companies who share
rights to exploit certain results while also contributing to
basic research and dissemination of fundamental
knowledge into public domain.
InnoCentive, USA, 2001 (www.innocentive.com)
First global web community for open innovation
marketplace, connecting public and private sectors.
Biomarkers Consortium, NIH–FDA–pharmaceutical sector, USA,
2006 (www.biomarkersconsortium.org)
Biomedical research partnership to develop and validate
effi cacy and safety markers in treatment of disease.
Innovative Medicines Initiative, European Commission-pharmaceutical
sector, EU, 2008 (www.imi.europa.eu)
Pre-competitive research collaboration to tackle bottlenecks
in pharmaceutical R&D.
Health Commons, supported by MIT, USA, 2009
(www.sciencecommons.org/projects/healthcommons)
Virtual marketplace to share data, knowledge, materials and
services to accelerate research.
Sage bionetwork, USA, 2009 (www.sagebase.org)
Seed money from private sources to build integrative, open
access platforms and databases for complex predictive
models of disease. Constitution of this Commons is being
drafted to cover formal standards, rules and rewards.
30
US patent 6,521,427 issued to Egea Biosciences in 2003, cited by May (2009).
22
| December 2010 | Realising European potential in synthetic biology
EASAC
range of other public-private research partnerships,
many of which include signifi cant commitment to open
innovation. Some examples are listed in Table 2, mainly
drawn from biomedical research, to illustrate the range
of initiatives that may serve as potential models for
data sharing in synthetic biology. However, many of
these initiatives still have questions to answer relating
to where the value is created in R&D, and how it should
be rewarded.
development of a fi eld: the creation of standards can
also determine R&D directions. Thus, the interface
between standard setting and IPR may become critical
for synthetic biology policy-making. EASAC encourages
the academies to help to take forward clarifi cation
of the options for freedom to operate in building an
open, standardised, co-operative research environment
while encouraging investment and avoiding infringing
existing rights. Lessons can be learned from a wide