Easac'10 sb indd

20    | December 2010 | Realising European potential in synthetic biology 

EASAC

6.4  Intellectual property rights

Patenting is also often viewed as an ethical issue. 

The patentability of biotechnology inventions is 

well established under the European Commission’s 

Biotechnology Directive 98/44/EC and its implementation 

in the European Patent Convention, using standard 

criteria for inventiveness. Exceptions are made for 

inventions contrary to morality. GMOs, microbiological 

processes and products thereof are patentable as a matter 

of principle. However, the morality clauses in European 

Patent Law are diffi cult to interpret and the EGE has 

probably not yet been suffi ciently involved in discussion of 

ethical implications relating to patenting.

The Royal Society report on synthetic biology notes that 

there are unresolved intellectual property rights (IPR) 

issues in synthetic biology with some tension already 

appearing between scientists and their universities 

regarding the potential commercialisation of innovative 

research (for example, in biofuels). Furthermore, the 

magnitude of the resources needed in synthetic biology 

makes private sector participation in basic research 

essential and the private sector can be induced to invest 

only if to some degree it can appropriate the results of its 

research.

The publication by the Royal Academy of the Netherlands 

and the German Statement on synthetic biology identify 

two main problems in IPR protection in synthetic biology:

(1)  overly broad patents may create monopolies, 

hamper collaboration and stifl e innovation by other 

researchers;

(2)  narrow patents may impede subsequent applications 

(for example, to set up a production system using 

standard components) because of the complexity of 

licensing arrangements to deal with multiple patent 

holders (patent thickets).

These challenges were discussed in detail at the 

Berlin meeting and patenting problems may seem 

to be accentuated in synthetic biology because of its 

multidisciplinarity (requiring patent expertise drawn from 

several disciplines), compounded by the complexity of 

products bringing together many defi ned parts and their 

necessary interconnectedness to achieve functionality. 

However, an alternative case can be made (Calvert 

the USA

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. The initiative by the Industry Association 

for Synthetic Biology to develop a global code of 

conduct

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 for DNA sequence screening, customer 

screening and ethical, safe and secure conduct in 

gene synthesis is a welcome step. Co-ordinated 

screening of potential orders requires companies to 

share access to international databases of sequence 

information (with their functional correlates). 

Companies producing synthetic sequences also 

need a national contact point to consult if they 

encounter suspect orders. As noted by the EGE 

(Appendix 2), further discussion is needed to define 

the responsibilities of the European Commission 

and national Competent Authorities in assuring the 

database(s) and acting on suspicious requests so as 

to provide a comprehensive security framework.

However, given the potential range of synthetic 

biology technologies, should control focus only on 

genetics and genomics? A case could be made that 

control is less necessary in a research area such as 

protocells, because the technical difficulty involved 

in such experiments means that they are likely to 

be confined to specialist research establishments. 

Moreover, the more different a synthetic biology 

system is from the natural system, the safer it is likely 

to be, because of the lack of interaction/integration 

with natural organisms. Paradoxically, however, it 

is the most unnatural systems that may be liable to 

provoke the most public concern.

The academies and the scientifi c community more 

generally must be involved in the continuing debate 

to fi nd the right balance between self-governance 

and statutory regulation. In the survey conducted 

by Synbiosafe (Appendix 2, Ganguli-Mitra et al. 

2009), synthetic biology researchers recognised it 

was important to prevent the public backlash that 

undermined agricultural GMO development. Most 

researchers in this survey would opt for a mix of 

international guidelines, national laws and self-

regulation, accompanied by initiatives in education 

and raising awareness. The scientifi c community 

must show leadership in open public debate but few 

synthetic biology researchers judged the ‘civil society 

participatory approach’ as particularly robust or 

feasible or likely to provide the requisite fl exibility to 

avoid the danger of constraining unforeseen advances 

in science and technology.

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A US report prepared by the Craig Venter Institute together with the Center for Strategic and International Studies and MIT 

(‘Synthetic Genomics: options for Governance’, 2007 at www.jcvi.org/research/synthetic-genomics-report) identifi ed three 

main areas for policy intervention:

(1)  Options for fi rms that supply synthetic DNA (including oligonucleotides)—e.g. fi rms must use special software to screen 

orders for potentially harmful DNA.

(2)  Options to regulate DNA synthesisers and reagents—e.g. owners of DNA synthesisers might be required to register their 

machines or be licensed to purchase reagents.

(3)  Options for legitimate users of synthetic genome technologies—e.g. education modules, previous review of experiments.

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‘Code of conduct for best practices in gene synthesis’ at www.ia-sb.eu.

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