Affiliated staffMaureen O'Malley (egenis), Adam Bostanci (Egenis PhD), Steve Hughes (Egenis)
The question which initiated this project was: what difference does genomics make to patenting? Gene patenting is a familiar phenomenon, but do we see a difference from the perspective of genomics, which takes the whole genome into account instead of just the single gene? We pursued this question by investigating five different and interrelated topics.
- Gene function from a genomic perspective: An assumption in patenting is that a gene is a chemical compound which has only one function. Genomics shows that gene function is more complex because many different genes can be involved in one biological function, and a single gene can have many different functions. This makes gene function a topic that is well-suited to the study of patenting from a genomic perspective.
- The patenting of genomic information: Genomic information is one of the most important outputs of genomics, so its patentability is an important issue. This relates to the study of gene function because in computational form, genomic information acquires new functions (for example, genomic databases can be compared).
- The patenting of whole genomes: A third strand of investigation is the patenting of genomes as opposed to genes. Genome patenting has received relatively little attention (Venter’s 2007 application being a recent exception). The study of genome patents overlaps with the study of informational patents, since in a patent a whole genome is represented in computational form. This topic raises questions about the importance of scientific concepts such as ‘genome’ in the day-to-day activities of patent examining.
- Patenting in the emerging life sciences: Genomics shows that gene function is complex. Systems biology extends this further by drawing attention to the complexity of the interactions of different types of molecule in biological systems. We may well see attempts in the future to patent computer-embodied representations of complex biological systems.
- Ownership regimes in the biosciences: Developments in the life sciences give rise to the question of how IP regimes should be organised in the context of new kinds of objects of study in the biosciences. Dynamic computational models in systems biology are perhaps suited to different ownership regimes from static objects. In synthetic biology, in contrast, interactive biological systems are divided up into parts which are substitutable. Life is made more machine-like, and more suited to patentability (although synthetic biology’s modularity also fits well with open source principles).
These five different strands all focus on the interaction of IP law with the objects of study in genomics and the emerging biosciences, objects which are constantly being re-conceptualised in scientific practice.
- Does genomics (as opposed to genetics) change our ideas about what is useful and what can be patented?
- Are the appropriate objects of IP in genomics biological objects or genomic information?
- How does the notion of a ‘genome’ figure in patent applications?
- How are the new objects of study in the emerging biosciences being dealt with by existing intellectual property regimes?
- What will be the consequences of the appropriation of interconnected models in systems biology?
- Should the emerging biosciences lead us to re-think existing ownership regimes?
- Document analysis, including the examination of patenting guidelines and selected gene and genome patents.
- Examination of patent file-wrappers (the written exchanges between patent attorneys and patent examiners)
- Semi-structured interviews with representatives of various groups involved in genomics and patenting in the UK, including scientists in universities and companies, technology transfer officials, patent attorneys, patent examiners and policy makers.
Gene function from a genomic perspective:
- Genomics shows that genes always work in a genomic context, so trying to patent an isolated function of a single gene becomes problematic
- Scientific changes are leading to new understandings of the kinds of entity that can be patented, but law often lags behind these developments
The patenting of genomic information:
- The simultaneously material and informational nature of DNA is exploited in patenting
- There is a move in genomic patenting away from biochemical tools and products towards information resources
The patenting of whole genomes:
- The notion of a ‘genome’, and the ways in which it may be different from a ‘gene’, plays no role in patent practice
- Patent examiners do not object to the patenting of complete genome sequences per se, instead, their objections are based on classification, rules and procedure
Patenting in the emerging life sciences:
- Patenting may bifurcate to cover the computer-based tools produced by systems biology and the material objects produced by synthetic biology.
- In synthetic biology scientists are re-building life in a way which fits with existing understandings of intellectual property
Ownership regimes in the biosciences:
- Collaborative ownership regimes may be more practical in the context of interacting and dynamic biological systems
O’Malley, M. A., Bostanci, A. and Calvert, J. (2005). Whole-genome patenting. Nature Reviews Genetics, 6 (6), 502-506.
Hughes, S. and Deibel, E. (2007). Plant breeders rights, room for manoeuvre? Tailoring Biotechnologies, 2, 77-86.
Bostanci, A. and Calvert, J. (forthcoming 2008) 'Invisible genomes: the genomics revolution and patenting practice' Studies in History and Philosophy of the Biological and Biomedical Sciences.