1. Intellectual Property in Contemporary Biology John Dupré, Director, Egenis University of Exeter

2. Overview What is the new science of genomics about? That is, what kinds of things does it tell us about? What is the new science of genomics about? That is, what kinds of things does it tell us about? How do changes in our understanding of biology affect the applicability of traditional patent laws? How do changes in our understanding of biology affect the applicability of traditional patent laws?

3. Recent biology has moved from a strongly reductionist mode Of understanding to an emphasis on complexity, context, and the necessity of analysing whole systems. This move is most clearly reflected in the growing investment in Systems Biology. Intellectual Property regimes, on the other hand, are rooted most strongly in engineering models and the reductionist understandings naturally associated with such models. Systems biology is not easily interpreted as describing possible commodities.

4. Intellectual Property What kinds of genomic objects can be patented? What kinds of genomic objects can be patented? Actual and attempted patents have included whole genomes, genes as material substances, and genomic data in computer-readable forms Actual and attempted patents have included whole genomes, genes as material substances, and genomic data in computer-readable forms Patenting regimes must make assumptions about the nature of genes and genomes Patenting regimes must make assumptions about the nature of genes and genomes

5. Intellectual Property, Continued Patenting of ‘genes’ as ‘compositions of matter’ requires identification of a specific function. Tends to implicitly assume a scientifically dubious linear model of gene function Patenting of ‘genes’ as ‘compositions of matter’ requires identification of a specific function. Tends to implicitly assume a scientifically dubious linear model of gene function Patenting genomic information introduces a quite different conception of the subject matter Patenting genomic information introduces a quite different conception of the subject matter Generally, it’s doubtful whether existing patent law is adequate to the needs of genomics Generally, it’s doubtful whether existing patent law is adequate to the needs of genomics See J. Calvert (2007), ‘Patenting Genomic Objects’, Science as Culture; See J. Calvert (2007), ‘Patenting Genomic Objects’, Science as Culture; M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. Nature Reviews Genetics. M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. Nature Reviews Genetics.

6. Patenting Genes “ a gene is but a chemical, albeit a complex one” (Amgen inc. vs. Chugai Pharmaceutical Co.) Not really: to be a particular gene is to be in a particular biological context

7. Genes DNA (a gene?)  RNA  Protein  Phenotypic trait X Then the DNA is a gene for X Almost everything is wrong with this story. All of these causal steps have multiple possible outcomes All of these causal steps have multiple possible outcomes Causation runs in both directions Causation runs in both directions Therefore whether a stretch of DNA is a gene for X, Y, Z, all of these, or nothing, depends on the context Therefore whether a stretch of DNA is a gene for X, Y, Z, all of these, or nothing, depends on the context

8. General point about biomolecules: countless possible functions; actual function depends on relation to rest of cell General point about biomolecules: countless possible functions; actual function depends on relation to rest of cell Compare also ‘moonlighting’ proteins. Compare also ‘moonlighting’ proteins. One is not, therefore, patenting a kind of stuff, which has found to be a gene for, e.g., tumour suppression, but something which can be a gene for tumour suppression, but can be many other things as well. One is not, therefore, patenting a kind of stuff, which has found to be a gene for, e.g., tumour suppression, but something which can be a gene for tumour suppression, but can be many other things as well.

9. Genomes are conceived in two very different ways for different purposes The genome as information The genome as information Ancestry tracing; forensic; comparative genomics (function; phylogeny) Ancestry tracing; forensic; comparative genomics (function; phylogeny) The genome as a material object The genome as a material object Gene therapy; stem cell science; genomics and agriculture Gene therapy; stem cell science; genomics and agriculture Both concepts have been extremely valuable, but their conflation can cause a lot of confusion; they also raise different issues for intellectual property Both concepts have been extremely valuable, but their conflation can cause a lot of confusion; they also raise different issues for intellectual property See Barry Barnes and John Dupré (in press), Genomes and What to Make of Them (Chicago University Press).

10. The Move to Systems Biology and Synthetic Biology Both reflect in different ways a perceived need to get beyond the reductionism of earlier molecular genetics and deal with larger more complex systems Both reflect in different ways a perceived need to get beyond the reductionism of earlier molecular genetics and deal with larger more complex systems

11. Systems Biology “important…properties come from the operation of a system and not from the operation of individual genes…if you want to acquire intellectual property…you’ve got to patent a system or a collection of genes” (Interview3. Interviews were conducted by Dr Jane Calvert.) “important…properties come from the operation of a system and not from the operation of individual genes…if you want to acquire intellectual property…you’ve got to patent a system or a collection of genes” (Interview3. Interviews were conducted by Dr Jane Calvert.) But this may result in impeding further research over a wide area, and thus be a very counter- productive use of Intellectual Property law. But this may result in impeding further research over a wide area, and thus be a very counter- productive use of Intellectual Property law.

12. Systems Biology, continued Apart from attempts to patent molecular networks, SB patents have also taken form of computer-based models. These raise issues about the general patentability of computer software; but also, by being simplifications of biological reality and more tractable and predictable, perhaps better suited to commodification. Apart from attempts to patent molecular networks, SB patents have also taken form of computer-based models. These raise issues about the general patentability of computer software; but also, by being simplifications of biological reality and more tractable and predictable, perhaps better suited to commodification.

13. Synthetic Biology “Systems biology in reverse” (interview30) “Systems biology in reverse” (interview30) Clear modelling on engineering and physical science traditions Clear modelling on engineering and physical science traditions ‘Biobricks’—standardised, hence interchangeable components; stabilisation of objects of ownership ‘Biobricks’—standardised, hence interchangeable components; stabilisation of objects of ownership Strong ‘open source’ ethos, though this also involves property rights through source licenses Strong ‘open source’ ethos, though this also involves property rights through source licenses Craig Venter’s minimal genome Craig Venter’s minimal genome

14. Conclusions The integrative life sciences suggest two different paths for IP: The integrative life sciences suggest two different paths for IP: Emergent phenomena inherently unsuitable for commodification, hence search for new ways of thinking about appropriation in the life sciences Emergent phenomena inherently unsuitable for commodification, hence search for new ways of thinking about appropriation in the life sciences Reduce complexity and unpredictability to fit better with existing ownership regimes. Reshape the life sciences to fit economic necessities. Reduce complexity and unpredictability to fit better with existing ownership regimes. Reshape the life sciences to fit economic necessities.

15. Work in Egenis on Intellectual Property J. Calvert (2007), “Patenting Genomic Objects”, Science as Culture. M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. Nature Reviews Genetics 6, 6, 2005, pp. 502-506. M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. Nature Reviews Genetics 6, 6, 2005, pp. 502-506. J.Calvert (2004), 'Genomic patenting and the utility requirement', New Genetics and Society, 23, 3, 2004, pp. 301-312. S. G. Hughes (2005), 'Navigating genomes: the space in which genes happen', Tailoring Biotechnologies, 1, pp. 35-46.

16. Acknowledgements Thanks to many colleagues at Egenis, and especially: Thanks to many colleagues at Egenis, and especially: Jane Calvert Jane Calvert Maureen O’Malley Maureen O’Malley Alex Powell Alex Powell Steve Hughes Steve Hughes