Intellectual Property in Intellectual Property in Contemporary BiologyContemporary Biology

John Dupré, Director, EgenisJohn Dupré, Director, Egenis

University of ExeterUniversity of Exeter

OverviewOverview

What is the new science of genomics about? What is the new science of genomics about? That is, what kinds of things does it tell us That is, what kinds of things does it tell us about?about?

How do changes in our understanding of How do changes in our understanding of biology affect the applicability of traditional biology affect the applicability of traditional patent laws?patent laws?

Recent biology has moved from a strongly reductionist mode Recent biology has moved from a strongly reductionist mode Of understanding to an emphasis on Of understanding to an emphasis on complexitycomplexity, , contextcontext, and, andthe necessity of analysing the necessity of analysing whole systems. whole systems. This move is mostThis move is mostclearly reflected in the growing investment inclearly reflected in the growing investment in Systems Biology. Systems Biology.

Intellectual Property regimes, on the other hand, are rootedIntellectual Property regimes, on the other hand, are rootedmost strongly in engineering models and the reductionist most strongly in engineering models and the reductionist understandings naturally associated with such models. understandings naturally associated with such models.

Systems biology is not easily interpreted as describing Systems biology is not easily interpreted as describing possible commodities.possible commodities.

Intellectual PropertyIntellectual Property

What kinds of genomic objects can be patented?What kinds of genomic objects can be patented? Actual and attempted patents have included whole Actual and attempted patents have included whole

genomes, genes as material substances, and genomic genomes, genes as material substances, and genomic data in computer-readable formsdata in computer-readable forms

Patenting regimes must make assumptions about the Patenting regimes must make assumptions about the nature of genes and genomesnature of genes and genomes

Intellectual Property, ContinuedIntellectual Property, Continued

Patenting of ‘genes’ as ‘compositions of matter’ requires Patenting of ‘genes’ as ‘compositions of matter’ requires identification of a specific function. Tends to implicitly identification of a specific function. Tends to implicitly assume a scientifically dubious linear model of gene function assume a scientifically dubious linear model of gene function

Patenting genomic information introduces a quite different Patenting genomic information introduces a quite different conception of the subject matterconception of the subject matter

Generally, it’s doubtful whether existing patent law is Generally, it’s doubtful whether existing patent law is adequate to the needs of genomicsadequate to the needs of genomics

See J. Calvert (2007), ‘Patenting Genomic Objects’, See J. Calvert (2007), ‘Patenting Genomic Objects’, Science as CultureScience as Culture;;

M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. Nature Nature

Reviews Genetics.Reviews Genetics.

Patenting GenesPatenting Genes

“ “ a gene is but a chemical, albeit a complex one” a gene is but a chemical, albeit a complex one” (Amgen inc. vs. Chugai Pharmaceutical Co.)(Amgen inc. vs. Chugai Pharmaceutical Co.)

Not really: to be a particular gene is to be in aNot really: to be a particular gene is to be in a

particular biological contextparticular biological context

GenesGenes

DNA (a gene?) DNA (a gene?) RNA RNA Protein Protein Phenotypic trait X Phenotypic trait XThen the DNA is a gene for XThen the DNA is a gene for X

Almost everything is wrong with this story.Almost everything is wrong with this story. All of these causal steps have multiple possible outcomesAll of these causal steps have multiple possible outcomes Causation runs in both directionsCausation runs in both directions Therefore whether a stretch of DNA is a gene for X, Y, Z, all Therefore whether a stretch of DNA is a gene for X, Y, Z, all

of these, or nothing, depends on the contextof these, or nothing, depends on the context

General point about biomolecules: countless General point about biomolecules: countless possible functions; actual function depends on possible functions; actual function depends on relation to rest of cellrelation to rest of cell

Compare also ‘moonlighting’ proteins. Compare also ‘moonlighting’ proteins. One is not, therefore, patenting a kind of stuff, One is not, therefore, patenting a kind of stuff,

which has found to be a gene for, e.g., tumour which has found to be a gene for, e.g., tumour suppression, but something which can be a gene suppression, but something which can be a gene for tumour suppression, but can be many other for tumour suppression, but can be many other things as well.things as well.

Genomes are conceived in two very Genomes are conceived in two very different ways for different purposesdifferent ways for different purposes

The genome as information The genome as information Ancestry tracing; forensic; comparative genomics (function; Ancestry tracing; forensic; comparative genomics (function;

phylogeny)phylogeny) The genome as a material objectThe genome as a material object

Gene therapy; stem cell science; genomics and agricultureGene therapy; stem cell science; genomics and agriculture Both concepts have been extremely valuable, but their Both concepts have been extremely valuable, but their

conflation can cause a lot of confusion; they also raise conflation can cause a lot of confusion; they also raise different issues for intellectual propertydifferent issues for intellectual property

See Barry Barnes and John Dupré (in press), See Barry Barnes and John Dupré (in press), Genomes and What to Make of ThemGenomes and What to Make of Them (Chicago University Press).(Chicago University Press).

The Move to Systems Biology The Move to Systems Biology and Synthetic Biologyand Synthetic Biology

Both reflect in different ways a perceived Both reflect in different ways a perceived need to get beyond the reductionism of need to get beyond the reductionism of earlier molecular genetics and deal with earlier molecular genetics and deal with larger more complex systemslarger more complex systems

Systems BiologySystems Biology

““important…properties come from the operation of important…properties come from the operation of a system and not from the operation of individual a system and not from the operation of individual genes…if you want to acquire intellectual genes…if you want to acquire intellectual property…you’ve got to patent a system or a property…you’ve got to patent a system or a collection of genes” collection of genes” (Interview3. Interviews were conducted by (Interview3. Interviews were conducted by Dr Jane Calvert.)Dr Jane Calvert.)

But this may result in impeding further research But this may result in impeding further research over a wide area, and thus be a very counter-over a wide area, and thus be a very counter-productive use of Intellectual Property law.productive use of Intellectual Property law.

Systems Biology, continuedSystems Biology, continued

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

Synthetic BiologySynthetic Biology

““Systems biology in reverse” (interview30)Systems biology in reverse” (interview30) Clear modelling on engineering and physical science Clear modelling on engineering and physical science

traditionstraditions ‘‘Biobricks’—standardised, hence interchangeable Biobricks’—standardised, hence interchangeable

components; stabilisation of objects of ownershipcomponents; stabilisation of objects of ownership Strong ‘open source’ ethos, though this also involves Strong ‘open source’ ethos, though this also involves

property rights through source licensesproperty rights through source licenses Craig Venter’s minimal genomeCraig Venter’s minimal genome

ConclusionsConclusions

The integrative life sciences suggest two different The integrative life sciences suggest two different paths for IP:paths for IP: Emergent phenomena inherently unsuitable for Emergent phenomena inherently unsuitable for

commodification, hence search for new ways of thinking commodification, hence search for new ways of thinking about appropriation in the life sciencesabout appropriation in the life sciences

Reduce complexity and unpredictability to fit better Reduce complexity and unpredictability to fit better with existing ownership regimes. Reshape the life with existing ownership regimes. Reshape the life sciences to fit economic necessities.sciences to fit economic necessities.

Work in Egenis on Intellectual Work in Egenis on Intellectual PropertyProperty

J. Calvert (2007), “Patenting Genomic Objects”, J. Calvert (2007), “Patenting Genomic Objects”, Science as CultureScience as Culture..

M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome M. A. O'Malley, A. Bostanci, A., and J. Calvert, (2005). Whole-genome patenting. patenting. Nature Reviews Genetics 6, Nature Reviews Genetics 6, 6, 2005, pp. 502-506. 6, 2005, pp. 502-506.

J.Calvert (2004), J.Calvert (2004), 'Genomic patenting and the utility requirement', 'Genomic patenting and the utility requirement', New New Genetics and SocietyGenetics and Society, 23, 3, 2004, pp. 301-312. , 23, 3, 2004, pp. 301-312.

S. G. Hughes (2005), S. G. Hughes (2005), 'Navigating genomes: the space in which genes 'Navigating genomes: the space in which genes happen', happen', Tailoring BiotechnologiesTailoring Biotechnologies, 1, pp. 35-46. , 1, pp. 35-46.

AcknowledgementsAcknowledgements

Thanks to many colleagues at Egenis, and Thanks to many colleagues at Egenis, and especially:especially:

Jane CalvertJane Calvert Maureen O’MalleyMaureen O’Malley Alex PowellAlex Powell Steve HughesSteve Hughes