Intellectual Property Issues in Biotechnology: Health and Industry (by Matthew Herder y E. Richard Gold)

Intellectual Property Issues in Biotechnology: Health and Industry, elaborado por Matthew Herder y E. Richard Gold, expone los escenarios de futuro en el horizonte 2030 que se vislumbran en el campo de los derechos sobre la propiedad intelectual de las aplicaciones de la biotecnología en la industria y las sanidad. Este documento se ha incluido en el informe The Bioeconomy to 2030: designing a policy agenda  que expone las oportunidades y los desafíos para la bioeconomía del futuro. Este informe es el resultado final del proyecto de bioeconomía  promovido por el Programa Internacional de Futuros (IFP) de la Organización para la Cooperación y Desarrollo Económico OCDE.

 

If a true “modern bioeconomy” is to emerge in the years ahead, intellectual property will no doubt play a critical role. Intellectual property rights – the manner in which they are recognised, traded and managed,

nationally as well as globally – will influence the form such a bioeconomy takes, where it will flourish and flounder, and to whom the principal benefits will flow. The general aim of this paper is to canvass those issues. In summarising the available evidence about intellectual property’s impact upon incentives and access, and applying that body of evidence to the health and industrial biotechnology sectors, we may formulate a rough forecast of our bioeconomic future.

Cognisant, however, that intellectual property increasingly constitutes the terrain upon which disputes over North-South inequalities are waged, our paper also attempts to place its analysis within current international discourse, as evidenced by the WIPO Development Agenda and the WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property. Throughout our analysis we endeavour to take the present “development divide” into account, recognising that the emergence of a modern bioeconomy portends, in the eyes of some, a new dimension of wealth and health inequity along a “biotechnology divide”, or else risks being perceived as a mechanism that helps perpetuate the status quo. While it is clearly premature to determine the truth behind any such allegation – the evidence of social welfare impacts of increased intellectual property protections in developing countries in the “post-TRIPs” era is, thus far, unclear – it would be a mistake to ignore it, as it shapes how different countries and regions understand and discuss intellectual property. In any event, to the extent that one is concerned with the impact of the bioeconomy on (especially developing) countries, one cannot ignore the importance of distributive justice in one’s analysis. The promise of a bioeconomy ought, therefore, to be connected to something greater than economic growth in and of itself. Indeed, developing countries have been encouraged to revamp or fundamentally alter their intellectual property systems in line with systems of the West on the strength of biotechnology’s promise to deliver nothing short of emancipation. We therefore offer our survey of intellectual property (IP) issues in the context of the current development divide and attendant distributive justice concerns.

In terms of structure, the paper is organised along a temporal dimension. Section 1 canvasses the “state of the art”, utilising the available empirical evidence (from the past, albeit as recent as possible) to probe two

intersecting relations: the role IP plays in terms of incentivising biotechnological innovation, and how IP facilitates versus circumscribes access to biotechnological research inputs and outputs. Our analysis of each relation, moreover, reflects the above normative agenda: we highlight ways in which the status quo fails to remedy the development divide while also suggesting potential solutions to address industrial and public health issues in developing country contexts – in essence, performing a global cost-benefit analysisthroughout. The first section concludes by foregrounding the risk of continuing to analyse IP issues from within an “innovation versus access” paradigm. Section 2 is best characterised as focusing on the present.

We explore several different IP regimes, whether or how they are likely to change or are already changing in response to globalising forces and international institutions, and in turn ponder how those (shifting) regimes could shape the evolution of a bioeconomy for a particular country, region, or perhaps even globally. The second section also considers whether changes in the field of biotechnology itself raise new or pressing IP challenges. Two cases are considered. The first speaks to the increasingly globalised nature of scientific research, by examining the patentability of stem cell technologies around the globe and delving into a host of other IP issues raised by one large-scale cross-border research initiative, the “Cancer Stem Cell Consortium” proposed between Canada and the State of California. The second case study zeroes in on one emerging area of biotechnology, synthetic biology, and evaluates whether it represents a “perfect storm” of IP problems as some commentators allege. Section 3 concludes the paper with a set of general remarks and cautious predictions about the future, the onset of a viable modern bioeconomy, and the place of IP in terms of advancing distributive justice concerns within each.

A final introductory word about scope: our review of the evidence and analysis of diverse IP regimes is necessarily overarching in nature and subject to certain limitations, including space. We are also working

with certain definitions of “health” and “industrial” biotechnology and, insofar as possible, attempting to limit our inquiry with those definitions in mind.9 However, as explained next, the available evidence is far

from complete, which requires us to stray outside these parameters on occasion. Further, given the general scarcity of evidence, we presume (unless there are particular reasons for resisting this) that what applies in one area applies in others. This is particularly true with regard to industrial biotechnology, which has been very lightly treated in comparison with the more widely studied health biotechnology. While there are obvious differences between health and industrial biotechnology – in terms of both industrial structure and policy implications – we have drawn on existing knowledge of the former to inform our analysis of the latter. Finally, while the analysis does contemplate multiple forms of IP protection (copyright; tradesecrets; know-how), it is heavily skewed towards patent rights as they are the dominant, if not preferred,mode of IP protection in the biotechnology realm, not to mention the most studied and controversial.