IP Policies for Large Bioresources: The Fiction, Fantasy and Future of Openness

Abstract

Much research in synthetic biology (SB) and genomics (Gx) is reliant on the use of large-scale collections of biological materials and data, often referred to as ‘biobanks’ or ‘bioresources’. Following substantial investment in the form of time, money, and personnel, some of these bioresources have reached a point where they can be regularly accessed by researchers and can realistically hope to facilitate innovation. At the same time, their maturity brings several challenges including how to promote access, ensure stewardship, and address financial sustainability. All these facets must be managed for on-going utility. Access promotes the likelihood of significant scientific findings and avoids under-utilisation; stewardship earns trust from sample donors and funders; and sustainable sources of income are crucial if the bioresources are to serve as infrastructure (rather than projects) and assist with longitudinal studies. A key part in managing these challenges – much less studied than issues of consent, return of incidental findings, and researchers’ eligibility for access – is the stance taken by large bioresources on intellectual property (IP) and financial conditions of access. Acquisition, ownership and sharing of intellectual property in life sciences is ethically charged, and financial conditions of access are controversial where they preclude or discourage external researchers from using the bioresource. There is limited guidance available for developing such policies in the fields of Gx and SB . Moreover – and this goes to the heart of this chapter – discussion of IP and business models for bioresources is a topic that falls in the shadow of hyperbole about openness.

This chapter aims to bring the issue of IP policies for large bioresources out of the long shadows of rhetoric about openness. It will highlight two fictions: first, that the idea of openness is clearly defined; and second, that organisations are committed to openness. It will also highlight the fantasy that harmonisation of bioresources’ access policies is feasible and desirable. The chapter will conclude by outlining future research to improve openness and intellectual property policies for large Gx and SB bioresources.