Genomics Research and Intellectual Property Emily Marden, J.D., M.Phil., A.M. April 28, 2011 Intellectual Property & Policy Research Group ipprg.wordpress.com University of British Columbia Faculty of Law

My Perspective Trained in Molecular Biology, History & Sociology of Science, IP and Regulatory Law Currently lead the Intellectual Property & Policy Research Group, UBC Faculty of Law ◦ Formed with Ed Levy, Ph.D. ◦ Genome Canada funded GE 3 LS research Focus on IP and regulation as tools to modulate genomics research and development 2

Intellectual Property & Policy Research Group (IPPRG) Platform IPPRG is a platform research group ◦ Law, genetics, philosophy, sociology Rigorously examines alternative approaches to IP and regulation to address issues along the genomics research, innovation and development continuum ◦ When, where and how do different approaches work? 3

IPPRG Scope Public Domain: C. Elegans Research Community Patent Pools: SARS Case Study Open Source: Is Drug Development Possible? Role of TTO in use of alternatives Research Exemption – A broader scope for research tools in Canada 4

Policy Brief Agree that knowledge management, rather than legislative changes to IP statutes, key to fostering the possibility of innovation Existing IP framework enables a range of tools that can facilitate knowledge sharing

Policy Brief Use of IP tool depends on location in continuum and appropriate balance of sharing and protection that allows for innovation ◦ Public domain ◦ Patent pools ◦ Open source May be additional tools to consider to facilitate sharing toward innovation

Public Domain Upstream C. Elegans community –share data, resources, research tools and results without IP barriers Research Findings: approach is widely accepted throughout community, as reflected in citations, attributions, contribution to communal resources Results provide basic insights, useful downstream In upstream contexts, public domain may facilitate research necessary for innovation

Patent Pools BCCA (& others) form PP to ensure access to tools for SARS vaccine development. ◦ Patenting as a proactive tool Research findings: patent pool expands zone of open science around fundamental discoveries, delays exclusionary rights ◦ vs. GlaxoSmithKline and UNITAID “ponds” May be effective tool to keep valued research findings widely available

Open Source Open source licensing, modeled on IT, widely claimed as route to less costly, more accessible drugs ◦ Patent, license with viral hook Research Findings: regulatory requirements, complex IP inputs, costliness make this an inefficient and potentially burdensome route to innovation “Acquisition” model may better facilitate

Open Source Upstream clearinghouse, no hook (e.g. Biobricks) ◦ Could still be issues when transition downstream Open source may be more applicable for aspects of basic research, but more work to be done

Routes to Facilitate Innovation Further analysis of IP tools at different points along R&D continuum Funding models that tie metrics of success to knowledge transfer Expansion of research exemption for research with patented inventions Potential regulatory exclusivities as incentives

IPPRG Members (2006-present) Emily Marden, J.D. Ed Levy, Ph.D. Rebecca Goulding, Ph.D. (genetics) Matthew Voell, J.D. Nelson Godfrey, J.D. Ben Warren, J.D. Lily Farris, M.A. Rachael Manion, J.D. (Health Canada) Isaac Filate, L.L.B. David Hartell M.A. (CIHR) Cheryl Powers, J.D., L.L.M. (Industry Canada) 12

13 Recent Publications Goulding R, Voell M, Marden E & Levy E, (2011) Expansion of the Canadian Research Exemption for Biotechnology Research Tools. Biotechnology Law Report Voell MR., Farris, L., Levy E. & Marden E. (2010) A Response to Rome: Pre- and Post-Publication Sharing in the C. elegans Research Community. BMC Genomics, 11:708. Goulding R., Marden, E., Manion R. & Levy, E. (2010) Alternative Intellectual Property for Genomics and the Activity of Technology Transfer Offices: Emerging Directions in Research. Boston University Journal of Science and Technology Law 16(2): Marden E. (2010)Open Source Drug Development: A Path to More Accessible Drugs and Diagnostics? Minnesota Journal of Law, Science and Technology 11(1): Levy, E., Marden, E., Warren, B., Hartell, D. and Filaté I. (2010) Patent Pools and Genomics: Navigating a Course to Open Science? Boston University Journal of Science and Technology Law 16(1):