AAAS Project on Science and Intellectual Property in the Public Interest Bringing a public interest perspective to science and intellectual property issues, by: Examining the effects of IPRs on science and innovation Promoting equity in access to the benefits of science Promoting a broad participation in public policy Developing models that facilitate open access to and cooperative uses of scientific information
Some SIPPI Activities Humanitarian Use Exemption Working Group Research Exemption Working Group International Survey of the Effects of IP on Research Monitoring IP Policy, Legislation, and Issues Survey on the Impact of Madey v. Duke Decision on University Research 2
The Need for a Humanitarian Use Exemption IP protections on research inputs and outputs can hinder development of pharmaceuticals and agricultural products appropriate to the needs of developing regions, and restrict the transfer of existing technologies to less developed countries. Goal: To develop novel IP arrangements that balance a fair return on investments in profitable markets with greater access and lower costs in poor countries. 3
HUE may be implemented in two ways: As part of negotiated agreements between two parties (e.g. a clause in licensing agreements) Through public policy initiatives or treaty obligations 4
AAAS Working Group on Developing an HUE Goals: to conceptualize the scope and applications of a proposed humanitarian use exemption and the circumstances under which it should apply, with a focus on biotechnology for agriculture and health. to identify good/best practices related to the management of intellectual property for research and development that can further the implementation of a humanitarian use exemption. to build on pioneering efforts of organizations like the Public Intellectual Property Resource for Agriculture (PIPRA) and the Center for the Management of Intellectual Property in Health Research and Development (MIHR). 5
Composition of the Group IP lawyers and legal scholars Scientists NGO representatives NIH staff Industry To be added to working group: potential beneficiaries 6
Issues Identified Differences between biotechnology for health and agriculture Appropriate boundaries for application of HUE (geographic, market, income level, etc.) How to build on existing statutory exemptions and TRIPS provisions Whether HUE applies to both profit and non-profit Whether HUE applies only to products for domestic consumption or also to goods for export 7
Progress Initial meeting July 13-14, Washington D.C. Developing Principles and Practices for the application of an HUE in agriculture and health Audience: IP holders preparing licensing agreements Includes models for humanitarian use clause in licensing agreements 8
Next steps Refine principles and practices, for presentation at December meeting Feedback from potential users of principles and practices document Consider broader public policy initiatives 9
The Need for a Research Exemption (Exception) Until recently, experimental use exemption was assumed. 2002 Madey v. Duke decision effectively eliminated practical application of experimental use defense to patent infringement in U.S. Potential adverse effects on health R&D: uncertainty, legal costs and delays, reduced availability of research tools. 10
Status of the Experimental Exemption in Europe and Japan National laws generally exempt experimentation on the subject-matter of the patent: Validity of the patent Features, properties, inherent characteristics or advantages of the patented subject matter Methods of making or using the patented subject matter Alternatives or substitutes 11
Experimental Exemption in Europe and Japan: Dilemmas Narrowness of the scope Inconsistent legal and judicial interpretation 12
AAAS Research Exemption Working Group Goals: Define appropriate scope for research exemption Determine principles for and necessary components of a successful research exemption Increase access to data for scientific research First meeting: October 18-19, 2004 13