University of New Hampshire University of New Hampshire Scholars' Repository University of New Hampshire – Franklin Pierce Law Faculty Scholarship School of Law 4-1-2006 Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies on Pandemic Influenza, Malaria and SARS Anatole Krattiger Arizona State University Stanley P. Kowalski Franklin Pierce Law Center, [email protected] Robert Eiss Oxford Centre for Innovation Anthony Taubman World Intellectual Property Organization Follow this and additional works at: https://scholars.unh.edu/law_facpub Part of the Influenza Virus accinesV Commons, Intellectual Property Law Commons, and the Parasitology Commons Recommended Citation Anatole Krattiger, Stanley P. Kowalski, Robert Eiss & Anthony Taubman. “Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies on Pandemic Influenza, Malaria and SARS.” 2 Innovation Strategy Today 2 (2006). This Conference Proceeding is brought to you for free and open access by the University of New Hampshire – Franklin Pierce School of Law at University of New Hampshire Scholars' Repository. It has been accepted for inclusion in Law Faculty Scholarship by an authorized administrator of University of New Hampshire Scholars' Repository. For more information, please contact [email protected]. InnovationStrategyToday eJournal • Volume 2 • Number 2 • 2006 Inside This Issue: Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies of Pandemic Influenza, Malaria, and SARS Anatole Krattiger, Stanley Kowalski, Robert Eiss and Anthony Taubman Meeting Report (Hosted by WIPO, Geneva, April 2006) Towards Patent Pools in Biotechnology? Patrick Gaulé Special volume published Made possible with in collaboration with the support of eJournal Patents An eJournal Sharing Creative and Innovative Ideas and Experiences about Global Issues in Agriculture, Health, 20020156037 6245532 EP0366239 20040109877 6337070 EP1216053 and the Environment Facing Developing Countries 20040265987 6337181 WO02064757 Innovation Strategy Today is published by bioDevelopments-International 20050054846 6531313 WO2004022760 Institute in collaboration with Cornell University and the Biodesign 5674502 6635246 WO2005018539 Institute at Arizona State University 5766601 6669943 WO2005020889 5882650 6740325 WO2005027825 5897873 6743900 WO2005090584 5916879 6866853 WO2005107797 6008036 6884613 WO2005113756 6136606 CN1618956 WO2005116258 6146873 CN1632124 WO2005116260 6221365 EP0366238 WO2005117958 Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies on Pandemic Influenza, Malaria and SARS Meeting hosted by WIPO, the World Intellectual Property Organization, Geneva, Switzerland, April 2006 Anatole Krattiger Stanley Kowalski Robert Eiss Anthony Taubman Research Professor MIHR and Franklin Pierce Law Center CEO, MIHR Head, Life Sciences Program Biodesign Institute 203 Loudon Road Oxford Centre for Innovation WIPO Arizona State University Unit No. 618 Mill Street 34 chemin des colombettes Tempe, AZ 86336, USA Concord, NH 03301, USA Oxford OX2 0JX, UK 1211 Geneva 20, Switzerland [email protected] [email protected] [email protected] [email protected] Executive Summary Achieving global access to vaccines, diagnostics, and trust considerations, bargaining difficulties caused pharmaceuticals remains a challenge. Throughout by asymmetric interests and asymmetric rights the developing world, intellectual property (IP) con‐ among IP holders (e.g. improvement vs. foundational straints complicate access to critically essential medi‐ patents), and the difficulties of securing financial cal technologies and products. Vaccines for malaria support given the significant transaction costs asso‐ and pandemic strains of influenza, as well as diag‐ ciated with pools. nostic and vaccine technologies for SARS, are not Because of the above conceptual and opera‐ only relevant to global public health but are particu‐ tional hurdles, patent pools do not appear to be a larly critical to the needs of developing countries. A feasible way to accelerate development. Other global access solution is urgently needed. This article mechanisms, however, can ameliorate IP constraints. offers a timely case‐by‐case analysis of preliminary For example, a key IP constraint related to pandemic patent landscape surveys and formulates options via influenza vaccines R&D appears to have been re‐ (print) encouraged. patent pools and other forms of creative IP man‐ solved when MedImmune secured the assembly of is 631X ‐ agement to accelerate development and access. The all relevant reverse genetics IP and pledged broad 1555 purposes analysis of the feasibility of patent pools reveals sev‐ access. Clearly, the landscape is complex and multi‐ ISSN • eral impediments to patent pools: these include anti‐ dimensional. Licensing systems are not the only is‐ commercial ‐ (online) non This project has been made possible thanks to a grant from the Sasakawa Peace Foundation, Japan. for 6328 ‐ The present report is based on a meeting hosted by WIPO in Geneva that, in addition to the authors of the present paper, included the 1555 internet following participants: Susan Ano (OTT-NIH), Konrad Becker, Mary M Bendig (University of Oxford), Claudia Chamas (FIOCRUZ), the ISSN • Nicoletta Dentico (DNDi), Rajeev Dhere (Serum Institute of India Ltd.), Andrew Farlow (Oxford University), Bruce Goldstein (OTT-NIH), H Richard Johnson (Arnold and Porter LLP), Kral Jorda (Franklin Pierce Law Center), David Fedson, Roger Kampf (WTO), Nguyen Tuyet through International Institute Inc.International Institute Nga (Company for Vaccine and Biological Product, Vietnam), Gillian Samuels (Pfizer Global Research and Development), Klaus Stöhr details. − (WHO), Anja Von Der Ropp (WIPO), and Richard Wilder (Sidley Austin LLP). Today for The views expressed in this document are those of the authors and do not necessarily reflect those of all the participants at the meet- cover Strategy ing, their respective institutions, or the publishers or donors. The present document does not represent a consensus but is intended to back H www.bioDevelopments.org reflect the varied discussions that took place at the Geneva meeting, which itself was built on a research project and the results of in- on at Developments terviews with many stakeholders from around the world. Use bio of Innovation online of Krattiger A, S Kowalski, R Eiss and A Taubman. 2006. Intellectual Property Management Strategies to Accelerate the Development and Access of Vaccines and Diagnostics: Case Studies on Pandemic Influenza, Malaria and SARS. Innovation Strategy Today 2(2):67-122. Terms © 2006. Sharing See Available www.biodevelopments.org/innovation/index.htm 67 sue. Measures must also be taken to limit regulatory 3. It would be a formidable obstacle to identify a hurdles and enable the swift, legal production of donor willing to fund the significant cost of es‐ pandemic influenza vaccines to meet the needs of tablishing a patent pool, especially in an area of developing countries. This is why a comprehensive limited commercial interest. analysis is so necessary. From a strictly legal perspective, IP systems work In the particular case of pandemic influenza, the ap‐ through the power to exclude. However, as this parent resolution of IP issues related to reverse genet‐ study’s exploration and formulation of creative li‐ ics technology suggests that other constraints besides censing strategies reveals, it is also true that IP can be IP are now more significant (e.g., finding effective structured and managed to work through the “power adjuvant technologies to extend antigen efficacy). to include.” More broadly, the speed of R&D is a major constraint. Further down the road, manufacturing capacity to Principal results produce a pandemic influenza vaccine rapidly and in Several important results emerged from this study of sufficient quantities will be a crucial factor. Interna‐ patent pools. First, one key constraint is related to a tional coordination and leadership from an appropri‐ platform technology—reverse genetics—that is es‐ ate type of organization are urgently needed to an‐ sential for rapidly developing influenza vaccines ef‐ ticipate and overcome these obstacles. Although IP fective against H5N1. One company was able to re‐ issues permeate these areas, patent pooling per se is solve this constraint by assembling all the relevant IP not expected to accelerate R&D or to leverage the and becoming a single licensing authority. Creating additional investments required for manufacturing. such a one‐stop licensing authority would accelerate Building appropriate partnerships might be the development, but it is not clear that a commercial best way to accelerate global access for pandemic entity would be willing to license a bundle of IP influenza vaccines. This would close gaps and might rights for developing country use. also cover R&D, manufacturing, etc., but not neces‐ Second, while the need for patent pools has been sarily all the areas needed. Sound technology transfer generally assumed (along with the determination of agreements must be achieved, and it will be critically the possible kinds of such pools), there may be no important to attend to such matters preemptively, immediate need for them. More importantly, imple‐