Skip to main content Accessibility help
×
Hostname: page-component-7bb8b95d7b-nptnm Total loading time: 0 Render date: 2024-10-04T02:43:23.002Z Has data issue: false hasContentIssue false

6 - Intellectual Property in Early-Phase Research Public–Private Partnerships in the Biomedical Sector

from Part I - Public Health

Published online by Cambridge University Press:  14 September 2018

Margaret Chon
Affiliation:
Seattle University School of Law
Pedro Roffe
Affiliation:
International Center for Trade and Sustainable Development
Ahmed Abdel-Latif
Affiliation:
International Renewable Energy Agency, Abu Dhabi
Get access

Summary

The chapter assesses the role of IP in early-phase research public-private partnerships (PPPs) in the biomedical sector. Pooling complementary resources and expertise, and sharing risks and other burdens between public and private stakeholders, increases effectiveness of PPPs. Diverse social, economic, legal, regulatory, and scientific factors mean the PPP model is complex. The chapter considers knowledge-sharing mechanisms as a key aspect of IP management for shared goals of multiple-stakeholder partnerships. It sheds light on the different aspects that come into play when mapping how IP is generated, protected, and managed (e.g. shared) within and beyond early-phase research PPPs. It considers the relevant concepts and typology of early-phase research PPPs, including pre-competitive PPPs. Following this are sections on key issues, including the boundaries of the pre-competitive partnership; the role of trust within those PPPs; IP ownership and access rights, including the importance of transparent IP rules underlying knowledge sharing strategies; and the role of IP in the performance of PPPs. It concludes with recommendations for best practices to facilitate efficient and equitable knowledge-sharing.
Type
Chapter

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Bengtsson, Maria and Kock, Soren, “Coopetition” in Business Networks – To Cooperate and Compete Simultaneously, 29 Indus. Mktg. Mgmt. (2000).Google Scholar
Bereuter, Thomas L. et al., IPR-Codes and Guidelines in Europe Facilitating Collaboration of Publicly Funded Research Organizations (PROs) with Businesses, 46 les Nouvelles (2011).Google Scholar
Börzel, Tanja A. and Risse, Thomas, Public–Private Partnerships: Effective and Legitimate Tools of International Governance?, in Complex Sovereignty: On the Reconstitution of Political Authority in the 21st Century (Grande, Edgar & Pauly, Louis W. eds., 2002).Google Scholar
Boyd, Michael R., The Position of Intellectual Property Rights in Drug Discovery and Development From Natural Products, 51 J. Ethnopharmacology (1996).Google Scholar
Brinkerhoff, Jennifer M., Government-Nonprofit Partnership: A Defining Framework, 22 Public Admin. Dev. (2002).Google Scholar
Brooke, Steve and Vail, Janet G.., Public- and Private-Sector Partnerships in Contraceptive Research and Development: Guiding Principles, 67 Int’l J. of Gynecology and Obstetrics (1999).Google Scholar
Bubela, Tania et al., Recalibrating Intellectual Property Rights to Enhance Translational Research Collaborations, 4 Sci. Translational Med 122, at (2012).Google Scholar
Buse, Kent Buse and Walt, Gill, Global Public–Private Partnerships: Part I - A New Development in Health?, 78 Bull. of the World Health Org. (2000).Google Scholar
Centre for Drug Design & Discovery, What is CD3?, www.cd3.eu/about-cd3/about-cd3what-is-cd3 (last visited Nov. 18, 2017).Google Scholar
Ciccone, Danna Karen, Arguing for a Centralized Coordination Solution to the Public–private Partnership Explosion in Global Health, 17 Glob. Health Promotion (2010).Google Scholar
Chesbrough, Henry, Open Business Models: How to Thrive in the New Innovation Landscape (2006).Google Scholar
Cressey, Daniel, Comment, Animal Research: Battle Scars, 470 Nature (2011).Google Scholar
Denee, Tom et al., Measuring the Value of Public–Private Partnerships in the Pharmaceutical Sciences, 11 Nature Revs. Drug Discovery (2012).Google Scholar
Editorial, Expanding Precompetitive Space, 10 Nature Rev. Drug Discovery (2011).Google Scholar
Editorial, With Strings – Researchers Should Shrug Off Their Fears and Welcome the Concept of Venture Philantrophy, 475 Nature (2011).Google Scholar
Elkins, Sean, Hupcey, Maggie A. Z., and Williams, Antony J. (eds.), Collaborative Computational Technologies for Biomedical Research (John Wiley & Sons, Inc. 2011).Google Scholar
European Commission, Commission Staff Working Document: Accompanying Document to the Proposal for the Council Decision on the Setting Up the Innovative Medicines Initiative Joint Undertaking, SEC(2007) 568 (2007) 28, https://ec.europa.eu/research/jti/pdf/imi_com_sec(2007)0568_en.pdf (last visited Nov. 18, 2017).Google Scholar
European Commission, Commission Staff Working Document: Joint Technology Initiatives: Background, State-of-Play and Main Features, SEC(2007) 692 (2007) 3, 12, https://ec.europa.eu/research/jti/pdf/background_jtis_en.pdf (last visited Nov. 18, 2017).Google Scholar
European Commission, Final Report from the Expert Group on Intellectual Property Valuation, 5, 13 (Nov. 29, 2013), https://ec.europa.eu/research/innovation-union/pdf/Expert_Group_Report_on_Intellectual_Property_Valuation_IP_web_2.pdf (last visited Nov. 18, 2017).Google Scholar
European Commission, Trade Secrets, https://ec.europa.eu/growth/industry/intellectual-property/trade-secrets_en (last visited Nov. 18, 2017).Google Scholar
European IPR Helpdesk, Case Study: Allocation of Shares of Jointly Developed Results, 3 (Feb. 2014), www.iprhelpdesk.eu/sites/default/files/newsdocuments/CS_Allocation_of_shares_of_jointly_developed_results.pdf (last visited Nov. 18, 2017).Google Scholar
European Parliament, Regulation 536/2014 of the European Parliament and of the Council of Apr. 16, 2014, on Clinical Trials on Medical Products for Human Use and Repealing Directive 2001/20/EC, 2014 O.J. (L 158).Google Scholar
Feldman, Robin, The Open Source Biotechnology Movement: Is It Patent Misuse?, 6 Minn. J. L., Sci. & Tech. (2004).Google Scholar
Feldman, Robin and Nelson, Kristopher A., Open Source, Open Access, and Open Transfer: Market Approaches to Research Bottlenecks, 1–2, 7 (May 2, 2008), http://ssrn.com/abstract=1127571.Google Scholar
Food and Drug Admin., Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinial Trial Data Monitoring Committees, ( 2006 ), www.fda.gov/OHRMS/DOCKETS/98fr/01d-0489-gdl0003.pdf (last visited Nov. 18, 2017).Google Scholar
Gilbert, Natasha, Universities Shun Europe’s Drug Initiative, 466 Nature (2010).Google Scholar
Giordano-Coltart, Jennifer and Calkins, Charles W., Best Practices in Patent License Negotiations, 25 Nature Biotechnology (2007).Google Scholar
Goldman, Michel, Comment, Reflections on the Innovative Medicines Initiative, 10 Nature Rev. Drug Discovery (2011).Google Scholar
Goldman, Michel, The Innovative Medicines Initiative: A European Response to the Innovation Challenge, 91 Clinical Pharmacology (2012).Google Scholar
Goldman, Michel, et al., The Innovative Medicines Initiative: An Engine for Regulatory Science, 14 Nature Rev. Drug Discovery (2014).Google Scholar
Gorbatyuk, Arina et al., Intellectual Property Ownership in Coupled Open Innovation Processes, 47 Int’l Rev. of Intell. Prop. and Competition L. (2016).Google Scholar
Hughes, J. P., Rees, S., Kalindjian, S. B. and Philpott, K. L., Principles of Drug Discovery, 162 British J. Pharmacology (2011).Google Scholar
Innovative Medicines Initiative, Bibliometric Analysis of Ongoing Projects: Innovative Medicines Initiative Joint Undertaking (IMI) Third Report, 9 (Oct. 2013), www.imi.europa.eu/sites/default/files/uploads/documents/reference-documents/IMI_BibliometricReport_3.pdf (last visited Nov. 23, 2017).Google Scholar
Innovative Medicines Initiative, Bibliometric Analysis of Ongoing Projects: Innovative Medicines Initiative Joint Undertaking (IMI) Fourth Report, 9–10 (Apr. 2014), www.imi.europa.eu/sites/default/files/uploads/documents/reference-documents/BibliometricReport4_Final.pdf (last visited Nov. 23, 2017).Google Scholar
Innovative Medicines Initiative, Clarification Note to the IMI IP Policy (on file with authors).Google Scholar
Innovative Medicines Initiative, IMI 2 Joint Undertaking, Model Grant Agreement, art. 23(a)–31 (Jan. 12, 2015), www.imi.europa.eu/sites/default/files/uploads/documents/apply-for-funding/call-documents/imi2/h2020-mga-imi_en.pdf (last visited Nov. 23, 2017).Google Scholar
Innovative Medicines Initiative, Governing Board Meeting, Chaired by Dr. Rudolf Strohmeier, Deputy-Director General of Directorate General for Research and Innovation (DG RTD) at the European Council, (Oct. 29, 2013) (notes on file with authors).Google Scholar
Innovative Medicines Initiative, IMI Guidance Note for IMI Applicants and Participants (Nov. 2010), www.imi.europa.eu/sites/default/files/uploads/documents/apply-for-funding/intellectual-property/GuidanceNote_Draft3-1_10Nov2010.pdf (last visited Nov. 23, 2017).Google Scholar
Innovative Medicines Initiative, The Innovative Medicines Initiative (IMI) Strategic Research Agenda: Revision 2011, 3, 10, 25 (June, 16, 2011), www.imi.europa.eu/sites/default/files/uploads/documents/reference-documents/SRArevised2011.pdf (last visited Nov. 23, 2017).Google Scholar
Innovative Medicines Initiative, IMI Intellectual Property Policy, (Jul. 1, 2007), https://ec.europa.eu/research/participants/portal/doc/call/fp7/imi-ju-03–2010/30831-imi-ipr-policy01august2007_en.pdf (last visited Nov. 18, 2017).Google Scholar
Innovative Medicines Initiative, Report of the Independent Expert Panel Accompanying the Commission Report: Assessment of European Innovative Medicines Initiative 2, A Joint Technology Initiative Under Horizon 2020, at 6–7 (Dec. 23, 2012), https://ec.europa.eu/research/health/pdf/imi-ppp-expert-panel-report_en.pdf (last visited Nov. 18, 2017).Google Scholar
Innovative Medicines Initiative, The Innovative Medicines Initiative (IMI) Research Agenda: Creating Biomedical R&D Leadership for Europe to Benefit the Patients and Society, 3, 7 (Feb. 15, 2008), http://rp7.ffg.at/upload/medialibrary/IMI-GB-research-agenda-006v2–15022008.pdf (last visited Nov. 18, 2017).Google Scholar
Intellectual Property Watch, Partnership To Share Research, Keep IP Rights, On Neglected Diseases, ¶ 2, IP-watch.org (Jan. 6, 2011), www.ip-watch.org/2011/06/01/partnership-to-share-research-keep-ip-rights-on-neglected-diseases/ (last visited Nov. 18, 2017).Google Scholar
Kaplan, Warren, Wirtz, Veronika, Mantel, Aukje, Stolk, Pieter, Duthy, Béatrice, and Laing, Richard, World Health Organization, Priority Medicines for Europe and the World 2013 Update, 186–87 (May 6, 2013), http://www.who.int/medicines/areas/priority_medicines/MasterDocJune28_FINAL_Web.pdf (last visited Nov. 18, 2017).Google Scholar
Kelly, Micheál J., Schaan, Jean-Louis and Joncas, Helene, Managing Alliance Relationships: Key Challenges in the Early Stages of Collaboration, 32 R&D Mgmt. (2002).Google Scholar
Kesselheim, Aaron and Shiu, N., The Evolving Role of Biomarker Patents in Personalized Medicine, 95 Clinical Pharmacology Therapeutics (2014).Google Scholar
Kling, Jim, Biotechs Follow Big Pharma Lead Back into Academia, 29 Nature Biotechnology (2011).Google Scholar
Larson, Maja and Chon, Margaret, The Greatest Generational Impact: The Open Neuroscience Movement as an Emerging Knowledge Commons, in Governing Medical Knowledge Commons (Strandburg, Katherine J., Frischmann, Brett M., & Madison, Michael J. eds., 2017).Google Scholar
Leten, Bart, et al., IP Models to Orchestrate Innovation Ecosystems; IMEC, a Public Research Institute in Nano-Electronics, 55 Cal. Mgmt. Rev. (2013).Google Scholar
Lim, Mark D., Consortium Sandbox: Building and Sharing Resources, 6 Sci. Translational Med. (2014).Google Scholar
Macilwain, Colin, Sharing Information Is Preferable to Patenting, 498 Nature (2013).Google Scholar
Mahoney, Richard T., et al., The Introduction of New Vaccines into Developing Countries: IV: Global Access Strategies, 25 Vaccine (2007).Google Scholar
Mectizan Donation Program, www.mectizan.org/ (last visited Sep. 22, 2017).Google Scholar
Melese, Teri, Lin, Salima M., Chang, Julia L. and Cohen, Neal H., Open Innovation Networks Between Academia and Industry: An Imperative for Breakthrough Therapies, 15 Nature Med. (2009).Google Scholar
Merz, Jon F., WHO, Intellectual Property and Product Development Public/Private Partnerships, 7 (May 16, 2005), www.who.int/intellectualproperty/studies/Merz%20WHO%20report.pdf?ua=1 (last visited Nov. 18, 2017).Google Scholar
Mullard, Asher, Could Pharma Open its Drug Freezers, 10 Nature Rev. Drug Discovery (2011).Google Scholar
Munos, Bernard H., Can Open-Source R&D Reinvigorate Drug Research?, 5 Nature Rev. Drug Discovery (2006).Google Scholar
Napa, Jagadeesh, Editorial, Open Source Drug Discovery, Pharma Focus Asia, https://www.pharmafocusasia.com/strategy/open-source-drug-discovery (last visited Nov. 18, 2017).Google Scholar
Passi, Jaakko, Valkokari, Katri, Rantala, Tuija, Nystén-Haarala, Soili, Lee, Nari and Huhtilainen, Laura. Bazaar of Opportunities for New Business Development – Bridging Networked Innovation, Intellectual Property and Business (2013).Google Scholar
Papadaki, Magdalini and Hirsch, Gigi, Curing Consortium Fatigue. 5 Sci. Translational Med. (2013).Google Scholar
Paradiso, Robert J. and Pietrowski, Elizabeth, Dilemmas of Joint Patent Ownership: Provide a Clear Understanding of the Parties’ Expectations, 197 N. J. L. J. (2009).Google Scholar
Pardoe, David A. et al., Assessing the Value of R&D Partnerships, 12 Drug Discovery World 9, ¶ 3 (2010).Google Scholar
Pozen, Robert and Kline, Heather, Defining Success for Translational Research Organizations, 3 Sci. Translational Med. (2011).Google Scholar
Rai, Arti K., Reichman, , Reichmann, Jerome H., Uhlir, Paul F., and Crossman, Colin R., Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery in Gene Patents and Collaborative Licensing Models. Patent Pools, Clearinghouses, Open Source Models and Liability Regimes (Van Overwalle, Geertrui Ed., 2009).Google Scholar
Ridley, Robert G., Putting the Partnership into Public–private Partnerships, 79 Bull. of the World Health Org. (2001).Google Scholar
Simpson, Peter B. and Melvin, Reichman, Comment, Opening the Lead Generation Toolbox, 13 Nature Revs. Drug Discovery (2014).Google Scholar
Son, Seungwoo, Legal Analysis on Public–Private Partnerships Regarding Model PPP Rules, presented at International Colloquium on Public–Private Partnerships (PPPs) in Vienna, 15 (June 2012), www.uncitral.org/pdf/english/colloquia/public-private-partnerships-2013/20120704_Report_on_PPP_legal_IssuesSon_Seungwoover.11.pdf (last visited Nov. 18, 2017).Google Scholar
Southwood, David, Comment, Research Collaboration: When International Partnerships Go Wrong, 488 Nature (2012).Google Scholar
Stevens, Hilde et al., Intellectual Property Policies in Early-Phase Research in Public–Private Partnerships, 34 Nature Biotechnology (2016).Google Scholar
Stevens, Hilde et al., Perspectives and Opportunities for Precompetitive Public–Private Partnerships in the Biomedical Sector, 32 Biotechnology L. Rep. (2013).Google Scholar
Stevens, Hilde, The Role of Intellectual Property in (Precompetitive) Public–Private Partnerships in the Biomedical Sector (2015).Google Scholar
Stevens, Hilde, Huys, Isabelle, Debackere, Koenraad, Goldman, Michel, Stevens, Philip, and Mahoney, Richard T., Vaccines: Accelerating Innovation and Access, WIPO Global Challenges Report (2017).Google Scholar
Stevens, Hilde and Huys, Isabelle, Case study analysis on behalf of IMI JU Executive Office under a service contract procedure: SUMMIT – IMIDIA – Open PHACTS NEWMEDS – eTOX – U-BIOPRED Innovative Medicines Initiative Joint Undertaking (IMI), summary in IMI, Annual Activity Report 2013, 25–27 (Feb. 14, 2014), www.europarl.europa.eu/document/activities/cont/201408/20140818ATT87695/20140818ATT87695EN.pdf.Google Scholar
Stevens, Hilde, Van Overwall, Geertrui, Van Looy, Bart, and Huys, Isabelle, Innovative Medicines Initiative (IMI) Case Study Analysis Reveals the True Added Value of Early-Phase Public–Private Partnerships (PPPs), 34 Biotechnology L. Rep. (2015).Google Scholar
Stolk, Pieter, Background Paper 8.1 Public Private Partnerships, 5, 12, 13 (May 1, 2013), www.who.int/medicines/areas/priority_medicines/BP8_1PPPs.pdf (last visited Nov. 18, 2017).Google Scholar
Strohmeier, Rudolf, et al., IMI Moves Forward, 29 Nature Biotechnology (2011).Google Scholar
Taubman, Antony, Council on Health Research for Development, Public–Private Management of Intellectual Property for Public Health Outcomes in the Developing World: The Lessons of Access Conditions in Research and Development Agreements, 17 (2004), http://announcementsfiles.cohred.org/gfhr_pub/assoc/s14831e/s14831e.pdf (last visited Nov. 18, 2017).Google Scholar
Treaty on European Union, art. 129, Feb. 7, 1992, 1992 O.J. (C 191), 31 I. L. M. 253.Google Scholar
U.N. Millennium Development Goals and Beyond, Goal 8: Develop a Global Partnership for Development, Target 8.E, 2015, www.un.org/millenniumgoals/global.shtml (last visited Nov. 18, 2017).Google Scholar
U.N. Secretary-General, High-Level Panel on Access to Medicines, 13–15, (Sep. 2016), https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d9c6ebf5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf (last visited Nov. 18, 2017).Google Scholar
U.N. Sustainable Development, Sustainable Development Goal 3, https://sustainabledevelopment.un.org/sdg3 (last visited Nov. 18, 2017).Google Scholar
U.N. Sustainable Development, Sustainable Development Goal 17, www.un.org/sustainabledevelopment/globalpartnerships/ (last visited Nov. 18, 2017).Google Scholar
Van Overwalle, Geertrui, Exclusive Ownership Versus Open Commons: The Case of Gene Patents, 4 The WIPO J. (2013).Google Scholar
Van Overwalle, Geertrui, Inventing Inclusive Patents. From Old to New Open Innovation, in Kritika-Essays on Intellectual Property, Vol. 1 (Drahos, Peter et al. eds., Edward Elgar 2015).Google Scholar
Van Overwalle, Geertrui, Of Thickets, Blocks, and Gaps. Designing Tools to Resolve Obstacles in the Gene Patents Landscape, in Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models and Liability Regimes (Geertrui Van Overwalle ed. 2009 ).Google Scholar
Van Looy, Bart, Landoni, Paolo, Callaert, Julie, Pottelsberghe, Brunovan, Sapsalis, Eleftherios, and Debackere, Koenraad, Entrepreneurial Effectiveness of European Universities: An Empirical Assessment of Antecedents and Trade-Offs, 40 Res. Pol’y (2011).Google Scholar
Vargas, Gabriel, Boutouyrie, B., Ostrowitzki, S., and Santarelli, L., Arguments Against Precompetitive Collaboration, 87 Clinical Pharmacology & Therapeautics (2010).Google Scholar
Wagner, Janet A., Prince, M., Wright, E.C., Ennis, M. M., Kochan, J., Nunez, D. J. R., Schneider, B., Wang, M.-D., Chen, Y., Ghosh, S., Musser, B. J., and Vassileva, M. T., The Biomarkers Consortium: Practice and Pitfalls of Open-Source Precompetitive Collaboration, 87 Clinical Pharmacology & Therapeutics (2010).Google Scholar
Widdus, Roy, Public–Private Partnership, 99 Transactions of the Royal Soc’y Tropical Med. & Hygiene (Supp.1 2005).Google Scholar
Widdus, Roy, Public–Private Partnerships for Health: Their Main Targets, Their Diversity, and Their Future Directions, 79 Bull. of the World Health Org. (2001).Google Scholar
Williams, R. Sanders and Desmond-Hellman, Susan, Making Translation Work, 332 Science (2011)Google Scholar
Woodcock, Janet, Precompetitive Research: A New Prescription for Drug Development?, 87 Clinical Pharmacology & Therapeutics (2010).Google Scholar
World Health Organization, Health in 2015: from MDGs, Millennium Development Goals to SDGs, Sustainable Development Goals, 28 (2015), www.who.int/gho/publications/mdgs-sdgs/en/ (last visited Nov. 23, 2017).Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×