Models for Change

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• Proprietary challenges in science: Prior working group efforts
• National Research Council (US) Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health. (2003) A marker in time that looks at the state of genomic and proteomic research and the current policies and practices promoting or restricting the dissemination of scientific information, tools, and products, and asks, “are there any storms over the horizon?”
• AUTM. In the public interest: Nine points to consider in licensing university technology (2007)
  This document reflects recommendations to assess licensing opportunities individually, and in a manner that reflects the ‘business needs and values of the institution, but at the same time, to the extent appropriate, also to bear in mind the concepts articulated herein when crafting agreements with industry.’
• Hunt P. Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines. (2008)  Section I discusses the importance of effective, transparent, accessible and independent accountability mechanisms in relation to the right to the highest attainable standard of health. Section II and the annex to the present report, containing the Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines, which set out the human rights responsibilities of pharmaceutical companies in that context. The Guidelines consider issues such as transparency, management, accountability, patents, licensing and pricing.
• The International Expert Group on Biotechnology, Innovation and Intellectual Property. Toward a New Era of Intellectual Property: From Confrontation to Negotiation. (Sept 2008) The members of the group provide an overview of their research findings, and more importantly, practical recommendations that respond to the critical need to develop policy tools and approaches to manage the transition from Old IP to New IP.
• Who Owns Science? The Manchester Manifesto. (2009) A consensus statement “on the issues, the problems and dangers, the opportunities and hopefully also some of the solutions which will enable science and innovation to flourish in ways compatible with human progress… and global justice.” This was followed by a second meeting in January 2009 and subsequent drafting and circulation of the Manifesto text, which was finalized and published in November 2009, with fifty signatories from the ‘Manifesto Group’.
• STEPS Centre. Innovation, Sustainability, Development: A New Manifesto. (2010) The authors argue that a radical shift is necessary in the way we approach innovation in order to solve many of the world’s existing and incipient challenges. At the heart of such a shift in global innovation agenda is a greater respect for cultural variety, regional diversity, and democratic accountability. The authors consider the issues and make recommendations for improvement.
• Singapore Statement on Research Integrity (2010)
  An international consensus document setting out principles and responsibilities for enhancing research integrity worldwide.
• National Research Council (US) Committee on Management of University Intellectual Property. Managing University Intellectual Property in the Public Interest (Oct 2010) See also: Summary
  The NRCs Board on Science, Technology and Law–supported by ten private foundations convened a group of experts from universities, industry, foundations, etc., to address a series of questions related to managing intellectual property in universities on the 30th anniversary of the Bayh-Dole act.  This document reports the committee’s findings.  The principal findings and recommendations are also outlined in a the 13-page summary document.
• Data Sharing and Materials Sharing: Proposals/policies/guidelines affirming principles in support of the rapid data release and (minimally-constrained) access, including to pre-publication data.
• Community-based agreements, e.g.,
• Bermuda principles (1996, 1997)Agreement among researchers involved in sequencing the human genome made at a meeting in Bermuda in 1996.  The group enunciated principles of rapid data release and public access to the primary genomic sequence.  These principles were reaffirmed and necessary steps for scientists and funders to ensure adherence to the principles were identified at a second meeting in 1997.
• Sharing Data from Large-scale Biological Research Projects (Fort Lauderdale Agreement, 2003)  Wellcome Trust sponsored this meeting to discuss pre-publication data release in the field of genomics. Attendees were in broad agreement that a tripartite system (sequence users, sequence producers, funders) of responsibility to encourage the continuation of the benefits of sharing was necessary.
• Hinxton Group. Consensus Statement on Transnational Cooperation in Stem Cell Research. (2006) “Insofar as hESC lines are a precious resource and replication and scientific collaboration are vital to scientific advancement, we encourage scientists conducting stem cell research to submit any stem cell lines they derive to national or international depositories that subscribe to internationally accepted standards of quality and make cell lines and data (e.g. DNA fingerprinting and microsatellite data) publicly available.”
• Bamako data sharing code of conduct (2008)  The WHO and several funders led by the Wellcome Trust supported the development of this code of conduct to encourage greater sharing of public health data.
• The Toronto Statement (2009) Attendees at the Toronto International Data Release Workshop recommend extending the rapid release of prepublication data (that has served the field of genomics well) to other biological data sets.
• Rome Agreement (2009) Post publication sharing of data and tools.
• International Agreements
• Trade-Related Aspects of Intellectual Property Rights (TRIPS)
• Doha Declaration on the TRIPS agreement and Public Health
  The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health In the declaration, ministers stress that it is important to implement and interpret the TRIPS Agreement in a way that supports public health — by promoting both access to existing medicines and the creation of new medicines.
• TRIPS-Plus (e.g., US Trade Representative (USTR) – Free Trade Agreements (FTAs)
• Organization for Economic Cooperation and Development (OECD)
• Funding Agency sharing policies, e.g.,
• NIH
• MRC
• BBSRC
• Wellcome Trust
• Gates sharing principles; Doris Duke
• Licensing guidelines
• NIH policies on research tools (1999)
• NIH “best practices” for licensing genomic inventions (2004)
• OECD guidelines for licensing genetic inventions (2006)
• “Nine Points” re licensing of university-based inventions
• Research Consortia, e.g.,
• Encyclopedia of DNA Elements (ENCODE – NHGRI)
• MalariaGEN – identify the genetic variants that confer protection against or increase susceptibility to the onset of severe malaria
• Collaborative Drug Discovery CDD Public – As a service to the community, CDD hosts Public Access Data relevant to drug discovery from leading research groups around the world. Scientists who wish to view or mine CDD’s repository of Public Access Data can register for a free account.
• The Sage Commons – will be a revolutionary accessible platform to define the molecular basis of disease and guide the development of effective human therapeutics and diagnostics
• CASIMIR (Coordination and Sustainability of International Mouse Informatics Resources): provides for co-ordination and integration of databases containing experimental data, including sequences, and material resources such as biological collections, relevant to the use of the mouse as a model organism for human disease.
• Zinc Finger Consortium (Chandrasekharanetal_NBT_2009) Established to ensure and promote continued research and development of engineered zinc finger technology.
• Journals – policies for sharing publication related data and materials
• Sharing Publication-Related Data and Materials (NAS) – the act of publishing is a quid pro quo in which authors receive credit and acknowledgment in exchange for disclosure of their scientific findings. An author’s obligation is not only to release data and materials to enable others to verify or replicate published findings (as journals already implicitly or explicitly require) but also to provide them in a form on which other scientists can build with further research.
• Conditions for publication: that authors share all relevant data, protocols and materials with readers, e.g., without undue qualifications (Nature) or with any restrictions disclosed in advance (Science)
• Open access to publications
• NIH publication access policy
• Open access journals (e.g., PLoS, etc.)
• Repositories and Banks – e.g.:
• International stem cell registries (Borstlap, et al., 2010)
• European hES Cell Registry
• Registry of hES Cell Line Provenance developed by the International Society for Stem Cell Research
• International Stem Cell Registry of hESC and iPSC lines established at the University of Massachusetts Medical School
• UKSCB – (free of charge, for now, w/MTA) (Glyn Stacey)
• Other areas of science
• Coriell Institute — By combining a functioning biobank facility with modern microarray technology, Coriell has created the ideal environment for the innovative Coriell Personalized Medicine Collaborative™project–a forward-thinking, collaborative effort involving volunteers, physicians, scientists, ethicists, genetic counselors and information technology experts whose goal is to better understand the impact of genome-informed medicine and to guide its ethical, legal and responsible implementation.
• Addgene Addgene is a non-profit organization operating a plasmid repository for the research community.
• IP Rights
• Reforms of patent law or patent office rules & procedures
• subject matter exemptions to render certain types of inventions to the public domain
• example: A strategy for energy innovation – making greenhouse gas reduction a public good
• Provisional Patented Paper Application procedure – PPPAs may promote earlier and fuller disclosures of novel scientific knowledge and provide an ample justification for requiring patentees to grant inexpensive licenses for use of their inventions by other parties conducting research, while protecting the integrity of patents and IPR.
• Regulatory review “voucher” idea to create incentives for developing-world applications (Ridley, Grabowski, et al., Health Affairs)
• Ad hoc or “commons” based redistributive mechanisms – generally create single clearings at specific points in the existing thicket (Bergman and Graff, 2007) also (Bergman and Graff)
• Compulsory licenses: Suffers from political and economic limitations, some have argued that while the NIH did not use its right under Bayh-Dole to request compulsory licensing of the WARF patents given that it had funded some of the work, having the right gave the agency some leverage. This created an opening, leading, at least in part, to the WiCell MOU for academic institutions.
• Open source licenses: still needs to prove itself to be a viable model. It is difficult to imagine it ever being cost effective, given the costs incurred in seeking patent protection of improvements, only to then give it back to the open source “collective”. Similar results may be possible at a fraction of the cost by publishing the improvement and placing it in the public domain.
• caBIG –The mission is to develop a collaborative information network that accelerates the discovery of new approaches for the detection, diagnosis, treatment and prevention of cancer.  The initiative operates through an open development community. (sponsored by NCI)
• Creative Commons – making it easier for people to share and build upon the work of others, consistent with the rules of copyright
• Mozilla: Mozilla’s mission is to promote openness, innovation, and opportunity on the web, using a community-based approach to create open source software and develop new types of collaborative activities.
• Open invention network (Linux): an intellectual property company that was formed to promote Linux by using patents to create a collaborative environment; Patents owned by Open Invention Network are available royalty-free to any company, institution or individual that agrees not to assert its patents against the Linux System.
• BiOS: BiOS is a response to inequities in food security, nutrition, health, natural resource management and energy; promote an innovation paradigm that focuses on a distinction between the tools of innovation and the products. We promote licenses that couple rights with responsibilities to foster efficient development, improvement, sharing and use of technology.
• Standard-setting, product-specific, or technology-based patent pools:
  Patent pooling may make the most sense in stem cells. However, in such a rapidly evolving field it will be difficult to define the “standards” around which to build a potential pool.
• UNITAID Medicines Patent Pool Initiative
• Pool for open innovation against neglected tropical diseases (Glaxo – centre of excellence for external drug discovery – ceedd )
• PIPRA – make it easy for developing countries to access new technologies
• Problems in constructing pools
• Valuation of IP that goes into the pool
• Validation of IP that goes into the pool (invalid claims are poison)
• Sufficient commonality of interests among patent-holders?
• Market based redistributive mechanisms – facilitate access to a wider range of proprietary technologies by managing or mediating market transactions of technologies or rights
• An IP clearinghouse mechanism for stem cells: a royalties allocation mechanism efficiently compensating rights holders for non-exclusive uses of proprietary technologies.
• Internet-based IP exchanges: Websites that aggregate and offer services surrounding existing technology that is available for licensing
• MPEG-LA effort to construct “supermarket” for nonexclusively licensing gene-based IP
• others
• Integrated Approaches
• Efficient progress of ethically accountable stem cell research requires considerations that span the complexities and bottlenecks across domains. They propose four specific actions for stem cell policy: (Winickoff, et al., 2009)
• Lead the development of practical common norms
• Require access in research contracts
• Build a common data resource
• Foster further collection action
• Cambia democratize innovation: to create a more equitable and inclusive capability to solve problems using science and technology.
• Initiative for Open Innovation (IOI)
• Patent Lens – easy access to international patent databases
• CambiaLabs: Invents and shares enabling technologies in the life sciences
• Public-private partnerships (PPP)/Strategic alliances (see PPP analysis by Herder via TIP)
• Innovative Medicines Initiative (IMI) (Jim Houlihan – UKPTO)
• IMI is a Joint Undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
• Supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe
• Stem Cells for Safer Medicines, (SC4SM) an independent not-for-profit company founded via a consortium. To enable the creation of a bank of stem cells, open protocols and standardised systems in stem cell technology that will enable consistent differentiation of stem cells into stable homogenous populations of particular cell types, with physiologically relevant phenotypes suitable for toxicology testing in high throughput platforms.
• The Biomarkers Consortium is a public-private biomedical research partnership of the Foundation for the National Institutes of Health, Inc. that involves a variety of public and private stakeholders including the National Institutes of Health (NIH); Food and Drug Administration (FDA); Centers for Medicare & Medicaid Services (CMS); the pharmaceutical, biotechnology, diagnostics, and medical device industries; non-profit
• Alzheimer’s Disease Neuroimaging Initiative (ADNI): large, collaborative project in which all agreed to share all the data, making every single finding public immediately, available to anyone with a computer anywhere in the world.
• Regenerative Medicine Consortium (CIRM): Provide a forum for the discussion of areas of mutual interest to the FDA and the RMC in order to shape and advance clear regulatory pathways for novel technologies; sharing of best practices and resources
• Structural genomics consortium (SGC – 2004): a public-private partnership whose mandate is to promote the development of new medicines by carrying out basic science of relevance to drug discovery and placing all information, reagents and know-how into the public domain without restriction.
• International AIDS Vaccine Initiative (IAVI 1996): core mission is to support in every way the development of preventive AIDS vaccines that are not only safe and effective, but also accessible to all people; IAVI invests the bulk of its resources in the research and clinical assessment of candidate vaccines
• Rare diseases
• Drugs for Neglected Diseases Initiative (DNDi 2003-): Seeks to improve the quality of life and the health of people suffering from neglected diseases by using an alternative model to develop drugs for these diseases and by ensuring equitable access to new and field-relevant health tools
• ChEMBL-NTD Neglected Tropical Disease Archive – Open access primary screening and medicinal chemistry data directed at neglected diseases
• Prize-based mechanisms (Crowdsourcing, challenges, contests, and open innovation prizes, etc).
• Health Impact Fund–Incentives for Global Health (IGH) – is an optional mechanism that offers pharmaceutical innovators a supplementary reward based on the health impact of their products, if they agree to sell those products at cost. The proposed Fund is to be financed mainly by governments.
• US federally funded catalogue of challenges – rewards for solutions–www.challenge.gov
• Prizes for health innovation: (Hynek, 2008) Proposes a program of voluntary Open Science Prizes that would draw large numbers of new players, who would in turn produce much new medical innovation, provide academic priority recognition, and develop a growing body of patent-beating prior art that would serve as public domain firewalls on a new supranational Hyper-Commons.