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Contracting to Preserve Open Science: Lessons for a Microbial Research
Commons
Contracting to Preserve Open Science: Lessons for a Microbial Research
Commons
Prof. Peter LeeUC Davis School of Law
October 8, [email protected]
Prof. Peter LeeUC Davis School of Law
October 8, [email protected]
AgendaAgenda
• Present ongoing research on private ordering to promote “open science”
• Apply lessons to designing a microbial research commons
• Explore additional design principles and considerations
ContextContext• Ongoing research on the role of “public institutions” in creating a
noncommercial research commons in biomedicine
Public Norms
Private ordering
Intellectual PropertyIntellectual Property
Physical PropertyPhysical Property
Research CommonsResearch Commons
Proprietary Scientific Inputs and Research Holdup
Proprietary Scientific Inputs and Research Holdup
• Patented biomedical research tools
Patented Research Tool
Patented Research Tool
ResearchResearch
ResearchResearch
ApplicationApplication
ApplicationApplication
ApplicationApplication
ApplicationApplication
The Challenge of Appropriate Access to Biomedical Research Tools
The Challenge of Appropriate Access to Biomedical Research Tools
• Wide access to research tools generates significant positive externalities
Commit research tools to the public domain?
• Many research tools are dual status inventions:– Aids in basic research– Commercial products or commercial precursors
Create a mediated semicommons• Traditional policy levers (legislation, judicial reform,
regulation) are inadequate
Private Ordering to Resolve Property-Based Holdup
Private Ordering to Resolve Property-Based Holdup
• Collective rights organizations• Cross-licensing and patent pools• Open source licensing
NormsContracts
NormsContracts Access
Disease Advocacy Groups
Disease Advocacy Groups
“Public” Institutions Engaged in “Private” Ordering
“Public” Institutions Engaged in “Private” Ordering
National Institutes of Health
National Institutes of Health
State Funding Agencies
State Funding Agencies
UniversitiesUniversities
Nonprofit Funding Organizations
Nonprofit Funding Organizations
Biomedical research commons
Biomedical research commons
The National Institutes of HealthThe National Institutes of Health
• $30 billion per year in research funds– Bayh-Dole Act– Principles and Guidelines (1999)
• Advocate wide availability of patented research tools for noncommercial uses
• Allow targeted exclusivity for commercial development– Compliance considered in awarding grants
NIHNIH
Resource DeveloperResource Developer
Consideration Qualified Access
The California Institute for Regenerative Medicine
The California Institute for Regenerative Medicine
• $3 billion over 10 years for stem cell research• Access requirements
– “A Grantee Organization agrees to make its CIRM-funded patented inventions readily accessible on reasonable terms . . . to other Grantee Organizations for non-commercial purposes.”
• CAL. CODE REGS. tit. 17, § 100306(a)– Grantees must make materials described in a
scientific publication widely available• CAL. CODE REGS. tit. 17, § 100304
The California Institute for Regenerative Medicine
The California Institute for Regenerative Medicine
• Commercialization of CIRM-funded inventions is encouraged– CIRM collects “proportionate” royalties– If multiple funding sources contributed to an
invention, the state is entitled to a share “proportionate to the support provided by CIRM for the discovery of the invention.”
• CAL. CODE REGS. tit. 17, § 100308(c)
UniversitiesUniversities
• Major contributors to biomedical research• Promoting open science in technology
transfer licenses– “Harvard will retain the right, for itself and other
not-for-profit research organizations, to practice the subject matter of the patent rights for internal research, teaching and other educational purposes.”
• Licensing Harvard Patent Rights: A Guideline to the Essentials of Harvard’s License Agreements
UniversitiesUniversities
• Systematic overvaluation of assets– 1991-2000: 238% increase in new patent
applications– Median net licensing income for research
institutions: $1.13 million– Hit or miss (largely miss)
• Normative plurality– Among universities– Within universities
• Research faculties, individual scientists• Offices of technology transfer
Non-Profit Funding OrganizationsNon-Profit Funding Organizations
• Significant sources of “scientific venture capital”
• Howard Hughes Medical Institute– HHMI “expects all HHMI research tools to be
made available to the scientific research community on reasonable terms and in a manner that enhances their widespread availability.”
• HHMI, Research Tools (SC-310), at 1– Consistent with NIH Principles and Guidelines
Contracting to Preserve Open Science
Contracting to Preserve Open Science
• Formalizing the informal norm of open science• Public institutions are engaged in private
ordering• Leveraging upstream scientific capital to
ensure access to proprietary research assets
AgendaAgenda
• Present ongoing research on private ordering to promote “open science”
• Apply lessons to designing a microbial research commons
• Explore additional design principles and considerations
Lessons for a Microbial Research Commons
Lessons for a Microbial Research Commons
• Integrated access to intellectual and physical property– Even pre-commercial assets are patented– Patent rights may need to be cleared in addition
to obtaining physical materials
Lessons for a Microbial Research Commons
Lessons for a Microbial Research Commons
• Formalizing informal norms: authority and process– Who speaks for the scientific community?– How does a community arrive at normative
consensus?– NIH Principles and Guidelines
• Thorough consultative process• Notice and comment
• Institutional buy-in– Normative plurality among and within institutions
Lessons for a Microbial Research Commons
Lessons for a Microbial Research Commons
• Encouraging participation– Systematic overvaluing of assets– Leverage upstream “public scientific capital” to
mandate or encourage compliance with access objectives
• Government agencies, universities, private foundations, scientific journals
Public Institutions
Public Institutions
Downstream Owners
Downstream Owners
Consideration QualifiedAccess
Lessons for a Microbial Research Commons
Lessons for a Microbial Research Commons
• Experience with dual-purpose assets– Noncommercial research use– Commercial application
• Apportioning upstream/downstream contributions and calculating appropriate compensation
• CIRM’s proportionality principle A BC
D?
Lessons for a Microbial Research Commons
Lessons for a Microbial Research Commons
• Institutional considerations– The need for centralized coordination and
standardization• Lower information and transaction costs
– The role of NIH or a similarly situated body– International challenges
AgendaAgenda
• Present ongoing research on private ordering to promote “open science”
• Apply lessons to designing a microbial research commons
• Explore additional design principles and considerations
The Cooperative Research GoalThe Cooperative Research Goal
• Incentives to share– Benefits: communal norms as well as self-interest
• Patent pools in the software industry– Costs: education about the expected value of
microbial assets• Distributing duplicates and derivatives
– Open source/viral licenses for microbes
Maintaining High Quality Standards
Maintaining High Quality Standards
• Enormous governance issues• Need for institutional leadership and
community consensus– Define standards– Assign monitoring responsibility– Delineate sanctions
Promoting Reputational BenefitsPromoting Reputational Benefits
• Critical to the “normative economy”• A response to the incentives question
– Participate to establish priority, increase citations, and obtain recognition
• Carrots and sticks– A community of strangers– Cultivating trust and identifying bad actors– User-generated ratings
• Distributed accreditation and “peer review”
Securing Equitable CompensationSecuring Equitable Compensation
• Challenges of liability rule regimes– Valuation and apportionment– Who determines “equitable compensation”?– How is a reasonable royalty calculated?
• Eliminating or mitigating the threat of exit– Ex ante commitments versus ex post profitability
• Looking forward: commercialization and patenting– Structured rules for recipients to inform providers
of patenting plans
SummarySummary
• The microbial research commons is eminently feasible and can benefit from related experiences– Multiple purpose assets– Integrate intellectual, physical, and informational
resources• Leveraging public norms and private ordering
– Formalizing an informal ethos of sharing• Institutional challenges and opportunities
– Standardization– Coordination– Determining equitable compensation
QuestionsQuestions