“open and collaborative” research: a new model for biomedicine arti k. rai professor, duke law...
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“Open and Collaborative” Research: A New Model for
BiomedicineArti K. Rai Arti K. Rai
Professor, Duke Law SchoolProfessor, Duke Law School
January 11, 2005January 11, 2005
[email protected]@law.duke.edu
Biology Research: A Simplified History
Until late 1970s, molecular biology not applicable Until late 1970s, molecular biology not applicable commercially commercially
Few IPRsFew IPRs But secrecy: fierce competition among small labs But secrecy: fierce competition among small labs
for publication priority for publication priority 1966: only 45% of biologists felt comfortable 1966: only 45% of biologists felt comfortable
talking outside lab (Walsh & Hong 2003)talking outside lab (Walsh & Hong 2003) Higher percentage than other sciences (cf. Merton Higher percentage than other sciences (cf. Merton
– communal production in prestige economy – communal production in prestige economy should lead to great openness)should lead to great openness)
The Move Towards Proprietary Rights in Research Molecular biology becomes commercially Molecular biology becomes commercially
appealing appealing Bayh-Dole encourages university patenting Bayh-Dole encourages university patenting
and exclusive licensing for purposes of and exclusive licensing for purposes of commercialization commercialization
Court of Appeals for the Federal CircuitCourt of Appeals for the Federal Circuit
Figure 2: University Patenting in Biotech: 1980-2000
0
200
400
600
800
1000
1200
1400
1980 1985 1990 1995 2000
Issue Year
Nu
mb
er
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
Sh
are
Total University Biotech Patents (Left Axis) University Share of All Biotech Patents (Right Axis)
University Biotechnology Patents: 1980-2000
Current Complaints
Some broad patents, exclusive licensingSome broad patents, exclusive licensing Possible “thickets” (Heller & Eisenberg Possible “thickets” (Heller & Eisenberg
1998)1998) Increasing secrecy? (Campbell et al. 2002) Increasing secrecy? (Campbell et al. 2002) NIH, NRC emphasize accessNIH, NRC emphasize access
Beyond Access:”Open and Collaborative” Production Disavows exclusionary IPRs Disavows exclusionary IPRs and and focus on focus on
individual small labindividual small lab Influenced by model of OS software (took Influenced by model of OS software (took
root when CS/cyberinfrastructure migrated root when CS/cyberinfrastructure migrated to biology)to biology)
Another foil: high energy physicsAnother foil: high energy physics
OS Production of Software: History Some roots in academic/Mertonian modes Some roots in academic/Mertonian modes
of production of production But always had explicit mechanisms for But always had explicit mechanisms for
information information integration integration
OS Software Now
Heterogeneous: 80,000 or so projectsHeterogeneous: 80,000 or so projects Most OS projects Most OS projects don’tdon’t occur in academic sector occur in academic sector
(intrinsic and extrinsic motivations well beyond (intrinsic and extrinsic motivations well beyond Merton)Merton)
Commercial firms make profits on complementary Commercial firms make profits on complementary servicesservices
But But biomedical researchbiomedical research inspired by OS model inspired by OS model often occurs in academia (though more often occurs in academia (though more hierarchy/integration than Merton) hierarchy/integration than Merton)
Categories of OC Biomed Research Highly modular: open source Highly modular: open source
bioinformatics softwarebioinformatics software Modular: genomic databasesModular: genomic databases Beyond modular information: wet labsBeyond modular information: wet labs
Empirical Project Thus Far
Semi-structured interviews of scientists Semi-structured interviews of scientists involved in OC work (snowball sampling)involved in OC work (snowball sampling)
Ask corresponding university tech transfer Ask corresponding university tech transfer officers about projectsofficers about projects
Interviewing tech transfer officers of “top” Interviewing tech transfer officers of “top” biotech, software patentees and recipients biotech, software patentees and recipients of NIH funding about OS software of NIH funding about OS software
OS Software Projects
www.bioinformatics.orgwww.bioinformatics.org (195 projects) (195 projects) Most licenses not “plain vanilla” GPL (as Most licenses not “plain vanilla” GPL (as
contrasted with 72% at Sourceforge)contrasted with 72% at Sourceforge) Cf. Lerner and Tirole (the scope of Open Cf. Lerner and Tirole (the scope of Open
Source)Source)
Policies of TTOs
Not much software patenting by universities Not much software patenting by universities (Drop from 1% to 0.6% of total in period from (Drop from 1% to 0.6% of total in period from 1980 to 2000?)1980 to 2000?)
Cultural differences: software vs. biologyCultural differences: software vs. biology Some TTOs in midst of formulating policySome TTOs in midst of formulating policy Others in “don’t ask, don’t tell” modeOthers in “don’t ask, don’t tell” mode MIT, Stanford, UT report deference to researchersMIT, Stanford, UT report deference to researchers Cf. University of Washington, Georgia StateCf. University of Washington, Georgia State
Genomic Databases
Human Genome Database paves way Human Genome Database paves way (copyleft vs. public domain)(copyleft vs. public domain)
Better sequencing machines improve Better sequencing machines improve modularitymodularity
Feb. 2003: principles extended to all Feb. 2003: principles extended to all genome sequencing projectsgenome sequencing projects
Collaborative improvement through DASCollaborative improvement through DAS Policy imposed on TTOsPolicy imposed on TTOs
International HapMap Project
Aims to catalogue patterns of genotypic variation Aims to catalogue patterns of genotypic variation (“haplotypes”) (“haplotypes”)
Achieve association of haplotypes with complex Achieve association of haplotypes with complex diseasedisease
HapMap Data Access Policy: copyleft model HapMap Data Access Policy: copyleft model (until recently)(until recently)
Until haplotypes determined and released, access Until haplotypes determined and released, access to individual genotype information conditioned on to individual genotype information conditioned on not using it to seek patents on haplotypes not using it to seek patents on haplotypes
“Wet Lab” Biology
Work often not modular (in case of AFCS, Work often not modular (in case of AFCS, “vast uncharted territory”)“vast uncharted territory”)
Harder to see translationHarder to see translation
AFCS
8 labs: 7 “wet labs,” 1 bioinformatics lab8 labs: 7 “wet labs,” 1 bioinformatics lab ““High-throughput” analysis of how cells High-throughput” analysis of how cells
respond to different chemicals respond to different chemicals Labs use same inputs, analyze different Labs use same inputs, analyze different
types of outputstypes of outputs Much work has gone into standardization of Much work has gone into standardization of
inputsinputs But work is still highly interdependentBut work is still highly interdependent
IPRs and Publication
Al Gilman required disavowal of all IPRsAl Gilman required disavowal of all IPRs Reluctance on part of participating TTOs Reluctance on part of participating TTOs Research reports published on Web after Research reports published on Web after
limited peer reviewlimited peer review
Evaluation: Software
Arguments for and against OS software Arguments for and against OS software (and public funding thereof)(and public funding thereof)
WMEABAS and transaction costsWMEABAS and transaction costs But modularity itself should reduce such But modularity itself should reduce such
costs somewhat (markets for technology)costs somewhat (markets for technology) Need for viral licensing unclearNeed for viral licensing unclear Universities won’t get involved unless lots Universities won’t get involved unless lots
of consulting revenuesof consulting revenues
Evaluation: Databases
Need for some (significant?) public funding Need for some (significant?) public funding to create databaseto create database
Agency pressure neededAgency pressure needed DAS and transaction cost reduction?DAS and transaction cost reduction? Transaction cost reduction for downstream Transaction cost reduction for downstream
players (e.g. pharma)? players (e.g. pharma)? Viral licensing could be problematic Viral licensing could be problematic Shows need for research exemption? Shows need for research exemption?
Evaluation: Wet Lab
Very significant coordination, funding needed; Very significant coordination, funding needed; limits on number of participantslimits on number of participants
But systems biology probably require resources of But systems biology probably require resources of more than one small labmore than one small lab
Lack of systems biology knowledge may be why Lack of systems biology knowledge may be why drugs are failingdrugs are failing
Disavowal of future IPRs may Disavowal of future IPRs may substantially substantially reduce transaction costs for collaborations in reduce transaction costs for collaborations in inchoate areas inchoate areas
Transaction Cost Problems
Complex non-disclosure agreements to prevent Complex non-disclosure agreements to prevent information leakageinformation leakage
Arguments about ownership of future discoveries Arguments about ownership of future discoveries in inchoate areasin inchoate areas
Default ownership rules in patent area unattractiveDefault ownership rules in patent area unattractive But default rules “information forcing,” avoid But default rules “information forcing,” avoid
anticommons; changes could be problematicanticommons; changes could be problematic AFCS vs. Cell Migration ConsortiumAFCS vs. Cell Migration Consortium
Viral Licensing, Incentives, and IPRs Viral licensing could be very problematic Viral licensing could be very problematic Insufficient incentives for young data generators?Insufficient incentives for young data generators? Move towards conventional publication? Move towards conventional publication? Should be able to publish based on publicly Should be able to publish based on publicly
available dataavailable data Long-term: publish first, peer review later? Long-term: publish first, peer review later?
(arXiv.org model)(arXiv.org model) Very hard to get universities to disavow IPRsVery hard to get universities to disavow IPRs
Conclusion
For modular information, OC may reduce For modular information, OC may reduce transaction costs to some extenttransaction costs to some extent
For “inchoate” wet lab biology, OC may For “inchoate” wet lab biology, OC may substantially reduce such costssubstantially reduce such costs
Institutional obstacles in both cases (greater Institutional obstacles in both cases (greater in latter case)in latter case)