“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

rai@law.duke.edurai@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

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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)