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Genomics and World Genomics and World Health: Navigating the Health: Navigating the
Information JungleInformation Jungle
From DNA Sequence to Human From DNA Sequence to Human WelfareWelfare
Sources: World Development Report 1993 (World Bank); World Health Organization 1990
Percent of population over 65
Sources of Health R&D Funding 1998
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
Government, advanced andtransition economies
Government, developingeconomies
Private pharmacueticalR&D
Private nonprofit
Source: Global Forum for Health ResearchMonitoring Financial Flows for Health Research 2001
Health Research Health Research FundingFunding
19407%
38%
55%
1965
68%
8%
24%
1998
46%
5%
49%
Industry
Philanthropy
Government
0
100
200
300
400
500
600
700
USA
Japa
n UKGerm
any
Canada EC
Netherl
ands
France
Sweden
SNP Con
sortiu
m
China
Russia
Korea
Estonia
Belgium
Austra
lia
Government-nonprofit Genomics Research Funding 2000($ million)
Genomics Funding: Genomics Funding: private>publicprivate>public(Year 2000)(Year 2000)
Genomics research funding($ million US)
1,653
2,061
900
0
500
1,000
1,500
2,000
2,500
Gov&nonprofit Genomics firms Pharma&biotech
Source: World Survey of Funding for Genomics ResearchStanford in Washington Programhttp://www.stanford.edu/class/siw198q/websites/genomics/
Government-nonprofit Genomics Funding per GDP(times 1000)
0.000
0.050
0.100
0.150
0.200
0.250
0.300
0.350
0.400
0.450
0.500
Estonia UK
Sweden
Netherl
ands
Japa
nGerm
any
USAFran
ceBelg
ium EC
Korea
Canad
aRus
siaAus
tralia
China
Genomics firms with publicly traded stock
0
20
40
60
80
Year# firms 8 10 14 19 25 28 73
1994 1995 1996 1997 1998 1999 2000
0102030405060708090
100
1994 1996 1998 2000
$B market value
Data through Year 2000Market Cap figures for end of yearNumber of firms at end of each year
Growth of Commercial Genomics
R&D v Market CapR&D v Market CapSum of R&D Expenditures for 15 Genomics Firms
-
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2000 2001 2002
Year
R&D
(Mill
ion
US$)
-
10,000
20,000
30,000
40,000
50,000
60,000
Mar
ket C
ap (M
illio
n U
S$)
Total R&D ExpendituresTotal Market Cap
Number of Patents Retrieved by the Search Algorithm vs. Year of Issue
0
500
1000
1500
2000
2500
3000
3500
4000
4500
500019
7119
7219
7319
7419
7519
7619
7719
7819
7919
8019
8119
8219
8319
8419
8519
8619
8719
8819
8919
9019
9119
9219
9319
9419
9519
9619
9719
9819
9920
0020
0120
0220
03
Year of Issue
Num
ber o
f Pat
ents
Ret
rieve
d by
the
Sear
ch A
lgor
ithm
Source: Io Nami-Wolk and LeRoy Walters, DNA Patent Database, February 2004
Preliminary Data about the 30 Entities Holding the Largest Numbers of DNA-Based Patents (as of 02-05-04)
0 100 200 300 400 500 600 700 800 900 1000
University of CaliforniaUnited States Government
GlaxoSmithKlineIncyte Genomics
AventisChiron
GenentechBayerWyeth
NovartisMerck
University of TexasHuman Genome Sciences
AmgenJohns Hopkins University
AppleraMassachusetts General Hospital
Novo NordiskHarvard University
PfizerStanford University
LillySalk Institute
Cornell UniversityMIT
AffymetrixColumbia University
University of WisconsinWashington University
University of Pennsylvania
Entit
y N
ame
Number of DNA-Based Patents
Academic Institution Government For Profit Firm
This research was supported by Grant No. R03 HG02683-02, “DNA Patent Policies at Academic Institutions,” from the National Human Genome Research Institute, NIH, and Grant No. DE FG 02 01ER63171, “Enhancing the DNA Patent Database,” from the U.S. Department of Energy. Io Nami Wolk 03-03-04
USA
JAPANFRANCE
UKGERMANY
OTHER
USA 80.0%Japan 7.1%France 2.4%UK 2.1%Germany 1.9%Other 7.1%
Ownership (assignee country) of 1078 DNA-based patents 1980-1993
Source: Stephen McCormack and Robert Cook-DeeganDNA Patent Database, August 1999, dnapatents.georgetown.edu
Patent assignees
US Gov’t6%
Public University
9%
Private University
14%
NonprofitResearchInstitute
13%
Other6%
For-ProfitCompany
52%
Source: Stephen McCormack and Robert Cook-DeeganDNA Patent Database dnapatents.georgetown.edu
Distinctive Features of Patents in Distinctive Features of Patents in Pharmaceuticals and BiotechPharmaceuticals and Biotech
Patent protection longer and stronger than Patent protection longer and stronger than other other ““high technologyhigh technology”” sectorssectorsDrug discovery highly dependent on Drug discovery highly dependent on academic researchacademic research
1/4 of products depend on academic research1/4 of products depend on academic researchAnother 1/4 would be long delayed without itAnother 1/4 would be long delayed without itMore patents held by academic institutionsMore patents held by academic institutionsMore citation of academically held patentsMore citation of academically held patentsPatents cite academic science articlesPatents cite academic science articles
Role of patentsRole of patentsImportant for private development of therapeutic Important for private development of therapeutic pharmaceuticals (EPO, pharmaceuticals (EPO, tPAtPA, GM, GM--CSF)CSF)
Is there another path?Is there another path?——not clearnot clearNot needed for tools arising from publicly funded Not needed for tools arising from publicly funded research (Cohenresearch (Cohen--Boyer, Axel) Boyer, Axel) but does but does generataegeneratae research funding for universitiesresearch funding for universitiesCurrent debate: diagnosticsCurrent debate: diagnosticsCan patents hinder innovation sometimes?Can patents hinder innovation sometimes?
AnticommonsAnticommons——HellerHeller--Eisenberg Eisenberg Cost (AxelCost (Axel--2003, Cox inhibitors)2003, Cox inhibitors)——RaiRai--Eisenberg Eisenberg
Obstacles to information flowObstacles to information flow
Securing scientific priority Securing scientific priority Pursuing worldwide patent rights*Pursuing worldwide patent rights*Signing nondisclosure agreementsSigning nondisclosure agreementsRestrictions on data access or control, or Restrictions on data access or control, or on publication (funding agreements)on publication (funding agreements)
*only item pertaining directly to patents*only item pertaining directly to patents
Sir John Sulston and the Open Genomics of the Worm
The Worm ProjectThe Worm Project
Coming: Rachel Ankeny: The Conqueror Worm
Another Success
The Third WayThe Third Way
Celera: Data by subscription
Spectrum of data accessSpectrum of data accessBermuda rules: 24Bermuda rules: 24--hour data releasehour data releaseMerck EST database,Merck EST database, cancer Genome Anatomy cancer Genome Anatomy Program, Mammalian Gene Collection, mouse Program, Mammalian Gene Collection, mouse mutant mutant collectionscollectionsApply for patent and abandon: SNP Apply for patent and abandon: SNP ConsortiumConsortiumCeleraCelera: data by subscription: data by subscriptionUniversities: genes for a license feeUniversities: genes for a license feeIncyteIncyte: high: high--priced multilateralismpriced multilateralismPharmaPharma: publish occasionally: publish occasionallyHGSHGS: trade secrecy plus patent: trade secrecy plus patent
Yellow = private R&D $; White = public $
The practical value of open The practical value of open genomicsgenomics
For the advancement of knowledgeFor the advancement of knowledgeFor technological developmentFor technological development
information flow (e.g., to companies) and information flow (e.g., to companies) and network efficienciesnetwork efficienciespursuing diverse leadspursuing diverse leadsdistributed allocation of workdistributed allocation of work
Efficient information clearinghouse in the Efficient information clearinghouse in the ““national innovation systemnational innovation system”” (how about (how about internationalinternational innovation system?)innovation system?)
Changing academic normsChanging academic normsUniversities seek patentsUniversities seek patentsTechnology licensing officesTechnology licensing officesPinnacles of excellence sustain academic R&D Pinnacles of excellence sustain academic R&D funding (biotech star system)funding (biotech star system)Hot science attracts private capital, as well as Hot science attracts private capital, as well as federal grantsfederal grantsTechnology translation through university Technology translation through university startupsstartupsFederally funded R&D as an exploitable Federally funded R&D as an exploitable resourceresource
Opening Information FlowOpening Information Flow
Use patents to enable earlier disclosure of Use patents to enable earlier disclosure of data (after filing patent applications)data (after filing patent applications)Research exemptions into licensing Research exemptions into licensing agreementsagreements““Humanitarian useHumanitarian use”” exemptionsexemptionsRein in investigators when they get too Rein in investigators when they get too greedygreedy
Duke Center for Public GenomicsDuke Center for Public Genomics
““Open genomicsOpen genomics”” ((RaiRai--Law School)*Law School)*Alternatives to exclusivity (Alternatives to exclusivity (ReichmanReichman/Lewis/Lewis--Law Law and Fuqua)*and Fuqua)*Case histories of DNA sequencing and Case histories of DNA sequencing and microarraymicroarray technologies (technologies (CookCook--DeeganDeegan))DNA Patent Database (DNA Patent Database (WaltersWalters--Georgetown)Georgetown)Interpretative and cultural studies (Interpretative and cultural studies (WaldWald/Mitchell/Mitchell--English)English)
* Initial case studies are relevant for access to * Initial case studies are relevant for access to essential medicines in resourceessential medicines in resource--poor countriespoor countries
Confluence and Confluence and Contrast:Contrast:Infectious Disease Burden and Infectious Disease Burden and
BiodefenseBiodefense
Pathogen sequencing Pathogen sequencing and and microarraysmicroarraysPlatform technologies for Platform technologies for vaccine and biologics and vaccine and biologics and for drug screeningfor drug screeningDrug and vaccine Drug and vaccine ““targetstargets”” in profusionin profusionEmerging infectionsEmerging infections
Many pathogens not on Many pathogens not on ““select agentselect agent”” priority listpriority listFocus on vaccines and Focus on vaccines and treatments for rich treatments for rich countries and soldierscountries and soldiersHealth infrastructure in Health infrastructure in resourceresource--poor countries poor countries not on the agendanot on the agenda
Genomics and World HealthGenomics and World HealthDust off April 2002 reportDust off April 2002 reportFully engage those directly familiar with infectious disease Fully engage those directly familiar with infectious disease catastrophescatastrophesPull out key examples and policies relevant to vaccines, Pull out key examples and policies relevant to vaccines, drugs and biologics in resourcedrugs and biologics in resource--poor countriespoor countriesUpdateUpdate–– BiodefenseBiodefense resources: Sanger Institute, Broad Institute, TIGR, etc.resources: Sanger Institute, Broad Institute, TIGR, etc.–– TRIPSTRIPS–– Alternative development frameworks (Alternative development frameworks (““virtual virtual pharmapharma””))–– Technology Managers for Global HealthTechnology Managers for Global Health–– Open sourceOpen source–– Alternatives to patenting (liability rulesAlternatives to patenting (liability rules——””use now, pay lateruse now, pay later””))
Explicitly link to Explicitly link to ““access to essential medicinesaccess to essential medicines””Include, but do not obsess about, intellectual property Include, but do not obsess about, intellectual property rights in products (Nuffield, UK Commission, etc.)rights in products (Nuffield, UK Commission, etc.)Do focus on information flow in research and developmentDo focus on information flow in research and development