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Preliminary Data on Preliminary Data on U.S. DNA-Based U.S. DNA-Based
Patents and Plans for a Patents and Plans for a Survey of Licensing Survey of Licensing
PracticesPractices
Robert Cook-Deegan, LeRoy Walters, Derrick Pau, Bi Ade, Robert Cook-Deegan, LeRoy Walters, Derrick Pau, Bi Ade, Stephen McCormack, Janella Gatchalian, and Richard Stephen McCormack, Janella Gatchalian, and Richard BurgessBurgess
Kennedy Institute of Ethics, Georgetown UniversityKennedy Institute of Ethics, Georgetown University
Collaborators are involved in the empirical studies but do not Collaborators are involved in the empirical studies but do not necessarily concur with analysis or conclusionsnecessarily concur with analysis or conclusions
ThemesThemesTrends in US DNA-based Trends in US DNA-based
patentspatentsWhy licensing is where the Why licensing is where the
action isaction isPublic-Private interactions in Public-Private interactions in
genomics, using DNA Patent genomics, using DNA Patent DatabaseDatabase
What is a DNA-based Patent?What is a DNA-based Patent?
One or more claims based on DNA or One or more claims based on DNA or RNARNA
Algorithm initially developed by Algorithm initially developed by James Martinell, USPTO, for OTAJames Martinell, USPTO, for OTA
Revising search algorithm, doing Revising search algorithm, doing sensitivity analysis, improving free sensitivity analysis, improving free public acesspublic acess
Search algorithmSearch algorithm(November 2002)(November 2002)
Patent classesPatent classes 047 (plant), 119 (animal), 260 (food), 426 (organic), 435 047 (plant), 119 (animal), 260 (food), 426 (organic), 435
(molecular biology and microbiology), 536/22.1 through (molecular biology and microbiology), 536/22.1 through 536/25.5 (organic compounds/nucleic acids), and 800 536/25.5 (organic compounds/nucleic acids), and 800 (multi-celled organisms)(multi-celled organisms)
TermsTerms Antisense, cDNA, centromere, deoxyoligonucleotide, Antisense, cDNA, centromere, deoxyoligonucleotide,
deoxyribonucleic, deoxyribonucleotide, DNA, exon, gene or deoxyribonucleic, deoxyribonucleotide, DNA, exon, gene or genes, genetic, genome or genomic, genotype, haplotype, genes, genetic, genome or genomic, genotype, haplotype, intron, mtDNA, nucleic, nucleotide, oligonucleotide, intron, mtDNA, nucleic, nucleotide, oligonucleotide, oligodeoxynucleotide, oligoribonucleotide, plasmid, oligodeoxynucleotide, oligoribonucleotide, plasmid, polymorphism, polynucleotide, polyribonucleotide, polymorphism, polynucleotide, polyribonucleotide, ribonucleotide, ribonucleic, recombinant DNA, RNA, mRNA, ribonucleotide, ribonucleic, recombinant DNA, RNA, mRNA, rRNA, siRNA, snRNA, or tRNA, ribonucleoprotein, hnRNP, or rRNA, siRNA, snRNA, or tRNA, ribonucleoprotein, hnRNP, or snRNP, SNPsnRNP, SNP
Terms tested and rejected after sensitivity Terms tested and rejected after sensitivity analysisanalysis
Seq. ID, sequence, atg*, telomere, dideoxy*Seq. ID, sequence, atg*, telomere, dideoxy*
Source: LeRoy Walters, DNA Patent Database, December 2001
DNA-Based U.S. Patents, 1970-2001
0
1000
2000
3000
4000
5000
600019
70
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
Year
Nu
mb
er
of
DN
A P
ate
nts
Note: searches done using Dec 2001 algorithm
Growth of DNA PatentsGrowth of DNA Patents
Patents IssuedPatents Issued
1970s1970s 292 292
1980s1980s 1,869 1,869
1990s1990s 19,08219,082
DPD Patent Coding SheetDPD Patent Coding Sheet
CategorizesCategorizes Inventor information (#, country of origin)Inventor information (#, country of origin) Patent filing informationPatent filing information Assignee information (#, country of origin, type Assignee information (#, country of origin, type
of organization)of organization) US government involvement (Bayh-Dole)US government involvement (Bayh-Dole) Types of claims (cDNA [gene], vector, Types of claims (cDNA [gene], vector,
transgenic animal, vaccine, etc.)transgenic animal, vaccine, etc.) DNA-based patents issued between 1980-1993 DNA-based patents issued between 1980-1993
were manually coded into the DPDwere manually coded into the DPD Patent Coding SheetPatent Coding Sheet
Patent assignees
US GOV’T 6%
FOR-PROFITCOMPANY
52% PUBLIC UNIVERSITY
9%
PRIVATE UNIVERSITY
14%
NON-PROFIT RESEARCH INSTITUTE
13%
OTHER
6%
Source: Stephen McCormack and Robert Cook-DeeganDNA Patent Database dnapatents.georgetown.edu
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 1068 DNA-based patents 1980-1993
Source: Stephen McCormack and Robert Cook-DeeganDNA Patent Database, August 1999, dnapatents.georgetown.edu
0
50
100
150
200
250
300
350
400
450
500
US
Gov UC
Incy
teC
hiro
nG
laxo
-SK
Gen
ente
chA
mge
nA
vent
isN
ovo
AH
PL
illy
Hop
kins
Har
vard
Hof
fman
n-L
RM
erck
MIT
Nov
arti
sSt
anfo
rdH
GS
Patents in DNA Patent Database1980-1999 <dnapatents.georgetown.edu>
Data through end of December 1999
Why study licensing?Why study licensing?
Move debate beyond patentabilityMove debate beyond patentability Presumption that patent law should Presumption that patent law should
apply to all kinds of inventions equallyapply to all kinds of inventions equally Question becomes how patent rights Question becomes how patent rights
are exercised, not whether they existare exercised, not whether they exist
What if EPO not patented?What if EPO not patented?
What if Cohen-Boyer licensed What if Cohen-Boyer licensed exclusively?exclusively?
Gedanken experiment: Sanger Gedanken experiment: Sanger sequencing patentsequencing patent
License with provision that sequence License with provision that sequence data be publicly disclosed per Bermuda data be publicly disclosed per Bermuda rulesrulesNo policy change in high-throughput No policy change in high-throughput sequencing centerssequencing centersWhat would Incyte, Human Genome What would Incyte, Human Genome Sciences, Celera, etc., have done?Sciences, Celera, etc., have done?What would universities do with other What would universities do with other sequences outside HGP?sequences outside HGP?
How Do We Know Universities Are How Do We Know Universities Are Important?Important?
Biotech/pharma highest fraction of Biotech/pharma highest fraction of products and services dependent on products and services dependent on academic research (Edwin Mansfield academic research (Edwin Mansfield surveys)surveys)
Patent citation literature (Cockburn, Patent citation literature (Cockburn, Henderson, Jaffe, Trajtenberg)Henderson, Jaffe, Trajtenberg)
Literature citation studies (Narin)Literature citation studies (Narin) Spillovers (Gambardella, Henderson-Spillovers (Gambardella, Henderson-
Cockburn)Cockburn) Synthesis (Nelson, Mowery)Synthesis (Nelson, Mowery)
What’s funny about universities?What’s funny about universities?
Mission = research + teachingMission = research + teaching Some publicly owned, all publicly Some publicly owned, all publicly
supported for researchsupported for research Don’t make productsDon’t make products Do sell services, run component Do sell services, run component
businessesbusinesses Take money > make moneyTake money > make money What to maximize? Net revenue or What to maximize? Net revenue or
net social good?net social good?
Funding Sources for Licensing Funding Sources for Licensing SurveySurvey
U.S. Department of EnergyU.S. Department of Energy National Human Genome Research National Human Genome Research
Institute, U.S. National Institutes of Institute, U.S. National Institutes of HealthHealth
Lori Pressman to do survey; who has Lori Pressman to do survey; who has done AUTM surveysdone AUTM surveys
Licensing SurveyLicensing Survey
24 US and Canadian “academic” 24 US and Canadian “academic” institutions (universities and nonprofit)institutions (universities and nonprofit)
Biggest recipients of US Federal R&DBiggest recipients of US Federal R&D Their U.S. DNA-patent holdingsTheir U.S. DNA-patent holdings Licensing practicesLicensing practices
Complement to Cho/Merz and Complement to Cho/Merz and Mowery/Nelson studiesMowery/Nelson studies
Licensing practicesLicensing practices Exclusive, co-exclusive, non-exclusive Exclusive, co-exclusive, non-exclusive
agreementsagreements Patent clustersPatent clusters Licensing incomeLicensing income Research tools treated differently?Research tools treated differently?
9-10 qualitative case studies of 9-10 qualitative case studies of “interesting” patent clusters or licensing “interesting” patent clusters or licensing practicespractices
Look for patents not reported to federal Look for patents not reported to federal government (cross-check to RaDiUS and government (cross-check to RaDiUS and PubBiomed databases)PubBiomed databases)
Institutions of InterestInstitutions of Interest
Most DNA-based patents:Most DNA-based patents:UC, UTx, Hopkins, Scripps, MassGeneral, UC, UTx, Hopkins, Scripps, MassGeneral,
Harvard, Stanford, Salk, WashU, Columbia, Harvard, Stanford, Salk, WashU, Columbia, MIT, Rockefeller, Cornell, UPenn, UWiscMIT, Rockefeller, Cornell, UPenn, UWisc
High fraction of patents are DNA-basedHigh fraction of patents are DNA-basedSalk, Dana Farber, Baylor, Scripps, Salk, Dana Farber, Baylor, Scripps,
Rockefeller, WashU, Harvard, Jefferson, Rockefeller, WashU, Harvard, Jefferson, MassGeneral, NYU, Yale, Hopkins, Columbia, MassGeneral, NYU, Yale, Hopkins, Columbia, Brigham&Women’sBrigham&Women’s
Valuable Gene PatentsValuable Gene PatentsHuman InsulinHuman InsulinClot-dissolving enzymesClot-dissolving enzymesGrowth FactorsGrowth Factors
– ErythropoietinErythropoietin– White blood cell lineagesWhite blood cell lineages
Gene patent for making Gene patent for making therapeutic proteintherapeutic protein
TechniquesTechniques
Cohen-Boyer rDNACohen-Boyer rDNA Polymerase chain Polymerase chain
reactionreaction 4-color fluorescence 4-color fluorescence
sequencingsequencing Multiplex Multiplex
sequencingsequencing Microarray Microarray
techniquestechniques Gene transferGene transfer
Public domain Public domain technologiestechnologies
Sanger sequencingSanger sequencing Maxam-Gilbert Maxam-Gilbert
sequencingsequencing Monoclonal Monoclonal
antibody antibody productionproduction
DiagnosticsDiagnostics Huntington’s by RFLPHuntington’s by RFLP Cystic FibrosisCystic Fibrosis
– Research exemptionResearch exemption ApoE for Alzheimer’sApoE for Alzheimer’s
– Exclusively licensedExclusively licensed BrCA1 & 2BrCA1 & 2
– One companyOne company HemochromatosisHemochromatosis Many genes and Many genes and
mutationsmutations
Most single Most single nucleotide nucleotide polymorphismspolymorphisms
Many genes and Many genes and mutationsmutations
Patents induce private Patents induce private developmentdevelopment investment investment
Automated sequencingAutomated sequencing Therapeutic proteins: gene patents Therapeutic proteins: gene patents
protect post-discovery development protect post-discovery development investmentinvestment– long clinical trial testing periodlong clinical trial testing period– Trials and manufacturing startup Trials and manufacturing startup
expensiveexpensive Microarray applicationsMicroarray applications
Patents were not essential to Patents were not essential to induce induce health researchhealth research investment investment
BrCA1 & 2 and hemochromatosisBrCA1 & 2 and hemochromatosis Cohen-BoyerCohen-Boyer PCRPCR Sequencing methodsSequencing methods Cell fusion and monoclonal antibody Cell fusion and monoclonal antibody
techniquestechniques Most university-based discoveriesMost university-based discoveries
Patents a source of revenuePatents a source of revenue
Startups (intellectual “capital”)Startups (intellectual “capital”) Universities (licensing income)Universities (licensing income)
Patents a tool for policy changePatents a tool for policy change
PXE International modelPXE International model– Sharon Terry co-inventorSharon Terry co-inventor
Indigenous Peoples movementIndigenous Peoples movement– Licensing rights to accessLicensing rights to access
NIH and universities as major NIH and universities as major “property managers”“property managers”– Create norms through licensingCreate norms through licensing– Increase transparencyIncrease transparency– Initiate pooling?Initiate pooling?
Bayh-Dole Act: PurposeBayh-Dole Act: Purpose
Commercially exploit inventions Commercially exploit inventions developed using federal fundsdeveloped using federal funds
Legal mandate and financial Legal mandate and financial incentive to do business with firms incentive to do business with firms that can develop an invention into a that can develop an invention into a product or serviceproduct or service
Policy Options: Bayh-DolePolicy Options: Bayh-Dole
TransparencyTransparency– Stop flying blindStop flying blind
Research exemption (Dreyfus)Research exemption (Dreyfus) Diagnostic use exemption (Rivers bill)Diagnostic use exemption (Rivers bill) More flexibility to pre-empt patentingMore flexibility to pre-empt patenting
– Lower threshold than “exceptional circumstances” Lower threshold than “exceptional circumstances” (Rai/Eisenberg) (Rai/Eisenberg)
– Simplify process Simplify process Licensing oversight and march-in Licensing oversight and march-in
(McGarey/CellPro)(McGarey/CellPro) Earlier release of sequence data Earlier release of sequence data
(BCD/McCormack)(BCD/McCormack)
Policy Options: UniversitiesPolicy Options: Universities
Informational “markets” on licensing Informational “markets” on licensing termsterms
Explicit attention to where scientific Explicit attention to where scientific and academic norms conflict with and academic norms conflict with business interests and revenue-business interests and revenue-maximizationmaximization
Due diligence on licenseesDue diligence on licensees Patent pools?Patent pools?
Policy options: NIHPolicy options: NIH
Guidance on disposition of research Guidance on disposition of research toolstools
Guidance on licensing practicesGuidance on licensing practices Develop criteria for “exceptional Develop criteria for “exceptional
circumstances”circumstances” Develop criteria for “march-in”Develop criteria for “march-in” Patent pool?Patent pool?
Policy Options: CompaniesPolicy Options: Companies
Consortia for preserving public Consortia for preserving public domain research tools domain research tools – ESTEST– SNPSNP
Patent poolsPatent pools Guidance on licensing practicesGuidance on licensing practices
– BIO and PhRMABIO and PhRMA
Policy Options: IP lawPolicy Options: IP law Research exemption for all patentsResearch exemption for all patents
– What about academic health centers as major service What about academic health centers as major service providers? Exemption kills that market.providers? Exemption kills that market.
Shift to “opposition” rather than re-examinationShift to “opposition” rather than re-examination Data exclusivity for FDA approval as a substitute Data exclusivity for FDA approval as a substitute
for patents (for therapeutics and devices)for patents (for therapeutics and devices) Liability rules and contract practices; unfair Liability rules and contract practices; unfair
competition law (per Reichman/Uhlir)competition law (per Reichman/Uhlir) Database protectionDatabase protection
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