Genomics and World Health: Navigating the Information Jungle. From DNA Sequence to Human Welfare

Transcription

1 Genomics and World Health: Navigating the Information Jungle From DNA Sequence to Human Welfare

2 Percent of population over 65 Sources: World Development Report 1993 (World Bank); World Health Organization 1990

3 Sources of Health R&D Funding Government, advanced and transition economies Government, developing economies Private pharmacuetical R&D Private nonprofit Source: Global Forum for Health Research Monitoring Financial Flows for Health Research 2001

4 Health Research Funding % % 38% Philanthropy 24% Industry % 68% 49% 46% Government 5%

5 UK Germany Canada EC Netherlands France Sweden SNP Consortium China Russia Korea Estonia Belgium Australia Japan USA Government-nonprofit Genomics Research Funding 2000 ($ million)

6 Genomics Funding: private>public (Year 2000) Genomics research funding ($ million US) 2,500 2,000 1,500 1, ,653 2, Gov&nonprofit Genomics firms Pharma&biotech Source: World Survey of Funding for Genomics Research Stanford in Washington Program

7 Australia China Government-nonprofit Genomics Funding per GDP (times 1000) Japan Germany USA France Belgium EC Korea Canada Russia Sweden Netherlands UK Estonia

8 Genomics firms with publicly traded stock Data through Year 2000 Market Cap figures for end of year Number of firms at end of each year # firms Year Growth of Commercial Genomics $B market value

9 R&D v Market Cap Sum of R&D Expenditures for 15 Genomics Firms 1,800 60,000 1,600 Total R&D Expenditures Total Market Cap 50,000 1,400 1,200 40,000 R&D (Million US$) 1, ,000 Market Cap (Million US$) , , Year -

10 2003 Number of Patents Retrieved by the Search Algorithm vs. Year of Issue Num ber of Patents Retrieved by the Search Algorithm Year of Issue Source: Io Nami-Wolk and LeRoy Walters, DNA Patent Database, February 2004

11 Preliminary Data about the 30 Entities Holding the Largest Numbers of DNA-Based Patents (as of ) Number of DNA-Based Patents Entity Name University of California United States Government GlaxoSmithKline Incyte Genomics Aventis Chiron Genentech Bayer Wyeth Novartis Merck University of Texas Human Genome Sciences Amgen Johns Hopkins University Applera Massachusetts General Hospital Novo Nordisk Harvard University Pfizer Stanford University Lilly Salk Institute Cornell University MIT Affymetrix Columbia University University of Wisconsin Washington University University of Pennsylvania Academic Institution Government For Profit Firm This research was supported by Grant No. R03 HG , 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

12 Ownership (assignee country) of 1078 DNA-based patents GERMANY OTHER UK FRANCE JAPAN USA USA 80.0% Japan 7.1% France 2.4% UK 2.1% Germany 1.9% Other 7.1% Source: Stephen McCormack and Robert Cook-Deegan DNA Patent Database, August 1999, dnapatents.georgetown.edu

13 Patent assignees Nonprofit Research Institute 13% Other 6% US Gov t 6% Private University 14% Public University 9% For-Profit Company 52% Source: Stephen McCormack and Robert Cook-Deegan DNA Patent Database dnapatents.georgetown.edu

14 Distinctive Features of Patents in Pharmaceuticals and Biotech Patent protection longer and stronger than other high technology sectors Drug discovery highly dependent on academic research 1/4 of products depend on academic research Another 1/4 would be long delayed without it More patents held by academic institutions More citation of academically held patents Patents cite academic science articles

15 Role of patents Important for private development of therapeutic pharmaceuticals (EPO, tpa,, GM-CSF) Is there another path? not clear Not needed for tools arising from publicly funded research (Cohen-Boyer, Axel) but does generatae research funding for universities Current debate: diagnostics Can patents hinder innovation sometimes? Anticommons Heller Heller-Eisenberg Cost (Axel-2003, Cox inhibitors) Rai Rai-Eisenberg

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17 Obstacles to information flow Securing scientific priority Pursuing worldwide patent rights* Signing nondisclosure agreements Restrictions on data access or control, or on publication (funding agreements) *only item pertaining directly to patents

18 Sir John Sulston and the Open Genomics of the Worm

19 The Worm Project Coming: Rachel Ankeny: The Conqueror Worm

20 Another Success

21 The Third Way Celera: Data by subscription

22 Spectrum of data access Bermuda rules: 24-hour data release Merck EST database, cancer Genome Anatomy Program, Mammalian Gene Collection, mouse mutant collections Apply for patent and abandon: SNP Consortium Celera: : data by subscription Universities: genes for a license fee Incyte: : high-priced multilateralism Pharma: : publish occasionally HGS: : trade secrecy plus patent Yellow = private R&D $; White = public $

23 The practical value of open genomics For the advancement of knowledge For technological development information flow (e.g., to companies) and network efficiencies pursuing diverse leads distributed allocation of work Efficient information clearinghouse in the national innovation system (how about international innovation system?)

24 Changing academic norms Universities seek patents Technology licensing offices Pinnacles of excellence sustain academic R&D funding (biotech star system) Hot science attracts private capital, as well as federal grants Technology translation through university startups Federally funded R&D as an exploitable resource

25 Opening Information Flow Use patents to enable earlier disclosure of data (after filing patent applications) Research exemptions into licensing agreements Humanitarian use exemptions Rein in investigators when they get too greedy

26 Duke Center for Public Genomics Open genomics (Rai-Law School)* Alternatives to exclusivity (Reichman( Reichman/Lewis-Law Law and Fuqua)* Case histories of DNA sequencing and microarray technologies (Cook( Cook-Deegan) DNA Patent Database (Walters( Walters-Georgetown) Interpretative and cultural studies (Wald( Wald/Mitchell- English) * Initial case studies are relevant for access to essential medicines in resource-poor countries

27 Confluence and Contrast: Infectious Disease Burden and Biodefense Pathogen sequencing and microarrays Platform technologies for vaccine and biologics and for drug screening Drug and vaccine targets in profusion Emerging infections Many pathogens not on select agent priority list Focus on vaccines and treatments for rich countries and soldiers Health infrastructure in resource-poor countries not on the agenda

28 Genomics and World Health Dust off April 2002 report Fully engage those directly familiar with infectious disease catastrophes Pull out key examples and policies relevant to vaccines, drugs and biologics in resource-poor countries Update Biodefense resources: Sanger Institute, Broad Institute, TIGR, etc. TRIPS Alternative development frameworks ( virtual( pharma ) Technology Managers for Global Health Open source Alternatives to patenting (liability rules use use now, pay later ) Explicitly link to access to essential medicines Include, but do not obsess about, intellectual property rights in products (Nuffield, UK Commission, etc.) Do focus on information flow in research and development