Edison Liu, M.D. [email protected] +65-68478-8007 WIPO Conference on Dispute Resolution in International Science and Technology Collaboration 25-26.

Edison Liu, [email protected]

+65-68478-8007

WIPO Conference on Dispute Resolution in International Science and Technology Collaboration

25-26 April, 2005 Geneva

Who am I?

• Physician: Oncologist

• Academic: Professor Medicine, Biochemistry, Genetics, Epidemiology

• Government: Scientific Director, NCI and Genome Institute of Singapore

• Businessman or Lawyer

Therefore this talk will be centered on Biomedicine

Fundamental Realities: 2005

• The state of the science is remarkable

• Phase shifts in conceptualization and action are taking place

• Disruptive changes in the industry are happening at a pace that outstrips legal and social/cultural responses

• Conflicts will inevitably arise

• Solutions will come easier if there is an understanding of scientific culture and its social history

Phase shifts in how governments view biology:

• Before 1900 (Europe): Biology as an academic exercise - privileged activity for gentleman scholars (or monks)

• 1900-2000 (USA): Biology with clinical impact – biological research for public health (NIH model): social service cost center

• 2001-future (Asia?): Biology with commercial impact – biology for public wealth:

revenue generator

Conflicts brought on by these phase shifts:

Europe vs. US:

“Making money from scientific research is immoral”

“I am not going to patent anything”

West vs. Asia:

“Companies are moving to Asia to avoid ethical requirements”

Conflicts brought on by these phase shifts:

Europe vs. US:

Europe – until recently patents were the personal responsibility of the professor

US – Bayh-Dole and institutional ownership and exploitation of university IP

Asia – government ownership and direct IP from universities and research institutes

Phase Shift in Biology:

Before After

Observational Creating

Single investigator Complex teams

Reductionist Data mining

Phase Shift in Pharmaceutical Industry:

Many key biomedical discoveries will come from well organized and coordinated national/international efforts.

Fundamental Realities: 2005

• Speed of discovery in biology and medicine is profound

Biomarkers:HER-2 and prognosis: one marker in 12 years (1989-2001)Array prognostics: 100-400 markers in 1 year (2004)

Drug developmentTarget discovery and validation: 1985 – one molecule and a thousand compound2005 – 40,000 cDNAs and 1 million compounds

Fundamental Realities: 2005

• The scope of knowledge necessary to be successful in biomedical research is remarkable

What you need to know to be a good biologist:

1965: Biology

2005: Developmental biologyMolecular biology

Biochemistry Structural biology

Model systems (mammalian, yeast, drosophila, C. elegans) Computational literacy

Fundamental Realities: 2005

• The scope of knowledge necessary to be successful in biology and medicine is remarkable

• Speed of discovery in biology and medicine is profound

No single entity can corner innovation and domain knowledge

Collaborations and alliances are essential

Collaborations are now highly complex

11

Biotech/Pharma Alliances

0

100

200

300

400

500

600

1993 1994 1995 1996 1997 1998 1999 2000

Source: Goldman Sachs Global Equity

Research

Collaborations are essential in today’s research labs

Active collaborations in my laboratory:

Karolinska Institute

University of Illinois, Champaign Urbana

NCI, USA

Johns Hopkins University

Eli Lilly

Cloning and sequencing group: GIS

Functional genomics: GIS

Bioinformatics group: GIS

Institute for Infocomm Research

RIKEN: Japan

Conflicts that arise:

Ownership of IPR

Control issues

Conflicts in key performance indicators:

Academic vs. Commercial entity

Open source vs. trade secrets

Academic emotion vs. business realities

Area of future conflict

• Governments play a pivotal role in the life sciences unlike other industries

• Models for governmental involvement differ between Americas, Europe, and Asia

• These differences are due to different social culture assumptions in addition to differential development

• These differences will be a source of future conflict

Points of strategic conflict: Biomedicine

– The differing concept of conflict of interest and the role of government in direct investment

Ministerial CommitteeDPM Dr Tony Tan (Chairman)Minister (Education)Minister (Health)Minister (Trade and Industry)

Executive CommitteePhilip Yeo, EDB/NSTB (Chairman)and Representatives from 12 Agencies

Intellectual Capital

• Public R&D

• IPR/Legal Framework

• Industry R&D

Industrial Capital

• Investment Promotion

• Infrastructure Development

• Equity Investments

International Advisory CouncilChairman -

Sir Richard Sykes,Rector, Imperial College &

Chmn, GSKCo-Chairman -

Sydney Brenner, Professor Salk Institute for Biological Studies

Human Capital

• BMS Education

• Undergrad Trg

• Grad/Post-Doc Trg

Ethical Framework

• Bioethics Advisory Committee

INTEGRATED BIOMEDICAL SCIENCES STRATEGY

Singapore Approach: High Level Integration

The Singapore Strategy: Government planning and large scale integration

Development of local manpower:

scholarships

Recruitmentoverseas

talent

Economic development: investments

Legal, ethical Framework: BAC

Change in education systemClinical Centers ofExcellence

Research Institutes

Extramuralfunding for PI

basedresearch

Add physical infra

structure:

Biopolis

•Airbus vs. Boeing•Cotton subsidies in the

US vs. the developing world

• Japan’s MITI in post war reconstruction

Conflicts from political philosophy:The role of government

Fundamental Realities: 2005

• Governments play a pivotal role in the life sciences unlike other industries

Auto manufacturing:

Local requirements - roads, logistics, power, blue collar workforce

Impact:

Jobs, air pollution

Fundamental Realities: 2005

• Governments play a pivotal role in the life sciences unlike other industries

Biotechnology:

Local requirements – schools, hospitals, universities, PhD workforce, enforcement of safety laws, legal framework (IP and human subjects protection), R&D infrastructure, highly varied reagents acquired in small quantities,

Impact: Life and death, reproduction

• Stem cell research• Xenotransplantation (pig vs cow)• Birth control research• GMO crops and animals• Creationism vs. Evolution

Moral issues in biotechnology strike at core national and religious values

Points of strategic conflict: Biomedicine

– Differences in the national histories relating to human experimentation in times of war, or commercial exploitation during times of colonial imperialism.

Safety, confidentiality, and research on human subjects laws are among the most restrictive in Germany and Japan.

Japanese pharmaceuticals and

organizations will have difficulty conducting clinical trials in China and Korea

Any breach of “ethics” by these countries

will lead to international incidents

World war II and the conduct of biomedicine today

Edison Liu, [email protected]

+65-68478-8007

WIPO Conference on Dispute Resolution in International Science and Technology Collaboration

25-26 April, 2005 Geneva