Intellectual Property And Outsourcing In China: Minimizing Risk Whilst Maximizing Return On Investment

Published by: Business Insights

Published: Dec. 1, 2008 - 128 Pages

Table of Contents

Intellectual Property and Outsourcing in China

Executive summary

Pharmaceutical outsourcing in China

IPR protection in outsourcing to China

Incorporating IPR protection

Future developments in IPR protection

Chapter 1 The pharmaceutical outsourcing market in China

Summary

Introduction

Trends in Chinese outsourcing

Growth of the industry

The attractiveness of China

Fast domestic growth

Enhanced growth driven by international companies

The drug discovery process

Current outsourcing trends by stage

Outsourcing of lead discovery and optimization

Outsourcing preclinical research

Outsourcing clinical research

Current service capabilities

Early stage drug discovery

Pharmacological property studies and in vivo preclinical research

Clinical trials

Contract manufacturing

Major players in the contract research market

Companies outsourcing to China

Outsourcing by pharma and biotech companies

Direct involvement of Western companies in R&D in China

Key issues

Chapter 2 IPR protection in China

Summary

Introduction

Western perceptions of IPR protection in China

IPR protection by phase of development

Target identification and validation

Lead discovery/optimization

Drug development (including both preclinical and clinical trials)

Manufacturing

IPR protection in China

The development of IPR protection in China

Copyright theft in China today

Trends in patent filing

IPR infringement prosecutions

IPR infringement prosecution transparency

SFDA involvement

IPR protection in Chinese pharmaceutical outsourcing

Process involved in outsourcing to a Chinese CRO/CMO

IPR protection involved in the first step of outsourcing process

CRO/CMO protection of IPR

The current situation

Weaknesses in the Chinese IPR protection system

Brief case studies

In-licensing

Shanghai Sunway Biotech and Onyx Pharmaceuticals.

Hainan Noken Pharmaceuticals and Medivir AB

Simcere and GSK

Outsourcing

WuXi Pharmatech and AstraZeneca

Novartis

Promega and the Guangzhuo Institute of Biomedicine and Health

Cases of pharmaceutical IPR infringement in China

Togjitang Chinese Medicines Company and Yulongyadong

Pharmaceuticals

Pfizer vs 12 Chinese pharmaceutical companies

Pfizer and Lianhua Pharmaceuticals

Chapter 3 Incorporating IPR protection into outsourcing strategies

Introduction

Potential risks in outsourcing to China

Assessing project suitability for outsourcing

Determining requirements and objectives for outsourced projects

Choosing a service provider

Classification of Chinese service providers

Criteria for selecting the ideal service provider

Measures being undertaken to protect IP at the service provider

Service quality

Cost

Geographic location

CRO/CMO business model

Management

Making the final decision

Strategies to protect IPR

Partnership

Incorporation of milestones or royalties into the contract

Alternative strategies

Best practice for protecting IPR during the outsourcing process

Risks and rewards

Chapter 4 Future developments in IPR protection and their impact on outsourcing

Summary

Introduction

Drivers and resistors

Further improvements in service capability and quality

Further improvement in IPR protection

Negotiating the Chinese pharmaceutical market

Establishing a facility in China

Advantages

Disadvantages

Forming a joint venture

Advantages

Disadvantages

Establishing a partnership

Advantages

Disadvantages

Outsourcing

Advantages

Disadvantages

Future outlook

Significant improvements in IPR protection

Fast growth in pharmaceutical outsourcing

Improvements in service capability

Market forecast

Chapter 5 Appendix

Company data

Research methodology

Glossary

Index

List of Figures

Figure 1.1: Country Attractiveness Index for Clinical Trials

Figure 1.2: The drug discovery, development and manufacturing process

Figure 1.3: Distribution of CROs/CMOs by technical area

Figure 2.4: IP risk levels at each stage

Figure 2.5: Milestones in the development of China’s IPR protection system

Figure 2.6: Patent applications in China (total applications), 2000-2008

Figure 2.7: Development of patent applications filed by domestic companies and foreign companies (total applications), 2000-2008

Figure 2.8: Lawsuit cases in China involving IPR infringement (total infringements), 2004-

Figure 2.9: Outsourcing to a Chinese CRO/CMO

Figure 3.10: Potential risks in outsourcing

Figure 3.11: Criteria for classification of Chinese service providers

Figure 3.12: Risks and rewards in outsourcing

Figure 4.13: The Chinese outsourcing industry size ($bn), 2007-2015

List of Tables

Table 1.1: Profile of Suzhou BioBay Industrial Park

Table 1.2: Major multinational CROs in China

Table 1.3: Distribution of CROs/CMOs by technical area

Table 1.4: Major Chinese players in contract research

Table 1.5: Major multinational CROs in China and their activities

Table 1.6: Multinational companies with projects outsourced to China

Table 1.7: Generic manufacturers with activities in China

Table 1.8: Venture capital firms with Chinese activities

Table 2.9: Government educational program

Table 2.10: Government actions to strengthen IPR protection

Table 2.11: Patent applications in China (total applications), 2000-2008

Table 2.12: Development of patent applications filed by domestic companies (total applications), 2000-2008

Table 2.13: Development of patent applications filed by foreign companies (total applications), 2000-2008

Table 2.14: IPR infringement cases in China

Table 3.15: Checklists for self-assessment of IPR risk tolerance level

Table 3.16: Criteria for selecting the ideal service provider

Table 4.17: Chinese outsourcing industry, 2007-2015

Table 5.18: Company Profile of WuXi PharmaTech

Table 5.19: Company Profile of ChemPartner

Table 5.20: Company profile of Shanghai Sunway Biotech Co.

Table 5.21: Company profile of BioDuro

Table 5.22: Company profile of Chemizon

Table 5.23: Company Profile of Radiant Pharma & Tech

Table 5.24: Company Profile of Jiangsu Zhongdan

Table 5.25: Company profile of Sundia Meditech

Table 5.26: Company profile of HD Biosciences

Abstract

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