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

Business Insights
December 1, 2008
128 Pages - SKU: RET2043194

Abstract Table of Contents Search inside this report Related Reports

Countries covered: China

The industry for Pharmaceutical outsourcing in China has experienced high growth in recent years. Today, in addition to an increasing number of traditional Chinese pharmaceutical companies becoming involved in the full scope of contract manufacturing services, more and more new, professional outsourcing service providers have emerged. The majority of Chinese CROs and CMOs are small in size and limited in service capability growth, however a growing number are matching the service levels provided by their foreign counterparts. Meanwhile, an increasing number of multinational CROs/CMOs have recently entered the Chinese market, and the number of pharma and biotech companies, both large multinationals and start-ups, conducting outsourcing activities in China has risen dramatically.

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

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