China’s Guidebook for Pharmaceutical Patent Protection
Description
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2011, sales on the Chinese drug market have reached RMB 1550 billion (about US$246 billion). China is expected to become the second largest drug market in the world by 2015 with a growth rate over 25 percent per annum in next three years. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies, which attracts more and more overseas pharmaceutical manufacturers and producers to enter such drug market and seize a larger part of such drug market. However, the Chinese social environment for the protection of intellectual property right is complex. The locally produced generics and copy products dominate the Chinese drug market. It is estimated that about 97 percent of the drugs produced by local companies are generics or counterfeits.
Facing such complex social environment and market, most overseas and multinational pharmaceutical companies fear that their imported drugs and pharmaceuticals produced in China will be imitated or copied, in turn, their intellectual property will be infringed and benefit will be violated. What reason incurred such fear of overseas and multinational pharmaceutical companies? Why did Eli Lilly & Company fail in its litigation of patent infringement dispute case in China? Why can Pfizer win in an administrative proceeding against the Patent Reexamination Board of the China State Intellectual Property Office (SIPO) for its Viagra patent? Lack of knowledge of the Chinese intellectual property right system and legislation institution, the cultural difference between China and Western countries as well as the language barriers incurred such result.
China’s Guidebook for Pharmaceutical Patent Protection is an essential resource for overseas and multinational pharmaceutical companies to achieve a successful patent protection for their intellectual property in China. This guidebook, targeting overseas and multinational pharmaceutical companies and combining case studies of patent infringement dispute in China from them, will provide a comprehensive and thorough knowledge of the Chinese patent system and legislation institution to guide overseas and multinational pharmaceutical companies step by step to achieve a successful patent protection for their intellectual property in China, which is beginning from the organization structure and the responsibility of Chinese patent authorities, the application for patent, the examination and approval of application for patent, the protection of patent right, to design for compositions of optimized patent protection strategies. Its audiences are the executives from overseas and multinational pharmaceutical companies who have the preliminary knowledge of patent. It is also a textbook for the readers studying in the patent protection for intellectual property rights relating to pharmaceuticals. After having skimmed through this guidebook, audiences and readers can not only be clearly aware of the Chinese patent system and legislation institution, but also design an optimized patent protection strategy for themselves to acquire an adequate protection for their patent right in China.
Guidebook Highlights
China’s Guidebook for Pharmaceutical Patent Protection provides a comprehensive and thorough knowledge of the Chinese patent system relating to pharmaceuticals, the detailed administrative, civil and criminal judicial pathways for protections of patent right, and the design for composition of optimized protection strategies.
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2011, sales on the Chinese drug market have reached RMB 1550 billion (about US$246 billion). China is expected to become the second largest drug market in the world by 2015 with a growth rate over 25 percent per annum in next three years. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies, which attracts more and more overseas pharmaceutical manufacturers and producers to enter such drug market and seize a larger part of such drug market. However, the Chinese social environment for the protection of intellectual property right is complex. The locally produced generics and copy products dominate the Chinese drug market. It is estimated that about 97 percent of the drugs produced by local companies are generics or counterfeits.
Facing such complex social environment and market, most overseas and multinational pharmaceutical companies fear that their imported drugs and pharmaceuticals produced in China will be imitated or copied, in turn, their intellectual property will be infringed and benefit will be violated. What reason incurred such fear of overseas and multinational pharmaceutical companies? Why did Eli Lilly & Company fail in its litigation of patent infringement dispute case in China? Why can Pfizer win in an administrative proceeding against the Patent Reexamination Board of the China State Intellectual Property Office (SIPO) for its Viagra patent? Lack of knowledge of the Chinese intellectual property right system and legislation institution, the cultural difference between China and Western countries as well as the language barriers incurred such result.
China’s Guidebook for Pharmaceutical Patent Protection is an essential resource for overseas and multinational pharmaceutical companies to achieve a successful patent protection for their intellectual property in China. This guidebook, targeting overseas and multinational pharmaceutical companies and combining case studies of patent infringement dispute in China from them, will provide a comprehensive and thorough knowledge of the Chinese patent system and legislation institution to guide overseas and multinational pharmaceutical companies step by step to achieve a successful patent protection for their intellectual property in China, which is beginning from the organization structure and the responsibility of Chinese patent authorities, the application for patent, the examination and approval of application for patent, the protection of patent right, to design for compositions of optimized patent protection strategies. Its audiences are the executives from overseas and multinational pharmaceutical companies who have the preliminary knowledge of patent. It is also a textbook for the readers studying in the patent protection for intellectual property rights relating to pharmaceuticals. After having skimmed through this guidebook, audiences and readers can not only be clearly aware of the Chinese patent system and legislation institution, but also design an optimized patent protection strategy for themselves to acquire an adequate protection for their patent right in China.
Guidebook Highlights
China’s Guidebook for Pharmaceutical Patent Protection provides a comprehensive and thorough knowledge of the Chinese patent system relating to pharmaceuticals, the detailed administrative, civil and criminal judicial pathways for protections of patent right, and the design for composition of optimized protection strategies.
- The organization structure of patent authorities and judicial system;
- A comprehensive and thorough knowledge of the Chinese patent system and the relevant laws and administrative regulations relating to pharmaceuticals;
- The patentable subject matter relating to pharmaceuticals in China;
- Administrative protection for patent right;
- Civil judicial procedures and remedies for patent right;
- Criminal punitions for infringement of patent right;
- Design for compositions of optimized protection strategies;
- Case studies and comparative analyses of patent infringement disputes.
- The English versions of latest Patent Law of the People’s Republic of China and the Rules for the Implementation of the Patent Law of the People's Republic of China to facilitate overseas pharmaceutical manufacturers and multinational pharmaceutical companies to understand the Chinese patent law and regulations
- Non-Chinese companies wishing to enter a lucrative drug market in China.
- Non-Chinese companies interested in understanding the latest Chinese laws and regulations for pharmaceutical patent protection in China.
- Non-Chinese pharmaceutical manufacturers and multinational pharmaceutical companies senior executive officers engaging in pharmaceutical patent protection in China.
- Non-Chinese pharmaceutical manufacturers and multinational pharmaceutical companies law affair officers engaging in pharmaceutical patent protection.
EXECUTIVE SUMMARY
PREFACE
CHAPTER 1. INTRODUCTION
CHAPTER 2. ORGANIZATION STRUCTURE OF PATENT AUTHORITIES AND JUDICIAL SYSTEM
2.1. Organization Structure of Patent Authorities
2.2. Organization Structure of Judicial System
2.3. Responsibilities of the State Intellectual Property Office (SIPO)
2.3.1. Responsibilities of the Patent Office
2.3.2. Responsibilities of the Patent Reexamination Board
CHAPTER 3. THE OBJECTS OF PATENT RIGHT
3.1. The Objects of Patent Right
3.2. The Non-Patentable Subject Matter
CHAPTER 4. THE PATENTABLE SUBJECT MATTER RELATING TO PHARMACEUTICALS
4.1. The Patentable Subject Matters for Invention
4.2. The Patentable Subject Matters for Utility Model
4.3. The Patentable Subject Matters for Design
CHAPTER 5. APPLICATION FOR PATENT
5.1. The Right of Patent Application
5.2. The Applicant for Patent
5.3. The Date of Filing and the Priority Date
5.3.1. The Date of Filing
5.3.2. The Priority Date
5.4. Application for Patent
5.4.1. Application for a Patent for Invention or Utility Model
5.4.2. Application for a Patent for Design
CHAPTER 6. EXAMINATION AND APPROVAL OF APPLICATION FOR PATENT
6.1. Examination and Approval of Application for Patent for Invention
6.2. Examination and Approval of Application for Patent for Utility Model and Design
6.3. Examination and Approval Procedure of Application for Patent for Invention
6.4. Examination and Approval Procedure of Application for Patent for Utility Model or Design
CHAPTER 7. REEXAMINATION OF PATENT APPLICATION AND INVALIDATION OF PATENT RIGHT
7.1. Reexamination of Patent Application
7.2. Reexamination of Invalidation of Patent Right
CHAPTER 8. LEGITIMATE RIGHTS AND LIABILITIES OF PATENTEE
8.1. Legitimate Rights and Interests of Patentee
8.2. Legitimate Liabilities of Patentee
CHAPTER 9. LIMITATION OF PATENT RIGHT
9.1. Exceptions to Patent Right Conferred
9.2. Compulsory License for Exploitation of Patent
CHAPTER 10. PROTECTION OF PATENT RIGHT
10.1. Duration and Scope of Patent Right Protection
10.2. Infringement of Patent Right and Legal Liability of Infringer
10.2.1. Infringement of Patent Right
10.2.2. Legal Liability of Infringer
10.3. Administrative Protection for Patent Right
10.3.1. Administrative Protection of the Patent Authorities
10.3.2. Administrative Protection of the Customs
10.4. Administrative Judicial Procedures for Protection of Patent Right
10.5. Civil Judicial Procedures and Remedies for Patent Right
10.5.1. Scope of Civil Patent Disputes
10.5.2. Jurisdiction
10.5.3. The Time Limit of Litigation
10.5.4. Application for Pre-trial Cessation of Infringement and Property Preservation
10.5.5. Litigation
10.5.6. Remedies and Compensations
10.6. Criminal Punitions for Infringement of Patent Right
CHAPTER 11. COMPOSITIONS OF OPTIMIZED PROTECTION STRATEGIES
11.1. Optimized Patent Protection Strategies based on the Kind of Patent Right
11.1.1. Review of Some Essentials of Knowledge
11.1.2. Compositions of Optimized Patent Protection Strategies based on the Kind of Patent Right
11.1.3. Case Studies
11. 2. Optimized Protection Strategies Beyond Patent Right
11.2.1. Case Study: Pfizer’s Viagra Patent and Trademark Dispute in China
11.2.2. Essential Knowledge of Registered Trademark in China
11.2.3. Optimized Protection Strategies beyond Patent Right
CHAPTER 12. APPENDICES
12.1. Case 1: A Patent Infringement Dispute of Eli Lilly (Eli Lilly and Company) v. Jiangsu Hansoh Pharmaceutical Corporation & Shanghai Institute of Pharmaceutical Industry in China
12.2. Case 2. A Patent Infringement Dispute of Abbott Laboratories v. Andrx Pharmaceuticals, INC.
12.3. List of the People’s Courts Accepting First Instance Administrative and Civil Litigations for Patent Case
12.4. Patent Registration and Patent Gazette in China
12.4.1. Patent Registration in China
12.4.2. Patent Gazette in China
12.5. References
12.6. Resources
12.7. Author’s Biography
12.8. Company’s Description
12.9. Patent Law of the People’s Republic of China (Revised in 2008)
12.10. Rules for the Implementation of the Patent Law of the People's Republic of China (Revised in 2010)
PREFACE
CHAPTER 1. INTRODUCTION
CHAPTER 2. ORGANIZATION STRUCTURE OF PATENT AUTHORITIES AND JUDICIAL SYSTEM
2.1. Organization Structure of Patent Authorities
2.2. Organization Structure of Judicial System
2.3. Responsibilities of the State Intellectual Property Office (SIPO)
2.3.1. Responsibilities of the Patent Office
2.3.2. Responsibilities of the Patent Reexamination Board
CHAPTER 3. THE OBJECTS OF PATENT RIGHT
3.1. The Objects of Patent Right
3.2. The Non-Patentable Subject Matter
CHAPTER 4. THE PATENTABLE SUBJECT MATTER RELATING TO PHARMACEUTICALS
4.1. The Patentable Subject Matters for Invention
4.2. The Patentable Subject Matters for Utility Model
4.3. The Patentable Subject Matters for Design
CHAPTER 5. APPLICATION FOR PATENT
5.1. The Right of Patent Application
5.2. The Applicant for Patent
5.3. The Date of Filing and the Priority Date
5.3.1. The Date of Filing
5.3.2. The Priority Date
5.4. Application for Patent
5.4.1. Application for a Patent for Invention or Utility Model
5.4.2. Application for a Patent for Design
CHAPTER 6. EXAMINATION AND APPROVAL OF APPLICATION FOR PATENT
6.1. Examination and Approval of Application for Patent for Invention
6.2. Examination and Approval of Application for Patent for Utility Model and Design
6.3. Examination and Approval Procedure of Application for Patent for Invention
6.4. Examination and Approval Procedure of Application for Patent for Utility Model or Design
CHAPTER 7. REEXAMINATION OF PATENT APPLICATION AND INVALIDATION OF PATENT RIGHT
7.1. Reexamination of Patent Application
7.2. Reexamination of Invalidation of Patent Right
CHAPTER 8. LEGITIMATE RIGHTS AND LIABILITIES OF PATENTEE
8.1. Legitimate Rights and Interests of Patentee
8.2. Legitimate Liabilities of Patentee
CHAPTER 9. LIMITATION OF PATENT RIGHT
9.1. Exceptions to Patent Right Conferred
9.2. Compulsory License for Exploitation of Patent
CHAPTER 10. PROTECTION OF PATENT RIGHT
10.1. Duration and Scope of Patent Right Protection
10.2. Infringement of Patent Right and Legal Liability of Infringer
10.2.1. Infringement of Patent Right
10.2.2. Legal Liability of Infringer
10.3. Administrative Protection for Patent Right
10.3.1. Administrative Protection of the Patent Authorities
10.3.2. Administrative Protection of the Customs
10.4. Administrative Judicial Procedures for Protection of Patent Right
10.5. Civil Judicial Procedures and Remedies for Patent Right
10.5.1. Scope of Civil Patent Disputes
10.5.2. Jurisdiction
10.5.3. The Time Limit of Litigation
10.5.4. Application for Pre-trial Cessation of Infringement and Property Preservation
10.5.5. Litigation
10.5.6. Remedies and Compensations
10.6. Criminal Punitions for Infringement of Patent Right
CHAPTER 11. COMPOSITIONS OF OPTIMIZED PROTECTION STRATEGIES
11.1. Optimized Patent Protection Strategies based on the Kind of Patent Right
11.1.1. Review of Some Essentials of Knowledge
11.1.2. Compositions of Optimized Patent Protection Strategies based on the Kind of Patent Right
11.1.3. Case Studies
11. 2. Optimized Protection Strategies Beyond Patent Right
11.2.1. Case Study: Pfizer’s Viagra Patent and Trademark Dispute in China
11.2.2. Essential Knowledge of Registered Trademark in China
11.2.3. Optimized Protection Strategies beyond Patent Right
CHAPTER 12. APPENDICES
12.1. Case 1: A Patent Infringement Dispute of Eli Lilly (Eli Lilly and Company) v. Jiangsu Hansoh Pharmaceutical Corporation & Shanghai Institute of Pharmaceutical Industry in China
12.2. Case 2. A Patent Infringement Dispute of Abbott Laboratories v. Andrx Pharmaceuticals, INC.
12.3. List of the People’s Courts Accepting First Instance Administrative and Civil Litigations for Patent Case
12.4. Patent Registration and Patent Gazette in China
12.4.1. Patent Registration in China
12.4.2. Patent Gazette in China
12.5. References
12.6. Resources
12.7. Author’s Biography
12.8. Company’s Description
12.9. Patent Law of the People’s Republic of China (Revised in 2008)
12.10. Rules for the Implementation of the Patent Law of the People's Republic of China (Revised in 2010)
LIST OF FIGURES
Figure 2.1.1. Organization Structure of the State Intellectual Property Office (SIPO)
Figure 2.2.1. Organization Structure of Judicial System
...
Figure 6.3.1. Examination and Approval Procedure of Application for Patent for Invention
Figure 6.4.1. Examination and Approval Procedure of Application for Patent for Utility Model or Design
COMPANIES MENTIONED
Eli Lilly (Eli Lilly and Company)
Abbott Laboratories
Andrx Pharmaceuticals, INC
China, Jiangsu Hansoh Pharmaceutical Corporation
China, Shanghai Institute of Pharmaceutical Industry
Figure 2.1.1. Organization Structure of the State Intellectual Property Office (SIPO)
Figure 2.2.1. Organization Structure of Judicial System
...
Figure 6.3.1. Examination and Approval Procedure of Application for Patent for Invention
Figure 6.4.1. Examination and Approval Procedure of Application for Patent for Utility Model or Design
COMPANIES MENTIONED
Eli Lilly (Eli Lilly and Company)
Abbott Laboratories
Andrx Pharmaceuticals, INC
China, Jiangsu Hansoh Pharmaceutical Corporation
China, Shanghai Institute of Pharmaceutical Industry
