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 inChina? 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.
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Table of Contents
Executive Summary 4
Preface 6
Chapter 1. Introduction 9
Chapter 2 . Organization Structure of Patent Authorities and Judicial
System 12
2.1. Organization Structure of Patent Authorities 12
2.2. Organization Structure of Judicial System 14
2.3. Responsibilities of the State Intellectual Property Office (SIPO) 15
2.3.1. Responsibilities of the Patent Office 15
2.3.2. Responsibilities of the Patent Reexamination Board 16
Chapter 3. The Objects of Patent Right 17
3.1. The Objects of Patent Right 17
3.2. The Non-Patentable Subject Matter 18
Chapter 4. The Patentable Subject Matter Relating to Pharmaceuticals 19
4.1. The Patentable Subject Matters for Invention 19
4.2. The Patentable Subject Matters for Utility Model 22
4.3. The Patentable Subject Matters for Design 22
Chapter 5. Application for Patent 23
5.1. The Right of Patent Application 23
5.2. The Applicant for Patent 24
5.3. The Date of Filing and the Priority Date 24
5.3.1. The Date of Filing 25
5.3.2. The Priority Date 25
5.4. Application for Patent 27
5.4.1. Application for a Patent for Invention or Utility Model 28
5.4.2. Application for a Patent for Design 33
Chapter 6. Examination and Approval of Application for Patent 34
6.1. Examination and Approval of Application for Patent for Invention 35
6.2. Examination and Approval of Application for Patent for Utility Model and Design 42
6.3. Examination and Approval Procedure of Application for Patent for Invention 48
6.4. Examination and Approval Procedure of Application for Patent for Utility Model or
Design 50
Chapter 7. Reexamination of Patent Application and Invalidation of Patent Right 51
7.1. Reexamination of Patent Application 51
7.2. Reexamination of Invalidation of Patent Right 53
Chapter 8. Legitimate Rights and Liabilities of Patentee 56
8.1. Legitimate Rights and Interests of Patentee 56
8.2. Legitimate Liabilities of Patentee 58
Chapter 9. Limitation of Patent Right 58
9.1. Exceptions to Patent Right Conferred 59
9.2. Compulsory License for Exploitation of Patent 60
Chapter 10. Protection of Patent Right 62
10.1. Duration and Scope of Patent Right Protection 62
10.2. Infringement of Patent Right and Legal Liability of Infringer 62
10.2.1. Infringement of Patent Right 63
10.2.2. Legal Liability of Infringer 64
10.3. Administrative Protection for Patent Right 65
10.3.1. Administrative Protection of the Patent Authorities 65
10.3.2. Administrative Protection of the Customs 67
10.4. Administrative Judicial Procedures for Protection of Patent Right 73
10.5. Civil Judicial Procedures and Remedies for Patent Right 74
10.5.1. Scope of Civil Patent Disputes 74
10.5.2. Jurisdiction 75
10.5.3. The Time Limit of Litigation 76
10.5.4. Application for Pre-trial Cessation of Infringement and Property Preservation 76
10.5.5. Litigation 79
10.5.6. Remedies and Compensations 81
10.6. Criminal Punitions for Infringement of Patent Right 83
Chapter 11. Compositions of Optimized Protection Strategies 83
11.1. Optimized Patent Protection Strategies based on the Kind of Patent Right 84
11.1.1. Review of Some Essentials of Knowledge 84
11.1.2. Compositions of Optimized Patent Protection Strategies based on the
Kind of Patent Right 87
11.1.3. Case Studies 91
11. 2. Optimized Protection Strategies beyond Patent Right 99
11.2.1. Case Study: Pfizer’s Viagra Patent and Trademark Dispute in China 100
11.2.2. Essential Knowledge of Registered Trademark in China 107
11.2.3. Optimized Protection Strategies beyond Patent Right 113
Chapter 12. Appendices 114
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 114
12.2. Case 2:: A Patent Infringement Dispute of Abbott Laboratories v. Andrx
Pharmaceuticals, INC. 130
12.3. List of the People’s Courts Accepting First Instance Administrative and
Civil Litigations for Patent Case 150
12.4. Patent Registration and Patent Gazette in China 153
12.4.1. Patent Registration in China 153
12.4.2. Patent Gazette in China 153
12.5. References 155
12.6. Resources 157
12.7. Author’s Biography 158
12.8. Company’s Description 159
12.9. Patent Law of the People’s Republic of China (Revised in 2008) 161
12.10. Rules for the Implementation of the Patent Law of the People's Republic of China (Revised in 2010) 184
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