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China’s Guidebook for Pharmaceutical Patent Protection

Published: May, 2014 | Pages: 230 | Publisher: Access China Management Consulting Ltd. Research
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Synopsis
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.

Summary
China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of Social Sciences. It is estimated that it will exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in next three years. China is expected to become the second largest drug market in the world by 2015.

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. 
 
Scope
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. It 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.

Reason To Buy
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.

Key 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

 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
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 
 



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