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Description

China is expected to become the fifth largest drug market in the world by 2010 with
a growth rate of 20-25 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.
Why did Eli Lilly & Company fail in its litigation of patent infringement
dispute case in China? Why can Pfizer win in an administrative China’s Guidebook for Pharmaceutical Patent Protection is an essential
proceeding against the Patent Reexamination Board of the China State resource for overseas and multinational pharmaceutical companies to achieve a
Intellectual Property Office for its Viagra patent? China’s Guidebook for successful patent protection for their intellectual property in China. This guidebook,
Pharmaceutical Patent Protection is an essential resource for overseas targeting overseas and multinational pharmaceutical companies and combining
case studies of patent infringement dispute in China from them, will provide a
and multinational pharmaceutical companies to achieve a successful comprehensive and thorough knowledge of the Chinese patent system and
patent protection for their pharmaceutically intellectual property in legislation institution to guide overseas and multinational pharmaceutical
China. 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

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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.
Table of Contents
5.3.1. The Date of Filing........................................................................................................
Executive
5.3.2. TheSummary..........................................................................................................4
Priority Date.........................................................................................................
Guidebook Highlights Preface...............................................................................................................................6
5.4. Application for Patent.....................................................................................................
Chapter 1. Introduction.....................................................................................................9
5.4.1. Application for a Patent for Invention or Utility Model.................................................
China’s Guidebook for Pharmaceutical Patent Protection provides a Chapter 2 . Organization
5.4.2. Application for a PatentStructure of Patent Authorities and Judicial
for Design..............................................................................
comprehensive and thorough knowledge of the Chinese patent system relating to System..............................................................................................................................12
Chapter 6. Examination and Approval of Application for Patent...................................
2.1.
6.1.Organization
ExaminationStructure of Patent Authorities..............................................................12
pharmaceuticals, the detailed administrative, civil and criminal judicial pathways for and Approval of Application for Patent for Invention.................................
2.2. Organization Structure of Judicial
6.2. Examination and Approval of Application System.................................................................14
for Patent for Utility Model and Design.........
protections of patent right, and the design for composition of optimized protection 2.3.
6.3.Responsibilities
Examination and of the State Procedure
Approval Intellectual of Property
Application Office for(SIPO)...............................15
Patent for Invention................
strategies. 2.3.1. Responsibilities of the Patent Office.......................................................................15
6.4. Examination and Approval Procedure of Application for Patent for Utility Model or
 The organization structure of patent authorities and judicial system; 2.3.2. Responsibilities of the Patent Reexamination Board..............................................16
Design...................................................................................................................................
Chapter
Chapter3.7.The Objects of Patent
Reexamination of PatentRight........................................................................17
Application and Invalidation of Patent Right......
 A comprehensive and thorough knowledge of the Chinese patent system and the 3.1. The Objects of Patent Right.......................................................................................17
7.1. Reexamination of Patent Application.............................................................................
relevant laws and administrative regulations relating to pharmaceuticals; 3.2.
7.2.The Non-Patentable
Reexamination Subject Matter
of Invalidation PAGEREF
of Patent _Toc159823770 \h 18
Right...............................................................
 The patentable subject matter relating to pharmaceuticals in China; Chapter 4. The Patentable Subject Matter Relating to Pharmaceuticals PAGEREF _Toc159823771 \h 19
Chapter 8. Legitimate Rights and Liabilities of Patentee..............................................
4.1. The Patentable Subject Matters for Invention PAGEREF _Toc159823772 \h 19
 Administrative protection for patent right; 8.1. Legitimate Rights and Interests of Patentee..................................................................
4.2. The Patentable Subject Matters for Utility Model PAGEREF _Toc159823773 \h 22
8.2. Legitimate Liabilities of Patentee...................................................................................
 Civil judicial procedures and remedies for patent right; 4.3. The Patentable Subject Matters for Design...............................................................22
Chapter 9. Limitation of Patent Right..............................................................................
 Criminal punitions for infringement of patent right; Chapter 5. Application
9.1. Exceptions to Patentfor Patent................................................................................23
Right Conferred............................................................................
 Design for compositions of optimized protection strategies; 5.1. The Right of Patent Application..................................................................................23
9.2. Compulsory License for Exploitation of Patent..............................................................
5.2. The Applicant
Chapter for Patent.............................................................................................24
10. Protection of Patent Right............................................................................
 Case studies and comparative analyses of patent infringement disputes. 5.3. The Date of Filing and the PriorityRight
Date.....................................................................24
10.1. Duration and Scope of Patent 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................................................................

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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

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gateway to enter the lucrative market of China. Access China is headquartered in Nanjing,
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Title: China’s Guidebook for Pharmaceutical Patent Protection

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