本報告已在2012年02月27日停止出版。
更改為出版
China's Guidebook for Pharmaceutical Patent Protection
出版日期 : 2012年02月
商品編碼: 232468
中國於2010年止預計可成為全球第五大醫療藥物市場，今後3年之年成長率可望達25％。中國因加盟WTO，更深度參與全球經濟，預計將更廣泛向海外製藥公司，開放其高收益性之醫療藥物市場。而中國國內製造之非專利藥、仿製藥等獨占其國內市場，國內製造商生產藥劑中約97％被認為是非專利藥或偽藥，因此，跨國製藥公司於中國生產之進口藥劑，將可能面臨被偽造、智慧財產權侵犯、獲利受阻等情況。
本報告為，綜合驗證中國醫療藥品專利制度，並匯整專利保護相關司法制度、最佳保護策略等，以下列摘要形式闡述。
實施概要
第1章 簡介
第2章 專利主管機關之組織結構及司法制度
- 專利主管機關之組織結構
- 司法制度之結構
- 智慧財產局之責任
第3章 專利權之目的
第4章 醫療藥物相關專利對象
第5章 專利申請
第6章 專利申請之審查及核准
- 發明相關申請之審查及核准
- 使用方式及設計相關申請之審查及核准
- 發明相關專利申請之審查及核准手續
- 使用方式及設計相關專利申請之審查及核准手續
第7章 專利申請之複審及專利無效
第8章 專利權人之正當權力及義務
第9章 專利權之限度
第10章 專利保護
- 專利保護之期間及範圍
- 專利之侵犯及侵犯人之法律責任
- 專利之行政保護
- 專利保護相關司法程序
- 專利權相關司法程序及修正
- 專利侵權之罰責
第11章 最適當之保護策略內容
- 符合專利權種類之最適當保護策略
- 超越專利權之最適當保護策略
第12章 附錄
Abstract
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.
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;
Table of Contents
Table of Contents
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
- 5.3.1. 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
