市場調査レポート

中国の医薬品特許保護に関するガイドブック

China's Guidebook for Pharmaceutical Patent Protection

発行 Access China Management Consulting 商品コード 232468
出版日 ページ情報 英文 231 Pages
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中国の医薬品特許保護に関するガイドブック China's Guidebook for Pharmaceutical Patent Protection
出版日: 2012年07月31日 ページ情報: 英文 231 Pages
概要

WTO加盟と世界経済への更なる参画により、中国の収益性の高い医薬品市場は海外の製薬会社にもさらに開放されるでしょう。しかし、中国の知的財産権保護の社会的環境は複雑です。国内で生産されたジェネリック医薬品や模倣品が同国の市場を独占しています。国内メーカーで生産された薬剤のおよそ97%がジェネリック医薬品または偽薬とみられています。こうした状況の中、多国籍製薬会社は中国で生産された輸入薬剤が模倣または偽造され、知的財産の侵害や利益の妨害に遭うことを恐れています。

当レポートでは、中国の医薬品に関する特許制度を包括的に分析し、特許権保護に関する法規や司法制度、最適な保護戦略について調査・考察して、その結果を概略以下の構成でお届けします。

エグゼクティブ・サマリー

序論

第1章 イントロダクション

第2章 特許機関・司法制度の組織構造

  • 特許機関の組織構造
  • 司法制度の組織構造
  • 国家知識産権局(SIPO)の責任
    • 特許局の責任
    • 特許再審査委員会の責任

第3章 特許保護の対象

  • 特許権の対象
  • 特許不可能な対象

第4章 特許可能な対象(医薬品関連)

  • 発明
  • 実用新案
  • 意匠(デザイン)

第5章 特許の申請

  • 特許申請権
  • 特許申請者
  • 登録日と有線日
    • 登録日
    • 優先日
  • 特許申請権
  • 特許申請者
    • 登録日
    • 優先日
  • 特許申請
    • 発明・実用新案に関する特許申請
    • 意匠に関する特許申請

第6章 特許申請の審査と承認

  • 発明に関する申請の審査と承認
  • 実用新案・意匠に関する申請の審査と承認
  • 発明に関する特許申請の審査・承認手続き
  • 実用新案・意匠に関する特許申請の審査・承認手続き

第7章 特許申請および特許権侵害の再審査

  • 特許申請の再審査
  • 特許権侵害の再審査

第8章 特許権者の正当な権利と責任

  • 特許権者の正当な権利と利益
  • 特許権者の正当な責任

第9章 特許権の制限

  • 特許権の例外事項
  • 特許活用のための強制実施権

第10章 特許権の保護

  • 特許権保護の期間と範囲
  • 特許権の侵害と侵害者の法的責任
    • 特許権の侵害
    • 侵害者の法的責任
  • 特許権の行政保護
    • 特許局の行政保護
    • 税関の行政保護
  • 特許権の保護に関する行政司法手続き
  • 特許権関連の民事司法手続きと修正
    • 特許関連の民事紛争の範囲
    • 管轄権
    • 訴訟の時効
    • 公判前における特許権侵害の停止および資産保全の適用
    • 訴訟
    • 救済と賠償
  • 特許権侵害の罰則

第11章 最適な保護戦略の内容

  • 特許権の種類に応じた、最適な特許保護戦略
    • 基礎的知識
    • 特許法に基づいた最適な特許保護戦略の内容
    • ケーススタディ
  • 特許権を超えた最適戦略
    • ケーススタディ:中国におけるPfizerのバイアグラ特許・商標関連の紛争
    • 中国の登録商標に関する基礎知識
    • 特許権を超えた最適な保護戦略

第12章 付録

  • 特許侵害紛争:ケース1(Eli Lilly (Eli Lilly and Company) v. Jiangsu Hansoh Pharmaceutical Corporation and Shanghai Institute of Pharmaceutical Industry in China)
  • 特許侵害紛争:ケース2(Abbott Laboratories v. Andrx Pharmaceuticals, INC.)
  • 特許権に関する行政・民事訴訟の第一審を受理する裁判所の一覧
  • 中国での特許登録と特許広報
  • 参考資料
  • 情報源
  • 著者情報
  • 企業情報
  • 中華人民共和国特許法(2008年改訂)
  • 特許法施行規則(2010年改訂)

図表一覧

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目次
Product Code: ACMC2012003

Abstract

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 for its Viagra patent? 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 pharmaceutically intellectual property in China.

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.

  • 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

Who should buy this report?

  • 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.

About Access China Management Consulting

Access China Management Consulting Ltd. is a professional provider of managements and consulting services specifically designed to provide overseas clients a virtual gateway to enter the lucrative market of China. Access China is headquartered in Nanjing, Jiangsu Province, Eastern China.

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. 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)
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