China's Guidebook For Pharmaceutical Patent Protection
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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 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.
Copy right © Access China Management Consulting Ltd.
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 1
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......................................................................................................... Preface...............................................................................................................................6 5.4. Application for Patent..................................................................................................... Chapter 1. Introduction.....................................................................................................9 5.4.1. Application for a Patent for Invention or Utility Model................................................. Chapter 2 . Organization Structure of Patent Authorities and Judicial 5.4.2. Application for a Patent for Design.............................................................................. System..............................................................................................................................12 Chapter 6. Examination and Approval of Application for Patent................................... 2.1. of Patent Authorities..............................................................12 6.1.Organization ExaminationStructure and Approval of Application for Patent for Invention................................. 2.2. Organization Structure of Judicial System.................................................................14 6.2. Examination and Approval of Application for Patent for Utility Model and Design......... 2.3. of the State Procedure Intellectual of Property Office 6.3.Responsibilities Examination and Approval Application for(SIPO)...............................15 Patent for Invention................ 2.3.1. Responsibilities of the Patent Office.......................................................................15 6.4. Examination and Approval Procedure of Application for Patent for Utility Model or 2.3.2. Responsibilities of the Patent Reexamination Board..............................................16 Design................................................................................................................................... Chapter Objects of Patent Right........................................................................17 Chapter3.7.The Reexamination of Patent Application and Invalidation of Patent Right...... 3.1. The Objects of Patent Right.......................................................................................17 7.1. Reexamination of Patent Application............................................................................. 3.2. Non-Patentable Subject Matter PAGEREF _Toc159823770 \h 18 7.2.The Reexamination of Invalidation of Patent Right............................................................... 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 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................................................................................... 4.3. The Patentable Subject Matters for Design...............................................................22 Chapter 9. Limitation of Patent Right.............................................................................. Chapter 5. Application Patent................................................................................23 9.1. Exceptions to Patentfor Right Conferred............................................................................ 5.1. The Right of Patent Application..................................................................................23 9.2. Compulsory License for Exploitation of Patent.............................................................. 5.2. The Applicant for Patent.............................................................................................24 Chapter 10. Protection of Patent Right............................................................................ 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................................................................
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.
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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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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.
Access China Order Form Title: China’s Guidebook for Pharmaceutical Patent Protection
At present, company provides consulting services for foreign clients as follows. Published Date: June 2008 Page Count: 160 Unit Price: US$ 1,495 Site License: US$ 4,995 Format: Electronic PDF copy Please send me ___________Copy/ies Payment: Pay by bank wire transfer to: Account Number: 4447803-007000-900079468 Swift Code: BKCHCNBJ 940 Bank Name: BANK OF CHINA, NANJING SAJIAWAN SUB-BRANCH Bank Address: 212 ZhongShan Beilu Road, Nanjing , People’s Republic of China
Research of Chinese pharmaceutical industry and market; license transfer; registration of imported drugs and new drugs; pharmaceutical patent applications; management of laws and regulations on pharmaceuticals; Consultancy on the Chinese laws, administrative regulations on pharmaceutical administration; Provide analyses of feasibility for mergers and acquisitions of the existing Chinese pharmaceutical enterprises; Act as agent, within a range of authorized, implement operation to purchase and merge the existing Chinese pharmaceutical enterprises in accordance with the order of foreign investors; Help foreign investors make the registration of Foreign Investment Enterprises, including Sino-foreign equity joint ventures (EJV), Sino-foreign cooperative joint ventures (CJV),wholly foreign-owned enterprises (WFOE), Representative Office; Provide a range of customized and standardized solutions including industry report, research report of strategic investment, market analyses, and other subscription-based research and information on the latest development and strategies used in a variety of sectors.
Delivery Details Title: ______________________ Full name: ____________________________ Job title: ___________________ Organization: ___________________________ Email Address: ____________________________________________________ Postal Address: ____________________________________________________
Access China Management Consulting pursues the principle of "integrating resources and creating value" to contribute to foreign clients.
Postal/Zip code: _________________ Country: __________________________ Phone number: ___________________ Fax number: ______________________
Access China Management Consulting Ltd, RUL: http://www.accesschinainfo.com
Signed: _________________________ Date: ____________________________
402 Suite, No. 70 Building , MuFu ShanZhuang He Yan Road, Nanjing 210038, People’s Republic of China Tel : +86-25-83422936 Fax: +86-25-85337409
Please send an E-mail and attached this form by [email protected] to us. As soon as we receive your payment, we'll send the report to you in four business days.
Copy right © Access China Management Consulting Ltd. All rights reserved. No part of this publication may be reproduced, abstracted, stored in any retrieval system or transmitted in any Access
China
Management
Consulting
Ltd
Copy right © Access China Management Consulting Ltd.
is
a
professional
provider
form or be any means without written permission of the copyright owner/publisher.
of 4
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.
Copy right © Access China Management Consulting Ltd.
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 1
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......................................................................................................... Preface...............................................................................................................................6 5.4. Application for Patent..................................................................................................... Chapter 1. Introduction.....................................................................................................9 5.4.1. Application for a Patent for Invention or Utility Model................................................. Chapter 2 . Organization Structure of Patent Authorities and Judicial 5.4.2. Application for a Patent for Design.............................................................................. System..............................................................................................................................12 Chapter 6. Examination and Approval of Application for Patent................................... 2.1. of Patent Authorities..............................................................12 6.1.Organization ExaminationStructure and Approval of Application for Patent for Invention................................. 2.2. Organization Structure of Judicial System.................................................................14 6.2. Examination and Approval of Application for Patent for Utility Model and Design......... 2.3. of the State Procedure Intellectual of Property Office 6.3.Responsibilities Examination and Approval Application for(SIPO)...............................15 Patent for Invention................ 2.3.1. Responsibilities of the Patent Office.......................................................................15 6.4. Examination and Approval Procedure of Application for Patent for Utility Model or 2.3.2. Responsibilities of the Patent Reexamination Board..............................................16 Design................................................................................................................................... Chapter Objects of Patent Right........................................................................17 Chapter3.7.The Reexamination of Patent Application and Invalidation of Patent Right...... 3.1. The Objects of Patent Right.......................................................................................17 7.1. Reexamination of Patent Application............................................................................. 3.2. Non-Patentable Subject Matter PAGEREF _Toc159823770 \h 18 7.2.The Reexamination of Invalidation of Patent Right............................................................... 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 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................................................................................... 4.3. The Patentable Subject Matters for Design...............................................................22 Chapter 9. Limitation of Patent Right.............................................................................. Chapter 5. Application Patent................................................................................23 9.1. Exceptions to Patentfor Right Conferred............................................................................ 5.1. The Right of Patent Application..................................................................................23 9.2. Compulsory License for Exploitation of Patent.............................................................. 5.2. The Applicant for Patent.............................................................................................24 Chapter 10. Protection of Patent Right............................................................................ 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................................................................
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.
Copy right © Access China Management Consulting Ltd.
2
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
Copy right © Access China Management Consulting Ltd.
3
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.
Access China Order Form Title: China’s Guidebook for Pharmaceutical Patent Protection
At present, company provides consulting services for foreign clients as follows. Published Date: June 2008 Page Count: 160 Unit Price: US$ 1,495 Site License: US$ 4,995 Format: Electronic PDF copy Please send me ___________Copy/ies Payment: Pay by bank wire transfer to: Account Number: 4447803-007000-900079468 Swift Code: BKCHCNBJ 940 Bank Name: BANK OF CHINA, NANJING SAJIAWAN SUB-BRANCH Bank Address: 212 ZhongShan Beilu Road, Nanjing , People’s Republic of China
Research of Chinese pharmaceutical industry and market; license transfer; registration of imported drugs and new drugs; pharmaceutical patent applications; management of laws and regulations on pharmaceuticals; Consultancy on the Chinese laws, administrative regulations on pharmaceutical administration; Provide analyses of feasibility for mergers and acquisitions of the existing Chinese pharmaceutical enterprises; Act as agent, within a range of authorized, implement operation to purchase and merge the existing Chinese pharmaceutical enterprises in accordance with the order of foreign investors; Help foreign investors make the registration of Foreign Investment Enterprises, including Sino-foreign equity joint ventures (EJV), Sino-foreign cooperative joint ventures (CJV),wholly foreign-owned enterprises (WFOE), Representative Office; Provide a range of customized and standardized solutions including industry report, research report of strategic investment, market analyses, and other subscription-based research and information on the latest development and strategies used in a variety of sectors.
Delivery Details Title: ______________________ Full name: ____________________________ Job title: ___________________ Organization: ___________________________ Email Address: ____________________________________________________ Postal Address: ____________________________________________________
Access China Management Consulting pursues the principle of "integrating resources and creating value" to contribute to foreign clients.
Postal/Zip code: _________________ Country: __________________________ Phone number: ___________________ Fax number: ______________________
Access China Management Consulting Ltd, RUL: http://www.accesschinainfo.com
Signed: _________________________ Date: ____________________________
402 Suite, No. 70 Building , MuFu ShanZhuang He Yan Road, Nanjing 210038, People’s Republic of China Tel : +86-25-83422936 Fax: +86-25-85337409
Please send an E-mail and attached this form by [email protected] to us. As soon as we receive your payment, we'll send the report to you in four business days.
Copy right © Access China Management Consulting Ltd. All rights reserved. No part of this publication may be reproduced, abstracted, stored in any retrieval system or transmitted in any Access
China
Management
Consulting
Ltd
Copy right © Access China Management Consulting Ltd.
is
a
professional
provider
form or be any means without written permission of the copyright owner/publisher.
of 4
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