【Table of Contents】

1. ARGENTINA

1.01 Introduction

1.02 Patents

1.03 Trademarks

1.04 Data Exclusivity and Public Access to Information

1.05 The Drug Approval Process

1.06 Packaging and Labeling

1.07 Government Price Controls on Pharmaceuticals

1.08 Government Drug Payment Plans

2. AUSTRALIA

2.01 Patents

2.02 Trade Mark/Trade Dress Protection for Pharmaceuticals

2.03 Data Exclusivity and Public Access to Information

2.04 The Drug Approval Process

2.05 Certification Requirements for TGA Pharmaceutical Registrations and Listings

2.06 Packaging and Labeling

2.07 Government Price Controls on Pharmaceuticals

2.08 Government Drug Payment Plan

2.09 List of Cases

2A. BELGIUM

2A.01 Patents

2A.02 Supplementary Protection Certificates

2A.03 Biotechnological Inventions & Compulsory Licenses

2A.04 Trademarks

2A.05 Registration of Pharmaceutical Products

2A.06 Pricing & Reimbursement

2A.07 Conflicts of Interest for Medical Professionals

2A.08 Advertising and Information

2A.09 Parallel Imports

2A.10 Product Liability

3. BRAZIL

3.01 General Information on the Brazilian Industrial Property Law

4. CANADA

4.01 General Background

4.02 Patents

4.03 Trade-mark/Trade Dress Protection for Pharmaceuticals

4.04 Data Exclusivity and Public Access to Information

4.05 The Drug Approval Process

4.06 Price Controls on Pharmaceuticals

4.07 Public Drug Payment Plans

5. CHINA

5.01 Patents

5.02 Trademark/Trade Dress Protection for Pharmaceuticals

5.03 Data Exclusivity and Confidentiality of Information

5.04 Drug Approval Process

5.05 Packaging and Labeling

5.06 Price Controls on Pharmaceuticals

5.07 Public Drug Benefit Programs

5A. CUBA

5A.01 General Information

5A.02 Patents

5A.03 Trademark/Trade Dress Protection

5A.04 Data Exclusivity and Public Access to Information

5A.05 The Drug Approval Process

5A.06 Government Price Controls on Pharmaceuticals

5A.07 Government Drug Payment Plans

5A.08 Drug Export and "Internet Pharmacy" Issues

6. THE CZECH REPUBLIC

6.01 General Background

6.02 General Patent Information on Industrial Property Rights

6.03 Patents

6.04 Utility Models

6.05 Trademark, Designs

6.06 The Drug Approval Process

6A. DENMARK

6A.01 General Background

6A.02 Patents

6A.03 Trademark/Trade Dress Protection for Pharmaceuticals

6A.04 Data Exclusivity and Public Access to Information

6A.05 The Drug Approval Process

6A.06 Packaging and Labelling

6A.07 Government Price Controls on Pharmaceuticals

6A.08 Government Drug Payment Plans

9A.09 Wholesale and Retail Sales of Pharmaceuticals

7. EUROPE

7.01 Patents

7.02 Trade Mark/Trade Dress Protection for Pharmaceuticals

7.03 Data Exclusivity and Public Access to Information

7.04 The Drug Approval Process

7.05 Packaging and Labeling

7.06 Government Price Controls on Pharmaceuticals

7.07 Government Drug Payment Plans

8. FRANCE

8.01 Patents

8.02 Trademark/Trade Dress Protection for Pharmaceuticals

8.03 Data Exclusivity and Public Access to Information

8.04 The Drug Approval Process

8.05 Packaging and Labeling

8.06 Government Price Controls on Pharmaceuticals

8.07 Government Drug Payment Plans

8A. GERMANY

8A.01 Introduction

8A.02 Patents and Utility Models

8A.03 Trademark/Trade Dress Protection for Pharmaceuticals

8A.04 Data Exclusivity for Medicinal Products and Public Access to Information

8A.05 The Drug Approval Process

8A.06 Packaging and Labeling (Sections 10, 11 and 11a PhA)

8A.07 Government Price Controls on Pharmaceuticals

8A.08 Government Drug Payment Plans (National Health Care System)

8A.09 Recent Changes in German Drug Reimbursement Law

9. INDIA

9.01 Introduction

9.02 Historical Perspective of Intellectual Property Rights in India

9.03 Legal System

9.04 Patent Act, 1970: Patentable Subject Matter, Patentability, Prosecution and Opposition Mechanism

9.05 Compulsory Licensing of Patents

9.06 Parallel Importation

9.07 Judicial Procedure in Relation to Patent Infringement

9.08 Trademarks and Passing Off

9.09 Important Decisions of the Indian Courts Relating to Pharmaceuticals

9.10 Drug Registration

10. ISRAEL

10.01 Introduction

10.02 Patents

10.03 Trade-mark Protection for Pharmaceuticals

10.04 Data Exclusivity and Public Access to Information

10.05 The Drug Approval Process

10.06 Bioequivalence And Generic Registration In Israel

11. ITALY

11.01 General Patent and Trademark Information

11.02 Filing a Patent Application

11.03 Patent Subject Matter for Pharmaceutical Inventions

11.04 Validity Requirements for Pharmaceutical Inventions

11.05 Patent Term and Term Extensions

11.06 Patent Infringement

11.07 Trademark/Trade Dress Protection for Pharmaceuticals

11.08 Data Exclusivity and Public Access to Information

11.09 Drug Approval Process

11.10 Packaging and Labeling

11.11 Government Price Controls on Pharmaceuticals

11.12 Government Drug Payment Plans

12. JAPAN

12.01 General

12.02 Patents

12.03 Trademark/Trade Dress Protection for Pharmaceuticals

12.04 Data Exclusivity and Public Access to Information

12.05 Drug Approval Process

12.06 Government Price Controls on Pharmaceuticals

12.07 Government Drug Payment Plans

13. MEXICO

13.01 Patents

13.02 Trademark Protection for Pharmaceuticals

13.03 Data Exclusivity and Public Access to Information

13.04 The Drug Approval Process

13.05 Packaging and Labeling

13.06 Government Price Controls on Pharmaceuticals

13.07 Government Drug Payment Plans

13A. THE NETHERLANDS

13A.01 General

13A.02 Patents

13A.03 Trademarks

13A.04 The Law Governing Preparation and Distribution of Medicinal Products

13A.05 Data Exclusivity for Medicinal Products

13A.06 Drug Approval

13A.07 Packaging and Labeling

13A.08 Health Care Insurance and Government Price Controls on Pharmaceuticals

13A.09 Advertisement and Awards

13A.10 Clinical Trials

14. POLAND

14.01 General Information

14.02 Trademark/Trade Dress Protection of Pharmaceuticals

14.03 Approval of New Drugs

14.03A Clinical Trials

14.03B Pharmacovigalence

14.04 Approval of Generic (Equivalent) Drugs

14.05 Access to Information and Data Exclusivity

14.06 Packaging and Labeling of Medicinal Products

14.07 Price Controls for Medicinal Products and Public Drug Payment Plans

14A. PORTUGAL

14A.01 Introduction

14A.02 Patents

14A.03 Trade Marks/Trade Dress Protection for Pharmaceuticals Products

14A.04 Data Exclusivity and Public Access to Information

14A.05 Drug Approval Process

14A.06 Packaging and Labeling

14A.07 Government Price Controls on Pharmaceuticals

14A.08 Government Drug Payment Plans

14A.09 "Internet Pharmacy" Issues (Other Than Patent and Trademark Issues)

14B. RUSSIAN FEDERATION

14B.01 General

14B.02 Patents

14B.03 Trade Mark/Trade Dress Protection for Pharmaceuticals

14B.04 Data Exclusivity and Public Access to Information

14B.05 The Drug Approval Process

14B.06 Packaging and Labeling

14B.07 Government Price Controls on Pharmaceuticals

14B.08 Government Drug Payment Plans

14B.09 Internet Pharmacy

15. SOUTH AFRICA

15.01 General

15.02 Patents

15.03 Trade Marks/Trade Dress Protection for Pharmaceuticals

15.04 Data Exclusivity and Public Access to Information

15.05 The Drug Approval Process

15.06 Packaging, Labeling and Advertising of Pharmaceuticals

15.07 Drug Payment Plans and Price Controls

15.08 Traditional Knowledge Protection (Traditional Medicines)

15A. SPAIN

15A.01 Patents

15A.02 Trademark/Trade Dress Protection for Pharmaceuticals

15A.03 Data Exclusivity and Public Access to Information

15A.04 The New Spanish Medicines Act

15A.05 Packaging and Labeling

15A.06 Financing Issues

15B. SWEDEN

15B.01 Patents

15B.02 Trademark/Trade Dress Protection for Pharmaceuticals

15B.03 Data Exclusivity and Public Access to Information

15B.04 The Drug Approval Process

15B.05 Packaging and Labeling

15B.06 Government Drug Payment Plans

15B.07 Retail Sales of Pharmaceuticals

16. SWITZERLAND

16.01 Patents

16.02 Trademarks

16.03 Data Exclusivity and Public Access to Information

16.04 The Drug Approval Process

16.05 Packaging and Labeling

16.06 Price Controls on Pharmaceuticals

17. TAIWAN

17.01 Introduction

17.02 Patents

17.03 Trademark/Trade Dress Protection for Pharmaceuticals

17.04 Data Exclusivity and Public Access to Information

17.05 The Drug Approval Process

17.06 Packaging and Labeling

17.07 Government Price Controls on Pharmaceuticals

17.08 Government Drug Payment Plans

17A. THAILAND

17A.01 Introduction

17A.02 Patents

17A.03 Trademark & Trade Dress Protection for Pharmaceuticals

17A.04 Data Exclusivity and Public Access to Information

17A.05 The Drug Approval Process

17A.06 Anticipated Developments in Thailand's Pharmaceutical Laws

18. UNITED KINGDOM

18.01 Patents

18.02 Trade Marks

18.03 Data Exclusivity and Public Access to Information

18.04 The Drug Approval Process

18.05 Government Price Controls on Pharmaceuticals

18.06 Government Drug Payment Plans

19. UNITED STATES

19.01 Patents

19.02 Obtaining Regulatory Approval for a New Pharmaceutical Product

19.03 Obtaining Drug Approval for a Generic Version of a Previously Approved Product

19.04 Trademark and Trade Dress

19.05 Copyright and Labeling