
世界の製薬関連法とその実務
International Pharmaceutical Law and Practice
特価 ¥103,784
薬品の製造から販売までの様々な場面に関わってくる法と実務‐特許・商標法、新薬承認制度、薬価統制など‐について、国ごとに解説した文献。
【主な内容】
○特許権の取得と保護の範囲 ○特許性要件 ○商標、トレードドレス保護 ○試験データの独占利用 ○新薬承認申請 ○ジェネリック医薬品 ○ラベリングおよび包装 ○薬価規制 等
【収録国】
アルゼンチン/オーストラリア/ベルギー/ブラジル/カナダ/チリ/中国/キューバ/チェコ/デンマーク/EU/フランス/ドイツ/インド/イスラエル/イタリア/日本/韓国/メキシコ/オランダ/ポーランド/ポルトガル/ロシア/南アフリカ/スペイン/スウェーデン/スイス/台湾/タイ/英国/米国
【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