International Pharmaceutical Law and Practice

by Adrian Zahl

Overview

Covers key pharmaceutical law topics in all of the major industrial countries and for each country discusses in detail:

•   Treaties and international law principles affecting patents, data exclusivity and other rights relating to pharmaceutical manufacture and sales

•   Patent procurement and the scope of patent protection afforded pharmaceutical subject matter

•   Substantive patentability requirements of novelty, utility and inventiveness

•   New drug approval process and supplementary approvals

•   Government price controls on pharmaceuticals and government drug payment plans

•   Obtaining an approval for a generic version of a drug

•   Compulsory Licensing

Product Details

ISBN-13:	9781579114725
Publisher:	LexisNexis
Publication date:	11/17/2017
Sold by:	Barnes & Noble
Format:	eBook
Pages:	1280
File size:	4 MB

Table of Contents

Chapter 1	Argentina
1.01	Introduction
1.02	Patents
1.03	Defenses Available to an Accused Infringer
Chapter 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	Packaging and Labeling
2.06	Government Price Controls on Pharmaceuticals
2.07	Government Drug Payment Plan
2.08	List Of Cases
Chapter 3	Brazil
3.01	General Information on the Brazilian Industrial Property Law
Chapter 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
Chapter 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
Chapter 6	The Czech Republic
6.01	General Information
Chapter 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
Chapter 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
Chapter 9	India
9.01	General
9.02	Patents
9.03	Trade marks
9.04	Control of Drug Manufacture and Sale
Chapter 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
Chapter 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
Chapter 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
Chapter 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
Chapter 14	Poland
14.01	General Information
14.02	Trademark/Trade Dress Protection of Pharmaceuticals
14.03	Approval of New Drugs
14.04	Approval of 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
Chapter 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 and Labeling of Pharmaceuticals
15.07	Drug Payment Plans and Price Controls
Chapter 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
Chapter 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
Chapter 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
Chapter 19	United States
19.01	Patents
19.02	Obtaining Regulatory Approval for a New Drug 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