Global Patent Law

Global Patent Law

Scrip Reports presents you with a complete overview of patents and the crucial role they play in the pharmaceutical industry.

Patents are a fundamental requirement for both the innovative and generic sectors of the pharmaceutical industry and yet there is still confusion surrounding the topic.

This report avoids complex jargon and presents information in a concise, well-defined manner. It covers all recent global developments, enabling you to keep fully up-to-date with new patent laws and current issues, such as the increasing influence of generics and the changing innovative industry.

Other topics Global Patent Law discusses include: the process of obtaining and exploiting patents, difficulties surrounding biotechnology patents, practice of enforcing patents in major countries and the current position on GATT TRIPs.

CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS
GLOSSARY OF TERMS

CHAPTER 1 INTRODUCTION
1.1 Structure of the report
1.2 General overview of the pharmaceutical industry
1.3 The importance of patents
1.4 The customer

CHAPTER 2 DRAFTING THE PATENT SPECIFICATION
2.1 The patent-research interface
2.1.1 Publication policy
2.1.2 Laboratory notebooks
2.2 Structure of the specification
2.2.1 Prior art
2.3 The priority application
2.4 The substantive application
2.4.1 Advantages of the invention
2.4.2 Sufficiency of description
2.4.3 The examples
2.4.4 Forms of claims
2.4.4.1 Categories of claims
2.4.4.2 Product
2.4.4.3 Composition
2.4.4.4 Use
2.4.4.5 Second medical use
2.4.4.6 Process
2.4.4.7 Packs
2.4.5 Drawings
2.5 Criteria for patentability
2.5.1 Novelty
2.5.2 Inventive step
2.5.2.1 Selection inventions
2.5.3 Industrial application

CHAPTER 3 FILING THE PATENT APPLICATION
3.1 Inventorship
3.2 Priority application
3.3 Substantive application
3.3.1 General considerations
3.3.2 Territorial scope
3.3.3 Filing routes
3.3.3.1 National
3.3.3.2 EPC
3.3.3.3 PCT
3.3.3.4 Eurasian Patent Office
3.4 Cost of obtaining patent protection
3.5 Trends in patent office practice

CHAPTER 4 PATENTS AND BIOTECHNOLOGY
4.1 General considerations
4.2 Patent factors peculiar to biotechnology
4.3 Research tools
4.4 The ethical dimension
4.5 Developing countries and biodiversity

CHAPTER 5 PATENT TERM
5.1 General considerations
5.2 Patent term restoration
5.2.1 US
5.2.2 Japan
5.2.3 France
5.2.4 Italy
5.2.5 EU

CHAPTER 6 PATENTS AS AN INFORMATION SOURCE
6.1 Availability of patent information
6.2 Use by scientists
6.3 Source of marketing information
6.4 Patent freedom

CHAPTER 7 USE OF THE PATENT RIGHT
7.1 General trends in the industry
7.2 Nature of the infringing act
7.3 Non-infringing acts
7.4 Clinical trials
7.5 Exhaustion of the patent right

CHAPTER 8 ENFORCING THE PATENT
8.1 Detection of infringement
8.1.1 Discovery and related matters
8.2 Requirements of the patentee
8.2.1 The team
8.2.2 Relief sought by the patentee
8.3 The patent infringement action
8.3.1 France
8.3.2 Germany
8.3.3 Japan
8.3.4 The Netherlands
8.3.5 UK
8.3.6 US
8.4 Scope of the patent claim
8.4.1 France
8.4.2 Germany
8.4.3 Japan
8.4.4 UK
8.4.5 US
8.5 Cross border injunctions

CHAPTER 9 THE ORGANISATION
9.1 The role and structure of the patent department
9.2 The location of the patent department
9.3 Interactions with other departments
9.3.1 Research department
9.3.2 Development department
9.3.3 Medical department
9.3.4 Pharmaceutical department
9.3.5 Marketing department
9.3.6 Licensing department
9.3.7 Accountancy department
9.3.8 Personnel (human resources) department

CHAPTER 10 INTERNATIONAL TRADE MATTERS
10.1 The role of patents
10.2 Technology transfer

CHAPTER 11 GATT TRIPS
11.1 History and general overview
11.2 Part I - general provisions and basic principles
11.3 Patent provisions - Part II, Section 5
11.3.1 Article 27
11.3.2 Article 28
11.3.3 Article 29
11.3.4 Article 30
11.3.5 Article 31
11.3.6 Article 33
11.3.7 Article 34
11.4 Enforcement - Part III
11.5 Dispute prevention and settlement - Part V
11.6 Transitional arrangements - Part VI
11.7 Final provisions
11.8 Current position on implementation
11.9 Protection of undisclosed information

CHAPTER 12 THE GENERIC SECTOR
12.1 Sources of generic medicines
12.2 Economic factors of the sector
12.3 Patent factors affecting the sector

CHAPTER 13 FUTURE DEVELOPMENTS
13.1 GATT TRIPs
13.2 The draft EU Biotechnology Directive
13.3 The EU Green Paper on patents
13.3.1 Background to the Green Paper
13.3.2 Current difficulties
13.3.3 Green Paper proposals
13.3.4 Comments on the Green Paper and resolution of current difficulties
13.4 Transatlantic Business Dialogue
13.5 Utility models
13.6 EU enlargement

CHAPTER 14 COLLABORATIVE RESEARCH
14.1 General considerations
14.1.1 Screening agreements
14.1.2 Joint research collaborations
14.2 Commercial partners
14.3 Academic institutions

CHAPTER 15 OTHER RELATED INTELLECTUAL PROPERTY RIGHTS
15.1 Know-how
15.2 Industrial designs
15.3 Copyright
15.4 Trade marks

CHAPTER 16 THE VALUE OF PATENTS
16.1 Introduction
16.2 The value of a patent
16.2.1 The product
16.2.2 Age of the patent
16.2.3 Competitive activity
16.2.4 Development products
16.3 Determination of the value of the patent
16.3.1 Royalty rates
16.3.2 Top-down method
16.4 Conclusion

REFERENCES

APPENDIX OF USEFUL ADDRESSES AND WEBSITES

LIST OF TABLES
Table 3.1 Patent costs to grant
Table 3.2 Total renewal fees
Table 3.3 PCT contracting states

Table 5.1 Term of patents existing in 1978 in EPC countries
Table 5.2 Eligibility for a SPC: transitional provisions

Table 6.1 Patent specification - first page information

Table 8.1 Patent term and claim type for a 1985 filed patent
Table 11.1 TRIPs - minimum provisions for patents

Table 16.1 Royalty rates for the use of technology, equipment, reagents and diagnostic products

LIST OF FIGURES
Figure 1.1 R&D expenditure in Europe
Figure 1.2 Rate of NCE introduction worldwide
Figure 1.3 Cash flow of a NCE
Figure 3.1 Patent filing routes

PUBLISHED: MARCH 1998
REF: BS943E
PAGES: 135
PRICE: £370/$780/¥89,000