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Title Pharmaceutical Parallel Trade
Sub title
Author Taylor Joynson Garrett
Publication date March 2000
ISBN 1860674070
Pages Information currently unavailable
Price pdf n/a   |   print £360 currency coverter link
Summary

Between 10 - 15% of all medicines currently being sold to the National Health Service in the UK, are parallel imports representing a turnover of £600m a year. The lack of price harmonisation for pharmaceutical products within the EU is the main reason why parallel importation is such a profitable concern.

This report is written by a team of commercial lawyers with extensive experience on parallel trade in the pharmaceutical industry. It provides practical guidance free of legal jargon telling you what is and is not permissible in working with parallel trade.

Key benefits:
  • Provides a practical review of the law relating to parallel importation


  • Details European Court of Justice cases which have impacted on the parallel import market


  • Discusses the impact of future enlargement of the EU on parallel trade


  • Provides trade dress and legal checklist strategies


  • Features case studies and evaluations of volume based and pricing strategies


  • Examines intellectual property, regulatory and commercial strategies

TABLE OF CONTENTS
Content

1: Introduction


2: The Law

Intellectual property rights vs free movement of goods
Exhaustion of rights
International exhaustion
Refusal to license
Agreements restricting the distribution of goods
References


3: Regulatory Regimes


4: Intellectual Property, Regulatory & Commerical Strategies

Intellectual property rights
Trade marks
The rights of a trade mark owner
Adopting different trade marks for the same product in different countries
Single EU-wide trade mark for medicinal products processed through the Centralised Application System
Patient information leaflets, labels and copyright
Copyright
Regulatory tactics
Commercial strategies
Direct supply
Agency
Limiting supplies
Trade incentives
Differences in the appearance of a pharmaceutical product
Drug dosage/differences in drug formulation
Litigation
Trade-dress
Reference

5: Trade Dress Strategies

Introduction
Efforts by manufacturers to adopt packaging and trade-dress to hinder parallel trade
To what extent can a manufacturer prevent repackaging of its goods?
The 1996 repackaging cases
Artificial partitioning of the EU market
Whether the original condition of the product is adversely affected
The other requirements to be met by the parallel importer
Points from the cases in favour of manufacturers
Points from the cases in favour of the parallel importer
Check-list of what is permissible and not permissible for parallel importers repackaging an original manufacturer's products
What is permissible
What is not permissible
'Grey areas'
'Mercantile necessity'
Customary pack sizes
References

6: Volume Based and Pricing Strategies

Volume-based strategies. Refusal to supply/limitation of supplies
The Bayer case
The facts
The Commission Decision
Bayer's application to the Court of First Instance for temporary suspension of the Commission Decision
Monitoring the sale of products
To what extent can companies use volume-based strategies to stop parallel imports?
Dominant companies
Non-dominant companies
Current position and following CFI Appeal if Bayer loses
Following CFI Appeal if Bayer wins Appeal
Independent wholesalers vs direct dealing
Pricing policies
Organon
Glaxo Wellcome
References


7: Legal Remedies

Legal proceedings for infringement of intellectual property rights
UK High Court action
Interim injunction
Speedy trial
Legal challenge to decision of regulatory authority
Interim injunction
Steps taken prior to commencement of legal proceedings: threats
Choice of jurisdiction
Proceedings in which the validity of a patent or trade mark is in issue
Steps in High Court proceedings
The Writ
Statement of Claim
Defence
Directions hearings
Trial
References

8: Impact

Extent of parallel trade
Response of the pharmaceutical companies
Intellectual property rights
Merck v. Primecrown
Levels of parallel trade
Effect of no patent protection and differing pricing structures
Volume-based strategies
Dual pricing
Conclusion
References

9: The Future

The law
Enlargement
Economic and monetary union
Single market
Attitude of the industry
Arguments against a single market
Attitude and role of the EU institutions
Approach of the ECJ
Action at Community level
Role of the Commission
What measures have the Commission taken?
The Bangemann initiative
The First Round Table Conference
The Second Round Table Conference
The Council's conclusions
The 1998 Communication
The Commission's aims
Possible solutions
Relaxation of price controls and the development of effective competition
Enlargement
Electronic commerce
The Third Round Table Conference
Effects of the Commission's proposals on parallel trade
How will the position change if the new proposals are implemented?
References

10: Conclusion




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