Competition Law and Intellectual Property Strategy in Pharmaceuticals Sector

Published by: PharmaVentures Ltd.

Published: Apr. 17, 2008 - 149 Pages

Table of Contents

Chapter 1 Introduction

1.1 The nature of competition in the pharmaceuticals sector

1.2 The nature and scope of IP rights in the pharmaceuticals sector

1.3 Parallel imports/exports: the EC free movement rules and competition rules contrasted

1.4 IP and regulatory challenges and opportunities

1.5 Pricing by dominant pharmaceutical companies

1.6 The application of the EC competition rules to R&D licensing and commercialisation agreements

1.7 Court actions for damages in competition law cases

Chapter 2 The Nature of Competition in the Pharmaceuticals Sector

2.1 Introduction

2.2 Competition in innovation: the importance of patents and SPCs

2.3 The framework provisions of EC competition law

2.4 The structure of EC and UK competition law post-Modernisation

2.5 The direct applicability of the exceptions criteria

Chapter 3 The Nature and Scope of Intellectual Property Rights

3.1 Patents

3.1.1 What is a patent?

3.1.2 The international conventions

3.1.3 Patentability: subject matter

3.1.4 Patentability: novelty, inventive step and enablement (suffi ciency of description)

3.1.5 Challenges to validity and revocation actions

3.1.6 Enforcement of patents

3.1.7 Compulsory licensing

3.2 Supplementary Protection Certifi cates

3.3 Trademarks (Community and national)

Chapter 4 Intellectual Property and Regulatory Developments: Challenges and Opportunities

4.1 Introduction

4.2 The experimental use and ‘Euro Bolar’ defences to patent infringement

4.3 Regulatory data protection for medicinal products in the EU

4.3.1 General principles

4.3.2 Term of protection

4.3.3 Variations and line extensions of an already authorised medicinal product: new indications, new strengths, pharmaceutical forms, administration routes and presentations

4.3.4 New combinations

4.3.5 Biological medicinal products

4.3.6 Bibliographic applications

4.3.7 Regulatory data protection in the US

4.4 Abuse of dominant position through alleged misuse of intellectual property procedures

4.5 Abuse of dominant position through misuse of the marketing authorisation system

4.6 Enforcement of intellectual property rights as a breach of EC competition law

4.7 Refusal to license intellectual property rights as an abuse of dominant position

4.8 Patent dispute settlement agreements

4.9 The European Commission’s pharmaceutical sector enquiry

Chapter 5 The Use of Intellectual Property Rights against Parallel Imports

5.1 Introduction

5.2 The principle of exhaustion of rights

5.2.1 General

5.2.2 Legislation

5.2.3 The meaning of placing on the market and Peak Holding v. Axolin Elinor

5.2.4 Role of Customs

5.2.5 Goods in transit

5.2.6 Exceptions to the intra-EEA exhaustion of rights rule under the Accession Treaties

5.3 International exhaustion of rights

5.3.1 General

5.3.2 Patents: international exhaustion (UK)

5.3.3 International exhaustion of rights and the meaning of consent

5.3.4 Implied consent: recent case law

5.3.5 Exhaustion of rights and the EFTA members of the EEA

5.4 Free movement rules: trademark repackaging cases

5.4.1 Exhaustion of rights in relation to repackaged products in trademark cases

Chapter 6 EC Competition law and parallel imports

6.1 Introduction

6.2 Contract terms deterring parallel exports: express terms

6.3 The meaning of an ‘agreement’ under the EC competition rules

6.4 Discriminatory pricing

6.4.1 Discriminatory pricing contrary to Article 81(1) EC

6.4.2 GSK v. Commission: the ECFI’s fi ndings under Article 81(1)

6.4.3 The ECFI’s application of the Article 81(3) exceptions criteria

6.4.4 The nature of competition in the pharmaceuticals sector

6.5 Competition law and abuse of dominant position: case law on refusal by dominant companies to supply export wholesalers

6.5.1 The Greek Syfait case

6.5.2 French Competition Council decision: Pharma-Lab, Pharmajet and Pharmadex

6.5.3 Pharma-Lab and Pharmajet cases in the Paris Court of Appeal

6.5.4 Spanish Tribunal for Fair Trade ruling: Pharmaceutical Laboratories

6.6 Case law trends: conclusions to be drawn

Chapter 7 Pricing issues concerning dominant pharmaceutical suppliers

7.1 Introduction

7.2 Dominant position

7.2.1 Market defi nition

7.2.2 Importance of market share in assessing dominance

7.3 Excessive pricing

7.4 Predatory pricing

7.5 Margin squeezing

7.6 Discounts

7.7 Discriminatory pricing

7.8 The Napp Pharmaceutical Holdings Ltd (Napp) case

7.9 Tying

Chapter 8 Research and Development Agreements

8.1 Research and development agreements within EC competition law

8.2 The R&D block exemption Regulation

8.2.1 Scope of the Regulation

8.2.2 Conditions for the Regulation to apply

8.2.3 Market share threshold and duration of exemption

8.2.4 Black-listed restrictions

8.3 Commission Guidelines on the application of competition rules to R&D collaboration agreements

8.3.1 Agreements limited to collaborative R&D

8.3.2 Agreements extending to joint or shared exploitation/commercialisation (including joint production and distribution)

8.4 Overall considerations for pharmaceuticals companies

Chapter 9 Technology Licensing Agreements

9.1 Introduction

9.2 Market share tests under the Technology Transfer block exemption Regulation

9.3 Exclusivity provisions under the Technology Transfer block exemption Regulation

9.4 Territorial restrictions permitted under the Technology Transfer block exemption

9.5 Non-compete obligations

9.6 Pricing restrictions under the block exemption Regulation

9.7 Field of use, tying and output restrictions

9.8 Further severable, non-permissible restrictions

9.9 Check list for drafting agreements to comply with the Technology Transfer block exemption Regulation

Chapter 10 Marketing and Distribution Agreements

10.1 Introduction

10.2 The various types of distribution and supply agreements under the competition rules

10.2.1 Agency agreements

10.2.2 Distribution, co-marketing and other vertical agreements

10.2.3 Co-promotion agreements

10.3 Payment structures under the competition rules

10.4 The PPRS

10.5 Analysis of restrictions typically included in vertical agreements

10.5.1 Exclusive arrangements

10.5.2 Territorial or customer restrictions

10.5.3 Non-compete obligations

10.5.4 Refusal to supply

Chapter 11 Private Enforcement of the Competition Rules

11.1 Introduction

11.2 Damages for cartel infringements

11.3 Damages for abuse of dominant position

11.4 Summary of the current position on damages in competition law cases

Abstract

• How legislation and case law has set out limits in various areas on the extent to which intellectual property can be enforced in the pharmaceuticals sector
• The use of intellectual property to control parallel imports and the impact of the EC rules on free circulation of goods
• Circumstances when the enforcement of intellectual property could infringe EC competition law
• The application of the EC competition rules to agreements and conduct restricting parallel imports and exports
• Case law and abuse of dominant position on pricing issues
• The EC competition regime in relation to R&D collaboration agreements and technology licensing agreements - which types of provisions can be included and when, and which should be avoided
• The EC competition regime in relation to vertical agreements in the pharmaceuticals sector including agency, distribution, co-marketing and co-promoting agreements, and which provisions should and should not be included
• The state of play on damages claims under the competition rules against cartels and abuse of dominance

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