Patent Law and Practice in Pharmaceuticals

Publication Date	January 2006
Publisher	Scrip Reports
Product Type	Report
Pages
ISBN Number	not applicable
Product Code	SCR00007

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£1,095.00
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Summary

Pharmaceutical counterfeiting is widely accepted to be a serious, global problem. No longer just a scourge on the developing world, counterfeit drugs now affect industrialised nations including the member states of the European Union (EU). This issue must be faced by businesses worldwide.

Today, it is estimated that up to 10% of all drugs may be counterfeit. But international and national organisations, as well as governmental authorities, appear to be unanimous in their assertion that it is extremely difficult to establish reliable statistics regarding the size of the phenomenon - or even to determine what constitutes counterfeiting. So, as well as discussing the extent of the problem, this report explores the definitions - in itself an indication of the many and varied forms counterfeiting can take.

The report also pays special attention to how counterfeit medicines breach intellectual property rights (IPR) as the problem is compounded by originator companies' needs to protect their IPR.

Even in the EU, where protection of IPR is rigorously enforced, data gathered by EU medicines enforcement officers (EMEO) have revealed a startling number of fake drugs in the legal supply chain. And figures presented by the EU's Directorate general for Tax and Customs show that in 2005, customs officers seized more than 500,000 counterfeit medicines.

As the counterfeiting of drugs in Europe threatens to spiral out of control, the European Commission (EC) has implemented stringent measures to deter and combat this type of fraud. Moreover, the European Medicines Agency and the Heads of Medicines Agencies have launched their own approaches to the problem, all of which are discussed in detail here.

In addition, this report contains a series of exclusive commentaries from selected EU countries which outline their opinions on the extent of the problem. This section details national measures that have been introduced to combat counterfeiting and highlights the efforts of the member states to move the fight onto an international stage.

And this report does not ignore the global scale of this problem. It gives an overview of the nature of the problem in countries around the world.

Businesses also have a role to play in the ongoing battle against counterfeit medicines. A number of large pharmaceutical companies have launched their own initiatives to combat counterfeiting. This report presents the solutions employed by some of pharma's biggest players.

Also in the frame is the role of parallel traders and whether their actions truly contribute to the proliferation of counterfeit medicines.

Finally, the report presents a range of practical options open to companies looking to combat the counterfeiting menace. It focuses on radio frequency identification (RFID), often viewed as the most promising technology in this sector.

A comprehensive guide to one of pharma's biggest concerns, this study explores the problem from numerous angles and highlights the biggest threats facing the industry. It also explains what is being done to tackle the issue and suggests what companies themselves can do. It is essential reading for anyone concerned with the safe provision of medicines.

Content

Chapter 1 Introduction to Patent Law and The Patent System
- 1.1 What Is A Patent?
- 1.2 The Patent as A Contract
- 1.3 Why Have A Patent System?
- 1.4 History of The Patent System
- 1.4.1 Early Exclusive Rights and The First Patent Laws
- 1.4.2 The Statute of Monopolies and English Law
- 1.4.3 Patent Law in The US
- 1.4.4 The Development of Patent Law in Other Countries
- 1.4.5 Conclusion
- 1.5 Patent Legislation - An Overview of Its Structure and
- Interrelationships
- 1.5.1 National Patent Laws
- 1.5.2 Regional Patent Laws and Systems
- 1.5.3 International Conventions and Treaties
- 1.6 The Role of Patent Offices
- 1.7 Overview of Court Structures for Patent Cases
- 1.8 References
Chapter 2 Standards for Patentability
- 2.1 What Is An Invention?
- 2.2 Patentable Inventions
- 2.2.1 Subject Matter Excluded as Inventions
- 2.2.2 Industrial Application
- 2.2.3 Exclusions of Medical Methods from Industrial
- Applicability
- 2.2.4 Further Exceptions to Patentability
- 2.3 Biotechnological Inventions and The Biotechnology Directive
- 2.4 Novelty
- 2.4.1 Conflicting Patent Applications as Prior Art
- 2.4.2 Selection Inventions
- 2.4.3 Novelty of Medical Indications
- 2.4.4 Patentability of Further Non-Medical Indications
- 2.4.5 Non-Prejudicial Disclosures
- 2.4.6 Novelty under US Law and Practice
- 2.5 Inventive Step
- 2.5.1 Hindsight
- 2.5.2 Indications of Inventive Step
- 2.5.3 Inventive Step in Chemical Cases
- 2.6 References
Chapter 3 The Patent Application
- 3.1 The Patent Specification
- 3.1.1 Description
- 3.1.2 Nucleotides and/or Amino Acid Sequences
- 3.1.3 Claims
- 3.1.4 Abstract
- 3.1.5 3.2 Unity of Invention
- 3.3 Sufficiency of Disclosure
- 3.3.1 Insufficiency in Biotechnological Inventions
- 3.3.2 Best Mode Requirement
- 3.4 Added Subject Matter
- 3.5 Interpretation of Patent Claims
- 3.5.1 Purposive Construction in The UK
- 3.5.2 The Doctrine of Equivalence in Germany
- 3.5.3 Doctrine of Equivalence in The US and File Wrapper
- Estoppel
- 3.6 The Patenting Procedure
- 3.6.1 Filing A Patent Application
- 3.6.2 Preliminary Examination
- 3.6.3 Search
- 3.6.4 Publication
- 3.6.5 Substantive Examination
- 3.6.6 Grant Procedure
- 3.6.7 Appeal from Rejection
- 3.6.8 Renewal Fees
- 3.7 References
Chapter 4 Patent Filing Strategies
- 4.1 General Aspects of A Patent Filing Strategy
- 4.1.1 Nature of Invention in Field
- 4.2 to File or Not to File?
- 4.3 Patent Applications to Ensure Freedom to Operate
- 4.4 Publication in A Patent Filing Strategy
- 4.5 First Filing of Patent Applications
- 4.5.1 First Filing in The UK
- 4.5.2 First Filing in The US
- 4.6 Further or Foreign Filing Strategies
- 4.6.1 Technical Confirmation of Invention
- 4.6.2 Assessment of Commercial Potential
- 4.6.3 Assessment of Patentability
- 4.6.4 Timing
- 4.7 Considerations for A Patent Filing Strategy
- 4.7.1 Inventions Excluded from Patentability
- 4.7.2 Competitor Activities
- 4.7.3 7.3 Licensing
- 4.8 Where and How to File Patent Applications
- 4.8.1 Refiling and Claiming Priority
- 4.8.2 Factors for Assessing Patent Filing Routes
- 4.8.3 National Patent Filing
- 4.8.4 Regional Patent Filings
- 4.8.5 International Patent Filing
- 4.9 The Costs of Patenting
- 4.9.1 Renewal Fees
- 4.10 References
Chapter 5 Patent Infringement
- 5.1 Patent Infringement
- 5.1.1 Direct Infringement in The UK
- 5.1.2 Direct Infringement in The US
- 5.1.3 Indirect Infringement in Europe
- 5.1.4 Supply of A Staple Commercial Product in Europe
- 5.1.5 Indirect Infringement in The US
- 5.2 Exceptions to Patent Infringement
- 5.2.1 Exceptions to Patent Infringement in Europe
- 5.2.2 Exceptions to Patent Infringement in The US
- 5.3 Experimental Use Exception and The Pharmaceutical Industry
- 5.3.1 UK
- 5.3.2 The Netherlands
- 5.3.3 Germany
- 5.3.4 Japan
- 5.3.5 US
- 5.4 Prior User Rights
- 5.4.1 Prior User Rights in Europe
- 5.4.2 Prior User Rights in The US
- 5.5 Remedies in Cases of Patent Infringement
- 5.5.1 Remedies under European Law
- 5.5.2 Provisional Protection in Europe
- 5.5.3 Remedies under US Law
- 5.5.4 Provisional Protection in The US
- 5.6 Periods of Limitation for Recovery of Damages
- 5.7 Requirements for Marking and Innocent Infringement
- 5.8 References
Chapter 6 Licensing Patent Rights
- 6.1 What Is A Patent Licence?
- 6.2 Why License A Patented Technology?
- 6.3 Categories of Patent Licence
- 6.3.1 Exclusive Patent Licences
- 6.3.2 Sole Patent Licences
- 6.3.3 Non-Exclusive Patent Licences
- 6.3.4 Other Forms of Patent Licence
- 6.3.5 Bare Patent Licences and Technology Transfer
- Agreements
- 6.4 Laws Regulating The Licensing of Patented Technology
- 6.5 National Competition Laws
- 6.5.1 Anticompetitive Agreements
- 6.5.2 Abuse of A Dominant Position
- 6.6 Eu Competition Laws
- 6.6.1 Article 81 and The Technology Transfer Regulation
- 6.6.2 Abuse of A Dominant Position
- 6.7 Essential Provisions of A Patent Licensing Agreement
- 6.7.1 Grant of Rights
- 6.7.2 Term of Agreement
- 6.7.3 Responsibilities of Parties
- 6.7.4 Improvements
- 6.7.5 Royalties and Payments
- 6.7.6 Termination
- 6.7.7 Most Favoured Nations
- 6.8 Recording Patent Licences
- 6.8.1 Effects of Non-Recordal of Patent Licence
- 6.8.2 Non-Registration of Exclusive Licence
- 6.9 Compulsory Licences
- 6.10 Licences of Right
- 6.11 References
Chapter 7 Challenging Patent Validity
- 7.1 Observations against Patent Applications
- 7.1.1 Provisions for Filing Observations
- 7.1.2 Strategy of Filing Observations
- 7.2 National Challenges to Validity
- 7.2.1 Revocation in The UK
- 7.2.2 Opposition Proceedings in Germany
- 7.2.3 Nullity Proceedings in Germany
- 7.2.4 Re-Examination Proceedings in The US
- 7.2.5 Challenges to Validity before US Courts
- 7.3 Opposition Proceedings before The European Patent Office
- 7.3.1 Numbers of Oppositions to European Patents
- 7.3.2 Legal Basis for Opposition
- 7.3.3 Grounds of Opposition
- 7.3.4 Who May Oppose A European Patent?
- 7.3.5 Opposition Procedure
- 7.3.6 Appeal from Decision of Opposition Division
- 7.3.7 New Grounds of Opposition
- 7.3.8 Late-Filed Documents, Evidence and Submissions
- 7.3.9 The Inescapable Trap
- 7.3.10 Intervention of An Alleged Infringer
- 7.3.11 Assignment of Opposition
- 7.3.12 Likelihood of Success in Opposition
- 7.4 References
Chapter 8 Patent Specifications as Sources of Information
- 8.1 Patent Bibliographic Information
- 8.1.1 Inid Codes
- 8.1.2 Official Patent Registers
- 8.2 The International Patent Classification (IPC)
- 8.2.1 History of The IPC and The Strasbourg Agreement
- 8.2.2 Principles of The IPC Classification
- 8.2.3 The Structure of The IPC
- 8.3 The Patent Specification as A Source of Information
- 8.3.1 Search Report
- 8.3.2 Introductory Section
- 8.3.3 Detailed Description of Invention
- 8.3.4 Examples
- 8.3.5 Claims
- 8.3.6 Abstract
- 8.4 Searching Facilities
- 8.5 Search Strategies
- 8.5.1 Name Searches
- 8.5.2 Search by Bibliographic Data
- 8.5.3 Subject Matter
- 8.5.4 Other Search Criteria
- 8.6 Geographical Search
- 8.7 Patent Status
- 8.8 Reasons for Patent Searching
- 8.8.1 R&d
- 8.8.2 Competitor Analysis
- 8.8.3 Policing Patents
- 8.8.4 Identifying Targets for New Ventures
- 8.8.5 Due Diligence
- 8.8.6 Freedom to Operate
- 8.8.7 Patentability
- 8.9 References
Chapter 9 Ownership and Inventorship of Patents
- 9.1 Inventorship
- 9.2 Ownership
- 9.2.1 Employment Contracts
- 9.3 Employee Inventors
- 9.3.1 UK
- 9.3.2 Germany
- 9.4 Employee Inventor Remuneration
- 9.4.1 UK
- 9.4.2 Germany
- 9.5 Co-Ownership of Patent Rights
- 9.5.1 US
- 9.5.2 UK
- 9.6 Challenging Ownership
- 9.7 Assignment of Patents and Applications
- 9.7.1 Form of Patent Assignment Document
- 9.8 Recordal of Assignment of Patents
- 9.9 References
Chapter 10 Final Aspects of Patent Systems
- 10.1 Supplementary Protection Certificates
- 10.1.1 Eu Regulation
- 10.2 Patent Term Restoration in The US
- 10.3 Exhaustion of Rights in The Eu
- 10.4 The Community Patent
- 10.5 Trips
- 10.5.1 Objectives and Principles
- 10.5.2 Patentable Subject Matter
- 10.5.3 Rights Conferred by Patents
- 10.5.4 Exceptions to Exclusive Rights
- 10.5.5 Term of Patent Protection
- 10.5.6 Burden of Proof in Process Patents
- 10.5.7 General Obligations
- 10.5.8 Transitional Provisions
- 10.6 Other Intellectual Property Rights
- 10.6.1 Know-How
- 10.6.2 Copyright
- 10.6.3 Industrial Designs
- 10.6.4 Trademarks
- 10.7 References
Chapter 11 Conclusion
- 10.7 References
Chapter 11 Conclusion 279 List of Tables Table
- 1.1: Extra-Territorial Effect of UK Patents by Registration. 29 Table
- 1.2: Contracting and Extension States of The Epc. 30 Table
- 1.3: Members of Paris Union 36 Table
- 1.4: Member Countries of The Patent Cooperation Treaty 39 Table
- 1.5: Countries Party to The Budapest Treaty 41 Table
- 4.1: Cost Comparisons for Patents 127 Table
- 4.2: Renewal Fees for UK Patents 128 Table
- 8.1: Member Countries of Strasbourg Agreement Relating to The IPC 214 Table
- 10.1: The Renewal Fee Payable to The UK Patent Office in Respect of Each Year of The Spc Is as Follows 261 List of Figures Figure
- 8.1: Example of A European Patent Application 208 Figure
- 8.2: Typical Entry in Register of European Patents 212 Figure
- 8.3: Searchable Fields for Entries in Register of European Patents 213 Figure
- 8.4: Typical European Search Report