Patent Law and Practice in Pharmaceuticals

Table of Contents

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 Figures
• 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

LIST OF TABLES

• Table 1.1: Extra-territorial effect of UK patents by registration
• Table 1.2: Contracting and extension states of the EPC
• Table 1.3: Members of Paris Union
• Table 1.4: Member countries of the Patent Cooperation Treaty
• Table 1.5: Countries party to the Budapest Treaty
• Table 4.1: Cost comparisons for patents
• Table 4.2: Renewal fees for UK patents
• Table 8.1: Member countries of Strasbourg Agreement relating to the IPC
• Table 10.1: The renewal fee payable to the UK Patent Office in respect of each year of the SPC as follows

LIST OF FIGURES

• Figure 8.1: Example of a European patent application
• Figure 8.2: Typical entry in Register of European patents
• Figure 8.3: Searchable fields for entries in Register of European patents
• Figure 8.4: Typical European search report