Abstract
The patent system plays a pivotal role in many industries. Perhaps the pharmaceutical industry places most reliance on the protection afforded by patents. The uncertainty, complexity and high costs of identifying new pharmaceutical products and bringing these to market has always provided, and continues to provide, motivation to pharmaceutical companies to protect the results of their research and development (R&D). The scale of patenting activity in the pharmaceutical sector and the importance of developing and providing improved standards of medicinal products as part of healthcare are reflected in the patent system itself. Many patent laws contain provisions explicitly addressing problems and issues that arise from the healthcare industry. Examples include patenting further medical indications of known pharmaceutically active compounds and the unique extension of patent terms available by way of supplementary protection certificates (SPCs).
The growing body of international case-law and judgments relating to pharmaceutical patents reflects the current high levels of activity in enforcing these patents and the efforts being made to push at the boundaries of patent law by creative pharmaceutical companies and their patent attorneys. the cases before the European Court of Justice (ECJ) relating to the free movement and parallel importation of pharmaceuticals between EU Member States are just an example of this creativity. Few would disagree that these cases were fundamental in defining the doctrine of exhaustion of rights now enshrined in European Community law.
The subject of patent law in general and its commercial applications is a fascinating topic, more so when focusing on the peculiarities of pharmaceutical patents and the related laws and legislation. This report will examine the fundamental aspects of patent law in Europe and worldwide, relating legislation and the commercial applications and implications of patents in the pharmaceutical sector. It will give the reader an understanding not only of the basics of patent law, in general and as it relates to pharmaceuticals, but also the relationship between patents and the commercial realities of doing business in the pharmaceutical sector. It will also help the reader to stop thinking of patents as perhaps a complicated legal entity and understand how to relate to patents as valuable business assets - in some cases the most valuable assets can a company can own.
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
