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
