This book highlights the special issues arising in obtaining, commercialising, enforcing or attacking intellectual property rights (including protection of regulatory data) in the pharmaceutical, biotechnology and chemical industries across the world's key jurisdictions. It is unique in presenting topic matter horizontally by subject to facilitate comparison between country practices. The first two chapters give a general introduction to the differences between the
jurisdictions and an overview of some of the key concepts in patent law. The remainder of the book is dedicated to a detailed analysis of the major legal issues arising in these areas of technology. Each component chapter has a comparative introduction, looking at the variances in the laws of
different domains, followed by side-by-side analysis of the relevant regimes, including tables and flow-charts which summarise and explain the key legal concepts. The jurisdictions covered are the United States, Europe (UK, Germany, Netherlands, France and Italy), Japan, Canada, Australia, India and China.
Edited by Duncan Bucknell, Patent Attorney and IP Consultant, Australia
PART A. INTRODUCTION AND OVERVIEW ; PART B. FUNDEMENTAL CONCEPTS ; 1. Overview ; 2. International treaties ; 3. Skilled addressee ; 4. Interpretation of patent claims and specifications ; 5. Inventorship ; 6. Ownership ; PART C. OBTAINING PATENT RIGHTS ; 1. Overview ; 2. Drafting bioscience patents ; 3. Drafting pharmaceutical patents ; 4. Overview of procedure from filing to grant ; 5. Types of examination and when to use them ; 6. Prosecution strategies ; 7. Types of application and their use ; 8. Disclosure of information to the patent offices ; PART D. THE PERIOD OF THE MONOPOLY ; 1. Overview ; 2. The patent term, renewal fees, withdrawals, cease & lapse ; 3. Extensions of term and supplementary protection certificates ; PART E. PATENT VALIDITY ; 1. Overview ; 2. Patent validity ; 3. Priority dates ; 4. Novelty ; 5. Grace period ; 6. Inventive step ; 7. Enablement/internal fair basis ; 8. Full description/stuffiness/written description ; 9. Utility ; 10. Indefiniteness ; 11. Secret use before prior date ; 12. Unity of invention ; 13. Fraud and misrepresentation ; 14. Lack of entitlement to the invention ; PART F. AMENDMENT ; 1. Overview ; 2. When Patents can be added? ; 3. What amendments are allowable? ; 4. Amended specifications ; PART G. INVALIDITY PROCEEDINGS AND STRATEGY ; 1. Overview ; 2. Third part intervention during prosecution ; 3. Opposition proceedings ; 4. Re-examination ; 5. Revocation/nullification proceedings ; 6. Declarations of validity ; PART H. INFRINGEMENT ; 1. Overview ; 2. Literal infringement ; 3. Infringement equivalents ; 4. Contributory infringement ; 5. Infringement proceedings & strategy ; 6. Remedies for patent infringements ; 7. Restrictions on remedies ; PART I. DEFENCES TO INFRINGEMENT ; 1. Overview ; 2. Prior secret use ; 3. Experimental use and clinical trials ; 4. The bolar exemption ; 5. Contributory infringement ; 6. Parallel importing and exhaustion of rights ; PART J. PATENT LITIGATION STRATEGIES ; 1. Overview ; 2. Court hierarchies ; 3. Overview of litigation ; 4. Preliminary injunctions ; 5. Split trials ; 6. Summary judgments ; 7. Multi-jurisdictional strategy ; 8. Practicalities of litigation ; 9. Settlement of litigation ; PART K. INTERACTION BETWEEN REGULATORY APPROVAL AND PATENTS ; 1. Overview ; 2. Regulatory bodies and relevant legislation ; 3. The pharmaceutical regulatory approval process ; 4. The biologicals regulatory approval process ; 5. The medical device regulatory approval process ; 6. The agricultural chemicals regulatory approval process ; 7. Regulatory filing strategies adopted by innovator companies ; 8. Regulatory filing strategies adopted by generic companies ; 9. Other relevant regulatory laws ; PART L. DATA EXCLUSIVITY ; 1. Overview ; 2. Comparison of data exclusivity with other right ; 3. New chemical entity data exclusivity periods for pharmaceuticals ; 4. Other data exclusivity periods for pharmaceuticals ; 5. Certified (listed) patents and approval of generic drugs ; 6. Data exclusivity strategies adopted by innovator companies ; 7. Data exclusivity strategies adopted by generic companies ; 8. Medical devices, agricultural chemicals and other non-pharmaceuticals ; PART M. COMPETITION LAW ; 1. Overview ; 2. Legal basis for IP as an exception to competition (anti-trust) law ; 3. Technology transfer arrangements (including Block Exemption) ; 4. Tie-in clauses / Tie-out clauses ; 5. Licenses which extend beyond patent term ; 6. Disclosure to industry standard setting organizations ; 7. Unjustified threats of patent infringement proceedings ; 8. Competition issues in settlement of litigation ; PART N. OTHER IP RIGHTS ; 1. Overview ; 2. Competition issues in settlement of litigation ; 3. Plant breeder's rights ; 4. Trade marks, passing off and unfair competition ; PART O. COMMERCIAL ARRANGEMENTS ; 1. Oveview ; 2. Research & development collaboration ; 3. Commercialisation strategies ; 4. Licensing ; 5. Assignments ; 6. IP due diligence ; 7. Compulsory licenses ; 8. Compulsory use or acquisition by government ; Tables and Figures