Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation

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