Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation

Hardcover | May 7, 2011

EditorDuncan Bucknell

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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 inpresenting 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 adetailed 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 whichsummarise 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.

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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 inpresenting topic matter horizontally by subject to...

Duncan Bucknell is a Patent Attorney and IP Consultant in Australia.

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Format:HardcoverDimensions:2100 pagesPublished:May 7, 2011Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199289018

ISBN - 13:9780199289011

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Table of Contents

Part A. Introduction and OverviewPart B. Fundemental Concepts1. Overview2. International treaties3. Skilled addressee4. Interpretation of patent claims and specifications5. Inventorship6. OwnershipPart C. Obtaining patent rights1. Overview2. Drafting bioscience patents3. Drafting pharmaceutical patents4. Overview of procedure from filing to grant5. Types of examination and when to use them6. Prosecution strategies7. Types of application and their use8. Disclosure of information to the patent officesPart D. The period of the monopoly1. Overview2. The patent term, renewal fees, withdrawals, cease and lapse3. Extensions of term and supplementary protection certificatesPart E. Patent validity1. Overview2. Patent validity3. Priority dates4. Novelty5. Grace period6. Inventive step7. Enablement/internal fair basis8. Full description/stuffiness/written description9. Utility10. Indefiniteness11. Secret use before prior date12. Unity of invention13. Fraud and misrepresentation14. Lack of entitlement to the inventionPart F. Amendment1. Overview2. When Patents can be added?3. What amendments are allowable?4. Amended specificationsPart G. Invalidity proceedings and strategy1. Overview2. Third part intervention during prosecution3. Opposition proceedings4. Re-examination5. Revocation/nullification proceedings6. Declarations of validityPart H. Infringement1. Overview2. Literal infringement3. Infringement equivalents4. Contributory infringement5. Infringement proceedings and strategy6. Remedies for patent infringements7. Restrictions on remediesPart I. Defences to infringement1. Overview2. Prior secret use3. Experimental use and clinical trials4. The bolar exemption5. Contributory infringement6. Parallel importing and exhaustion of rightsPart J. Patent litigation strategies1. Overview2. Court hierarchies3. Overview of litigation4. Preliminary injunctions5. Split trials6. Summary judgments7. Multi-jurisdictional strategy8. Practicalities of litigation9. Settlement of litigationPart K. Interaction between regulatory approval and patents1. Overview2. Regulatory bodies and relevant legislation3. The pharmaceutical regulatory approval process4. The biologicals regulatory approval process5. The medical device regulatory approval process6. The agricultural chemicals regulatory approval process7. Regulatory filing strategies adopted by innovator companies8. Regulatory filing strategies adopted by generic companies9. Other relevant regulatory lawsPart L. Data exclusivity1. Overview2. Comparison of data exclusivity with other right3. New chemical entity data exclusivity periods for pharmaceuticals4. Other data exclusivity periods for pharmaceuticals5. Certified (listed) patents and approval of generic drugs6. Data exclusivity strategies adopted by innovator companies7. Data exclusivity strategies adopted by generic companies8. Medical devices, agricultural chemicals and other non-pharmaceuticalsPart M. Competition law1. Overview2. Legal basis for IP as an exception to competition (anti-trust) law3. Technology transfer arrangements (including Block Exemption)4. Tie-in clauses / Tie-out clauses5. Licenses which extend beyond patent term6. Disclosure to industry standard setting organizations7. Unjustified threats of patent infringement proceedings8. Competition issues in settlement of litigationPart N. Other IP rights1. Overview2. Competition issues in settlement of litigation3. Plant breeder's rights4. Trade marks, passing off and unfair competitionPart O. Commercial arrangements1. Oveview2. Research and development collaboration3. Commercialisation strategies4. Licensing5. Assignments6. IP due diligence7. Compulsory licenses8. Compulsory use or acquisition by governmentTables and Figures