Pharmaceutical, Biotechnology and Chemical Inventions

World Protection and Exploitation

Edited by Duncan Bucknell

Major new title giving comprehensive coverage of intellectual property and patent law issues in the pharmaceutical, biotechnology and chemical industries
Unique topic-by-topic approach allows for a truly comparative analysis of the law in these sectors across 12 key jurisdictions
Practical information on patent procedure in the different regimes enables patent owners, licensors, licensees, and those acting on behalf of them to make fully informed decisions regarding protection and exploitation of patent rights
Jurisdictions covered include the United States, Japan, Canada, Australia, India, China, a European overview, as well as separate sections for the UK, Germany, Netherlands, France and Italy
Written by a handpicked team of expert practitioners from each territory covered

Pharmaceutical, Biotechnology and Chemical Inventions

World Protection and Exploitation

Edited by Duncan Bucknell

Description

Pharmaceutical, Biotechnology, and Chemical Inventions: World Protection and Exploitation, This book highlights the special issues arising in obtaining, commercializing, 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 summarize 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.

Pharmaceutical, Biotechnology and Chemical Inventions

World Protection and Exploitation

Edited by Duncan Bucknell

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

Pharmaceutical, Biotechnology and Chemical Inventions

World Protection and Exploitation

Edited by Duncan Bucknell

Author Information

Edited by Duncan Bucknell, Patent Attorney and IP Consultant, Australia

Contributors:

Pravin Anand, Anund and Anund, India
John Bateman, Kenyon & Kenyon, USA
Susan Beaubien, Moffat & Co, Macera & Jarzyna LLP, Canada
Theo Bodewig, Humboldt University, Germany (Consultant Editor)
Simon Cohen, Taylor Wessing, UK
Wayne Condon, Griffith Hack, Australia
Marina Couste, Howrey LLP, France
Robert A. Dormer, Hyman, Phelps & McNamara, P.C., United States
Atsushi Hakoda, Nakamura & Partners, Japan
Juany Huang, Panawell and Partners LLC, China
Reuben E. Jacob, R. G. C. Jenkins, UK
Fabrizio Jacobacci, Studio Legale Jacobacci & Associati, Italy
Kurt R. Karst, Hyman, Phelps & McNamara, P.C., United States
Klaus Kupka, Taylor Wessing, Germany
David C. Musker, R. G. C. Jenkins, UK
Cyra Nargolwalla, Cabinet Plasseraud, France
Nina Resinek, Taylor Wessing, Germany
Toshio Takizawa, Nakamura & Partners, Japan
Koichi Tsujii, Nakamura & Partners, Japan
Klaus Schweitzer, Plate Schweitzer Zounek, Patentanwaelte, Germany
Deborah Somerville, Kenyon & Kenyon, USA
Paul Steinhauser, Arnold Siedsma, Netherlands
Nigel Stoate, Taylor Wessing, UK
Rosie Stramandinoli, Griffith Hack, Australia
Otto Swens, Vondst Advocaten, The Netherlands
Andreas Walkenhorst, Tergau & Pohl Patentanwälte, Germany
Silvie Wertwijn, Vondst Advocaten, Netherlands
William Yang Panawell & Partners LLC, China
Federico Zanardi Landi, Studio Legale Jacobacci & Associati, Italy