Pharmaceutical, Biotechnology and Chemical Inventions

• 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

Readership: Patent agents, patent attorneys, solicitors and barristers working in patent and intellectual property law worldwide. Scientists, researchers and managers in the chemicals, pharmaceuticals and biotechnology industries.

edited by Duncan Bucknell, CEO & IP Strategist, Think IP Strategy, Australia

"The Kat hasn't had a chance to read the book from cover-to-cover-to-cover-to-cover-to-cover, and probably - given its vast extent - would be finishing it just in time for the second edition. However, he likes the bits he has dabbled in. It is plain that a great deal of careful planning has gone into this work and that its execution has been accordingly meticulous. The Kat congratulates Duncan, the book's contributors and the Oxford University Press folk who have combined to make this not only a truly useful reference work but the best argument to date for (i) reinforced workdesks or (ii) abandoning the printed page in favour of Nooks, Kindles and other electronic reading devices." - IPKAT

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

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