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Vol 21 No 11 Nov/Dec 2016

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Protecting and Enforcing Life Science Inventions in Europe under EPC and EU Law: From Antibodies to Zebrafish 2nd ed

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ISBN13: 9781849469111
Published: February 2015
Publisher: Hart Publishing
Country of Publication: UK
Format: Hardback
Price: £195.00



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Both legislators and the Boards of Appeal of the European Patent Office have invested considerable effort over the last two decades to adjust the law and practice governing life science inventions to the rapidly changing technological landscape.

This book provides an introduction to life science patent practice and jurisdiction in Europe according to PCT, EPC and secondary EU law. This book aims to help experts and corporations in the field of life sciences to convert their research into protective, enforceable rights in Europe. It conveys a sense of the requirements for patentability and the issues influencing patent enforcement by presenting illustrative examples of relevant decisions and claims. Thus, while clearly addressing patent professionals, the book serves as a starting point for readers requiring general guidance as to the factors influencing patent protection for life science inventions, and examples of claim language used.

Where the first edition focused primarily on biotechnological subject matter, the second edition addresses the broader field of life sciences. It also includes a new chapter on the enforcement of patent rights throughout Europe and an outline of the forthcoming Unitary Patent and Unified Patent Court system.

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Subjects:
Intellectual Property Law
Contents:
Abbreviated Table of Contents:
A. Life Science Matter
A.I. Summary of historical development
A.II. Definition of life science matter

B. Legal Provisions
B.I. European Patent Convention (EPC)
B.II. EU Law (EU Biotech Directive and its Implementation into the EPC
EU Regulations Concerning the Creation of a Supplementary Protection Certificate [SPC] for Medicinal Products [MSPC], Pediatric Extension of Duration for Medicinal Products [PE] and Plant Protection Products [PSPC], Council Regulation on Community Plant Variety Rights [CPVR], EU Bolar Directive)

C. General Aspects on Protection
C.I. Protection under the EPC C.II. Protection under the EU Regulations

D. Protectable Matter in the Life Sciences
D.I. Small Molecules and Polymers
D.II. Nucleic acids
D.III. Proteins
D.IV. Antibodies
D.V. Microorganisms
D.VI. Plants
D.VII. Animals
D.VIII. Human Body E. Patent Infringement

E.I. Introduction (Pre-Suit Considerations
Cross-Border Issues
General Principles - limited territorial reach
Cross-Border Injunction
Torpedo Actions)
E.II. Scope of Protection (Claim Construction and Literal Infringement
Equivalent Infringement and Purposive Construction
Specific Claim Categories
Product Claims/Compound Claims
Composition claims
Product-by-Process Claims
Second Medical Use Claims/"Off label" Use
Companion Diagnostic Claims
Screening Processes and Reach Through Claims
SPCs
Plant Variety Rights
Effects of the Patent
Issues particular to life sciences
Bolar Provision
Experimental Use
Research Tools
EU Biotech Directive
Limitations of patent protection available to gene sequences - the Monsanto-decision) E.III. Enforcement options (Introduction
Cease and Desist Letter
Criminal Proceedings
Border Seizure
Decision on the merits
Bifurcation
Discovery
Preliminary Relief/Preliminary Injunctions) E.IV. Antitrust Law (Introduction
Sector Inquiry [Pharmaceuticals]
"Pay-for-delay"/Lundbeck decision) E.V. Unitary Patent and Unified Patent Court (Introduction
Language
Unified Patent Court
Structure Jurisdiction Transitional Period and "opt out"
Panels
Sources of Law
Provisional Measures
Parties and their Representation before the UPC
Procedural Issues) ANNEX (EPC: Articles and Rules concerning Patentability, Biological sequences, Biological deposits, Form of claims, EU Directive 98/44/EC - Biotech Directive, EU Regulations on SPCs [Medicinal products/Plant protection products], EU and international regulations relating to plant varieties, EU Directives 2001/82/EC [amended] and 2001/83/EC [amended], Bolar Directives, Register of cited decisions)