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Protecting and Enforcing Life Science Inventions in Europe under EPC and EU Law

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

Author: Franz-Josef Zimmer; Steven M Zeman; Jens Hammer; Klara Goldbach; Bernd Allekotte
Publisher: Hart Publishing
ISBN: 9781849469111
Published In: February 2015
Format: Hardback , 450 pages
Jurisdiction: European Union ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents
Author

Details

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.

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)

Franz-Josef Zimmer, Steven M Zeman, Jens Hammer and Klara Goldbach are all Patentanwälte, European Patent Attorney, European Trade Mark Attorney in Munich.
Bernd Allekotte is Rechtsanwalt, Attorney at Law in Munich.