Katarzyna Zbierska

Application and Importance of Supplementary Protection Certificates for Medicinal Products in the European Union


Front	Back

ISBN:

978-3-8440-0543-1

Series:

Augsburger Schriften zum Arzneimittel- und Medizinprodukterecht
Herausgeber: Prof. Dr. Ulrich M. Gassner
Augsburg

Volume:

Keywords:

Intellectual Property-Law; extension of patent protection; Pharmaceutical regulatory law; Supplementary Protection Certificate for Medicinal Product; Patent Law; First Marketing Authorisation; Regulation 469/2009

Type of publication:

Thesis

Language:

English

Pages:

384 pages

Figures:

34 figures

Weight:

575 g

Format:

21 x 14,8 cm

Bindung:

Paperback

Price:

49,80 € / 99,60 SFr

Published:

April 2012

Buy:

Download:

Available PDF-Files for this title:

You need the Adobe Reader, to open the files. Here you get help and information, for the download.

These files are not printable.


	Document		Document
	Type		PDF
	Costs		37,35 EUR
	Action		Purchase in obligation and display of file - 2,5 MB (2664971 Byte)
	Action		Purchase in obligation and download of file - 2,5 MB (2664971 Byte)


	Document		Table of contents
	Type		PDF
	Costs		free
	Action		Display of file - 110 kB (113150 Byte)
	Action		Download of file - 110 kB (113150 Byte)


	Document		Abstract
	Type		PDF
	Costs		free
	Action		Display of file - 43 kB (43629 Byte)
	Action		Download of file - 43 kB (43629 Byte)

User settings for registered users

You can change your address here or download your paid documents again.

User:	Not logged in.
Actions:	Login / Register Forgotten your password?

Recommendation:

You want to recommend this title?

Review copy

Here you can order a review copy.

Link

You want to link this page? Click here.

Abstract

The book focuses on supplementary protection certificates for medicinal products (SPC) created on the basis of the Council Regulation (EEC) no. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (currently Regulation (EC) no. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products). Since an SPC extends patent protection for a product, it provides an important advantage to innovative pharmaceutical companies in the European Union. The author discusses in detail various aspects of the legal mechanism of an SPC. She also presents similar legal concept in the USA as a benchmark for comparison of the European solution. The publication challenges the question of the importance and impact of an SPC on the European pharmaceutical market, among others, from a competition law perspective, as well as the role of an SPC in the context of other legal instruments available, such as market exclusivity and data exclusivity. This is particularly important as the current circumstances on the European pharmaceutical market differ much from those when the legal regime of the SPC was adopted. The publication also elaborates on the shortfalls of the current SPC system and identifies those areas which require amendments to address issues resulting from the rapidly changing situation on the pharmaceutical market in the European Union.