Header

Shop : Details

Shop
Details
49,80 €
ISBN 978-3-8440-0543-1
Softcover
384 pages
34 figures
575 g
21 x 14,8 cm
English
Thesis
April 2012
Katarzyna Zbierska
Application and Importance of Supplementary Protection Certificates for Medicinal Products in the European Union
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.
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
Augsburger Schriften zum Arzneimittel- und Medizinprodukterecht
Edited by Prof. Dr. Ulrich M. Gassner, Augsburg
Volume 14
Available online documents for this title
You need Adobe Reader, to view these files. Here you will find a little help and information for downloading the PDF files.
Please note that the online documents cannot be printed or edited.
Please also see further information at: Help and Information.
 
 DocumentDocument 
 TypePDF 
 Costs37,35 € 
 ActionDownloadPurchase in obligation and download the file 
     
 
 DocumentTable of contents 
 TypePDF 
 Costsfree 
 ActionDownloadDownload the file 
     
 
 DocumentAbstract 
 TypePDF 
 Costsfree 
 ActionDownloadDownload the file 
     
User settings for registered online customers (online documents)
You can change your address details here and access documents you have already ordered.
User
Not logged in
Export of bibliographic data
Shaker Verlag GmbH
Am Langen Graben 15a
52353 Düren
Germany
  +49 2421 99011 9
Mon. - Thurs. 8:00 a.m. to 4:00 p.m.
Fri. 8:00 a.m. to 3:00 p.m.
Contact us. We will be happy to help you.
Captcha
Social Media