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  The Sound of Silence: International Treaties and Data Exclusivity as a Limit to Compulsory Licensing

Spina Alì, G. (2016). The Sound of Silence: International Treaties and Data Exclusivity as a Limit to Compulsory Licensing. European Intellectual Property Review, 38(12), 744-754.

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 Creators:
Spina Alì, Gabriele1, Author           
Affiliations:
1MPI for Innovation and Competition, Max Planck Society, ou_2035291              

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Free keywords: Access to medicines; Compulsory licensing; Data protection; Developing countries; Pharmaceuticals; Preferential trade agreements; Regulatory bodies; TRIPS
 Abstract: Among various grounds, data exclusivity is often criticised for impeding the correct functioning of the flexibilities guaranteed by the TRIPS Agreement in relation to compulsory licensing. Several commentators have noted that, in cases where a generic competitor obtains a non voluntary licence on a patented pharmaceutical compound, the impossibility of relying on the regulatory data submitted by a previous applicant prevents access to the market and therefore neutralises the effectiveness of the licence. By thoroughly looking at the relevant international provisions and state practices, this article brings into question the soundness of these claims. International legal sources, once rightly interpreted, rarely limit the possibility to waive data exclusivity in a more stringent manner than in patent regimes, so that the real threat to compulsory licensing lies in the political disparities between developed and developing countries rather than in the substantive law of data exclusivity.

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Language(s): eng - English
 Dates: 2016
 Publication Status: Issued
 Pages: -
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 Table of Contents: -
 Rev. Type: -
 Identifiers: -
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Title: European Intellectual Property Review
  Abbreviation : EIPR
Source Genre: Journal
 Creator(s):
Affiliations:
Publ. Info: -
Pages: - Volume / Issue: 38 (12) Sequence Number: - Start / End Page: 744 - 754 Identifier: ISSN: 0142-0461
ZDB: 7933-9
CoNE: https://pure.mpg.de/cone/journals/resource/110978977740233