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6 J. World Intell. Prop. 139 (2003)
An International Standard of Protection for Test Data Submitted to Authorities to Obtain Marketing Authorization for Drugs: TRIPS Article 39.3

handle is hein.journals/jwip6 and id is 135 raw text is: 








    An International Standard of Protection for Test
 Data Submitted to Authorities to Obtain Marketing
                      Authorization for Drugs

                             TRIPs   Article  39.3


                             Lucas R. ARRIVILLAGA*



I.  INTRODUCTION

    A  process of marketing authorization for drugs involves a considerable amount of
economical and human   resources and takes place in different stages over a long period
of time-seven  years on average in the developed countries.

     It is easy to be aware of the fact that there are a great number of interests and reasons
behind the procedures to obtain marketing authorization for drugs (medicines and agro-
chemical drugs): public health policies; large investments; free entry to the markets;
unfair competition; and unjust enrichment situations, to name but a few.

    From  an economical  point of view, the necessity to regulate the system has been
acknowledged   and Article 39.3  of the Agreement   on  Trade-Related  Aspects of
Intellectual Property Rights (TRIPs), is an initiative to address this issue in the
international framework, giving the first international standard of protection for the
information involved in this procedure. However, the provision does not seem to be
clear enough and thus does not give any kind of certainty to this issue.

    The  lack of clarity over some basic issues related with this process, for example:

    -    what kind of drugs would be considered new, or better;

    -    where  the test of newness of the drug should be performed;

    -    information concerning the previous registration of the drugs;

    -    the imprecise limitations of the provision in the framework of the intellectual
         property category;



   * Lawyer, University of Belgrano, Buenos Aires, Argentina; Member of the Buenos Aires Bar Association;
post graduate in international intellectual property law from the University of Torino and the World Intellectual
Property Organization (Wipo) Academy.
     The author may be contacted at: <ducasarrivillaga@yahoo.frn.

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