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22 March 2010
The interpretation of the rules of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) on the legal protection of undisclosed test or other data necessary for the marketing approval of pharmaceutical or agricultural chemical products ('scientific data') (Article 39.3) is a matter of intense debate.
One opinion is that scientific data protection constitutes a new and autonomous IP category. This view considers that only the acknowledgement of a new IP category is suitable for the protection of the data originator's rights. Such acknowledgement as an autonomous category has occurred with the approval of TRIPs.
Article 1(2) of TRIPs, which is included in Part I relating to "General Provisions and Basic Principles", under the title "Nature and Scope of Obligations" establishes that:
"For the purposes of this Agreement, the term 'intellectual property' refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II."
Therefore, copyright and related rights, trademarks, geographical indications, industrial designs, patents, layout designs (topographies) of integrated circuits and the protection of undisclosed information (which includes the scientific data protection of Article 39.3) are all IP categories.
Regardless of the clarity of the rules and their context, the debate about whether scientific data protection is an autonomous IP category continues. Part of the debate relates to the conflicting interests between the research-based industry and the generics industry.
On the other hand, certain interpretative doubts (of academic or authoritative nature) that are not directly related to the above-mentioned conflicting interests refer to the background of the negotiations that led to Article 39.3 of TRIPs.
Briefly, two opposing points of view arose in such negotiations: (i) that commercial secrets and, specifically, scientific data protection constitute an IP category; and (ii) that the protection of commercial secrets, including the protection of scientific data, does not constitute an IP category.
The final text of TRIPs supports the first point of view, since Article 1(2) precisely includes scientific data protection as an IP category in Article 39.3.
Consequently, it can be concluded that within the legal frameworks of the member countries to TRIPs, the scientific data protection established in Article 39.3 constitutes an IP category protected according to Article 39, to which all common provisions that govern IP branches and are included in Part III of TRIPs apply.
Within the framework of the existing regulations on the protection of scientific data, Article 39.3 of TRIPs is of vital importance.
Article 39.3 establishes a series of requirements that, once present, create an obligation for member countries' governments to protect scientific data against unfair commercial use. The article states as follows:
"Members, when requiring, as a condition for approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary, to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use."
As a general principle when interpreting Article 39.3, it is essential to consider the basic purpose of the establishment of a legal system for scientific data protection (ie, to encourage the introduction of new pharmaceutical and agricultural chemical products into the market). While some commentators argue that the protection against 'unfair commercial use' applies only to cases where a subsequent applicant obtains data dishonestly, it would be unfair and unjust to allow those that have not made the required investment in order to save significant set costs obtaining marketing approval by referring to a previous health registration of the originator's data.
It is clear that the acceptance of such use would discourage necessary investment in the introduction of new products into the market, which is what Article 39.3 seeks to encourage.
If a member country depends either directly or indirectly on the data produced by the innovator and thus benefits a competitor, the member does not grant the innovator the protection established in Article 39.3.
The Argentine Confidentiality Law (24,766) is supposed to implement Article 39.2 relating to trade secrets and Article 39.3 relating to scientific data of TRIPs.
However, the Confidentiality Law and Decree 150/92 allow third parties to rely on the scientific data of a product that has already been approved. Such reliance is permitted without any consideration for the investment and efforts made by the originator of the data.
The Constitution gives precedence to international treaties over national law. Consequently, the Confidentiality Law could be considered unconstitutional due to its conflict with Article 39.3 of TRIPs, since reliance on third-party scientific data for the purpose of approving new pharmaceutical products could be understood as unfair commercial use of scientific data according to Article 39.3.
Therefore, in case of conflict between TRIPs and the Confidentiality Law or Decree 150/92, TRIPs should prevail.
For further information on this topic please contact Carlos O Mitelman or Daniel R Zuccherino at Obligado & Cia by telephone (+54 11 4114 1100), fax (+54 11 4311 5675) or email (firstname.lastname@example.org or email@example.com).
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