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14 April 2009
It is a well-known fact that the innovative research process plays a fundamental role in the chemical-pharmaceutical and chemical-agricultural industries. The results of these innovative activities must be legally protected. There are several legal protection mechanisms, among which patent and data exclusivity must be highlighted.
Patents on inventions are one of the main safeguards for protecting the results of innovative research.
In order to obtain authorization to commercialize products which utilize new chemical entities, it is necessary to file the data with the regulatory authorities. It is obvious that such vulnerable data should be safeguarded, whether or not it is protected by a patent.
Within the framework of the existing regulations to protect scientific data, Article 39(3) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) is of key importance.
Article 39(3) of the TRIPs Agreement establishes a series of requisites that, once present, bind the governments of member countries to protect data against any unfair commercial use.
According to Article 39(3):
"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, [m]embers shall protect such data against disclosure, except where necessary, to protect the public or unless steps are taken to ensure that the data [is] protected against unfair commercial use."
As a general principle, when interpreting Article 39(3) it is essential to consider the basic purpose of establishing a legal system for data protection (ie, to encourage the introduction of new pharmaceutical and agricultural chemical products onto the market). It is unfair and unjust to allow a third party which has not made the necessary investments to introduce new products onto the market, saving significant costs and thereby discouraging the necessary investments of the innovators.
If a member country depends directly or indirectly on the scientific data produced by the innovator and by so doing favours a competitor, it is infringing the protection envisaged in Article 39(3) of the TRIPs Agreement.
There is no indication in the TRIPs Agreement that a competitor must acquire the data by means of dishonest practice or conduct in order for a commercial use to be considered unfair. It is sufficient that the competitor has unfairly benefited from the innovator's original investment in producing the scientific data.
When Argentina enacted the Confidentiality Law (24,766) in December 1996, it was assumed that this rule was intended to bring Argentine local legislation into line with the requirements of Article 39(3) of the TRIPs Agreement, which establishes the obligation to protect scientific data filed with the health authorities. However, the Confidentiality Law fails to grant adequate legal protection to scientific data in terms of the TRIPs Agreement.
Since the data which meets the requirements of Article 39(3) must be protected against unfair commercial use, when a health authority allows the direct or indirect use of the originator's data by third parties without the originator's authorization, the authority infringes Article 39(3) of the TRIPs Agreement. This is precisely the case with Section 5 of the Confidentiality Law, which allows such reliance on the originator's data by unauthorized third parties.
The health authorities' approval of products by similarity under the Confidentiality Law is inconsistent with Article 39(3) of the TRIPs Agreement, since such reliance of a member country on the data filed by an innovator in another member country commercially benefits a competitor of the originator and consequently constitutes unfair commercial use under the terms of Article 39(3).
Several legal actions have recently been brought by data originators against unauthorized third parties that have obtained marketing approval for pharmaceutical products relying on the originator's data.
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