. /.RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/269/Add.3
18 September 2001
(01-4433)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  Spanish
REVIEW OF LEGISLATION
Replies by Costa Rica to the Follow-up Questions Posed by Switzerland
Addendum
By means of a communication from the Permanent Mission of Costa Rica, dated
17 September 2001, the Secretariat has received the following reply to the follow-up questions posed
by Switzerland, which were circulat ed in document IP/C/W/263/Add.1.
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A. PROTECTION OF UNDISCLOSED INFORMATION
Additional response to question 6:
A.  Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State Agency in the procedure for market authorization of a pharmaceutical or of
an agricultural chemical product, please explain in detail if your law prohibits a second
applicant from relying on, or from referring to, the original data of the first applicant, when
applying subsequently for market authorization for his own product.  Does the responsible State
Agency require the same amount of data from the second applicant as from the first applicant?
What will the new draft regulation provide in  this regard?  Will the draft amendment set a
specific term of protection for  undisclosed test or other data of the first applicant?
Previously, Costa Rica had no specific legislation concerning undisclosed information, so it
adopted Law No. 7975 on 4 January 2000.  The Law does not set a particular term of protection for
this type of trade or industrial secret.  Protection remains in force as long as the undisclosedinformation continues to fulfill the requirements established in Article 2 of the Law.
Article 2, paragraph 1, of Law No. 7975 of  4 January 2000 provides protection for
undisclosed information;  which is understood to mean any information relating to trade and industrial
secrets kept on a confidential basis by natural or legal persons, to prevent information lawfully withintheir control from being disclosed to, acquired by or used by others without their consent in a manner
contrary to honest commercial practices so long as such information:
- Is secret in the sense that it is not, as a body or in the precise configuration and
assembly of its components, generally known among or readily accessible to personswithin the circles that normally deal with the kind of information in question;
- is lawfully in control of a person who has taken reasonable and proportionate steps to
keep it secret;IP/C/W/269/Add.3
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- has commercial value because it is secret.
One of the innovations introduced into Costa Rican legislation by Law No. 7975 is the
regulation of cases where undisclosed test or other data must be submitted to official bodies as a
condition for the approval of the marketing of pharmaceutical or agricultural chemical products;  suchdata is protected against any unfair commercial use and any disclosure under Article 8 of the
aforementioned Law No. 7975.
In fact, while the competent bodies are not currently preparing an amendment to the Law,
they are working on the regulations necessary to impl ement this legislation.  Among other things, the
regulations will deal in more detail with the scope of Article 8 of the aforesaid Law.
In addition, attention should be drawn to Article 9 of Law No. 7975, which refers to the
protection of undisclosed information in administrative or judicial proceedings.  It provides that, in
any administrative or judicial proceedings in which one of the parties is required to present
undisclosed information, the authority hearing the case shall take all necessary steps to prevent its
disclosure to third parties not involved in the dispute.
More specifically, human medicines are registered with the Ministry of Health, while
veterinary medicines and agricultural chemicals are registered with the Ministry of Agriculture and
Livestock.
If it is decided to import or market patents on medicines or agricultural chemical products,
they must first be registered at the respective ministry.  For that to take place, a series of requirements
need to be met, including the provision of formulas (qualitative and quantitative), although officials
are forbidden to reveal such formulas for the term  of protection of the patent, i.e. 20 years.  This
prohibition derives from the provisions of the Law on Undisclosed Information, Law No. 7975 of4 January 2000.
In the case of both the importation and the marketing of products, the information supplied by
the first registrant is not public.  In the event of a second registrant wishing to market or import the
product, he will have to request the Ministry to check that the respective formulas are identical.
However, in no circumstances will private individuals have access to the information.
B.  Please explain in more detail what your legislation considers as "practices that
unreasonably restrain trade" (as mentioned in your answer).
As was explained in the previous reply, the competent bodies are not currently preparing an
amendment to the Law on Undisclosed Information, but are working on the regulations necessary toimplement that legislation.  Among other things, these regulations will deal in more detail with the
scope of Article 8 of the Law.
One of the aspects that will have to be considered in developing these regulations will be the
scope of what should be understood as practices that unreasonably restrain trade.  This meansreferring, at least, to the provisions of Law No. 7472 of 20 December 1995 (Law on the Promotion of
Competition and Effective Protection of Consumers).  Article 1 of this Law stipulates that the purpose
of the Law is to protect, in an effective manner, the legitimate rights and interests of consumers, to
protect and promote the process of competition and free market participation through the prevention
and prohibition of monopolies, monopolistic practices and other restraints on the effective operationof the market, and to eliminate unnecessary regulation of economic activity
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