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- if the undisclosed protected data resulting from trials or from other data are
essential for the marketing approval of a product subject to a compulsory
license, provided that the fair compensation arising from the compulsory
license also takes due account of the economic value of the undisclosed data
resulting from trials or from other data on the basis of which the authority
grants the marketing approval for the product manufactured under license.
Article 378: The grant of marketing approval by the competent authority for goods whose
commercialization depends on the approval referred to in Article 377 shall not
take into consideration the existence or validity of the intellectual property rights
in the goods concerned and must not be invoked as a personal defense, or in the
form of immunity from prosecution following infringement of an intellectual
property right.
Article 379: The provisions of Article 375 shall not prohibit a subsequent applicant from
relying on data resulting from trials or on other data communicated by a prior
applicant, provided that they come from sources available to the public,
regardless of whether the prior applicant has given his consent.
In this case, the trials and data communicated by the subsequent applicant must
meet the necessary legal conditions for obtaining marketing approval.
This provision shall not apply to the data obtained by the subsequent applicant
further to an act deemed unfair in Burundi.
Article 380: Under Article 374, chemical entities shall be considered new if their marketing
has not been approved or if they have not been marketed in another way in any
territory within a period of 18 months starting from the date of the first grant of
marketing approval or the first marketing anywhere in the world.
Undisclosed data resulting from trials or from other data on products whose
main characteristic is to constitute a new indication, a new use, a new dosage or
a new formulation, which do not contain a new chemical entity but which are
nevertheless subject to marketing approval, must only be protected against
disclosure.
Article 381: The provisions of this Section shall not apply to the undisclosed data resulting
from trials or from other data concerning the following cases:
- if the use of these data is not unfair by nature or has no commercial character,
particularly in the case of use by certain institutions such as universities or
research centers which may be tasked by government authorities with
verifying and testing the goods, even after marketing approval has been
granted, provided that these authorities guarantee the confidential nature of
the data;
- if the authorities responsible for granting the marketing approval rely on these
data exclusively to anticipate the grant of marketing approval in Burundi,
provided that the subsequent applicant undertakes not to market the good in
Burundi prior to the expiration of the period provided for in Article 376;