Subsection B.2.j. Undisclosed Information

Artícle 1. Protection of undisclosed information

[1.1. In the course of ensuring effective protection against unfair competition, as provided in Article 10bis of the Paris Convention (1967), each Party shall protect:

1. undisclosed information in accordance with Article 39.2 of the TRIPS Agreement;
2. data submitted to governments or governmental agencies in accordance with Article 39.3 of the TRIPS Agreement.]

[1.2. If a Party requires the submission of information concerning the safety and efficacy of a pharmaceutical or agricultural chemical product prior to permitting the marketing of such product, such Party shall not permit third parties not having the consent of the party providing the information to market the same or a similar product on the basis of the approval granted to the party submitting such information for a period of at least five (5) years from the date of approval.16]

[1.3. If a Party provides a means of granting approval to market products specified in paragraph 1.2 on the basis of the grant of an approval for marketing of the same or similar product in another Party, the Party shall defer the date of any such approval to third parties not having the consent of the party providing the information in the other Party for a period of at least five (5) years from the date of approval in the Party or the date of approval in the other Party, whichever is later.]

[1.4. Where a product is subject to a system of marketing approval pursuant to paragraphs 1.2 or 1.3 and is also subject to a patent in the Party:

1. the Party shall not approve an application to market a product on the basis of information in an earlier marketing approval for the same product where that application has been filed by a party other than the recipient of the original marketing approval or with his consent, and shall not otherwise authorize a third party to market the same product, prior to the expiration of the patent; and
2. the Party shall not alter the term of protection specified in paragraphs 1.2 and 1.3 in the event that the patent expires on a date earlier than the end of the term of such protection.
3. In addition, if the product is subject to a patent in one Party as well as in another Party, the second Party shall extend the term of the patent within its territory to expire no earlier than the date of expiration of the patent in the first Party.]