Common use of Relationship to Copyright Clause in Contracts

Relationship to Copyright. The subject matter of protection of a design right may be protected under copyright legislation if the conditions for such protection are met. The extent to which, and the conditions under which, such protection is conferred, including the level of originality required, shall be determined by each Party. Patents 1. The Parties shall comply with Articles 2 through 9 of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done in Budapest on 28 April 1977 and amended on 26 September 1980. 2. The European Union shall make all reasonable efforts to comply with the Patent Law Treaty, adopted at Geneva on 1 June 2000 (hereinafter referred to as the "PLT"). The signatory Andean Countries shall make all reasonable efforts to accede to the PLT. 3. When the marketing of a pharmaceutical or agricultural chemical product [71] in a Party requires to obtain an authorisation by its competent authorities in such matters, such Party shall make its best efforts to process the corresponding application expeditiously with a view to avoiding unreasonable delays. The Parties shall cooperate and provide mutual assistance to achieve this objective. 4. With respect to any pharmaceutical product that is covered by a patent, each Party may, in accordance with its domestic legislation, make available a mechanism to compensate the patent owner for unreasonable curtailment of the effective patent term resulting from the first marketing approval of that product in that Party. Such mechanism shall confer all of the exclusive rights of a patent, subject to the same limitations and exceptions applicable to the original patent. Protection of data of certain regulated products 1. Each Party shall protect undisclosed test or other data related to safety and efficacy of pharmaceutical products [72] and agricultural chemical products, in accordance with Article 39 of the TRIPS Agreement and its domestic legislation. 2. According to paragraph 1, and subject to paragraph 4, when a Party requires, as a condition for approving the marketing of pharmaceutical or of agricultural chemical products which contain new chemical entities, the submission of undisclosed test or other data related to safety and efficacy, that Party shall grant an exclusivity period normally of five years from the date of marketing approval in the territory of that Party for pharmaceutical products, and 10 years for agricultural chemical products, period during which a third party may not commercialise a product based on such data, unless he/she presents proof of the explicit consent of the holder of the protected information or his/her own test data. 3. For the purpose of this Article, a "new chemical entity" is the one which has not been previously approved in the territory of the Party for its use in a pharmaceutical or chemical agricultural product, pursuant to its domestic legislation. Accordingly, the Parties need not apply this Article with respect to pharmaceutical products that contain a chemical entity that has been previously approved in the territory of the Party. 4. The Parties may regulate: (a) exceptions for reasons of public interest, situations of national emergency or extreme urgency, when it is necessary to allow access to those data to third parties; and (b) abbreviated marketing approval procedures in their territory, relying on a marketing approval granted by another Party. In such case, the period of exclusive use of the data submitted in connection with obtaining the approval shall begin from the date of the first marketing approval relied on, when the approval is granted within six months from the filing of a complete application. 5. With regard to agricultural chemical products, the Parties may provide procedures which make it possible to remit or refer to the undisclosed information on safety and efficacy related to tests and studies that involve vertebrate animals. During the term of protection, the interested person in using such information shall compensate the holder of the protected information. The costs of such compensation shall be determined in a fair, equitable, transparent and non-discriminatory manner. The right to this compensation shall apply for as long as the protection of the undisclosed information on safety and efficacy lasts. 6. In accordance with the provisions of Article 197 paragraph 5, the protection provided for in this Article does not prevent a Party from adopting measures in response to the abuse of intellectual property rights or practices which unreasonably restrain trade. Plant varieties The Parties shall cooperate to promote and ensure the protection of plant varieties based on the International Convention for the Protection of New Varieties of Plants (hereinafter referred to as "UPOV Convention"), as revised on 19 March 1991, including the optional exception to the right of the breeder as referred to in Article 15(2) of such Convention. Unfair competition 1. Each Party shall grant effective protection against unfair competition in accordance with Article 10 bis of the Paris Convention. For this purpose, any act carried out in respect of industrial property in the course of trade that is contrary to honest commercial practices shall be considered unfair in accordance with the domestic legislation of each Party. 2. In accordance with the domestic legislation of each Party, this Article may be applied without prejudice to the protection granted under this Title.

Relationship to Copyright. The subject matter of protection of a design right may be protected under copyright legislation if the conditions for such protection are met. The extent to which, and the conditions under which, such protection is conferred, including the level of originality required, shall be determined by each Party. Patents. 1. The Parties shall comply with Articles 2 through 9 of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done in Budapest on 28 April 1977 and amended on 26 September 1980. 2. The European Union shall make all reasonable efforts to comply with the Patent Law Treaty, adopted at Geneva on 1 June 2000 (hereinafter referred to as the "‘PLT"’). The signatory Andean Countries shall make all reasonable efforts to accede to the PLT. . 3. When the marketing of a pharmaceutical or agricultural chemical product [(71] ) in a Party requires to obtain an authorisation authori­ sation by its competent authorities in such matters, such Party shall make its best efforts to process the corresponding application appli­ cation expeditiously with a view to avoiding unreasonable delays. The Parties shall cooperate and provide mutual assistance to achieve this objective. . 4. With respect to any pharmaceutical product that is covered by a patent, each Party may, in accordance with its domestic legislation, make available a mechanism to compensate the patent owner for unreasonable curtailment of the effective patent term resulting from the first marketing approval of that product in that Party. Such mechanism shall confer all of the exclusive rights of a patent, subject to the same limitations and exceptions applicable to the original patent. Protection of data of certain regulated products. 1. Each Party shall protect undisclosed test or other data related to safety and efficacy of pharmaceutical products [(72] ) and agricultural chemical products, in accordance with Article 39 of the TRIPS Agreement and its domestic legislation. 2. According to paragraph 1, and subject to paragraph 4, when a Party requires, as a condition for approving the marketing of pharmaceutical or of agricultural chemical products which contain new chemical entities, the submission of undisclosed test or other data related to safety and efficacy, that Party shall grant an exclusivity period normally of five years from the date of marketing approval in the territory of that Party for pharmaceutical products, and 10 years for agricultural agri­ cultural chemical products, period during which a third party may not commercialise a product based on such data, unless he/she presents proof of the explicit consent of the holder of the protected information or his/her own test data. 3. For the purpose of this Article, a "new chemical entity" is the one which has not been previously approved in the territory of the Party for its use in a pharmaceutical or chemical agricultural product, pursuant to its domestic legislation. Accordingly, the Parties need not apply this Article with respect to pharmaceutical products that contain a chemical entity that has been previously approved in the territory of the Party. 4. The Parties may regulate: (a) exceptions for reasons of public interest, situations of national emergency or extreme urgency, when it is necessary to allow access to those data to third parties; and (b) abbreviated marketing approval procedures in their territory, relying on a marketing approval granted by another Party. In such case, the period of exclusive use of the data submitted in connection with obtaining the approval shall begin from the date of the first marketing approval relied on, when the approval is granted within six months from the filing of a complete application. 5. With regard to agricultural chemical products, the Parties may provide procedures which make it possible to remit or refer to the undisclosed information on safety and efficacy related to tests and studies that involve vertebrate animals. During the term of protection, the interested person in using such information shall compensate the holder of the protected information. The costs of such compensation shall be determined in a fair, equitable, transparent and non-discriminatory manner. The right to this compensation shall apply for as long as the protection of the undisclosed information on safety and efficacy lasts. 6. In accordance with the provisions of Article 197 paragraph 5, the protection provided for in this Article does not prevent a Party from adopting measures in response to the abuse of intellectual property rights or practices which unreasonably restrain trade. Plant varieties The Parties shall cooperate to promote and ensure the protection of plant varieties based on the International Convention for the Protection of New Varieties of Plants (hereinafter referred to as "UPOV Convention"), as revised on 19 March 1991, including the optional exception to the right of the breeder as referred to in Article 15(2) of such Convention. Unfair competition 1. Each Party shall grant effective protection against unfair competition in accordance with Article 10 bis of the Paris Convention. For this purpose, any act carried out in respect of industrial property in the course of trade that is contrary to honest commercial practices shall be considered unfair in accordance with the domestic legislation of each Party. 2. In accordance with the domestic legislation of each Party, this Article may be applied without prejudice to the protection granted under this Title.