(a) third persons are not permitted, without the consent of the person that previously submitted such information, to market the same or a similar (19) product on the basis of that information, or the marketing approval granted to the person that submitted that information, for a period of at least 10 years from the date of marketing approval of the previously approved agricultural chemical product; or
(b) applicants for marketing approval are generally required to submit a full set of test data, even in cases where there was a prior application for the same product, for a period of at least 10 years, from the date of approval of a prior application. (20)
2. For the purposes of this Article, a new agricultural chemical product is a product that contains (21) a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.
Article 17.62. Protection of Undisclosed Test or other Data for Pharmaceutical Products
1. If a Party requires, as a condition for approving the marketing of a new pharmaceutical product, the submission of undisclosed test or other data, that Party shall not permit third persons, without the consent of the person that previously submitted that information, to place on the market the same or a similar (22) product on the basis of:
(a) that information; or
(b) the marketing approval granted to the person that submitted that information, for at least five years from the date of marketing approval of the previously approved pharmaceutical product; such date to be determined in accordance with each Party's law.
2. For the purposes of this Article, a new pharmaceutical product means a pharmaceutical product that does not contain (23) a chemical entity or biologic that has been previously approved in that Party.
Section J. Trade Secrets
Article 17.63. Trade Secrets
1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention, each Party shall provide that trade secret holders shall have the possibility of preventing their trade secrets from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices.
2. Subject to paragraphs 3 and 4, each Party shall provide that at least each of the following shall be considered contrary to honest commercial practices:
(a) the acquisition of a trade secret without the consent of the trade secret holder, whenever carried out by unauthorised access to, appropriation of, or copying of any documents, objects, materials, substances, or electronic files, lawfully under the control of the trade secret holder, containing the trade secret or from which the trade secret can be deduced;
(b) the use or disclosure of a trade secret whenever carried out, without the consent of the trade secret holder, by a person who is found to meet any of the following conditions:
(i) having acquired the trade secret in a manner referred to in subparagraph (a);
(ii) being in breach of a confidentiality agreement or any other duty not to disclose the trade secret; or
(iii) being in breach of a contractual or any other duty to limit the use of the trade secret; and
(c) the acquisition, use or disclosure of a trade secret whenever carried out by a person who, at the time of the acquisition, use, or disclosure, knew or ought, under the circumstances, to have known that the trade secret had been obtained directly or indirectly from another person who was disclosing the trade secret in a manner referred to in subparagraph (b).
3. Nothing in this subsection shall be understood as requiring a Party to consider any of the following conduct as contrary to honest commercial practices:
(a) independent discovery or creation;
(b) reverse engineering of a product by a person who is lawfully in possession of it and who is free from any legally valid duty to limit the acquisition of the relevant information;
(c) acquisition, use, or disclosure of information as required or permitted by the Party's law;
(d) in the exercise of the right of workers or workers' representatives to information and consultation in accordance with the Party's law; or
(e) use by employees of their experience and skills honestly acquired in the normal course of their employment.
4. Each Party may provide for limited exceptions and limitations to the rights of trade secret holders in circumstances where the legitimate interests of third parties, the general public, or the Party outweigh the legitimate interests of trade secret holders, such as in the following cases:
(a) for exercising the right to freedom of expression and information, including respect for the freedom and pluralism of the media;
(b) for revealing misconduct, wrongdoing, or illegal activity, provided that the person acquiring, using, and disclosing the trade secret did so for the purpose of protecting the general public interest; and
(c) disclosure by workers to their representatives as part of the legitimate exercise by those representatives of their functions in accordance with the Party's law, provided that such disclosure was necessary for that exercise.
Section K. Enforcement
Subsection K.1. Enforcement - General Obligations
Article 17.64. General Obligations
1. Each Party shall provide for the measures, procedures, and remedies set out in this Section in respect of the enforcement of intellectual property rights:
(a) measures, procedures, and remedies must be:
(i) fair, equitable, and effective;
(ii) applied in such a manner as to avoid the creation of barriers to legitimate trade, including electronic commerce, and to provide for safeguards against their abuse; and
(iii) be implemented in a manner consistent with the Party's laws, including laws concerning freedom of expression, fair process, and the right to privacy;
(b) measures and procedures must not be unnecessarily complicated or costly, entail unreasonable time-limits, or give rise to unwarranted delays; and
(c) remedies must be dissuasive and proportionate, taking into account the seriousness of the infringement and the interests of third parties.
2. The Parties recognise the importance of ensuring that right holders (24) and alleged infringers have access to justice.
3. For the purposes of enforcing intellectual property rights and defending claims of infringement of intellectual property rights, each Party shall:
(a) have in place an effective judicial system;
(b) permit the use of alternative dispute resolution mechanisms; and
(c) endeavour to promote alternative dispute resolution.
4. This Section does not create any obligation:
(a) to put in place a judicial system for the enforcement of intellectual property rights distinct from that for the enforcement of law in general, nor does it affect the capacity of each Party to enforce its law in general; or
(b) with respect to the distribution of resources as between the enforcement of intellectual property rights and the enforcement of law in general.
Subsection K.2. Enforcement - Civil Remedies
Article 17.65. Entitled Applicants
Each Party shall make available to a right holder civil judicial procedures concerning the enforcement of any intellectual property right covered under this Chapter.
Article 17.66. Provisional Measures for Preserving Evidence
1. Each Party shall provide that its judicial authorities may order prompt and effective provisional measures to preserve relevant evidence in relation to an alleged infringement, subject to the protection of confidential information.
2. Each Party shall provide that its judicial authorities may adopt provisional measures, where appropriate, without the other party having been heard, in particular if any delay is likely to cause irreparable harm to the right holder or if there is a demonstrable risk of evidence being destroyed. Each Party may provide that such measures include the detailed description, with or without the taking of samples, or the physical seizure of the infringing goods, and the materials and implements used in the production or distribution of these goods and related documents.
Article 17.67. Provisional and Precautionary Measures
1. Each Party shall provide that its judicial authorities may, on request of the applicant:
(a) order against the alleged infringer an interlocutory injunction intended to prevent any imminent infringement of an intellectual property right, or to forbid, on a provisional basis and subject, as appropriate, to a recurring penalty payment where provided for by its law, the continuation of the alleged infringements of that right, or to make such continuation subject to the lodging of guarantees intended to ensure the compensation of the right holder;
(b) order against an intermediary whose services are being used by an alleged infringer of intellectual property rights an interlocutory injunction for the same purpose and under the same conditions as apply under subparagraph (a); and
(c) order the seizure or delivery up of goods suspected of infringing rights in a trade mark, copyright or related right or, where a Party's law allows, any other intellectual property right.
2. In the case of an alleged infringement committed on a commercial scale, each Party shall provide that if the applicant demonstrates circumstances likely to endanger the recovery of damages, its judicial authorities may order the precautionary seizure of the movable and immovable property of the alleged infringer, including the blocking of the alleged infringer's bank accounts and other assets.
Article 17.68. Safeguards
1. Each Party shall provide that its judicial authorities have the authority to require the applicant for measures provided for in Article 17.66 (Provisional Measures for Preserving Evidence) or Article 17.67 (Provisional and Precautionary Measures) to provide:
(a) reasonably available evidence in order to satisfy the judicial authority, with a sufficient degree of certainty, that the applicant's right is being infringed or that the infringement is imminent; and
(b) security or equivalent assurance set at a level:
(i) that is sufficient to protect the person against whom a measure is sought and to prevent abuse; and
(ii) that shall not unreasonably deter recourse to those procedures.
2. Each Party shall provide that in relation to a civil judicial proceeding concerning the enforcement of an intellectual property right, its judicial or other authorities have the authority to:
(a) order a party, at whose request a measure was taken and who has abused the enforcement proceeding, to adequately compensate a person wrongly enjoined or restrained for injury suffered because of that abuse;
(b) order a party to pay the defendant's expenses, which may include appropriate attorneys' fees; and
(c) impose sanctions on a party to the proceedings, counsel, experts, or other persons subject to the court's jurisdiction for violation of judicial orders concerning the protection of confidential information produced or exchanged in that proceeding.
Article 17.69. Right to Information
1. Each Party shall provide that, in the context of civil proceedings concerning an infringement of an intellectual property right and in response to a justified and proportionate request of the claimant, the competent judicial authorities may order a person specified in paragraph 2 to provide relevant information in that person's control or possession on the origin and distribution networks of the goods or services that infringe or allegedly infringe an intellectual property right. An order described in paragraph 1 shall be available against:
(a) a person who has infringed, or is alleged to have infringed, an intellectual property right; and
(b) any other person who was:
(i) found in possession of the infringing, or allegedly infringing, goods on a commercial scale;
(ii) found to be using the infringing, or allegedly infringing, services on a commercial scale;
(iii) found to be providing, on a commercial scale, services used in the infringing, or allegedly infringing, activities; or
(iv) indicated by the person referred to in subparagraph (b)(i), subparagraph (b)(ii), or subparagraph (b)(iii) as being involved in the production, manufacture, or distribution of the goods, or the provision of the services.
3. The information referred to in paragraph 1 may include:
(a) the names and addresses of the producers, manufacturers, distributors, suppliers, and other previous holders of the goods or services, as well as the intended wholesalers and retailers; or
(b) information on the quantities produced, manufactured, delivered, received, or ordered, as well as the price obtained for the goods or services in question.
4. This Article shall apply without prejudice to other provisions in a Party's law that:
(a) permit the competent authorities or order the infringer or alleged infringer to provide additional information;
(b) govern the use in civil or criminal proceedings of the information communicated under this Article;
(c) govern responsibility for the misuse of the right of information;
(d) afford an opportunity for refusing to provide information where doing so would amount to an admission of a person's participation, or that of their close relatives, in an infringement of an intellectual property right;
(e) govern the protection of confidentiality of information sources;
(f) govern personal data; or
(g) govern privilege.
Article 17.70. Injunctions
1. Each Party shall provide that, if its judicial authority has found an infringement of an intellectual property right, the authority may grant an injunction aimed at prohibiting the continuation of the infringement.
2. The injunction provided for in paragraph 1 shall be available against:
(a) the infringer; or
(b) anintermediary whose services are used by an infringer to infringe an intellectual property right.
Article 17.71. Corrective Measures
1. Each Party shall provide that, on request of the applicant and without prejudice to any damages due to the right holder by reason of the infringement, its judicial authorities may order the definitive removal from the channels of commerce, or the destruction of goods that were found to be infringing an intellectual property right. Each Party shall provide that its judicial authorities may also order, as appropriate, the destruction of materials and implements predominantly used in the creation or manufacture of those goods.
2. Each Party shall provide that its judicial authorities may order the measures referred to in paragraph 1 to be carried out at the expense of the infringer.
Article 17.72. Damages
1. Each Party shall provide that, on application of an injured party, its judicial authorities may order an infringer, who knowingly or with reasonable grounds to know, engaged in an infringing activity, to pay the right holder adequate compensation for the injury the right holder has suffered as a result of the infringement.
2. A Party may provide that its judicial authorities have the authority to order recovery of profits even where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity.
Article 17.73. Costs
Each Party shall provide that its judicial authorities may order, in accordance with its law, that reasonable and proportionate legal costs and other expenses incurred by the successful party in legal proceedings concerning the infringement of intellectual property rights shall be borne by the unsuccessful party.
Subsection K.3. Enforcement - Border Measures
Article 17.74. Border Measures
1. Each Party:
(a) shall provide for applications and procedures to suspend the release of, or to detain, suspected goods under customs control; and
(b) may provide for applications in respect of other goods that are suspected of infringing intellectual property rights.
2. For the purposes of this Article:
(a) "competent authorities" may include the appropriate judicial, administrative, or law enforcement authorities under a Party's law; and
(b) "suspected goods" means goods that are suspected of infringing a trade mark or copyright under the law of the Party providing for applications and procedures under paragraph 1.
3. With respect to the initiation of the procedures provided for in paragraph 1 by a right holder, each Party shall provide that the relevant right holder is required:
(a) to provide adequate evidence to satisfy the competent authorities that, under its law, there is prima facie an infringement of the right holder's intellectual property right; and
(b) to supply sufficient information that may reasonably be expected to be within the right holder's knowledge to make the suspected goods reasonably recognisable by its competent authorities.
4. A Party may provide that, if its competent authorities have detained or suspended the release of suspected goods, those authorities may inform the right holder of the names and addresses of the consignor, exporter, consignee, or importer; a description of the goods; the quantity of the goods; and, if known, the country of origin of the goods. This paragraph is without prejudice to a Party's law pertaining to privacy or confidentiality.
5. Each Party shall provide that its competent authorities may initiate border measures ex officio, without the need for a formal complaint from a third party or right holder, with respect to suspected goods under customs control that are imported or destined for export. Each Party shall provide for its customs authorities to use risk management to identify suspected goods, which may include random selection.
6. Each Party shall ensure that its competent authorities decide about granting or recording applications to suspend the release of suspected goods, within a reasonable period of time after the initiation of procedures described in paragraph 1.
7. Each Party shall adopt and maintain procedures under which its competent authorities may determine, within a reasonable period after initiation of procedures described in paragraph 1, whether suspected goods infringe an intellectual property right.
8. Each Party shall provide that its competent authorities have the authority to order the destruction or disposal of suspected goods under customs control following a determination that the goods are infringing an intellectual property right. In cases in which the goods are not destroyed, each Party shall provide that, except in exceptional circumstances, the goods are disposed of outside the channels of commerce in such a manner as to avoid any harm to the right holder. With regard to counterfeit trade mark goods, the simple removal of the trade mark unlawfully affixed shall not be sufficient, other than in exceptional cases, to permit the release of the goods into the channels of commerce.
9. Each Party may provide that, if requested by the customs authorities, the holder of the granted or recorded application shall be obliged to reimburse the costs incurred by the customs authorities, or other parties acting on behalf of customs authorities, including storage, handling, and any costs relating to the destruction or disposal of the goods.
10. Each Party may exclude from the application of this Article small quantities of goods of a non-commercial nature contained in travellers' personal luggage or sent in small consignments.
11. It is understood that there shall be no obligation to apply the procedures described in this Article to imports of goods put on the market in another country by, or with the consent of, the right holder, (25) or to goods in transit.
Subsection K.4. Enforcement - Criminal Remedies
Article 17.75. Criminal Offences
1. Each Party shall provide for criminal procedures and penalties to be applied at least in cases of wilful trade mark counterfeiting or copyright or related rights piracy on a commercial scale. For the purposes of this Article, the term "on a commercial scale" includes at least:
(a) acts carried out for commercial advantage or financial gain; and
(b) significant acts, not carried out for commercial advantage or financial gain, that have a substantial prejudicial impact on the interests of the copyright or related rights holder in relation to the marketplace. (26)
2. Each Party shall treat wilful importation or exportation of counterfeit trade mark goods or pirated copyright goods on a commercial scale as unlawful activities subject to criminal penalties. (27)
3. Each Party shall provide for criminal procedures and penalties to be applied in cases of wilful importation (28) and domestic use, in the course of trade and ona commercial scale, of a label or packaging:
(a) to which a trade mark has been applied without authorisation that is identical to, or cannot be distinguished from, a trade mark registered in its territory; and
(b) that is intended to be used in the course of trade on goods that are identical to goods for which that trade mark is registered.
4. With respect to the offences specified in this Article, (29) each Party shall provide that criminal liability for aiding and abetting is available under its law.
Article 17.76. Penalties
1. With respect to the offences specified in Article 17.75 (Criminal Offences), each Party shall provide for penalties that include imprisonment and monetary fines sufficiently high to provide a deterrent to future acts of infringement, consistent with the level of penalties applied for crimes of a corresponding gravity.
2. Each Party shall provide that its judicial authorities may, in determining penalties, account for the seriousness of the circumstances, which may include circumstances that involve threats to, or effects on, health or safety.
Article 17.77. Seizure, Forfeiture, and Destruction
1. With respect to the offences specified in Article 17.75 (Criminal Offences), each Party shall provide the following:
(a) its judicial or other competent authorities shall have the authority to order the seizure of suspected counterfeit trade mark goods or pirated copyright goods, any related materials and implements used in the commission of the alleged offence, documentary evidence relevant to the alleged offence, and assets derived from, or obtained through, the alleged infringing activity. If a Party requires identification of items subject to seizure as a prerequisite for issuing a judicial order referred to in this subparagraph, that Party shall not require the items to be described in greater detail than necessary to identify them for the purpose of seizure;
(b) its judicial authorities shall have the authority in accordance with that Party's law to order the forfeiture of any assets derived from, or obtained through, the infringing activity;
(c) subject to paragraph 2, its judicial authorities shall have the authority, in accordance with that Party's law, to order the forfeiture or destruction of:
(i) counterfeit trade mark goods or pirated copyright goods;
(ii) materials and implements that have been predominantly used in the creation of pirated copyright goods or counterfeit trade mark goods; and