A design shall also be eligible for protection under the copyright law of a Party as from the date on which the design was created or fixed in any form. The extent to which, and the conditions under which, such a protection is conferred, including the level of originality required, shall be determined by each Party.
Subsection 5. Patents
Article 312. International Agreements
The Parties shall adhere to the provisions of the WIPO Patent Cooperation Treaty and shall make all reasonable efforts to comply with the WIPO Patent Law Treaty.
Article 313. Patents and Public Health
1. The Parties recognise the importance of the Declaration of the Ministerial Conference of the WTO on the TRIPS Agreement and Public Health, adopted on 14 November 2001. In interpreting and implementing the rights and obligations under this Chapter, the Parties shall ensure consistency with that Declaration.
2. The Parties shall respect the Decision of the WTO General Council of 30 August 2003 on paragraph 6 of the declaration referred to in paragraph 1 of this Article and shall contribute to its implementation.
Article 314. Supplementary Protection Certificate
1. The Parties recognise that medicinal and plant protection products protected by a patent may be subject to an administrative authorisation procedure before being put on their market. They recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on their respective market, as defined for that purpose by domestic law, may shorten the period of effective protection under the patent.
2. Each Party shall provide for a further period of protection for a medicinal or plant protection product which is protected by a patent and which has been subject to an administrative authorisation procedure, that period being equal to the period referred to in the second sentence of paragraph 1, reduced by a period of five years.
3. Notwithstanding paragraph 2, the duration of the further period of protection may not exceed five years.
4. In the case of medicinal products for which paediatric studies have been carried out, and provided that results of those studies are reflected in the product information, the Parties shall provide for a further six months extension of the period of protection referred to in paragraph 2.
Article 315. Protection of Data Submitted to Obtain an Authorisation to Put a Medicinal Product on the Market
1. Each Party shall implement a comprehensive system to guarantee the confidentiality, non-disclosure and non-reliance of data submitted for the purpose of obtaining an authorisation to put a medicinal product on the market. (1)
2. Each Party shall ensure that any required information that is submitted to obtain an authorisation to put a medicinal product on the market remains undisclosed to third parties and benefits from protection against unfair commercial use.
To that end,
(a) during a period of at least five years, starting from the date of the grant of a marketing authorisation in the Party concerned, no person or entity, whether public or private, other than the person or entity who submitted such undisclosed data, shall be allowed to rely directly or indirectly on such data, without the explicit consent of the person or entity who submitted that data, in support of an application for the authorisation to put a medicinal product on the market;
(b) during a period of at least seven years, starting from the date of the grant of a marketing authorisation in the Party concerned, a marketing authorisation for any subsequent application shall not be granted, unless the subsequent applicant submits his/her own data, or data used with authorisation of the holder of the first authorisation, meeting the same requirements as in the case of the first authorisation. Products registered without submission of such data shall be removed from the market until the requirements are met.
3. The seven-year period referred to in paragraph 2(b) shall be extended to a maximum of eight years if, during the first five years after obtaining the initial authorisation, the holder obtains an authorisation for one or more new therapeutic indications considered to be of significant clinical benefit in comparison with existing therapies.
4. The provisions of this Article shall not have retroactive effect. They shall not affect the marketing of medicinal products authorised before the entry into force of this Agreement.
5. The Republic of Moldova undertakes to align its legislation concerning data protection for medicinal products with that of the Union at a date to be decided by the Association Committee in Trade configuration, as set out in Article 438(4) of this Agreement.
Article 316. Data Protection on Plant Protection Products
1. Each Party shall determine safety and efficacy requirements before authorising the placing on the market of plant protection products.
2. Each Party shall assign a temporary data protection right to the owner of a test or study report submitted for the first time to obtain a marketing authorisation for a plant protection product.
During the period of validity of the data protection right, the test or study report shall not be used for the benefit of any other person aiming to obtain a marketing authorisation for a plant protection product, except when the explicit consent of the owner is provided.
3. The test or study report shall fulfil the following conditions:
(a) that it is necessary for the authorisation or for an amendment of an authorisation in order to allow the use on other crops; and
(b) that it is certified as compliant with the principles of good laboratory practice or of good experimental practice.
4. The period of data protection shall be at least 10 years from the first authorisation in the Party concerned. In case of low risk plant protection products, the period may be extended to 13 years.
5. The periods referred to in paragraph 4 shall be extended by three months for each extension of authorisation for minor uses (1) if the applications for such authorisations are made by the holder of the authorisation at the latest five years after the date of the first authorisation. The total period of data protection may in no case exceed 13 years. For low risk plant protection products the total period of data protection may in no case exceed 15 years.
6. A test or study report shall also be protected if it was necessary for the renewal or review of an authorisation. In those cases, the period for data protection shall be 30 months.
Article 317. Plant Varieties
The Parties shall protect plant varieties rights, in accordance with the International Convention for the Protection of New Varieties of Plants including the optional exception to the breeder's right as referred to in Article 15(2) of the said Convention, and shall cooperate to promote and enforce those rights.
Section 3. Enforcement of Intellectual Property Rights
Article 318. General Obligations
1. The Parties reaffirm their commitments under the TRIPS Agreement, in particular Part III thereof, and shall provide for the complementary measures, procedures and remedies set forth in this Section necessary to ensure the enforcement of intellectual property rights (2).
2. Those complementary measures, procedures and remedies shall be fair and equitable, and shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.
3. Those complementary measures and remedies shall also be effective, proportionate and dissuasive and shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.
Article 319. Entitled Applicants
Each Party shall recognise as persons entitled to seek application of the measures, procedures and remedies referred to in this Section and in Part III of the TRIPS Agreement:
(a) the holders of intellectual property rights in accordance with the provisions of the applicable law;
(b) all other persons authorised to use those rights, in particular licensees, in so far as permitted by and in accordance with the provisions of the applicable law;
(c) intellectual property collective rights management bodies which are regularly recognised as having a right to represent holders of intellectual property rights, in so far as permitted by and in accordance with the provisions of the applicable law; and
(d) professional defence bodies which are regularly recognised as having a right to represent holders of intellectual property rights, in so far as permitted by and in accordance with the provisions of the applicable law.
Subsection 1. Civil Enforcement
Article 320. Measures for Preserving Evidence
1. Each Party shall ensure that, even before the commencement of proceedings on the merits of the case, the competent judicial authorities may, on application by a party who has presented reasonably available evidence to support his/her claims that his/her intellectual property right has been infringed or is about to be infringed, order prompt and effective provisional measures to preserve relevant evidence in respect of the alleged infringement, subject to the protection of confidential information.
2. Such measures may include the detailed description, with or without the taking of samples, or the physical seizure of the alleged infringing goods, and, in appropriate cases, the materials and implements used in the production and/or distribution of those goods and the documents relating thereto. Those measures shall be taken, if necessary, without the other party being heard, in particular where any delay is likely to cause irreparable harm to the right holder or where there is a demonstrable risk of evidence being destroyed.
Article 321. Right of Information
1. Each Party shall ensure that, in the context of 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 that information on the origin and distribution networks of the goods or services which infringe an intellectual property right be provided by the infringer and/or any other person who:
(a) was found in possession of the infringing goods on a commercial scale;
(b) was found to be using the infringing services on a commercial scale;
(c) was found to be providing on a commercial scale services used in infringing activities;
(d) was indicated by the person referred to in point (a), (b) or (c) as being involved in the production, manufacture or distribution of the goods or the provision of the services.
2. The information referred to in paragraph 1 shall, as appropriate, comprise:
(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;
(b) information on the quantities produced, manufactured, delivered, received or ordered, as well as the price obtained for the goods or services in question.
3. Paragraphs 1 and 2 shall apply without prejudice to other statutory provisions which:
(a) grant the right holder rights to receive fuller information;
(b) govern the use in civil or criminal proceedings of the information communicated pursuant to this Article;
(c) govern responsibility for misuse of the right of information;
(d) afford an opportunity for refusing to provide information which would force the person referred to in paragraph 1 to admit to his/her own participation or that of his/her close relatives in an infringement of an intellectual property right; or
(e) govern the protection of confidentiality of information sources or the processing of personal data.
Article 322. Provisional and Precautionary Measures
1. Each Party shall ensure that the judicial authorities may, at the request of the applicant, issue 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, where appropriate, to a recurring penalty payment where provided for by domestic 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. An interlocutory injunction may also be issued, under the same conditions, against an intermediary whose services are being used by a third party to infringe an intellectual property right.
2. An interlocutory injunction may also be issued to order the seizure or delivery of goods suspected of infringing an intellectual property right, so as to prevent their entry into or movement within the channels of commerce.
3. In the case of an alleged infringement committed on a commercial scale, the Parties shall ensure that, if the applicant demonstrates circumstances likely to endanger the recovery of damages, the judicial authorities may order the precautionary seizure of the movable and immovable property of the alleged infringer, including the blocking of his/her bank accounts and other assets. To that end, the competent authorities may order the communication of bank, financial or commercial documents, or appropriate access to the relevant information.
Article 323. Corrective Measures
1. Each Party shall ensure that the competent judicial authorities may order, at the request of the applicant and without prejudice to any damages due to the right holder by reason of the infringement, and without compensation of any sort, at least the definitive removal from the channels of commerce, or the destruction, of goods that they have found to be infringing an intellectual property right. If appropriate, the competent judicial authorities may also order the destruction of materials and implements predominantly used in the creation or manufacture of those goods.
2. The Parties' judicial authorities shall have the power to order that those measures shall be carried out at the expense of the infringer, unless particular reasons are invoked for not doing so.
Article 324. Injunctions
Each Party shall ensure that, where a judicial decision has been taken, finding an infringement of an intellectual property right, the judicial authorities may issue against the infringer, as well as against an intermediary whose services are used by a third party to infringe an intellectual property right, an injunction aimed at prohibiting the continuation of the infringement.
Article 325. Alternative Measures
The Parties may provide that, in appropriate cases and at the request of the person liable to be subject to the measures provided for in Article 323 and/or Article 324 of this Agreement, the competent judicial authorities may order pecuniary compensation to be paid to the injured party instead of applying the measures provided for in those two Articles if that person acted unintentionally and without negligence, if execution of the measures in question would cause him/her disproportionate harm and if pecuniary compensation to the injured party appears reasonably satisfactory.
Article 326. Damages
1. Each Party shall ensure that the judicial authorities, on application of the injured party, order the infringer who knowingly, or with reasonable grounds to know, engaged in an infringing activity, to pay the right-holder damages appropriate to the actual prejudice suffered by him/her as a result of the infringement. When the judicial authorities set the amount of damages:
(a) they shall take into account all appropriate aspects, such as the negative economic consequences, including lost profits, which the injured party has suffered, any unfair profits made by the infringer and, in appropriate cases, elements other than economic factors, such as the moral prejudice caused to the right holder by the infringement; or
(b) as an alternative to point (a), they may, in appropriate cases, set the amount of damages as a lump sum on the basis of elements such as, at least, the amount of royalties or fees which would have been due if the infringer had requested authorisation to use the intellectual property right in question.
2. Where the infringer did not knowingly, or with reasonable grounds to know, engage in the infringing activity, the Parties may lay down that the judicial authorities may order in favour of the injured party the recovery of profits or the payment of damages which may be pre-established.
Article 327. Legal Costs
Each Party shall ensure that reasonable and proportionate legal costs and other expenses incurred by the successful party shall, as a general rule, be borne by the unsuccessful party, unless equity does not allow this.
Article 328. Publication of Judicial Decisions
Each Party shall ensure that, in legal proceedings instituted for infringement of an intellectual property right, the judicial authorities may order, at the request of the applicant and at the expense of the infringer, appropriate measures for the dissemination of the information concerning the decision, including displaying the decision and publishing it in full or in part.
Article 329. Presumption of Authorship or Ownership
For the purposes of applying the measures, procedures and remedies provided for in this Section:
(a) for the author of a literary or artistic work, in the absence of proof to the contrary, to be regarded as such, and consequently to be entitled to institute infringement proceedings, it shall be sufficient for his/her name to appear on the work in the usual manner;
(b) point (a) shall apply mutatis mutandis to the holders of rights related to copyright with regard to their protected subject matter.
Subsection 2. Other Provisions
Article 330. Border Measures
1. Each Party shall, unless otherwise provided for in this Sub-Section, adopt procedures to enable a right holder, who has valid grounds for suspecting that the importation, exportation, re-exportation, entry or exit of the customs territory, placement under a suspensive procedure or placement under a free zone or a free warehouse of goods infringing an intellectual property right (1) may take place, to lodge an application in writing with the competent authorities, whether administrative or judicial, for the suspension by the customs authorities of the release or detention of such goods.
2. Each Party shall provide that when the customs authorities, in the course of their actions and before an application has been lodged by a right holder or granted, have sufficient grounds for suspecting that goods infringe an intellectual property right, they may suspend the release of the goods or detain them in order to enable the right holder to submit an application for action in accordance with paragraph 1.
3. Any rights or obligations concerning the importer which are established in domestic law for the implementation of this Article and of Section 4 of Part III of the TRIPS Agreement shall be also applicable to the exporter or to the holder of the goods.
4. Each Party shall provide that its competent authorities require a right holder who requests the procedures described in paragraph 1 to provide adequate evidence to satisfy the competent authorities that, under the law of the Party providing the procedures, there is a prima facie infringement of the right holder's intellectual property right, and to supply sufficient information that may reasonably be expected to be within the right holder's knowledge to make the suspect goods reasonably recognisable by the competent authorities. The requirement to provide sufficient information shall not unreasonably deter recourse to the procedures described in paragraph 1.
5. With a view to establishing whether an intellectual property right has been infringed, the customs office shall inform the right holder, at his/her request and if known, of the names and addresses of the consignee, the consignor or the holder of the goods and the origin and provenance of goods suspected of infringing an intellectual property right.
The customs office shall also give the applicant the opportunity to inspect goods whose release has been suspended or which have been detained. When examining goods, the customs office may take samples and hand them over or send them to the right holder, at his/her request, strictly for the purposes of analysis and to facilitate the subsequent proce- dure.
6. The customs authorities shall be active in targeting and identifying shipments containing goods suspected of infringing an intellectual property right on the basis of risk analysis techniques. They shall set up systems for close co- operation with right holders, including effective mechanisms to collect information for the risk analysis.
7. The Parties agree to cooperate with a view to eliminating international trade in goods infringing intellectual property rights. In particular, for that purpose, they shall, where appropriate, exchange information and arrange for co-operation between their competent authorities with regard to trade in goods infringing intellectual property rights.
8. For goods in transit through the territory of a Party destined for the territory of the other Party, the former Party shall provide information to the latter Party to enable effective enforcement against shipments of goods suspected of infringing an intellectual property right.
9. Without prejudice to other forms of cooperation, Protocol III on Mutual Administrative Assistance in Customs Matters will be applicable with regard to paragraphs 7 and 8 of this Article with respect to breaches of customs legislation related to intellectual property rights.
10. The Customs Sub-Committee referred to in Article 200 of this Agreement shall act as the responsible Committee to ensure the proper functioning and implementation of this Article.
Article 331. Codes of Conduct
The Parties shall encourage:
a) the development by trade or professional associations or organisations of codes of conduct aimed at contributing towards the enforcement of intellectual property rights; and
b) the submission to the competent authorities of the Parties of draft codes of conduct and of any evaluations of the application of those codes of conduct.
Article 332. Cooperation
1. The Parties agree to cooperate with a view to supporting implementation of the commitments and obligations undertaken under this Chapter.
2. Subject to the provisions of Title VI (Financial Assistance, and Anti-Fraud and Control Provisions) of this Agreement, areas of cooperation include, but are not limited to, the following activities:
(a) exchange of information on the legal framework concerning intellectual property rights and relevant rules of protection and enforcement; exchange of experiences on legislative progress in those areas;
(b) exchange of experiences and information on enforcement of intellectual property rights;
(c) exchange of experiences on central and sub-central enforcement by customs, police, administrative and judiciary bodies; coordination to prevent exports of counterfeit goods, including with other countries;
(d) capacity-building; exchange and training of personnel;
(e) promotion and dissemination of information on intellectual property rights in, inter alia, business circles and civil society; public awareness of consumers and right holders;
(f) enhancement of institutional cooperation, for example between intellectual property offices;
(g) active promotion of awareness and education of the general public on policies concerning intellectual property rights; formulation of effective strategies to identify key audiences, and the creation of communication programmes to increase consumer and media awareness on the impact of intellectual property violations, including the risk to health and safety and the connection to organised crime.
Chapter 10. Competition
Section 1. Antitrust and Mergers
Article 333. Definitions
For the purposes of this Section:
(1) "competition authority" means for the Union, the European Commission, and for the Republic of Moldova, the Competition Council;
(2) "competition laws" means:
(a) for the Union, Articles 101, 102 and 106 of the Treaty on the Functioning of the European Union, Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (the EC Merger Regulation), and their implementing regulations or amendments;
(b) for the Republic of Moldova, Competition Law No 183 of 11 July 2012 and its implementing regulations or amendments; and
(c) any changes that the instruments referred to in points (a) and (b) may undergo after the entry into force of this Agreement.
Article 334. Principles
The Parties recognise the importance of free and undistorted competition in their trade relations. The Parties acknowledge that anti-competitive business practices have the potential to distort the proper functioning of markets and undermine the benefits of trade liberalisation.
Article 335. Implementation
1. Each Party shall maintain in its respective territory comprehensive competition laws which effectively address anti-competitive agreements, concerted practices and anti-competitive unilateral conduct of undertakings with dominant market power and provide effective control of concentrations.
2. Each Party shall maintain an operationally independent authority with adequate human and financial resources in order to effectively enforce the competition laws referred to in Article 333(2).
3. The Parties recognise the importance of applying their respective competition laws in a transparent and non- discriminatory manner, respecting the principles of procedural fairness and rights of defence of the undertakings concerned.
Article 336. State Monopolies, Public Undertakings and Undertakings Entrusted with Special or Exclusive Rights
1. Nothing in this Chapter prevents a Party from designating or maintaining state monopolies or public undertakings or entrusting undertakings with special or exclusive rights according to their respective laws.
2. With regard to state monopolies of a commercial character, public undertakings and undertakings entrusted with special or exclusive rights, each Party shall ensure that such undertakings are subject to the competition laws referred to in Article 333(2), in so far as the application of those laws does not obstruct the performance, in law or in fact, of the particular tasks of public interest assigned to the undertakings in question.
Article 337. Cooperation and Exchange of Information
1. The Parties recognise the importance of cooperation and coordination between their respective competition authorities to enhance effective competition law enforcement, and to fulfil the objectives of this Agreement through the promotion of competition and the curtailment of anti-competitive business conduct or anti-competitive transactions.
2. To that end, each competition authority may inform the other competition authority of its willingness to cooperate with respect to the enforcement activity of any of the Parties. Neither Party shall be prevented from taking autonomous decisions on the matters subject to the cooperation.
3. With a view to facilitating the effective enforcement of their respective competition laws, the competition authorities may exchange non-confidential information. All exchange of information shall be subject to the standards of confidentiality applicable in each Party. Whenever the Parties exchange information under this Article, they shall take into account the limitations imposed by the requirements of professional and business secrecy in their respective jurisdictions.
Article 338. Dispute Settlement
The provisions on the dispute settlement mechanism in Chapter 14 (Dispute Settlement) of Title V (Trade and Trade-related Matters) of this Agreement shall not apply to this Section.
Section 2. State Aid
Article 339. General Principles and Scope
1. State aid granted by the Union or the Republic of Moldova, or through the resources of one of the Parties, in any form whatsoever, which distorts or threatens to distort competition by favouring certain undertakings or the production of certain goods and services and which affects trade between the Parties, shall be incompatible with this Agreement.
2. This Chapter shall not apply to state aid related to fisheries, products covered by Annex 1 to the Agreement on Agriculture or other aids covered by the Agreement on Agriculture. Article 340 Assessment of state aid
1. State aid shall be assessed on the basis of the criteria arising from the application of the competition rules applic- able in the EU, in particular Article 107 of the Treaty on the Functioning of the European Union and interpretative instruments adopted by the EU institutions, including the relevant jurisprudence of the Court of Justice of the European Union.
2. The obligations deriving from this Article shall apply within five years from the date of entry into force of this Agreement. Article 341 State aid legislation and authority
1. The Parties shall adopt or maintain, as appropriate, legislation for the control of state aid. They shall also establish or maintain, as appropriate, an operationally independent authority entrusted with the powers necessary for the control of state aid. That authority shall have, inter alia, the powers to authorise state aid schemes and individual state aid measures, as well as the powers to order the recovery of state aid that has been unlawfully granted.
2. The obligations deriving from this Article shall be fulfilled within two years from the date of entry into force of this Agreement.