与贸易有关的知识产权协定(中英文)

Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.  In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

 

 

SECTION 8:  CONTROL OF ANTI-COMPETITIVE PRACTICES

IN CONTRACTUAL LICENCES

 

 

Article 40

 

1.         Members agree that some licensing practices or conditions pertaining to intellectual property rights which restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology.

 

2.         Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market.  As provided above, a Member may adopt, consistently with the other provisions of this Agreement, appropriate measures to prevent or control such practices, which may include for example exclusive grantback conditions, conditions preventing challenges to validity and coercive package licensing, in the light of the relevant laws and regulations of that Member.

 

3.         Each Member shall enter, upon request, into consultations with any other Member which has cause to believe that an intellectual property right owner that is a national or domiciliary of the Member to which the request for consultations has been addressed is undertaking practices in violation of the requesting Member's laws and regulations on the subject matter of this Section, and which wishes to secure compliance with such legislation, without prejudice to any action under the law and to the full freedom of an ultimate decision of either Member.  The Member addressed shall accord full and sympathetic consideration to, and shall afford adequate opportunity for, consultations with the requesting Member, and shall cooperate through supply of publicly available non-confidential information of relevance to the matter in question and of other information available to the Member, subject to domestic law and to the conclusion of mutually satisfactory agreements concerning the safeguarding of its confidentiality by the requesting Member.

 

4.         A Member whose nationals or domiciliaries are subject to proceedings in another Member concerning alleged violation of that other Member's laws and regulations on the subject matter of this Section shall, upon request, be granted an opportunity for consultations by the other Member under the same conditions as those foreseen in paragraph 3.

 

 

PART III

 

ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS

 

 

SECTION 1:  GENERAL OBLIGATIONS

 

 

Article 41

 

1.         Members shall ensure that enforcement procedures as specified in this Part are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements.  These procedures 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.

 

2.         Procedures concerning the enforcement of intellectual property rights shall be fair and equitable.  They shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.

 

3.         Decisions on the merits of a case shall preferably be in writing and reasoned.  They shall be made available at least to the parties to the proceeding without undue delay.  Decisions on the merits of a case shall be based only on evidence in respect of which parties were offered the opportunity to be heard.

 

4.         Parties to a proceeding shall have an opportunity for review by a judicial authority of final administrative decisions and, subject to jurisdictional provisions in a Member's law concerning the importance of a case, of at least the legal aspects of initial judicial decisions on the merits of a case.  However, there shall be no obligation to provide an opportunity for review of acquittals in criminal cases.

 

5.         It is understood that this Part does not create any obligation 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 Members to enforce their law in general.  Nothing in this Part creates any obligation with respect to the distribution of resources as between enforcement of intellectual property rights and the enforcement of law in general.

 

 

SECTION 2:  CIVIL AND ADMINISTRATIVE PROCEDURES AND REMEDIES

 

 

Article 42

 

Fair and Equitable Procedures

 

            Members shall make available to right holders[11]