第五节　专利

Section E
Patents

Section F:
Patents and Undisclosed Test or Other Data

F节　专利和未披露的试验或其他数据

Subsection A: General Patents

A分节　普通专利

第三十六条　可授予专利的客体

Article 11.36: Patentable Subject Matter

Article 18.37: Patentable Subject Matter

第18.37条：可授予专利的客体

　　一、在符合第二款和第三款规定的前提下，每一缔约方应当规定所有技术领域的任何发明，无论产品还是方法，只要此类发明具有新颖性、包含创造性步骤并且能用于产业应用的³²，都可以获得专利。

1.　Subject to paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step, and are capable of industrial application³².

1.　Subject to paragraphs 3 and 4, each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step and is capable of industrial application.³⁰

　　1．在遵守第3款和第4款的前提下，每一缔约方应保证所有技术领域的任何发明，无论是产品还是方法，均可授予专利，只要此类发明具有新颖性、包含创造性步骤且可供工业应用。³⁰

³²就本节而言，缔约方可以认为“创造性步骤”和“可供工业应用”分别与“非显而易见性”和“实用性”的含义相同。

³²For the purposes of this Section, “inventive step” and “capable of industrial application” may be deemed by a Party to be synonymous with "non-obvious" and "useful", respectively.

³⁰For the purposes of this Section, a Party may deem the terms “inventive step” and “capable of industrial application” to be synonymous with the terms “non-obvious” and “useful”, respectively. In determinations regarding inventive step, or non-obviousness, each Party shall consider whether the claimed invention would have been obvious to a person skilled, or having ordinary skill in the art, having regard to the prior art.

³⁰就本节而言，缔约方可认为“创造性步骤”和“可供工业应用”两个用语分别与“非显而易见性”和“实用性”两个用语的含义相同。在认定创造性步骤或非显而易见性时， 每一缔约方应考虑申请专利的发明对于相关技术领域具有一般技术的人员来说是否是显而易见的，并注意到现有技术。

在遵循本条第三款以及第十三节（过渡期和技术援助）规定的情况下，每一缔约方应当规定专利是可获得的以及专利权是可享有的，不因发明地点、技术领域、产品是进口或当地生产而受到歧视。

Subject to paragraph 3 and Section M (Transition Periods and Technical Assistance), patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology, and whether products are imported or locally produced.

2.　Subject to paragraphs 3 and 4 and consistent with paragraph 1, each Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product. A Party may limit those new processes to those that do not claim the use of the product as such.

　　2．在遵守第3款和第4款并与第1款相一致的前提下，每一缔约方确认以下至少一种类型主张的发明可授予专利：已知产品的新用途，使用已知产品的新方法、使用已知产品的新工序。缔约方可将此种新工序的范围限定为非主张对产品本身的使用。

　　二、一缔约方可以排除特定发明的可专利性，如在其领土内阻止这些发明的商业利用是为维护公共秩序或道德，包括保护人、动物或植物的生命或健康，或者避免对环境造成严重损害所必需的，只要此种排除不是仅仅因为此种利用被其法律法规所禁止。

2.　A Party may exclude from patentability inventions, the prevention within its territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health, or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by its laws and regulations.

3.　A Party may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to nature or the environment, provided that such exclusion is not made merely because the exploitation is prohibited by its law.

　　3．一缔约方可拒绝对某些发明授予专利权，如在其领土内阻止对此类发明的商业利用是维护公共秩序或道德，包括保护人类、动物或植物的生命或健康，或避免对自然或环境造成严重损害所必需的，只要此种拒绝授予并非仅因为此种利用为其法律法规所禁止。

　　三、一缔约方可以排除下列各项的可专利性：

3.　A Party may also exclude from patentability:

A Party may also exclude from patentability:

一缔约方还可拒绝对下列内容授予专利：

　　（一）医治人或动物的诊断、治疗和外科手术方法；

(a) diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; and

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

　　（a）医治人类或动物的诊断、治疗和外科手术方法；及

　　（二）除微生物外的植物和动物，以及除非生物学方法和微生物学方法外的生产植物或动物的主要生物学方法。

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

(b) animals other than microorganisms, and essentially biological processes for the production of plants or animals, other than nonbiological and microbiological processes.

　　（b）除微生物外的动物，以及除非生物学方法和微生物学方法外的生产植物和动物的实质生物学方法。

但是，每一缔约方应当规定通过专利或一种有效的专门制度或通过这两者的任何组合以保护植物品种。

However, each Party shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

4.　A Party may also exclude from patentability plants other than microorganisms. However, consistent with paragraph 1 and subject to paragraph 3, each Party confirms that patents are available at least for inventions that are derived from plants.

　　4．一缔约方也有权拒绝授予植物专利权，但微生物除外。但在与第1款相一致并在遵守第3款的前提下，每一缔约方确认，专利至少可授予源自于植物的发明。

缔约方应当根据《与贸易有关的知识产权协定》的第二十七条第三款第（二）项做出的任何修订审议本项，以决定是否对本项采取类似的修正。

The Parties shall review this subparagraph upon any amendment to subparagraph 3(b) of Article 27 of the TRIPS Agreement with a view to deciding whether to adopt a similar amendment to this subparagraph.

第三十七条　授予的权利

Article 11.37: Rights Conferred

　　一、每一缔约方应当规定一专利应当赋予其所有权人下列专有权：

1.　Each Party shall provide that a patent shall confer on its owner the following exclusive rights:

　　（一）如一专利的客体为产品，为阻止第三方未经所有权人同意而制造、使用、许诺销售、销售或为此类目的而进口³³该产品的行为；

(a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of making, using, offering for sale, selling, or importing³³ for these purposes that product; and

³³本权利，同本章授予的其他所有关于商品的使用、销售、进口或其他分销的权利一样，遵循第十一章第六条（知识产权权利用尽）。

³³This right, like all other rights conferred under this Chapter in respect of the use, sale, importation, or other distribution of goods, is subject to Article 11.6 (Exhaustion of Intellectual Property Rights).

　　（二）如一专利的客体为方法，为阻止第三方未经所有权人同意而使用该方法的行为，以及防止使用、许诺销售、销售或为这些目的而进口至少是通过该方法直接获得的产品的行为。

(b) where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent from the act of using the process, and from the acts of using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.

　　二、专利所有权人也应当有权转让或以继承方式转移其专利和订立许可合同。

2.　Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.

第三十八条　授予权利的例外

Article 11.38: Exceptions to Rights Conferred

Article 18.40: Exceptions

第18.40条：例外

　　一缔约方可以规定专利专有权的有限的例外，只要在顾及第三方合法利益的前提下，该例外不会不合理地与专利的正常利用相冲突，也不会不合理地损害专利所有人的合法权益。

A Party may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

A Party may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

　　一缔约方可以规定专利专有权的有限的例外，只要在顾及第三方合法利益的前提下，该例外不会不合理地与专利的正常利用相冲突，也不会不合理地损害专利所有人的合法权益。

第三十九条　未经权利持有人授权的其他使用

Article 11.39: Other Use without Authorisation of the Right Holder

Article 18.41: Other Use Without Authorisation of the Right Holder

第18.41条：未经权利持有人授权的其他使用

　　为进一步明确，本协定中的任何内容不得限制一缔约方依据《与贸易有关的知识产权协定》第三十一条和第三十一条之二以及其附件和附件的附录的权利和义务。

For greater certainty, nothing in this Agreement shall limit a Party’s rights and obligations under Article 31 and Article 31bis of the TRIPS Agreement, and the Annex and Appendix to the Annex to the TRIPS Agreement.

The Parties understand that nothing in this Chapter limits a Party’s rights and obligations under Article 31 of the TRIPS Agreement, any waiver or any amendment to that Article that the Parties accept.

　　缔约方理解，本章并不限制缔约方在TRIPS协定第31条下的权利和义务，也不限制该缔约方接受的对该条的任何豁免或者修改。

第四十条　专利的实验性使用

Article 11.40: Experimental Use of a Patent

　　在不限制第十一章第三十八条（授予权利的例外）的情况下，每一缔约方应当规定，任何人可以出于与专利发明的客体有关的实验目的³⁴而作出在其他情况下可能侵犯一项专利的行为。

Without limiting Article 11.38 (Exceptions to Rights Conferred), each Party shall provide that any person may do an act that would otherwise infringe a patent if the act is done for experimental purposes³⁴ relating to the subject matter of a patented invention.

³⁴为进一步明确，每一缔约方可以决定，在符合第十一章第三十八条（授予权利的例外）规定的前提下，何种行为属于“实验目的”。

³⁴For greater certainty, each Party may determine, consistent with Article 11.38 (Exceptions to Rights Conferred), what acts fall within the meaning of “experimental purposes”.

Article 18.42: Patent Filing

第18.42条：专利申请

Each Party shall provide that if an invention is made independently by more than one inventor, and separate applications claiming that invention are filed with, or for, the relevant authority of the Party, that Party shall grant the patent on the application that is patentable and that has the earliest filing date or, if applicable, priority date,³³ unless that application has, prior to publication,³⁴ been withdrawn, abandoned or refused.

　　每一缔约方应规定，如一项发明被不同的发明者独立创造，且分别向该缔约方的有关机关申请该项发明为专利，则该缔约方应将专利权授予符合专利授予条件且申请日或如适用，优先权日在前的申请，³³除非该申请在公告之前³⁴已经被撤回、放弃或驳回。

³³A Party shall not be required to apply this Article in cases involving derivation or in situations involving any application that has or had, at any time, at least one claim having an effective filing date before the date of entry into force of this Agreement for that Party or any application that has or had, at any time, a priority claim to an application that contains or contained such a claim.

³³缔约方在下列情形下缔约方无需适用本条：涉及衍生，或者涉及包含或在任何时候曾经包含至少一个在本协定对该缔约方生效前存在有效的申请日的权利主张的任何申请，或者涉及包含或在任何时候曾经包含存在或曾经存在此等权利主张的一个申请主张优先权的任何申请。

³⁴For greater certainty, a Party may grant the patent to the subsequent application that is patentable, if an earlier application has been withdrawn, abandoned, or refused, or is not prior art against the subsequent application.

³⁴为进一步明确，如在先申请被撤回、放弃或驳回或并未对在后申请构成现有技术，缔约方可把专利权授予在后提出的可专利申请。

第四十一条　审查、注册的程序事项

Article 11.41: Procedural Aspects of Examination and Registration

　　一、缔约方认识到提高各自专利制度的质量和效率以及简化和精简各自主管机关的程序的重要性，以造福于各自专利制度的所有使用者和全体公众。

1.　The Parties recognise the importance of improving the quality and efficiency of their respective patent systems as well as simplifying and streamlining the procedures and processes of their respective competent authorities for the benefit of all users of their respective patent systems and the public as a whole.

　　二、每一缔约方应当规定一项专利制度，该制度包括：

2.　Each Party shall provide a patent system, which includes:

　　（一）向申请人提供一份有关驳回专利授权理由的书面通知的要求；

(a) a requirement to provide to the applicant a communication in writing of the reasons for a refusal to grant a patent;

Article 18.43: Amendments, Corrections and Observations

第18.43条：修正、更正和陈述意见

　　（二）提供一次对其专利申请进行修正和陈述意见的机会；³⁵

(b) an opportunity for the applicant to make amendments and observations in connection with their applications;³⁵

　　Each Party shall provide a patent applicant with at least one opportunity to make amendments, corrections and observations in connection with its application.³⁵

　　每一缔约方应为专利申请人提供至少一次对其专利申请进行修改、更正和陈述意见的机会。³⁵

³⁵就本项而言，缔约方理解“修正”可以包括更正，“陈述意见”可以包括对主管机关就其申请作出的决定的解释或回复，不论该回复是否与该申请的修正或更正同时提出。

³⁵For the purposes of this subparagraph, the Parties understand that “amendments” may include corrections and “observations” may include explanations or responses to a finding on its application by the competent authority whether or not such response is given in conjunction with an amendment or correction to the application.

³⁵A Party may provide that such amendments do not go beyond the scope of the disclosure of the invention, as of the filing date.

³⁵一缔约方可规定此类修正不得超出该发明截至申请日的披露范围。

　　（三）在专利获得授权之前，提供进行以下至少一项行为的机会：

(c) an opportunity to do at least one of the following in relation to a patent before it has been granted:

　　1．提交专利申请异议；或者

(i) file an opposition against the patent application; or

　　2．向主管机关提供可以否定专利申请中主张的新颖性和创造性步骤的信息；

(ii) provide the competent authority with information that could deny novelty or inventive step of an invention claimed in the patent application;

　　（四）在专利获得授权之后，提供进行以下至少一项行为的机会：

(d) an opportunity to do at least one of the following in relation to a patent after it has been granted:

　　1．对授权提出异议；

(i) oppose the grant;

Article 18.39: Patent Revocation

第18.39条：专利撤销

　　2．寻求撤销；

(ii) seek revocation;

1.　Each Party shall provide that a patent may be cancelled, revoked or nullified only on grounds that would have justified a refusal to grant the patent. A Party may also provide that fraud, misrepresentation or inequitable conduct may be the basis for cancelling, revoking or nullifying a patent or holding a patent unenforceable.

　　1．每一缔约方应规定，只有基于可拒绝专利授权的事由，方可注销、撤销专利或宣告专利无效。一缔约方也可规定，欺诈、虚假陈述或不公正行为可能导致专利被注销、撤销、宣告无效或不可执行。

　　3．寻求注销；或者

(iii) seek cancellation; or

　　4．寻求使该专利无效；以及

(iv) seek invalidation; and

　　（五）异议、撤销、注销或无效程序的行政决定³⁶应当说明理由并采取书面形式的要求。此类决定可以以电子方式提供。

(e) a requirement that administrative decisions³⁶ in opposition, revocation, cancellation, or invalidation proceedings shall be reasoned and in writing. Such decisions may be provided electronically.

³⁶就本项而言，“行政决定”可以包括准司法决定。

³⁶For the purposes of this subparagraph, “administrative decisions” may include quasijudicial decisions.

2.　Notwithstanding paragraph 1, a Party may provide that a patent may be revoked, provided it is done in a manner consistent with Article 5A of the Paris Convention and the TRIPS Agreement.

　　2．尽管有本条第1款的规定，但是一缔约方仍可规定撤销专利，只要以与巴黎公约第5A条和TRIPS协定相一致的方式规定。

第四十二条　专利宽限期

Article 11.42: Grace Period for Patents

Article 18.38: Grace Period

第18.38条：宽限期

　　缔约方认识到，在认定一项发明是否新颖以支持创新时，专利宽限期在不用考虑发明的特定方面公开披露信息的优势。

The Parties recognise the benefits of patent grace periods to disregard certain public disclosures of inventions when determining if an invention is novel in order to support innovation.

Each Party shall disregard at least information contained in public disclosures used to determine if an invention is novel or has an inventive step, if the public disclosure:^31,32

　　每一缔约方在确定某一发明是否具有新颖性或是否包含创造性步骤时，至少不得考虑已公开披露的信息，如此类公开披露：^31,32

³¹No Party shall be required to disregard information contained in applications for, or registrations of, intellectual property rights made available to the public or published by a patent office, unless erroneously published or unless the application was filed without the consent of the inventor or their successor in title, by a third person who obtained the information directly or indirectly from the inventor.

³¹缔约方不得忽视由专利局向公众提供或发布的知识产权申请或注册中包含的信息，除非错误发布，或该申请系由未经发明者或其继承人的同意而由从发明者处直接或间接获得信息的第三人提交。

³²For greater certainty, a Party may limit the application of this Article to disclosures made by, or obtained directly or indirectly from, the inventor or joint inventor. For greater certainty, a Party may provide that, for the purposes of this Article, information obtained directly or indirectly from the patent applicant may be information contained in the public disclosure that was authorised by, or derived from, the patent applicant.

³²为进一步明确，一缔约方可将本条的适用限于发明者或共同发明者作出的或从其直接或间接获得的披露。为进一步明确，一缔约方可规定，就本条而言，从专利申请人处直接或间接获得的信息可是专利申请人授权或源于专利申请人的公开披露中包含的信息。

(a) was made by the patent applicant or by a person that obtained the information directly or indirectly from the patent applicant; and

　　（a）是由专利申请人所为或从专利申请人处直接或间接获取信息的人所为；及

(b) occurred within 12 months prior to the date of the filing of the application in the territory of the Party.

　　（b）发生在该缔约方领土内的申请日之前12个月内。

第四十三条　专利电子申请制度

Article 11.43: Electronic Patent Application System

　　鼓励每一缔约方采用专利电子申请制度，以便利专利申请人申请。

Each Party is encouraged to adopt an electronic patent application system so as to facilitate ease of application by patent applicants.

第四十四条　18个月公布

Article 11.44: 18-Month Publication

Article 18.44: Publication of Patent Applications

第18.44条：专利申请的公布

　　一、每一缔约方应当在专利申请提交日或者在主张优先权的情况下，在最早的优先权日起的18个月届满后，迅速公布任何专利申请，除非该申请已被提前公布或者已经被撤回、放弃或者驳回³⁷。

1.　Each Party shall publish any patent application promptly after the expiry of 18 months from its filing date or, if priority is claimed, from its earliest priority date, unless the application has been published earlier, or has been withdrawn, abandoned, or refused³⁷.

1.　Recognising the benefits of transparency in the patent system, each Party shall endeavour to publish unpublished pending patent applications promptly after the expiration of 18 months from the filing date or, if priority is claimed, from the earliest priority date.

　　1．认识到透明度在专利制度中的积极作用，每一缔约方应努力在专利申请日或最早的优先权（如存在优先权主张）起18个月后迅速公布尚未公布的未决专利申请。

³⁷缔约方理解，就本条而言，根据缔约方各自的法律和法规撤回，放弃或驳回申请。

³⁷The Parties understand that, for the purposes of this Article, an application is withdrawn, abandoned, or refused in accordance with the respective Party’s laws and regulations.

　　二、如一项未决申请未依照第一款的规定迅速公布，该缔约方应当尽快公布该申请或相应的专利。

2.　If a pending application is not published promptly in accordance with paragraph 1, the Party shall publish that application or the corresponding patent as soon as practicable.

2.　If a pending application is not published promptly in accordance with paragraph 1, a Party shall publish that application or the corresponding patent, as soon as practicable.

　　2．如未决申请未依照第1款迅速公布，一缔约方应尽可能快地公布该申请或相应专利。

　　四、每一缔约方应当规定，申请人可以请求在第一款所提及的期限届满前提前公布申请。

4.　Each Party shall provide that the applicant may request the early publication of an application prior to the expiry of the period referred to in paragraph 1.

3.　Each Party shall provide that an applicant may request the early publication of an application prior to the expiration of the period referred to in paragraph 1.

　　3．每一缔约方应规定，专利申请人可请求在第1款所述的期限届满之前早期公布其申请。

Article 18.45: Information Relating to Published Patent Applications and Granted Patents

第18.45条：与已公布专利申请和授权专利有关的信息

For published patent applications and granted patents, and in accordance with the Party’s requirements for prosecution of such applications and patents, each Party shall make available to the public at least the following information, to the extent that such information is in the possession of the competent authorities and is generated on, or after, the date of the entry into force of this Agreement for that Party:

　　对于已公布专利申请和已授权专利，依照缔约方管理此类专利申请和授权专利的规定，每一缔约方应向公众提供至少下列信息，只要此类信息由主管机关持有且产生于本协定对该缔约方生效之日或之后：

(a) search and examination results, including details of, or information related to, relevant prior art searches;

　　（a）检索和审查结果，包括相关现有技术检索的细节或相关信息；

(b) as appropriate, non-confidential communications from applicants; and

　　（b）如适当，申请人的非保密来文；及

(c) patent and non-patent related literature

　　（c）申请人和相关第三方提交的与专利或非专利相关的引用文献。

　　三、本条不得被解释为要求一缔约方公布其认为如披露则会有违其国家安全、公共秩序或道德的任何信息。

3.　Nothing in this Article shall be construed to require a Party to publish any information the disclosure of which it considers to be contrary to its national security or to public order or morality.

第四十五条　在互联网上向公众提供的在先技术的信息

Article 11.45: Information as Prior Art Made Available to the Public on the Internet

　　缔约方认识到在互联网上向公众提供的信息可以构成在先技术的一部分。

The Parties recognise that information made available to the public on the internet may form part of the prior art.

Article 18.46: Patent Term Adjustment for Unreasonable Granting Authority Delays

第18.46条：因专利局的迟延而调整专利保护期

1.　Each Party shall make best efforts to process patent applications in an efficient and

　　1．每一缔约方应尽最大努力及时有效地处理专利申请，以避免不合理或不必要的延迟。

第四十六条　快速审查

Article 11.46: Expedited Examination

2.　A Party may provide procedures for a patent applicant to request to expedite the examination of its patent application.

　　2．一缔约方可为专利申请人提供加速审查其专利申请的程序。

　　每一缔约方应当致力于规定专利申请人要求依照该缔约方的法律、法规和规章加速对其专利申请进行审查的国内程序。

Each Party shall endeavour to provide for domestic procedures for a patent applicant to request to expedite the examination of its patent application in accordance with that Party’s laws, regulations, and rules.

3.　If there are unreasonable delays in a Party’s issuance of patents, that Party shall provide the means to, and at the request of the patent owner shall, adjust the term of the patent to compensate for such delays.³⁶

　　3．如一缔约方不合理地延迟授予专利，该缔约方应提供途径，并应专利所有人的请求，调整专利权的期限以补偿该延迟。³⁶

³⁶Annex 18-D applies to this paragraph.

³⁶附件18-D适用于本款。

4.　For the purposes of this Article, an unreasonable delay at least shall include a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later. A Party may exclude, from the determination of such delays, periods of time that do not occur during the processing³⁷ of, or the examination of, the patent application by the granting authority; periods of time that are not directly attributable³⁸ to the granting authority; as well as periods of time that are attributable to the patent applicant.³⁹

　　4．就本条而言，不合理的延迟至少应包括自在该缔约方领土内提交申请之日起超过5年或者自请求审查专利之日起超过3年（以较后的日期为准）仍未授予专利。在确定此迟延时，一缔约方可将专利授权机关处理³⁷或审查专利申请过程之外的时间、不直接归因于³⁸专利授权机关的时间以及归因于专利申请人的时间排除在外。³⁹

³⁷For the purposes of this paragraph, a Party may interpret processing to mean initial administrative processing and administrative processing at the time of grant.

³⁷就本款而言，缔约方可将“处理”解释为初始行政处理程序和授权时的行政处理程序。

³⁸A Party may treat delays “that are not directly attributable to the granting authority” as delays that are outside the direction or control of the granting authority.

³⁸缔约方可将“不直接归因于授权机关的迟延”视为授权机关无法控制的迟延。

³⁹Notwithstanding Article 18.10 (Application of Chapter to Existing Subject Matter and Prior Acts), this Article shall apply to all patent applications filed after the date of entry into force of this Agreement for that Party, or the date two years after the signing of this Agreement, whichever is later for that Party.

³⁹尽管有第18.10条（本章对于现有客体和先前行为的适用）的规定，本条应适用于本协定对该缔约方生效日或本协定签署2周年日（以对该缔约方而言更晚的日期为准）以后提交的所有的专利申请。

第四十七条　引入国际专利分类制度

Article 11.47: Introduction of International Patent Classification System

　　每一缔约方应当致力于使用与1971年3月24日在斯特拉斯堡签订的《国际专利分类斯特拉斯堡协定》及其不时的修正相一致的专利分类制度。

Each Party shall endeavour to use a patent classification system that is consistent with the Strasbourg Agreement Concerning the International Patent Classification done at Strasbourg on 24 March 1971, as amended from time to time.

第四十八条　保护植物新品种³⁸

Article 11.48: Protection of New Varieties of Plants³⁸

³⁸缔约方理解，就本条而言，根据缔约方各自的的法律和法规撤回，放弃或驳回申请。

³⁸For greater certainty, with respect to the protection of plant varieties, subparagraph 3(b) of Article 11.36 (Patentable Subject Matter) is subject to this Article.

　　为进一步明确，对于植物品种的保护，第十一章第三十六条（可授予专利的客体）第三款第二项遵循本条。

For greater certainty, with respect to the protection of plant varieties, subparagraph 3(b) of Article 11.36 (Patentable Subject Matter) is subject to this Article.

Subsection B: Measures Relating to Agricultural Chemical Products

B分节　对农业化学品有关的措施

Article 18.47: Protection of Undisclosed Test or Other Data for Agricultural Chemical Products

第18.47条：对农业化学品的未披露试验或其他数据的保护

1.　If a Party requires, as a condition for granting marketing approval⁴⁰ for a new agricultural chemical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product,⁴¹ that Party shall not permit third persons, without the consent of the person that previously submitted such information, to market the same or a similar⁴² product on the basis of that information or the marketing approval granted to the person that submitted such test or other data for at least 10 years⁴³ from the date of marketing approval of the new agricultural chemical product in the territory of the Party.

　　1．作为授予一新农业化学品上市许可⁴⁰的条件，如一缔约方要求提交关于该产品安全性和有效性的未披露试验或其他数据，⁴¹则自该新农业化学品在该缔约方获得上市许可之日起至少10年⁴²内，该缔约方不得允许第三方未经先前提交此类信息的人的同意而上市销售基于该信息或授予提交该试验或其他数据的人的上市许可销售的相同或相似⁴³产品。

⁴⁰For the purposes of this Chapter, the term “marketing approval” is synonymous with “sanitary approval” under a Party’s law.

⁴⁰就本章而言，“上市许可”一词与缔约方法律中的“卫生许可”具有相同含义。

⁴¹Each Party confirms that the obligations of this Article apply to cases in which the Party requires the submission of undisclosed test or other data concerning: (a) only the safety of the product, (b) only the efficacy of the product or (c) both.

⁴¹每一缔约方确认，本条的义务适用于缔约方要求提交以下未披露试验或其他数据的情况：（a）仅涉及产品的安全性，（b）仅涉及产品的有效性，或（c）同时涉及两者。

⁴²For greater certainty, for the purposes of this Section, an agricultural chemical product is “similar” to a previously approved agricultural chemical product if the marketing approval, or, in the alternative, the applicant’s request for such approval, of that similar agricultural chemical product is based upon the undisclosed test or other data concerning the safety and efficacy of the previously approved agricultural chemical product, or the prior approval of that previously approved product.

⁴³为进一步明确，就本节而言，如一农业化学品的上市许可或申请人的许可申请依据已获批上市的产品的安全性和有效性的未披露试验或其他数据，或是依据已获批上市的产品的在先许可，则该农业化学品与已获批上市农业化学品“相似”。

⁴³For greater certainty, a Party may limit the period of protection under this Article to 10 years.

⁴²为进一步明确，一缔约方可将本条下的保护期限定为10年。

2.　If a Party permits, as a condition of granting marketing approval for a new agricultural chemical product, the submission of evidence of a prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of the person that previously submitted undisclosed test or other data concerning the safety and efficacy of the product in support of that prior marketing approval, to market the same or a similar product based on that undisclosed test or other data, or other evidence of the prior marketing approval in the other territory, for at least 10 years from the date of marketing approval of the new agricultural chemical product in the territory of the Party.

　　2．作为批准一新农业化学品上市许可的条件，如一缔约方允许提交该产品在其他领土已获批上市许可的证据，则自该新农业化学品在该缔约方获得上市许可之日起至少10年内，该缔约方不得批准第三方未经先前提交关于产品安全性和有效性的未披露试验或其他数据以支持其获得上市许可的人的同意而基于该未披露试验或其他数据或在其他领土获得在先上市许可的证据上市销售相同或相似产品。

3. For the purposes of this Article, a new agricultural chemical product is one that contains⁴⁴ a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.

　　3．就本条而言，新农业化学品指包含⁴⁴此前从未在该缔约方领土内被批准用于农业化学品的化学成分的农业化学品。

⁴⁴For the purposes of this Article, a Party may treat “contain” as meaning utilise. For greater certainty, for the purposes of this Article, a Party may treat “utilise” as requiring the new chemical entity to be primarily responsible for the product’s intended effect.

⁴⁴就本条而言，缔约方可将“包含”理解为使用。为进一步明确，就本条而言，缔约方可将“使用”视为要求新化学成分对产品预期效用起主要作用。

Subsection C: Measures Relating to Pharmaceutical Products

C分节　与药品有关的措施

Article 18.48: Patent Term Adjustment for Unreasonable Curtailment

第18.48条：因不合理缩短而调整专利保护期

1.　Each Party shall make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays.

　　1．每一缔约方应尽最大努力及时有效地处理药品的上市许可申请，以避免不合理或不必要的延迟。

2.　With respect to a pharmaceutical product⁴⁵ that is subject to a patent, each Party shall make available an adjustment⁴⁶ of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.^47,48

　　2．对于受专利保护的药品⁴⁵，每一缔约方应保证调整⁴⁶专利保护期的可能性，以补偿专利所有人因上市许可程序导致的专利保护期的不合理缩短。^47,48

⁴⁵A Party may comply with the obligations of this paragraph with respect to a pharmaceutical product or, alternatively, with respect to a pharmaceutical substance.

⁴⁵缔约方可以就药品产品或作为替代，药品物质遵守本款义务。

⁴⁶For greater certainty, a Party may alternatively make available a period of additional sui generis protection to compensate for unreasonable curtailment of the effective patent term as a result of the marketing approval process. The sui generis protection shall confer the rights conferred by the patent, subject to any conditions and limitations pursuant to paragraph 3.

⁴⁶为进一步明确，缔约方可提供额外的专门保护期，以补偿因上市许可程序而导致的专利有效期的不合理缩短。在遵守第3款的条件和限制的前提下，该专门保护应授予专利所授予的权利。

⁴⁷Notwithstanding Article 18.10 (Application of Chapter to Existing Subject Matter and Prior Acts), this Article shall apply to all applications for marketing approval filed after the date of entry into force of this Article for that Party.

⁴⁷尽管有第18.10条（本章对现有客体和先前行为的适用）的规定，本条应适用于本条对该缔约方生效日以后提交的所有上市申请。

⁴⁸Annex 18-D applies to this paragraph.

⁴⁸附件18-D适用于本款。

3.　For greater certainty, in implementing the obligations of this Article, each Party may provide for conditions and limitations, provided that the Party continues to give effect to this Article.

　　3．为进一步明确，在实施本条义务时，只要继续使本条的规定生效，每一缔约方可规定一些条件和限制。

4.　With the objective of avoiding unreasonable curtailment of the effective patent term, a Party may adopt or maintain procedures that expedite the processing of marketing approval applications.

　　4．为避免专利有效保护期的不合理缩短，缔约方可采取或维持加速处理上市许可申请的程序。

Article 18.49: Regulatory Review Exception

第18.49条：监管审查例外

Without prejudice to the scope of, and consistent with, Article 18.40 (Exceptions), each Party shall adopt or maintain a regulatory review exception⁴⁹ for pharmaceutical products.

　　在不损害第18.40条（例外）的范围并与该条相一致的情况下，每一缔约方应对药品采取或维持监管审查例外⁴⁹。

⁴⁹For greater certainty, consistent with Article 18.40 (Exceptions), nothing prevents a Party from providing that regulatory review exceptions apply for purposes of regulatory reviews in that Party, in another country or both.

⁴⁹为进一步明确，以与第18.40条（例外）相一致的情况下，缔约方有权规定，监管审查的例外适用于其本国的监管审查，或适用于其他国家的监管审查，或均适用。

Article 18.50: Protection of Undisclosed Test or Other Data⁵⁰

第18.50条：保护未披露试验或其他数据⁵⁰

⁵⁰Annex 18-B and Annex 18-C apply to paragraphs 1 and 2 of this Article.

⁵⁰附件18-B和18-C适用于本条第1款和第2款。

1.

(a) If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product,⁵¹ that Party shall not permit third persons, without the consent of the person that previously submitted such information, to market the same or a similar⁵² product on the basis of:

　　1．（a）作为授予某一新药上市许可的条件，如一缔约方要求提交关于产品安全性和有效性未披露试验或其他数据⁵¹，则自该新药在该缔约方领土内获得上市许可之日起至少5年内⁵²，该缔约方不得批准第三人未经先前提交此类信息的人的同意而上市销售相同或相似⁵³产品：

⁵¹Each Party confirms that the obligations of this Article, and Article 18.51 (Biologics) apply to cases in which the Party requires the submission of undisclosed test or other data concerning: (a) only the safety of the product, (b) only the efficacy of the product or (c) both.

⁵¹每一缔约方确认，本条和第18.51条（生物制剂）的义务适用于缔约方要求提交下列未披露试验或其他数据的情况：（a）仅涉及产品的安全性，（b）仅涉及产品的有效性，或（c）同时涉及两者。

⁵²For greater certainty, for the purposes of this Section, a pharmaceutical product is “similar” to a previously approved pharmaceutical product if the marketing approval, or, in the alternative, the applicant’s request for such approval, of that similar pharmaceutical product is based upon the undisclosed test or other data concerning the safety and efficacy of the previously approved pharmaceutical product, or the prior approval of that previously approved product.

⁵³为进一步明确，就本节而言，如一药品的上市许可或者申请人的许可申请是基于已获批上市产品安全性和有效性的未披露试验或其他数据，或是基于已获批上市产品的在先许可，则该药品与已获批药品“相似”。

(i) that information; or

　　（i）该信息；或

(ii) the marketing approval granted to the person that submitted such information,

　　（ii）授予此类信息提交人的上市许可。

for at least five years⁵³ from the date of marketing approval of the new pharmaceutical product in the territory of the Party.

⁵³For greater certainty, a Party may limit the period of protection under paragraph 1 to five years, and the period of protection under Article 18.51.1(a) (Biologics) to eight years.

⁵²为进一步明确，缔约方可将第1款的保护期限定为5年，将第18.51条第1款（a）项（生物制剂）下的保护期限定为8年。

(b) If a Party permits, as a condition of granting marketing approval for a new pharmaceutical product, the submission of evidence of prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of a person that previously submitted such information concerning the safety and efficacy of the product, to market a same or a similar product based on evidence relating to prior marketing approval in the other territory for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of that Party.⁵⁴

　　（b）作为批准该新药上市许可的条件，如一缔约方允许提交药品在其他领土已获得上市许可的证据，则自该新药在该缔约方领土内获得上市许可之日起至少5年内，该缔约方不得批准第三方未经先前提交关于该产品安全性和有效性的信息的人的同意基于与其他领土先前上市许可相关的证据的而上市销售相同或相似产品。⁵⁴

⁵⁴Annex 18-D applies to this subparagraph.

⁵⁴附件18-D适用于本项。

2.　Each Party shall:⁵⁵

　　2．每一缔约方应：⁵⁵

⁵⁵A Party that provides a period of at least eight years of protection pursuant to paragraph 1 is not required to apply paragraph 2.

⁵⁵根据第1款提供至少8年保护期的缔约方不需要适用第2款。

(a) apply paragraph 1, mutatis mutandis, for a period of at least three years with respect to new clinical information submitted as required in support of a marketing approval of a previously approved pharmaceutical product covering a new indication, new formulation or new method of administration; or, alternatively,

　　（a）对于为支持已获批药品的新效用、新配方或新给药方法的上市许可而提交的新的临床信息，比照第1款适用至少3年的期限；或，作为替代，

(b) apply paragraph 1, mutatis mutandis, for a period of at least five years to new pharmaceutical products that contain⁵⁶ a chemical entity that has not been previously approved in that Party.⁵⁷

　　（b） 对于含有⁵⁶未获该缔约方获批的化学成分的新药，比照第1款适用至少5年的期限。⁵⁷

⁵⁶For the purposes of this Article, a Party may treat “contain” as meaning utilise.

⁵⁶就本条而言，缔约方可将“包含”理解为使用。

⁵⁷For the purposes of Article 18.50.2(b) (Protection of Undisclosed Test or Other Data), a Party may choose to protect only the undisclosed test or other data concerning the safety and efficacy relating to the chemical entity that has not been previously approved.

⁵⁷就第18.50条第2款（b）项（保护未披露试验或其他数据）而言，缔约方可仅保护有关未获批上市的化学成分的安全性和有效性的未披露的试验或其他数据。

3.　Notwithstanding paragraphs 1 and 2 and Article 18.51 (Biologics), a Party may take measures to protect public health in accordance with:

　　3．尽管有上述第1款、第2款和第18.51条（生物制剂），但是一缔约方仍可根据下列各项采取措施保护公共健康：

(a) the Declaration on TRIPS and Public Health;

　　（a）TRIPS协定与公共健康宣言；

(b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration on TRIPS and Public Health and that is in force between the Parties; or

　　（b）WTO成员为执行TRIPS协定与公共健康宣言依据WTO协定作出的任何条款的任何豁免且该豁免缔约方之间生效；或

(c) any amendment of the TRIPS Agreement to implement the Declaration on TRIPS and Public Health that enters into force with respect to the Parties.

　　（c）对缔约方生效的、为执行TRIPS协定与公共健康宣言而对TRIPS协定所作的任何修正。

Article 18.51: Biologics⁵⁸

第18.51条：生物制剂⁵⁸

⁵⁸Annex 18-B, Annex 18-C and Annex 18-D apply to this Article.

⁵⁸附件18-B、附件18-C和附件18-D适用于本条。

1.　With regard to protecting new biologics, a Party shall either:

　　1．对于保护新的生物制剂，缔约方应：

(a) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic,^59,60 provide effective market protection through the implementation of Article 18.50.1 (Protection of Undisclosed Test or Other Data) and Article 18.50.3, mutatis mutandis, for a period of at least eight years from the date of first marketing approval of that product in that Party; or, alternatively,

　　（a）对于属于或含有生物成分的新药在一缔约方领土内的首次上市许可，^59,60通过比照适用第18.50条第1款（保护未披露试验或其他数据）和第18.50条第3款提供自在该缔约方内首次上市许可之日起至少8年的有效的市场保护；或，作为替代

⁵⁹Nothing requires a Party to extend the protection of this paragraph to:

(a) any second or subsequent marketing approval of such a pharmaceutical product; or

(b) a pharmaceutical product that is or contains a previously approved biologic.

⁵⁹缔约方无需将本款的保护缔约方延伸至：

　　（a）该药品的第二次或后续的上市许可；或

　　（b）属于或包含已获批准的生物成分的药品。

⁶⁰Each Party may provide that an applicant may request approval of a pharmaceutical product that is or contains a biologic under the procedures set forth in Article 18.50.1(a) (Protection of Undisclosed Test or Other Data) and Article 18.50.1(b) within five years of the date of entry into force of this Agreement for that Party, provided that other pharmaceutical products in the same class of products have been approved by that Party under the procedures set forth in Article 18.50.1(a) and Article 18.50.1(b) before the date of entry into force of this Agreement for that Party.

⁶⁰每一缔约方可规定，自本协定对该缔约方生效后5年内，申请人可根据第18.50条第1款（a）项（保护未披露试验或其他数据）及第18.50条第1款（b）项规定的程序，申请对属于生物制剂或含有生物成分的药品的许可，只要在本协定对该缔约方生效前同种类的其他药品已经根据第18.50条第1款（a）项及第18.50条第1款（b）项规定的程序获得该缔约方的批准。

(b) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:

　　（b）对于属于或含有生物成分的新药在缔约方的首次上市许可通过下列方式提供有效的市场保护以在市场上达到可比的效果：

(i) through the implementation of Article 18.50.1 (Protection of Undisclosed Test or Other Data) and Article 18.50.3, mutatis mutandis, for a period of at least five years from the date of first marketing approval of that product in that Party,

　　（i）通过比照适用第18.50条第1款（保护未披露试验或其他数据）和第18.50条第3款，自该产品在该缔约方获得首次上市许可之日起提供至少5年的保护期；

(ii) through other measures, and

　　（ii）通过其他措施；以及

(iii) recognising that market circumstances also contribute to effective market protection

　　（iii）认识到市场状况也有助于有效的市场保护。

to deliver a comparable outcome in the market.

2.　For the purposes of this Section, each Party shall apply this Article to, at a minimum, a product that is, or, alternatively, contains, a protein produced using biotechnology processes, for use in human beings for the prevention, treatment, or cure of a disease or condition.

　　2．就本节而言，每一缔约方应至少将本条适用于属于或含有以生物方法生产的蛋白质的用于人类预防、治疗或治愈疾病或症状的产品。

3.　Recognising that international and domestic regulation of new pharmaceutical products that are or contain a biologic is in a formative stage and that market circumstances may evolve over time, the Parties shall consult after 10 years from the date of entry into force of this Agreement, or as otherwise decided by the Commission, to review the period of exclusivity provided in paragraph 1 and the scope of application provided in paragraph 2, with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.

　　3．认识到对属于或含有生物成分的新药的国际和国内规范尚处于形成阶段，且市场情况可能会不断变化，缔约方应在本协定生效之日起10年后进行协商，或由自贸协定委员会决定，对第1款规定的专有权的期限和第2款规定的适用范围进行审议，以有效激励属于或包含生物成分的新药的开发，促进后续的生物仿制药的及时获得，并保证其适用范围与属于或包含生物成分的新增种类的新药的许可的国际发展保持一致。

Article 18.52: Definition of New Pharmaceutical Product

第18.52条：新药品的定义

For the purposes of Article 18.50.1 (Protection of Undisclosed Test or Other Data), a new pharmaceutical product means a pharmaceutical product that does not contain⁶¹ a chemical entity that has been previously approved in that Party.

　　就第18.50条第1款（保护未披露试验或其他数据）而言，新药品指不包含⁶¹此前已在该缔约方获得上市许可的化学成分的药品。

⁶¹For the purposes of this Article, a Party may treat “contain” as meaning utilise.

⁶¹就本条而言，一缔约方可将“包含”理解为“使用”。

Article 18.53: Measures Relating to the Marketing of Certain Pharmaceutical Products

第18.53条：与部分药品上市销售有关的措施

1.　If a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by the Party or in another territory, that Party shall provide:

　　1．作为批准药品上市销售的条件，如一缔约方允许最初提交涉及药品安全性和有效性信息的人之外的人依赖已获批药品的安全性和有效性的证据或信息，例如在该缔约方或其他领土获得的在先上市许可的证据，则该缔约方应提供：

(a) a system to provide notice to a patent holder⁶² or to allow for a patent holder to be notified prior to the marketing of such a pharmaceutical product, that such other person is seeking to market that product during the term of an applicable patent claiming the approved product or its approved method of use;

　　（a）一项制度，在该药品上市销售前通知专利持有人⁶²或允许专利持有人获得通知，在其获批产品或方法专利的保护期间内，一申请人正寻求上市销售该药品的；

⁶²For greater certainty, for the purposes of this Article, a Party may provide that a “patent holder” includes a patent licensee or the authorised holder of marketing approval.

⁶²为进一步明确，就本条而言，一缔约方可规定“专利持有人”包括专利被许可人或上市许可的授权持有人。

(b) adequate time and opportunity for such a patent holder to seek, prior to the marketing⁶³ of an allegedly infringing product, available remedies in subparagraph (c); and

　　（b）充足的时间和机会，以便专利持有人在涉嫌侵权的产品上市销售⁶³ 之前能够寻求（c）项所规定的救济；及

⁶³For the purposes of paragraph 1(b), a Party may treat “marketing” as commencing at the time of listing for purposes of the reimbursement of pharmaceutical products pursuant to a national healthcare programme operated by a Party and inscribed in the Appendix to Annex 26-A (Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices).

⁶³就第1款（b）项而言，一缔约方可将“上市”理解为自被列入缔约方国家医疗项目药品报销清单和被写入附件26-A（关于药品和医疗设备的透明度和程序公平）的附录之日起。

(c) procedures, such as judicial or administrative proceedings, and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.

　　（c）司法或行政程序等程序以及临时禁令或等同有效的临时措施等快速救济，以便及时解决关于已获批药品或其获批使用方法的专利的有效性或侵权的纠纷。

2.　As an alternative to paragraph 1, a Party shall instead adopt or maintain a system other than judicial proceedings that precludes, based upon patent-related information submitted to the marketing approval authority by a patent holder or the applicant for marketing approval, or based on direct coordination between the marketing approval authority and the patent office, the issuance of marketing approval to any third person seeking to market a pharmaceutical product subject to a patent claiming that product, unless by consent or acquiescence of the patent holder.

　　2．作为第1款的替代，缔约方应采用或维持一非司法程序之外的制度。在该制度下，除非经专利持有人的同意或默许，不得基于专利持有人或上市许可人向上市许可审批机关提交的与专利相关的信息，或基于上市许可审批机关与专利局之间的直接协调，向寻求上市销售该专利药品的任何第三方发放上市许可。

Article 18.54: Alteration of Period of Protection

第18.54条：保护期限的变更

Subject to Article 18.50.3 (Protection of Undisclosed Test or Other Data), if a product is subject to a system of marketing approval in the territory of a Party pursuant to Article 18.47 (Protection of Undisclosed Test or Other Data for Agricultural Chemical Products), Article 18.50 or Article 18.51 (Biologics) and is also covered by a patent in the territory of that Party, the Party shall not alter the period of protection that it provides pursuant to Article 18.47, Article 18.50 or Article 18.51 in the event that the patent protection terminates on a date earlier than the end of the period of protection specified in Article 18.47, Article 18.50 or Article 18.51.

　　在遵守第18.50条第3款（保护未披露试验或其他数据）的前提下，如一产品根据第18.47条（对农业化学品的未披露试验或其他数据的保护）、第18.50条或第18.51条（生物制剂）在一缔约方领土受到上市许可制度的规制，且同时受到该缔约方领土内的专利保护，则在该专利权保护期限比第18.47条、第18.50条或第18.51条所规定的保护期限先行届满的情况下，该缔约方不得变更其依据第18.47条、第18.50条或第18.51条规定的保护期。