Measures for Compulsory Licensing of Patent Implementation 2012

COPYRIGHT TRANSLATION IP DRAGON 2012

Measures for Compulsory Licensing of Patent Implementation 

No.64

The Measures for Compulsory Licensing of Patent Implementation has passed the review of the directorate meeting, which are hereby promulgated and will come into force on as of May 1 st, 2012.

Director General: Tian Lipu

March 15, 2012

国家知识产权局令

第 六十四 号

《专利实施强制许可办法》已经局务会议审议通过,现予公布,自2012年5

 

 

 

月1日起施行。

局 长 田力普

二○一二年三月十五日

Measures for Compulsory Licensing of Patent Implementation

专利实施强制许可办法

Chapter I General Provisions

第一章

总则

Article 1 In order to standardize implementing the granting, expenses determination and termination procedures for compulsory licensing of invention patent or patent of utility models (hereinafter referred to as the compulsory licensing), the Measures are hereby formulated in accordance with the Patent Law of the PRC (hereinafter referred to as the Patent Law), the Implementation Rules of the Patent Law of the PRC (hereinafter referred to as the Implementation Rules of the Patent Law) and the relevant laws and regulations.

第一条 为了规范实施发明专利或者实用新型专利的强制许可(以下简称强制许可)的给予、费用裁决和终止程序,根据《中华人民共和国专利法》(以下简称专利法)、《中华人民共和国专利法实施细则》及有关法律法规,制定本办法。

 

Article 2 The State Intellectual Property Office is in charge of the acceptance and reviewing as well as makes decision on petitions for compulsory licensing, the adjudication of the use fees of compulsory licensing and termination of the compulsory licensing.

第二条 国家知识产权局负责受理和审查强制许可请求、强制许可使用费裁决请 求和终止强制许可请求并作出决定。

 

Article 3 The petitions for granting compulsory licensing, for adjudication of the use fees of compulsory licensing and for termination of compulsory licensing shall be handled with in Chinese in a written form.  Where any certificate and certified document submitted in compliance with the measures are in foreign languages,and where The State Intellectual Property Office deems it necessary, it may request a Chinese translation of the certificate and the certified document to be submitted within a specified time limit; where the translation is not submitted within the specified time limit, the certificate and certified document shall be deemed not to have been submitted.

第三条 请求给予强制许可、请求裁决强制许可使用费和请求终止强制许可, 应当使用中文以书面形式办理。依照本办法提交的各种证件、证明文件是外文的,国家知识产权局认为必要时,  可以要求当事人在指定期限内附送中文译文;期满未附送的,视为未提交该证件、证明文件。

 

Article 4 When a foreigner, a foreign enterprise or any other organization in a foreign country having no habitual residence or business offices in China handles compulsory licensing affairs, he or it shall authorize a patent agency established in accordance with the law with such affairs. When a party concerned authorizes a patent agency to handle compulsory licensing affairs, the party shall provide the power of attorney and the authority indicated. If one side consists of no less than two parties concerned without authorized a patent agency, the first party concerned as indicated in the written documents submitted shall be deemed as the representative, unless otherwise stated.

第四条 在中国没有经常居所或者营业所的外国人、外国企业或者外国其他组织 办理强制许可事务的,应当委托依法设立的专利代理机构办理。当事人委托专利代理机构办理强制许可事务的,应当提交委托书,写明委托权 限。一方当事人有两个以上且未委托专利代理机构的,除另有声明外,以提交的书 面文件中指明的第一当事人为该方代表人。

Chapter 2: Submission and Acceptance of Petitions for Compulsory Licensing

第二章 强制许可请求的提出与受理

 

Article 5 When a patent right holder does not implement or does not fully implement its patent without legitimate grounds within three years from the date on which the patent is granted and within four years from the date on which the patent application is submitted, the unit or individual meeting the implementation conditions may petition for the granting compulsory licensing in accordance with the provision of Item (1) of Article 48 of the Patent Law.  When the patent right holder’s exercising the patent is determined as the monopoly behavior in accordance with the law, the unit or individual meeting the implementation conditions may petition for the granting compulsory licensing in accordance with the provision of Item (2) of Article 48 of the Patent Law for the purpose of eliminating or reducing the adverse impact of the monopoly behavior on competition.

第五条 专利权人自专利权被授予之日起满3年,且自提出专利申请之日起满4年,无正当理由未实施或者未充分实施其专利的,具备实施条件的单位或者个人可以根 据专利法第四十八条第一项的规定,请求给予强制许可。专利权人行使专利权的行为被依法认定为垄断行为的,为消除或者减少该行为 对竞争产生的不利影响,具备实施条件的单位或者个人可以根据专利法第四十八条 第二项的规定,请求给予强制许可。

 

Article 6 In emergency or irregular event of the state,or for the purposes of public interest,the relevant competent department of the State Council may recommend the State Intellectual Property Office to grant the compulsory licensing of patent implementation to their designated units that meet the implementation conditions in accordance with the provision of Article 49 of the Patent Law.

第六条 在国家出现紧急状态或者非常情况时,或者为了公共利益的目的,国务院有关主管部门可以根据专利法第四十九条的规定,建议国家知识产权局给予其指 定的具备实施条件的单位强制许可。

Article 7 For the purpose of protecting public health, a unit meeting the implementation conditions may, in accordance with the provision of Article 50 of the Patent Law, petition for grant of compulsory licensing for manufacturing the patented drugs and exporting such drugs to the following countries or regions:

(1) The least developed countries or regions; and

(2) The developed members or developing members of the World Trade Organization that inform the World Trade Organization of their intention to be the importers in accordance with the relevant international treaties.

第七条 为了公共健康目的,具备实施条件的单位可以根据专利法第五十条的规 定,请求给予制造取得专利权的药品并将其出口到下列国家或者地区的强制许可:

(一)最不发达国家或者地区;

(二)依照有关国际条约通知世界贸易组织表明希望作为进口方的该组织的发 达成员或者发展中成员。

 

Article 8 In case an invention or utility model obtaining patent is of material technological advancement in obvious economic significance as compared with the previous one that has obtained patent and its implementation depends on the implementation of the previous invention or utility model, the patent holder thereof may according to the provision of Article 51 of the Patent Law petition for granting the compulsory licensing in implementing the former patent, and vice versa.

第八条 一项取得专利权的发明或者实用新型比前已经取得专利权的发明或者实 用新型具有显著经济意义的重大技术进 步,其实施又有赖于前一发明或者实用新 型的实施的,该专利权人可以根据专利法第五十一条的规定请求给予实施前一专利 的强制许可。国家知识产权局给予实施前一专利的强制许可的,前一专利权人也可 以请求给予实施后一专利的强制许可。

 

Article 9 When petitioning for grant of compulsory licensing,the petition for compulsory licensing should be submitted to the State Intellectual Property Office, indicating the following items:

(1)Name and address of the petitioner;

(2)Nationality of the petitioner or the country/area where the petitioner registries;

(3)The name,patent number,date of application and date of authorized announcement of the invention patent or patent of utility models relating to the petitioned compulsory licensing;Name of the right holders of the invention patent or patent of utility models relating to the petitioned compulsory licensing;

(4) Reasons, facts and terms for petitioning for granting the compulsory licensing;

(5) When authorizing a patent agency, the petitioner shall indicate the name, code of the authorized patent agency as well as the name, the agent code and contact telephone of the agent assigned by the patent agency should be indicated;

(6) The signature or stamp of the petitioner;and if there is an authorized agency,the stamp of the agency is required also;

(7) List of the attached documents;

(8) Other items required to state.

The petition and attached documents should be executed in two copies.

第九条 请求给予强制许可的,应当提交强制许可请求书,写明下列各项:

(一)请求人的姓名或者名称、地址、邮政编码、联系人及电话;

(二)请求人的国籍或者注册的国家或者地区;

(三)请求给予强制许可的发明专利或者实用新型专利的名称、专利号、申请 日、授权公告日,以及专利权人的姓名或者名称;

(四)请求给予强制许可的理由和事实、期限;

(五)请求人委托专利代理机构的,受托机构的名称、机构代码以及该机构指  定的代理人的姓名、执业证号码、联系电话;

(六)请求人的签字或者盖章;委托专利代理机构的,还应当有该机构的盖章;

(七)附加文件清单;

(八)其他需要注明的事项。

请求书及其附加文件应当一式两份。

 

Article 10 In case a petition for compulsory licensing involves two or more patent right holders,the copy number of the petition and attached documents should be the number of patent right holders.

第十条 强制许可请求涉及两个或者两个以上的专利权人的,请求人应当按专利 权人的数量提交请求书及其附加文件副本。

 

Article 11 When the granting compulsory licensing is petitioned in accordance with the provisions of Item (1) of Article 48 or Article 51 of the Patent Law, the petitioner shall provide evidence to prove that it requests the patent right holder for implementing the patent on reasonable terms but fails to obtain the licensing within a reasonable period of time. If the granting of compulsory licensing is requested in accordance with the provision of Item (2) of Article 48 of the Patent Law, the petitioner shall submit the effective judgment or decision determining that the patent right holder’s exercising the patent as the monopoly behavior in accordance with the law. These judgment or decision is issued by the judicial authority or anti-monopoly law enforcement authority.

第十一条 根据专利法第四十八条第一项或者第五十一条的规定请求给予强制许 可的,请求人应当提供证据,证明其以合理的条件请求专利权人许可其实施专利,但未能在合理的时间内获得许可。根据专利法第四十八条第二项的规定请求给予强制许可的,请求人应当提交已 经生效的司法机关或者反垄断执法机构依法将专利权人行使专利权的行为认定为垄 断行为的判决或者决定。

 

Article 12 When the relevant competent department of the State Council recommends the grant of compulsory licensing in accordance with Article 49 of the Patent Law, it shall specify the following items:

(1) The grant of compulsory licensing is required when the country is in a state of emergency or extraordinary situation or for the purpose of safeguarding public interest;

(2) The name, patent number, application date, grant announcement date and the name of the patent right holder of the invention patent or utility model patent of which the granting of compulsory licensing is recommended;

(3) The term of compulsory licensing recommended to be granted;

(4) The name, address, postal code, contact person and telephone number of the designated unit that meets the implementation conditions; and

(5) Other items required to state.

第十二条 国务院有关主管部门根据专利法第四十九条建议给予强制许可的,应 当指明下列各项:

(一)国家出现紧急状态或者非常情况,或者为了公共利益目的需要给予强制许 可;

(二)建议给予强制许可的发明专利或者实用新型专利的名称、专利号、申请日、 授权公告日,以及专利权人的姓名或者名称;

(三)建议给予强制许可的期限;

(四)指定的具备实施条件的单位名称、地址、邮政编码、联系人及电话;

(五)其他需要注明的事项。

 

Article 13 When the petition for granting compulsory licensing is made in accordance with the provision of the Article 50 of the Patent Law, the petitioner shall provide the relevant information about the importer and the drugs that the importer needs and the granting of compulsory licensing.

第十三条 根据专利法第五十条的规定请求给予强制许可的,请求人应当提供进 口方及其所需药品和给予强制许可的有关信息。

Article 14 In any of the following cases relating to the compulsory licensing,the State Intellectual Property Office will not accept the petition with notification to the petitioner:

(1) The patent number of the invention patent or patent of utility models which are petitioned for compulsory licensing is not clear or is hard to identify;

(2) The petitioning documents without Chinese version;

(3) Obviously no reason available for petitioning compulsory licensing; or

(4) The patent which is petitioned for granting compulsory licensing has been terminated or has been declared invalid.

第十四条 强制许可请求有下列情形之一的,不予受理并通知请求人:

(一) 请求给予强制许可的发明专利或者实用新型专利的专利号不明确或者难以 确定;

(二)请求文件未使用中文;

(三)明显不具备请求强制许可的理由;

(四)请求给予强制许可的专利权已经终止或者被宣告无效。

 

Article 15 In case the petitioning documents do not meet the provisions of Articles 4, Article9 and Article10 of the Measures, the petitioner shall within 15 days upon receipt of the notice make up for the documents. In case of failure to making up for the documents required, the petition will be deemed as no submission.

第十五条 请求文件不符合本办法第四条、第九条、第十条规定的,请求人应当 自收到通知之日起15日内进行补正。期满未补正的,该请求视为未提出。

 

Article 16 The State Intellectual Property Office shall send the copy of the petition to the patent right holder when it accepts the petitions for granting compulsory licensing. Unless otherwise specified, the patent right holder may state its opinions within 15 days upon the receipt of the notice. In case of no reply beyond the time schedule, the State Intellectual Property Office may make a decision as usual.

第十六条 国家知识产权局受理强制许可请求的,应当及时将请求书副本送交专 利权人。除另有指定的外,专利权人应当自收到通知之日起15日内陈述意见;期 满未答复的,不影响国家知识产权局作出决定。

 

Chapter 3: Review and Decisions of Petitions for Compulsory Licensing

第三章 强制许可请求的审查和决定

 

Article 17 The State Intellectual Property Office shall review the reasons stated, the information provided and the relevant certification documents submitted by the petitioner and the opinions stated by the patent right holder. In case of field verification required, the State Intellectual Property Office shall assign no less than two staff members to conduct the field verification.

第十七条 国家知识产权局应当对请求人陈述的理由、提供的信息和提交的有关证 明文件以 及专利权人陈述的意见进行审查;需要实地核查的,应当指派两名以上工作 人员实地核查。

Article 18 In case the petitioner or the patent right holders request for hearing, the State Intellectual Property Office may organize a hearing. The State Intellectual Property Office shall seven days before the hearing send notification to the petitioner, patent right holders and other persons of interest. Except for involvement of state secrets, commercial secrets or personal privacy,the hearing should be held in open session. The hearing should be recorded in writing, which should be singed or stamped upon confirmation without error by the participants. The hearing procedure is not applicable to the petitions for grant of compulsory licensing according to the provisions of Article 49 or Article 50 of the Patent Law.

第十八条 请求人或者专利权人要求听证的,由国家知识产权局组织听证。国家知识产权局应当在举行听证 7 日前通知请求人、专利权人和其他利害关系人。除涉及国家秘密、商业秘密或者个人隐私外,听证公开进行。举行听证时,请求人、专利权人和其他利害关系人可以进行申辩和质证。举行听证时应当制作听证笔录,交听证参加人员确认无误后签字或者盖章。根据专利法第四十九条或者第五十条的规定建议或者请求给予强制许可的,不适用 听证程序。

 

Article 19 The petitioner may withdraw its request before the State Intellectual Property Office makes the decision, while the procedure for reviewing the petition for compulsory licensing shall be terminated. In case of reaching a licensing contract on patent implementation by and between the petitioner and the patent right holder prior to the decision by the State Intellectual Property Office, timely notice should be given to the State Intellectual Property Office and the petition for compulsory licensing should be withdrawn directly.

第十九条 请求人在国家知识产权局作出决定前撤回其请求的,强制许可请求的审查 程序终止。 在国家知识产权局作出决定前,请求人与专利权人订立了专利实施许可 合同的,应当及时通知国家知识产权局,并撤回其强制许可请求。

 

Article 20 Where, upon examination, the petition for compulsory licensing is related to any of the following cases, the State Intellectual Property Office shall make a decision on rejecting the petition for compulsory licensing.

(1) The petitioner does not comply with the provisions of Article 4, Article 5, Article 7 or Article 8 of these Measures;

(2) The reasons for petitioning for granting the compulsory licensing are not in compliance with the provisions of Articles 48, 50 and 51 of the Patent Law;

(3) The reasons are not in compliance with the provision of Article 52 of the Implementation Rules of the Patent Law when the petition for compulsory licensing involves the invention and creation of semiconductor technologies.

(4) The reasons are not in compliance with the provision of Article 11 or Article 13 of these Measures; or

(5) The reasons stated, the information provided or the relevant certification documents submitted by the petitioner are insufficient or false. The State Intellectual Property Office may prior to the refusal to the petition of compulsory licensing send the petitioner a notification that it intends to make a refusal decision and the reasons for it. Unless otherwise specified, the petitioner may state its opinions within 15 days upon the receipt of the notice.

第二十条 经审查认为强制许可请求有下列情形之一的,国家知识产权局应当作出驳 回强制许可请求的决定:

(一)请求人不符合本办法第四条、第五条、第七条或者第八条的规定;

(二)请求给予强制许可的理由不符合专利法第四十八条、第五十条或者第五十一条 的规定;

(三)强制许可请求涉及的发明创造是半导体技术的,其理由不符合专利法第五十二条 的规定;

(四)强制许可请求不符合本办法第十一条或者第十三条的规定;

(五)请求人陈述的理由、提供的信息或者提交的有关证明文件不充分或者不真实。国家知识产权局在作出驳回强制许可请求的决定前,应当通知请求人拟作出的决定 及其理由。除另有指定的外,请求人可以自收到通知之日起 15 日内陈述意见。

 

Article 21 Where, upon examination the reasons for petitioning the grant of the compulsory licensing is tenable, the State Intellectual Property Office shall make a decision on granting compulsory licensing. The State Intellectual Property Office may prior to granting compulsory licensing send the petitioner and the patent right holder a notification that it intends to grant compulsory licensing and the reasons for it. Unless otherwise specified, the petitioner and the patent right holder may state its opinions within 15 days upon the receipt of the notice. Before the State Intellectual Property Office makes a decision of granting compulsory licensing according to the provisions of Article 49 of the Patent Law, it shall send the patent right holder a notification that it intends to grant compulsory licensing and the reasons for it.

第二十一条 经审查认为请求给予强制许可的理由成立的,国家知识产权局应当 作出给予强制许可的决定。在作出给予强制许可的决定前,应当通知请求人和专利 权人拟作出的决定及其理由。除另有指定的外,双方当事人可以自收到通知之日起 15日内陈述意见。国家知识产权局根据专利法第四十九条作出给予强制许可的决定前,应当通知 专利权人拟作出的决定及其理由。

 

Article 22 The decision on granting compulsory licensing shall state the following items:

(1)Name and address of the individual or unit obtaining the compulsory licensing for patent implementation;

(2)The name, patent number, date of application and date of authorized announcement of the invention patent or patent of utility models relating to the petitioned compulsory licensing;

(3)Scope and term of the compulsory licensing granted;

(4)Reasons, facts and legal basis for the decisions;

(5)The stamp of the State Intellectual Property Office and the signature of the responsible persons;

(6)Date of decisions; and

(7)Other relevant matters.

The decision on granting the compulsory licensing should be notified to the petitioner and the patent right holder within 5 days upon making the decision.

第二十二条 给予强制许可的决定应当写明下列各项:

(一)取得强制许可的单位或者个人的名称或者姓名、地址;

(二)被给予强制许可的发明专利或者实用新型专利的名称、专利号、申请日 及授权公告日;

(三)给予强制许可的范围和期限;

(四)决定的理由、事实和法律依据;

(五)国家知识产权局的印章及负责人签字;

(六)决定的日期;

(七)其他有关事项。

给予强制许可的决定应当自作出之日起5日内通知请求人和专利权人。

 

Article 23 The State Intellectual Property Office makes a decision of granting compulsory licensing according to the provisions of Article 50 of the Patent Law, with the following items stated

(1) The quantity of the drugs manufactured under compulsory licensing shall not exceed the quantity required by the importer and all of the drugs shall be exported to the importer;

(2) The drugs manufactured under compulsory licensing shall use specific labels or tags to state clearly that the drugs are manufactured under compulsory licensing. Where feasible and provided that the price of the drugs will not be significantly affected, the drugs shall be in a special color or shape or packaged in a special way; and

(3) Before the drugs are packed and shipped, the entity that has obtained the compulsory licensing shall publish the information such as the quantity of the drugs shipped to the importer and the identification features of the drugs specified in Item (2) of this Article, on its website or the relevant website of World Trade Organization.

第二十三条 国家知识产权局根据专利法第五十条作出给予强制许可的决定的,还应当在该决定中明确下列要求:

(一)依据强制许可制造的药品数量不得超过进口方所需的数量,并且必须全 部出口到该进口方;

(二)依据强制许可制造的药品应当采用特定的标签或者标记明确注明该药品 是依据强制许可而制造的;在可行并且不会对药品价格产生显著影响的情况下,应 当对药品本身采用特殊的颜色或者形状,或者对药品采用特殊的包装;

(三)药品装运前,取得强制许可的单位应当在其网站或者世界贸易组织的有 关网站上发布运往进口方的药品数量以及本条第二项所述的药品识别特征等信息。

 

Article 24 Where, after the State Intellectual Property Office makes a decision of granting compulsory licensing according to the provisions of Article 50 of the Patent Law, the relevant competent department of the State Council shall inform the World Trade Organization of the following information:

(1) The name and address of the entity obtaining compulsory licensing;

(2) The name and quantity of the exported drugs;

(3) The importer;

(4) The term of the compulsory licensing; and

(5) The website specified in Item (3) of Article 23 of these Measures

第二十四条 国家知识产权局根据专利法第五十条作出给予强制许可的决定的,由国务院有关主管部门将下列信息通报世界贸易组织:

(一)取得强制许可的单位的名称和地址;

(二)出口药品的名称和数量;

(三)进口方;

(四)强制许可的期限;

(五)本办法第二十三条第三项所述网址。

 

Chapter IV Review and Finding of the Petitions for Adjudication of the Use Fees of the Compulsory Licensing

第四章 强制许可使用费裁决请求的审查和裁决

Article 25 In case of petitioning for determining the use fees of the compulsory licensing, an application should be submitted for adjudication of the use fees of the compulsory licensing, indicating the following items:

(1) Name and address of the petitioner;

(2) Nationality of the petitioner or the country/area where the petitioner registries;

(3) Document number that making the decisions on granting the compulsory licensing;

(4) Name and address of the petitioned;

(5) Reasons for petition of the adjudication of the use fees of the compulsory licensing;

(6) When authorizing a patent agency, the petitioner shall indicate the name, code of the authorized patent agency as well as the name, the agent code and contact telephone of the agent assigned by the patent agency should be indicated;

(7) The signature or stamp of the petitioner; and if there is an authorized agency, the stamp of the agency is required also;

(8)List of the attached documents;

(9)Other items required to state.

The petition and attached documents should be executed in two copies.

第二十五条 请求裁决强制许可使用费的,应当提交强制许可使用费裁决请求书,写明下列各项:

(一)请求人的姓名或者名称、地址;

(二)请求人的国籍或者注册的国家或者地区;

(三)给予强制许可的决定的文号;

(四)被请求人的姓名或者名称、地址;

(五)请求裁决强制许可使用费的理由;

(六)请求人委托专利代理机构的,受托机构的名称、机构代码以及该机构指 定的代理人的姓名、执业证号码、联系电话;

(七)请求人的签字或者盖章;委托专利代理机构的,还应当有该机构的盖章;

(八)附加文件清单;

(九)其他需要注明的事项。

请求书及其附加文件应当一式两份。

Article 26 In any of the following cases relating to the petitions for the adjudication of the use fees of the compulsory licensing,the State Intellectual Property Office shall refuse the petitions, with notification sent to the petitioner:

(1) The decisions of granting the compulsory licensing are not made;

(2) The petitioner is not patent right holder or the entity or individual that obtains the compulsory licensing;

(3) Both parties have not conducted any negotiation or have reached an agreement upon negotiation.

第二十六条 强制许可使用费裁决请求有下列情形之一的,不予受理并通知请求人:

(一)给予强制许可的决定尚未作出;

(二)请求人不是专利权人或者取得强制许可的单位或者个人;

(三)双方尚未进行协商或者经协商已经达成协议。

Article 27 The State Intellectual Property Office shall send the copy of the petition to the counterpart when it accepts the petitions for adjudication of the use fees of the compulsory licensing. Unless otherwise specified, the counterpart may state its opinions within 15 days upon the receipt of the notice. In case of no reply beyond the time schedule,the State Intellectual Property Office may make a decision as usual.  During the adjudication of the use fees of the compulsory licensing,the parties concerned may submit written opinions. The State Intellectual Property Office may listen to the oral opinions of both parties as required by the actual circumstances of the case.

第二十七条 国家知识产权局受理强制许可使用费裁决请求的,应当及时将请求 书副本送交对方当事人。除另有指定的外,对方当事人应当自收到通知之日起15 日内陈述意见;期满未答复的,不影响国家知识产权局作出决定。强制许可使用费裁决过程中,双方当事人可以提交书面意见。国家知识产权局可以根据案情需要听取双方当事人的口头意见。

 

Article 28 In case the petitioner withdraws its petitions for adjudication prior to the decision made by the State Intellectual Property Office, the adjudication procedures terminates.

第二十八条 终止。请求人在国家知识产权局作出决定前撤回其裁决请求的,裁决程序

 

Article 29 The State Intellectual Property Office shall within 3 months upon receipt of the petition make a decision on adjudication of the use fees of the compulsory licensing.

第二十九条 国家知识产权局应当自收到请求书之日起3个月内作出强制许可使用 费的裁决决定。

Article 30 The decision on the adjudication of the use fees of the compulsory licensing shall indicate the following items:

(1) Name and address of the individual or unit obtaining the compulsory licensing for patent implementation;

(2) The name, patent number, date of application and date of authorized announcement of the invention patent or patent of utility models relating to the petitioned compulsory licensing;

(3)Reasons for the adjudication;

(4)The stamp of the State Intellectual Property Office and the signature of the responsible persons;

(5) Date of decisions;and

(6) Other relevant matters.

The decisions on adjudication of the use fees of the compulsory licensing should be notified to both parties within 5 days upon making the decision.

第三十条 强制许可使用费裁决决定应当写明下列各项:

(一)取得强制许可的单位或者个人的名称或者姓名、地址;

(二)被给予强制许可的发明专利或者实用新型专利的名称、专利号、申请日及授权公告日;

(三)裁决的内容及其理由;

(四)国家知识产权局的印章及负责人签字;

(五)决定的日期;

(六)其他有关事项。

强制许可使用费裁决决定应当自作出之日起5日内通知双方当事人。

 

Chapter V Review and Decision on Petition for Terminating the Compulsory Licensing

第五章  终止强制许可请求的审查和决定

 

Article 31 In any of the following cases, the compulsory licensing may be terminated automatically:

(1) The expiry of the valid term of the compulsory licensing specified by the decision on granting the compulsory licensing; or

(2) The invention patent or utility model patent of which compulsory licensing is granted has been terminated or has been declared invalid.

第三十一条 有下列情形之一的,强制许可自动终止:

(一)给予强制许可的决定规定的强制许可期限届满;

(二)被给予强制许可的发明专利或者实用新型专利终止或者被宣告无效。

 

Article 32 In case the reasons for compulsory licensing are eliminated without reoccurrence prior to the expiry of the valid term of the compulsory licensing specified in the decision on granting the compulsory licensing, the patent right holders may request for the State Intellectual Property Office to make a decision on terminating the compulsory licensing. In case of petitioning for terminating the compulsory licensing,an application should be submitted for terminating the compulsory licensing, indicating the following items:

(1) Name and address of the patent right holders;

(2)Nationality of the patent right holder or the country/area where the patent right holder registries;

(3) Document number that makes the decisions on the compulsory licensing requested to terminate;

(4) Reasons for petition of terminating the compulsory licensing;

(5) When authorizing a patent agency, the patent right holder shall indicate the name, code of the authorized patent agency as well as the name, the agent code and contact telephone of the agent assigned by the patent agency should be indicated;

(6) The signature or stamp of the patent right holder;and if there is an authorized agency, the stamp of the agency is required also;

(7) List of the attached documents;

(8) Other items required to state.

The patent right holder shall submit the petition application and attached documents in two copies.

第三十二条 给予强制许可的决定中规定的强制许可期限届满前,强制许可的理 由消除并不再发生的,专利权人可以请求国家知识产权局作出终止强制许可的决定。请求终止强制许可的,应当提交终止强制许可请求书,写明下列各项:

(一)专利权人的姓名或者名称、地址;

(二)专利权人的国籍或者注册的国家或者地区;

(三)请求终止的给予强制许可决定的文号;

(四)请求终止强制许可的理由和事实;

(五)专利权人委托专利代理机构的,受托机构的名称、机构代码以及该机构  指定的代理人的姓名、执业证号码、联系电话;

(六)专利权人的签字或者盖章;委托专利代理机构的,还应当有该机构的盖 章;

(七)附加文件清单;

(八)其他需要注明的事项。

请求书及其附加文件应当一式两份。

Article 33 In any of the following cases relating to the petitions for terminating the compulsory licensing, the State Intellectual Property Office may not accept the petitions,with notification sent to the petitioner:

(1)The petitioner is not the right holders of the invention patent or the patent of utility model requested under the compulsory licensing;

(2)The document number is not clear for the decision on granting the compulsory licensing requested to terminate are not clear or not published;

(3) The petitioning documents without Chinese version;or

(4) Obviously no reason available for terminating the compulsory licensing.

第三十三条 终止强制许可的请求有下列情形之一的,不予受理并通知请求人:

(一)请求人不是被给予强制许可的发明专利或者实用新型专利的专利权人;

(二)未写明请求终止的给予强制许可决定的文号;

(三)请求文件未使用中文;

(四)明显不具备终止强制许可的理由。

 

Article 34 In case the petitioning documents do not meet the provisions of Articles 32 of the Measures, the petitioner shall within 15 days upon receipt of the notice make up for the documents. In case of failure to making up for the documents required,the petition will be deemed as no submission.

第三十四条 请求文件不符合本办法第三十二条规定的,请求人应当自收到通知  之日起15日内进行补正。期满未补正的,该请求视为未提出。

Article 35 The State Intellectual Property Office shall send the copy of the petition to the  individual or unit obtaining the compulsory licensing for patent implementation when it accepts the petitions for terminating the compulsory licensing. Unless otherwise specified, the individual or unit obtaining the compulsory licensing for patent implementation may state its opinions within 15 days upon the receipt of the notice. In case of no reply beyond the time schedule, the State Intellectual Property Office may make a decision as usual. During the adjudication of the use fees of the compulsory licensing, the parties concerned may submit written opinions. The State Intellectual Property Office may listen to the oral opinions of both parties as required by the actual circumstances of the case.

第三十五条 国家知识产权局受理终止强制许可请求的,应当及时将请求书副本 送交取得强制许可的单位或者个人。除另有指定的外,取得强制许可的单位或者个 人应当自收到通知之日起15日内陈述意见;期满未答复的,不影响国家知识产权 局作出决定。

 

Article 36 The State Intellectual Property Office shall review the reasons stated by the patent right holder and the relevant certification documents, as well as the opinions stated by the individual or unit obtaining the compulsory licensing for patent implementation. In case of field verification required, the State Intellectual Property Office shall assign no less than two persons to carry out the field verification.

第三十六条 国家知识产权局应当对专利权人陈述的理由和提交的有关证明文件 以及取得强制许可的单位或者个人陈述的意见进行审查;需要实地核查的,应当指 派两名以上工作人员实地核查。

 

Article 37 In case the patent right holder withdraws its petitions prior to the decision made by the State Intellectual Property Office, the corresponding procedures terminates.

第三十七条 止。专利权人在国家知识产权局作出决定前撤回其请求的,相关程序终

 

Article 38 When holding that the reasons for petition of terminating the compulsory licensing do not hold water through review, the State Intellectual Property Office shall make a decision on rejecting the petition of terminating the compulsory licensing. The State Intellectual Property Office may prior to rejecting the petition of terminating the compulsory licensing send the patent right holder a notification that it intends to rejecting the petition of terminating compulsory licensing and the reasons for it. Unless otherwise specified, the patent right holder may state its opinions within 15 days upon the receipt of the notice.

第三十八条 经审查认为请求终止强制许可的理由不成立的,国家知识产权局应 当作出驳回终止强制许可请求的决定。在作出驳回终止强制许可请求的决定前,应 当通知专利权人拟作出的决定及其理由。除另有指定的外,专利权人可以自收到通 知之日起15日内陈述意见。

 

Article 39 Where, upon examination the reasons for petitioning of terminating the compulsory licensing is tenable, the State Intellectual Property Office shall make a decision on terminating the compulsory licensing. The State Intellectual Property Office may prior to terminating the compulsory licensing send the individual or unit obtaining the compulsory licensing for patent implementation a notification that it intends to terminate the compulsory licensing and the reasons for it. Unless otherwise specified, the individual or unit obtaining the compulsory licensing for patent implementation may state its opinions within 15 days upon the receipt of the notice. The decision on terminating compulsory licensing shall indicate the following items :

(1) Name and address of the patent right holder;

(2) Name and address of the individual or unit obtaining the compulsory licensing for patent implementation;

(3) The name, patent number, date of application and date of authorized announcement of the invention patent or patent of utility models obtaining the compulsory licensing;

(4) Document number of deciding the grant of the compulsory licensing;

(5) Facts and legal basis for the decisions;

(6) The stamp of the State Intellectual Property Office and the signature of the responsible persons;

(7) Date of decisions;and

(8) Other relevant matters.

The decision on the petition of terminating the compulsory licensing should be notified to the patent right holders and the unit or individual obtaining the compulsory implementation licensing within 5 days upon making the decision.

第三十九条 经审查认为请求终止强制许可的理由成立的,国家知识产权局应当 作出终止强制许可的决定。在作出终止强制许可的决定前,应当通知取得强制许可 的单位或者个人拟作出的决定及其理由。除另有指定的外,取得强制许可的单位或 者个人可以自收到通知之日起15日内陈述意见。终止强制许可的决定应当写明下列各项:

(一)专利权人的姓名或者名称、地址;

(二)取得强制许可的单位或者个人的名称或者姓名、地址;

(三)被给予强制许可的发明专利或者实用新型专利的名称、专利号、申请日 及授权公告日;

(四)给予强制许可的决定的文号;

(五)决定的事实和法律依据;

(六)国家知识产权局的印章及负责人签字;

(七)决定的日期;

(八)其他有关事项。

终止强制许可的决定应当自作出之日起5日内通知专利权人和取得强制许可的 单位或者个人。

 

Supplementary Provisions

附 则

 

Article 40 The decision that has come into force on granting the compulsory licensing and terminating the compulsory licensing as well as the compulsory licensing which is terminated automatically shall be registered on the patent register and published on the patent gazette.

第四十条 已经生效的给予强制许可的决定和终止强制许可的决定,以及强制许 可自动终止的,应当在专利登记簿上登记并在专利公报上公告。

 

Article 41 In case the party concerned objects to the decision on compulsory licensing by the State Intellectual Property Office, it may apply for an administrative reconsideration or initiate an administrative litigation in accordance with the law.

第四十一条 当事人对国家知识产权局关于强制许可的决定不服的,可以依法申 请行政复议或者提起行政诉讼。

 

Article 42 The interpretation of the Measures is vested with the State Intellectual Property Office.

第四十二条 本办法由国家知识产权局负责解释。

 

Article 43 The Measures shall come into force as of May 1 st , 2012. Measures for Compulsory Licensing of Patent Implementation promulgated by Order No.31 of the State Intellectual Property Office on June 13th, 2003 and the Measures on the Compulsory Licensing for Patent Implementation Involving Public Health Issues promulgated by Order No.37 of the State Intellectual Property Office on November 29th, 2005 shall be nullified simultaneously.

第四十三条 本办法自2012年5月1日起施行。2003年6月13日国家知识产权局 令第三十一号发布的《专利实施强制许可办法》和2005年11月29日国家知识产 权局令第三十七号发布的《涉及公共健康问题的专利实施强制许可办法》同时废止。

COPYRIGHT TRANSLATION IP DRAGON 2012

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