Measures on Compulsory Patent Licensing
专利实施强制许可办法
These Measures regulate the granting of, royalty rulings for, and termination procedure for, compulsory licences for invention patents and utility model patents.
(Promulgated by the State Intellectual Property Office on March 15 2012 and effective as of May 1 2012.)
(国家知识产权局于二零一二年三月十五日公布，自二零一二年五月一日起施行。)
Order of Sipo No.64
知识产权局令第64号
第一章 总 则
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。
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。
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。
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。
第二章 强制许可请求的提出与受理
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
第三章 强制许可请求的审查和决定
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。
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。
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。
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。
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。
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。
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。
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。
第四章 强制许可使用费裁决请求的审查和裁决
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。
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。
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。
第二十八条 请求人在国家知识产权局作出决定前撤回其裁决请求的，裁决程序终止。
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。
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。
第五章 终止强制许可请求的审查和决定
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。
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。
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。
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。
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。
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。
第三十七条 专利权人在国家知识产权局作出决定前撤回其请求的，相关程序终止。
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。
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。
附 则
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。
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。
第四十二条 本办法由国家知识产权局负责解释。
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。
Part One: General provisions
Article 1: These Measures have been formulated pursuant to the PRC Patent Law (Patent Law) (中华人民共和国专利法), the Implementing Rules for the PRC Patent Law (中华人民共和国专利法实施细则) and related laws and regulations in order to regulate the granting of, royalty rulings for, and termination procedure for, compulsory licences for invention patents and utility model patents (Compulsory Licences/Compulsory Licensing).
Article 2: The State Intellectual Property Office is responsible for accepting and reviewing petitions for Compulsory Licences, for royalty rulings for Compulsory Licences and for the termination of Compulsory Licences and rendering decisions thereon.
Article 3: Petitions for the granting of Compulsory Licences, for royalty rulings for Compulsory Licences and for the termination of Compulsory Licences shall be made in writing in Chinese.
If a certificate or supporting document submitted in accordance herewith is in a foreign language, the State Intellectual Property Office may, if it deems it necessary, require the concerned party to provide a Chinese translation thereof within a specified period of time. A failure to do so will be deemed a failure to provide such certificate or supporting document.
Article 4: A foreign national, foreign enterprise or other foreign organisation without a habitual residence or place of business in China wishing to carry out a Compulsory Licence matter shall appoint a lawfully established patent agency to handle the matter.
When a party appoints a patent agency to handle a Compulsory Licensing matter, such party shall submit a power of attorney expressly stating the extent of the patent agency's authority. If a party consists of two or more parties and they have not appointed a patent agency, the first party indicated in the submitted written documents shall be the representative of such party, unless otherwise stated.
Part Two: Submission and acceptance of petitions for Compulsory Licences
Article 5: If a patentee has failed, without a legitimate reason, to exploit or fully exploit its patent after the lapse of a full three years following the date of granting of the patent and a full four years following the date of filing of the patent application, an entity or individual that satisfies the criteria for exploiting the patent may petition for the granting of a Compulsory Licence pursuant to Item (1) of Article 48 of the Patent Law.
If the exercise by a patentee of its patent rights is found in accordance with the law to be a monopolistic act, an entity or individual that satisfies the criteria for exploiting the patent may petition for the granting of a Compulsory Licence pursuant to Item (2) of Article 48 of the Patent Law in order to eliminate or reduce the adverse effect that such act has on competition.
Article 6: In the case of a state emergency or exceptional circumstance, or in the public interest, a relevant competent department of the State Council may, pursuant to Article 49 of the Patent Law, propose that the State Intellectual Property Office grant a Compulsory Licence to an entity designated by it that satisfies the criteria for exploiting the patent.
Article 7: For public health reasons, an entity that satisfies the criteria for exploiting the patent may, pursuant to Article 50 of the Patent Law, petition for the granting of a Compulsory Licence to manufacture a patented pharmaceutical and export it to the following countries or regions:
(1) a least developed country or region; or
(2) pursuant to a relevant international treaty, a developed member or developing member of the World Trade Organisation that has notified such organisation that it wishes to be an importer of the pharmaceutical.
Article 8: If a patented invention or utility model represents a major technical advance, with clear economic significance, over a previously patented invention or utility model and the exploitation of the former is dependent on the exploitation of the latter, the patentee of the former patent may, pursuant to Article 51 of the Patent Law, petition for the granting of a Compulsory Licence to exploit the previous patent. If the State Intellectual Property Office grants a Compulsory Licence to exploit the previous patent, the patentee of the previous patent may also petition for the granting of a Compulsory Licence to exploit the later patent.
Article 9: To petition for the granting of a Compulsory Licence, a written petition for a Compulsory Licence, providing the following information, shall be submitted:
(1) the name, address, postal code, contact person and telephone number of the petitioner;
(2) the nationality, or the country or region of registration, of the petitioner;
(3) the title, patent number, filing date and gazette date of the granting of the invention patent or utility model patent for which the grant of a Compulsory Licence is being petitioned, and the name of the patentee;
(4) the grounds for petitioning for the grant of a Compulsory Licence and the facts and term thereof;
(5) if the petitioner has appointed a patent agency, the agency's name and organisation code and the name, licence number and contact telephone number of the agent designated by the agency;
(6) the signature or seal of the petitioner; and if a patent agency has been appointed, the seal of the agency;
(7) a list of the accompanying documents; and
(8) other matters that need to be stated.
The written petition and the accompanying documents shall be prepared in duplicate.
Article 10: If a petition for a Compulsory Licence involves two or more patentees, the petitioner shall submit the written petition and the accompanying documents in a number of duplicates equivalent to that of the number of patentees.
Article 11: If a petition for the granting of a Compulsory Licence is made pursuant to Item (1) of Article 48 or Article 51 of the Patent Law, the petitioner shall provide evidence to the effect that it approached the patentee requesting a licence to exploit the patent on reasonable conditions, but failed to obtain such licence within a reasonable period of time.
If a petition for the granting of a Compulsory Licence is made pursuant to Item (2) of Article 48 of the Patent Law, the petitioner shall submit an effective judgment or decision lawfully rendered by a judicial authority or anti-monopoly law enforcement authority finding that the exercise of the patent rights by the patentee is a monopolistic act.
Article 12: When a relevant competent department of the State Council proposes the granting of a Compulsory Licence pursuant to Article 49 of the Patent Law, it shall indicate the following:
(1) that the Compulsory Licence needs to be granted due to a state emergency or exceptional circumstance, or in the public interest;
(2) the title, patent number, filing date and gazette date of the granting of the invention patent or utility model patent for which it is proposing the grant of a Compulsory Licence, and the name of the patentee;
(3) the term of the proposed Compulsory Licence;
(4) the name, address, postal code, contact person and telephone number of the entity that satisfies the criteria for exploiting the patent that it is designating; and
(5) other matters that need to be stated.
Article 13: When a petition for the grant of a Compulsory Licence is made pursuant to Article 50 of the Patent Law, the petitioner shall provide information on the importer, the pharmaceutical it requires and the granting of the Compulsory Licence.
Article 14: A petition for a Compulsory Licence will not be accepted and the petitioner notified thereof if:
(1) the patent number for the invention patent or utility model patent for which the grant of a Compulsory Licence is being petitioned is unclear or difficult to determine;
(2) the petition documents are not in Chinese;
(3) there clearly are no grounds for petitioning for a Compulsory Licence; or
(4) the patent for which the granting of a Compulsory Licence is being petitioned has terminated or been declared invalid.
Article 15: If the petition documents are not in conformity with Article 4, 9 or 10 hereof, the petitioner shall rectify the matter within 15 days from the date of receipt of the notice. If it fails to do so, the petition shall be deemed as not having been submitted.
Article 16: When the State Intellectual Property Office accepts a petition for a Compulsory Licence, it shall deliver a duplicate of the written petition to the patentee in a timely manner. Unless otherwise indicated, the patentee shall state its opinion within 15 days from the date of receipt of the notice. A failure by it to do so shall not affect the rendering of a decision by the State Intellectual Property Office.
Part Three: Review of, and decision on, a CompulsoryLicence petition
Article 17: The State Intellectual Property Office shall review the grounds stated, information provided and relevant supporting documents submitted by the petitioner and the opinions stated by the patentee. If an on-the-spot check is required, the State Intellectual Property Office shall assign at least two members of its working personnel to conduct the same.
Article 18: If the petitioner or patentee requests a hearing, the State Intellectual Property Office shall arrange for such hearing.
The State Intellectual Property Office shall notify the petitioner, patentee and other materially interested parties seven days before holding the hearing.
Unless state secrets, trade secrets or personal privacy is involved, the hearing shall be open to the public.
When the hearing is being conducted, the petitioner, patentee and other materially interested parties may present their arguments and conduct cross examinations.
When the hearing is being conducted, a written record shall be kept thereof, which shall be presented to the hearing attendees for their signature or seal after they confirm that it is in order.
The hearing procedure shall not apply in cases where the grant of a Compulsory Licence is proposed or petitioned for pursuant to Article 49 or 50 of the Patent Law.
Article 19: If a petitioner withdraws its petition before the State Intellectual Property Office renders its decision, the review procedure for the Compulsory Licence petition shall terminate.
If the petitioner enters into a patent licensing contract with the patentee before the State Intellectual Property Office renders its decision, it shall notify the State Intellectual Property Office of the same in a timely manner and withdraw its Compulsory Licence petition.
Article 20: The State Intellectual Property Office shall render a decision rejecting a petition for a Compulsory Licence if, following review, it deems that:
(1) the petitioner does not comply with Article 4, 5, 7 or 8 hereof;
(2) the grounds on which the petition for the grant of a Compulsory Licence are made do not conform with Article 48, 50 or 51 of the Patent Law;
(3) where the invention or creation involved in the Compulsory Licence petition is semiconductor technology, the grounds do not conform with Article 52 of the Patent Law;
(4) the Compulsory Licence petition does not conform with Article 11 or 13 hereof; or
(5) the grounds stated, the information provided or the relevant supporting documents submitted by the petitioner are insufficient or untruthful.
Before rendering its decision to reject the petition for a Compulsory Licence, the State Intellectual Property Office shall notify the petitioner of its proposed decision and the reasons therefor. Unless otherwise indicated, the petitioner may state its opinion within 15 days from the date of receipt of the notice.
Article 21: If, following the review, the State Intellectual Property Office deems the grounds for the petition of a Compulsory Licence to be tenable, it shall render a decision to grant a Compulsory Licence. Before rendering its decision to grant a Compulsory Licence, the State Intellectual Property Office shall notify the petitioner and patentee of its proposed decision and the reasons therefor. Unless otherwise indicated, the parties may state their opinions within 15 days from the date of receipt of the notice.
Before rendering its decision to grant a Compulsory Licence pursuant to Article 49 of the Patent Law, the State Intellectual Property Office shall notify the patentee of its proposed decision and the reasons therefor.
Article 22: A decision to grant a Compulsory Licence shall provide the following:
(1) the name and address of the entity or individual granted the Compulsory Licence;
(2) the title, patent number, filing date and gazette date of the granting of the invention patent or utility model patent for which the Compulsory Licence is granted;
(3) the scope and term of the granted Compulsory Licence;
(4) the grounds, facts and legal basis of the decision;
(5) the seal of the State Intellectual Property Office and the signature of the person in charge;
(6) the date of the decision; and
(7) other relevant matters.
The petitioner and patentee shall be notified of the decision to grant a Compulsory Licence within five days from the date on which it is rendered.
Article 23: If the State Intellectual Property Office renders a decision to grant a Compulsory Licence pursuant to Article 50 of the Patent Law, it shall additionally set forth the following requirements in the decision:
(1) the quantity of the pharmaceutical manufactured based on the Compulsory Licence may not exceed the quantity required by the importer, and all of it must be exported to the importer;
(2) a specific label or mark shall be used on the pharmaceutical manufactured based on the Compulsory Licence expressly stating that the pharmaceutical is manufactured based on the Compulsory Licence; where feasible and provided that doing so would not significantly affect the price of the pharmaceutical, a special colour or shape shall be used for the pharmaceutical itself or special packaging shall be used for the pharmaceutical; and
(3) before shipment of the pharmaceutical, the entity granted the Compulsory Licence shall post on its website or the relevant website of the World Trade Organisation information such as the quantity of the pharmaceutical it is shipping to the importer and the identifying characteristics of the pharmaceutical as described in item (2) of this Article.
Article 24: If the State Intellectual Property Office renders a decision to grant a Compulsory Licence pursuant to Article 50 of the Patent Law, the relevant competent department of the State Council shall provide the following information to the World Trade Organisation:
(1) the name and address of the entity granted the Compulsory Licence;
(2) the description and quantity of the pharmaceutical to be exported;
(3) the importer;
(4) the term of the Compulsory Licence; and
(5) the website address described in Item (3) of Article 23 hereof.
Part Four: Review of, and ruling on, a petition for a royalty ruling for a Compulsory Licence
Article 25: When a petition is made for a royalty ruling for a Compulsory Licence, a written petition for such ruling, providing the following information, shall be submitted:
(1) the name and address of the petitioner;
(2) the nationality, or the country or region of registration, of the petitioner;
(3) the document number of the decision granting the Compulsory Licence;
(4) the respondent's name and address;
(5) the reason for the petition for a royalty ruling for a Compulsory Licence;
(6) if the petitioner has appointed a patent agency, the agency's name and organisation code and the name, licence number and contact telephone number of the agent designated by the agency;
(7) the signature or seal of the petitioner; and if a patent agency has been appointed, the seal of the agency;
(8) a list of the accompanying documents; and
(9) other matters that need to be stated.
The written petition and the accompanying documents shall be prepared in duplicate.
Article 26: A petition for a royalty ruling for a Compulsory Licence will not be accepted, and the petitioner will be notified of the same, if:
(1) the decision on granting the Compulsory Licence has yet to be rendered;
(2) the petitioner is not the patentee or the entity or individual that has been granted the Compulsory Licence; or
(3) the parties have yet to conduct negotiations or have reached an agreement after consultations.
Article 27: When the State Intellectual Property Office accepts a petition for a royalty ruling for a Compulsory Licence, it shall deliver a duplicate of the written petition to the other party in a timely manner. Unless otherwise indicated, the other party shall state its opinion within 15 days from the date of receipt of the notice. A failure by it to do so shall not affect the rendering of a decision by the State Intellectual Property Office.
During the course of the royalty ruling for a Compulsory Licence, both parties may submit written comments. The State Intellectual Property Office may, as required by the circumstances of the case, listen to the oral opinions of the parties.
Article 28: If a petitioner withdraws its petition for a ruling before the State Intellectual Property Office renders its decision, the ruling procedure shall terminate.
Article 29: The State Intellectual Property Office shall render its decision on a royalty ruling for a Compulsory Licence within three months from the date of receipt of the written petition.
Article 30: A decision on a royalty ruling for a Compulsory Licence shall provide the following:
(1) the name and address of the entity or individual granted the Compulsory Licence;
(2) the title, patent number, filing date and gazette date of the granting of the invention patent or utility model patent for which the Compulsory Licence was granted;
(3) the contents of, and grounds for, the ruling;
(4) the seal of the State Intellectual Property Office and the signature of the person in charge;
(5) the date of the decision; and
(6) other relevant matters.
The parties shall be notified of the royalty ruling for a Compulsory Licence within five days from the date on which the decision is rendered.
Part Five: Review of, and decision on, a petition for termination of a Compulsory Licence
Article 31: A Compulsory Licence shall terminate automatically if:
(1) the term of the Compulsory Licence specified in the decision granting the Compulsory Licence expires; or
(2) the invention patent or utility model patent for which the Compulsory Licence was granted terminates or is declared invalid.
Article 32: If, before the expiration of the term of a Compulsory Licence specified in the decision granting the Compulsory Licence, the grounds for the Compulsory Licence cease to exist and do not again arise, the patentee may petition the State Intellectual Property Office to render a decision to terminate the Compulsory Licence.
To petition for the termination of a Compulsory Licence, a written petition for termination of a Compulsory Licence, providing the following information, shall be submitted:
(1) the name and address of the patentee;
(2) the nationality, or the country or region of registration, of the patentee;
(3) the document number of the decision granting the Compulsory Licence the termination of which is petitioned for;
(4) the grounds for petitioning for the termination of the Compulsory Licence and the facts thereof;
(5) if the patentee has appointed a patent agency, the agency's name and organisation code and the name, licence number and contact telephone number of the agent designated by the agency;
(6) the signature or seal of the patentee; and if a patent agency has been appointed, the seal of the agency;
(7) a list of the accompanying documents; and
(8) other matters that need to be stated.
The written petition and the accompanying documents shall be prepared in duplicate.
Article 33: A petition for termination of a Compulsory Licence will not be accepted, and the petitioner will be notified of the same, if:
(1) the petitioner is not the patentee of the patent for the invention or utility model for which the Compulsory Licence was granted;
(2) the document number of the decision granting the Compulsory Licence for which termination is petitioned has not been provided;
(3) the petition documents are not in Chinese; or
(4) the grounds for termination of the Compulsory Licence clearly do not exist.
Article 34: If the petition documents do not conform with Article 32 hereof, the petitioner shall rectify the matter within 15 days from the date of receipt of the notice. If it fails to do so, the petition shall be deemed as not having been submitted.
Article 35: When the State Intellectual Property Office accepts a petition for termination of a Compulsory Licence, it shall deliver a duplicate of the written petition to the entity or individual granted the Compulsory Licence in a timely manner. Unless otherwise indicated, the entity or individual granted the Compulsory Licence shall state its opinion within 15 days from the date of receipt of the notice. A failure by it to do so shall not affect the rendering of a decision by the State Intellectual Property Office.
Article 36: The State Intellectual Property Office shall review the grounds stated and the relevant supporting documents submitted by the patentee and the opinions stated by the entity or individual granted the Compulsory Licence. If an on-the-spot check is required, the State Intellectual Property Office shall assign at least two members of its working personnel to conduct the same.
Article 37: If the patentee withdraws its petition before the State Intellectual Property Office renders its decision, the relevant procedure shall terminate.
Article 38: If, following the review, the State Intellectual Property Office deems the grounds for the petition to terminate the Compulsory Licence to be untenable, it shall render a decision rejecting the petition to terminate the Compulsory Licence. Before rendering its decision to reject the petition for termination of the Compulsory Licence, the State Intellectual Property Office shall notify the patentee of its proposed decision and the reasons therefor. Unless otherwise indicated, the patentee may state its opinion within 15 days from the date of receipt of the notice.
Article 39: If, following the review, the State Intellectual Property Office deems the grounds for the petition to terminate the Compulsory Licence to be tenable, it shall render a decision to terminate the Compulsory Licence. Before rendering its decision to terminate the Compulsory Licence, the State Intellectual Property Office shall notify the entity or individual granted the Compulsory Licence of its proposed decision and the reasons therefor. Unless otherwise indicated, the entity or individual granted the Compulsory Licence may state its opinion within 15 days from the date of receipt of the notice.
A decision to terminate a Compulsory Licence shall provide the following:
(1) the name and address of the patentee;
(2) the name and address of the entity or individual granted the Compulsory Licence;
(3) the title, patent number, filing date and gazette date of the granting of the invention patent or utility model patent for which the Compulsory Licence was granted;
(4) the document number of the decision granting the Compulsory Licence;
(5) the facts and legal basis of the decision;
(6) the seal of the State Intellectual Property Office and the signature of the person in charge;
(7) the date of the decision; and
(8) other relevant matters.
The patentee and the entity or individual granted the Compulsory Licence shall be notified of the decision to terminate the Compulsory Licence within five days from the date on which it is rendered.
Supplementary provisions
Article 40: An effective decision granting a Compulsory Licence or terminating a Compulsory Licence, and the automatic termination of aCompulsory Licence shall be recorded in the patent register and announced in the patent gazette.
Article 41: If a concerned party is dissatisfied with the decision on a Compulsory Licence rendered by the State Intellectual Property Office, it may apply for administrative review or institute an administrative action in accordance with the law.
Article 42: The State Intellectual Property Office is in charge of interpreting these Measures.
Article 43: These Measures shall be effective as of May 1 2012. The Measures for Compulsory Patent Licensing issued with Order of Sipo No.31 on June 13 2003 and the Measures for Compulsory Patent Licensing Relating to Public Health Issues issued with Order of Sipo No.37 on November 29 2005 shall be repealed simultaneously.
clp reference:5100/12.03.15prc reference:知识产权局令第64号promulgated:2012-03-15effective:2012-05-01This premium content is reserved for
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