Order of the Director of the State Intellectual Property Office 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, 2012.
Director General: TIAN Lipu
March 15, 2012
Measures for Compulsory Licensing of Patent Implementation
Chapter I - General Provisions
Article 1 In order to standardize the implementation of granting, fees adjudication and termination procedures for compulsory licenses of patents of inventions or utility models (hereinafter referred to as “compulsory license”), these Measures are formulated in accordance with the Patent Law of the People’s Republic of China (hereinafter referred to as the Patent Law), the Implementing Regulations of The Patent Law of The People’s Republic of China and the relevant laws and regulations.
Article 2 The State Intellectual Property Office shall be responsible for handling the acceptance and examination of petitions, and shall make decisions on granting the compulsory license, the adjudication of use fees of the compulsory license and the termination of the compulsory license.
Article 3 Petitions for granting a compulsory license, for adjudication of use fees of the compulsory license and for termination of the compulsory license shall be executed in Chinese in writing. If the certificates or certification documents submitted in compliance with these Measures are in a foreign language, the State Intellectual Property Office can, if deemed necessary, request the party concerned to provide the Chinese translation thereof within a specified period of time; failure to submit the Chinese translation within this period of time will be deemed as failure to provide the relevant certificates or certification documents.
Article 4 If a foreigner having no habitual residence or place of business in China, a foreign enterprise or other foreign organization applies for a compulsory license, the handling of the procedure should be entrusted to a legally established patent agency. If the party concerned entrusts a patent agency to handle the compulsory licensing procedures, they shall submit a power of attorney clearly indicating in writing the delegation of authority. If the party concerned consists of more than one member and authority is not entrusted to
a patent agency, then unless otherwise declared, the first member indicated in the submitted documents will be regarded as the representative.
Chapter II - Submission and Acceptance of Petitions for Compulsory Licensing
Article 5 If a patentee has without good reason not implemented or fully implemented their patent within three years from the date of grant of the patent right and within four years from the date of filing of the patent, then an entity or individual which is able to implement the patent can petition for a compulsory license based on the provisions of Article 48 paragraph 1 of the Patent Law. If the actions of a patent right holder in exercising their patent right are legally deemed to be monopolistic actions, then in order to eliminate or reduce the negative effects of said actions on competition, an entity or individual which is able to implement the patent can petition for a compulsory license based on the provisions of Article 48 paragraph 2 of the Patent Law.
Article 6 In an emergency or irregular event of the state, or for the purposes of public interest, the competent department under the State Council is entitled to recommend the State Intellectual Property Office to grant a compulsory license for implementing the invention patent or utility model patent of the petition based on the provisions of Article 49 of the Patent Law.
Article 7 For purposes of public health, an entity which is able to implement the patent can petition for a compulsory license based on the provisions of Article 50 of the Patent Law for the manufacture of patented medicines and export of the same to the following countries or regions: 1. The most underdeveloped countries or regions. 2. Developed or developing members of the World Trade Organization that express via said organization that they wish to be importers based on the relevant international treaties.
Article 8 If a patented invention or utility model is an important technical advancement over a previously patented invention or utility model and has prominent economic significance, and if the implementation thereof depends on the implementation of the earlier invention or utility model, the patent holder can request that the compulsory license be issued for the previous patent based on the provisions of Article 51 of the Patent Law. If the
State Intellectual Property Office grants a compulsory license to implement the previous patent, the patent holder of the previous patent may request that the compulsory license be issued for a later patent.
Article 9 When petitioning for the grant of a compulsory license, an application for a compulsory license should be submitted to the State Intellectual Property Office, indicating the following items: 1. The name, address, postcode, contact telephone number of the petitioner; 2. The nationality of the petitioner or registered country or area; 3. The name, patent number, date of application and date of grant of the invention patent or utility model patent which is the subject of the petitioned compulsory license, and the name of the right holder of the invention patent; 4. The reasons for, facts relating to and term of the compulsory license; 5. If authorizing a patent agency, the name and ID thereof, and name, registration number and contact telephone number of the agent specified by the agency; 6. The signature or stamp of the petitioner and if there is an authorized agency the stamp of the agency; 7. A list of attached documents; 8. Any other items that must be stated. The petition and attached documents should be executed in two copies.
Article 10 If a petition for a compulsory license relates to more than one patent right holder, the petitioner should submit copies of the petition and attached documents according to the number of patent right holders.
Article 11 If a petition for a compulsory license is made based on Article 48 paragraph 1 or Article 51 of the Chinese Patent Law, the petitioner should provide evidence proving that a reasonable request was made to the patent right holder to permit the petitioner to implement the patent, but within a reasonable period of time the petitioner was unable to obtain such permission. If a petition for a compulsory license is made based on Article 48 paragraph 2 of the Chinese Patent Law, the petitioner should submit an in-force judgment or determination by a judicial authority or an anti-monopoly law enforcement agency that the actions of the patent right holder in exercising their patent right are deemed to be monopolistic actions according to the law.
Article 12 If a department under the State Council makes a recommendation to grant a compulsory license based on Article 49 of the Chinese Patent Law, it should indicate the following: 1. That it is necessary to grant a compulsory license because of an emergency or irregular event of the state, or for the purposes of public interest;
2. The name, patent number, date of application and date of grant of the invention patent or utility model patent which is the subject of the petitioned compulsory license, and the name of the right holder of the invention patent; 3. The term of the compulsory license; 4. The name, address, postcode, contact person and telephone number of the entity able to implement the patent; 5. Any other necessary information.
Article 13 If a request to grant a compulsory license is made based on Article 50 of the Chinese Patent Law, the petitioner should submit information related to the importer, the medicines they require and the granting of the compulsory license.
Article 14 In any of the following cases the petition for a compulsory license will not be accepted and the petitioner will be notified thereof: 1. The patent number of the invention patent or utility model patent relating to the petitioned compulsory license is not clear or is hard to identify; 2. The petition documents are not in Chinese; 3. It is clear that there is no reason for the petition for a compulsory license; 4. The patent right which is the subject of the petition has terminated or been invalidated.
Article 15 If the petitioning documents do not meet the provisions of Articles 4, 9 or 10 of these Measures, the petitioner shall within 15 days upon receipt of notification thereof rectify the documents. If the petitioner fails to rectify the documents, the petition will be deemed as not submitted.
Article 16 If the State Intellectual Property Office accepts a petition for a compulsory license, it shall timely forward a copy thereof to the patent right holder. Except where specified, the patent right holder should state their opinion within 15 days of receiving this notification; however, if no response is made, this will not negatively influence the decision of the State Intellectual Property Office.
Chapter III - Examination and Determination of Petitions for Compulsory Licensing
Article 17 The State Intellectual Property Office shall examine the reasons, information and related evidentiary documents submitted by the petitioner, and the opinion of the patent right holder. If an on-site examination is required, it shall dispatch at least two employees to perform the on-site examination.
Article 18
If the petitioner or patent right holder requests a hearing, the State Intellectual Property Office may organize a hearing. The State Intellectual Property Office shall notify the petitioner, patent right holder and any other interested parties 7 days before the hearing. Unless it relates to state secrets, company secrets or personal and private matters, the hearing shall be public. In the hearing, each of the petitioner, the patent right holder and any other interested party may defend themselves and cross-examine the other party. A written record will be made of the hearing and passed to all participants in the hearing who will sign or seal the same after confirming that there are no mistakes therein. Procedures relating to a hearing do not apply if a petition for granting of a compulsory license is made based on the provisions of Article 49 or Article 50 of the Chinese Patent Law.
Article 19 The petitioner may withdraw their petition for a compulsory license prior to the decision by the State Intellectual Property Office, at which point the examination procedures relating to the petition for a compulsory license terminate. If the petitioner and patent right holder agree on a licensing contract for patent implementation 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 a compulsory license should be withdrawn directly.
Article 20 If during examination of the petition for compulsory license any of the following apply, the State Intellectual Property Office shall refuse the petition for a compulsory license: 1. The petition does not conform to the provisions of Articles 4, 5, 7 or 8 of these Measures; 2. The reasons for petitioning for the grant of the compulsory license do not conform to the provisions of Articles 48, 50 or 51 of the Patent Law; 3. If the petition for a compulsory license involves the invention and creation of semiconductor technologies, and the reasons thereof do not conform to the provisions of Article 52 of the Implementing Regulations of the Patent Law; 4. The petition for a compulsory license does not conform to the provisions of Articles 11 or 13 of these Measures; 5. The reasons, information or evidentiary documents submitted by the petitioner are insufficient or incorrect. Before the State Intellectual Property Office issues a decision to reject a petition for a compulsory license, it shall notify the petitioner of the intended decision and state the reasons thereof. Except where specified, the petitioner can submit an opinion within 15 days of receiving said notification.
Article 21 If the Examiner has carried out examination and asserts that the reasons for granting the petition for a compulsory license are valid, the State Intellectual Property Office shall grant a compulsory license. Before making the decision to grant a compulsory license, it
shall notify the petitioner and patent right holder of the intended decision and the reasons thereof. Except where specified, both parties can submit an opinion within 15 days of receiving said notification. Before the State Intellectual Property Office makes the decision to grant a compulsory license based on Article 49 of the Chinese Patent Law, it shall notify the patent right holder of the intended decision and the reasons thereof.
Article 22 The decision to grant a compulsory license should clearly indicate the following: 1. The name and address of the individual or entity obtaining the compulsory license; 2. The name, patent number, date of application and date of grant of the invention patent or utility model patent which is the subject of the petitioned compulsory license, and the name of the right holder of the invention patent; 3. The scope and term of the granted compulsory license; 4. The reasons for, facts relating to, and legal basis for the decision; 5. The stamp of the State Intellectual Property Office and the signature of the responsible persons; 6. The date of the decision; 7. Any other relevant matters. The petitioner and the patent right holders should be notified of the decision to grant the compulsory license within 5 days of making the decision.
Article 23 If the State Intellectual Property Office grants a compulsory license based on Article 50 of the Chinese Patent Law, it should clearly state the following in the decision: 1. The amount of medical products produced under the compulsory license should not exceed the amount needed by the importer; moreover, all of if must be exported to the importer; 2. The medical products produced under the compulsory license should bear a special tag or mark clearly indicating that they are produced under the compulsory license; when feasible, and provided that it does not obviously negatively influence the price of the medical products, the medical products themselves should adopt a special color or shape, or special packaging should be used for the medical products. 3. Prior to shipping the medical products, the entity that has obtained the compulsory license should publish the amount of medical products being sent to the importer and information relating to the distinguishing features of the medical product according to (2) above, on its web page or on the related web page of the WTO.
Article 24 If the State Intellectual Property Office grants a compulsory license based on Article 50 of the Chinese Patent Law, the competent department under the State Council shall provide the following information to the WTO: 1. The name and address of the entity that has obtained the compulsory license; 2. The name and amount of the exported medical products; 3. The importer; 4. The term of the compulsory license;
5. The web page according to Article 23 Item 3 of these Measures.
Chapter IV - Examination and Adjudication of Fee Adjudication Requests of a Compulsory License
Article 25 Upon requesting adjudication of use fees for a compulsory license, the party concerned should submit a Request for Adjudication of Compulsory License Use Fees, therein clearly indicating the following: 1. The name and address of the petitioner; 2. The nationality of the petitioner or registered country or area; 3. The document number of the decision to grant the compulsory license; 4. The name and address of the petitioned; 5. The reasons for requesting adjudication of the use fees of the compulsory license; 6. If authorizing a patent agency, the name and ID thereof, and name, registration number and contact telephone number of the agent specified by the agency; 7. The signature or stamp of the petitioner; and if there is an authorized agency, the stamp of the agency; 8. A list of the attached documents; 9. Any other items that must be stated. The Request and attached documents should be executed in two copies.
Article 26 In any of the following cases relating to the request for adjudication of the use fees of the compulsory license, the State Intellectual Property Office will not accept the request and notify the petitioner: 1. The decision to grant a compulsory license has not yet been made; 2. The petitioner is not the patent right holder or an entity or individual holding a compulsory license; 3. The two parties have not held negotiations or have already reached an agreement as a result of negotiations.
Article 27 If the State Intellectual Property Office receives a Request for Adjudication of Compulsory License Use F, ees, it shall timely send a copy of the Request to the other party. Except where specified, the other party should state their opinion within 15 days of receiving this notification; however, if no response is made, this will not negatively influence the decision of the State Intellectual Property Office. In the process of adjudicating use fees of the compulsory license, both parties can submit written opinions. The State Intellectual Property Office may, if necessary, hear the oral opinions of both parties concerned.
Article 28 If the petitioner withdraws their petition for adjudication prior to the decision by the State Intellectual Property Office, the adjudication procedure terminates.
Article 29 The State Intellectual Property Office shall within three months upon receipt of the petition make a decision on adjudication of the use fees of the compulsory license.
Article 30 The decision on the adjudication of the use fees of the compulsory license shall indicate the following items: 1. The name and address of the individual or entity obtaining the compulsory license; 2. The name, patent number, date of application and date of grant of the invention patent or utility model patent which is the subject of the granted compulsory license; 3. The reasons for the adjudication; 4. The stamp of the State Intellectual Property Office and the signature of the responsible persons; 5. The date of the decision; and 6. Any other relevant matters.
Both parties shall be notified of the decision on adjudication of the use fees of the compulsory license within 5 days of the decision being made.
Chapter V - Examination and Decision regarding Terminating the Compulsory License
Article 31 The compulsory license automatically terminates under any of the following conditions: 1. The term of the compulsory license as specified in the decision to grant the compulsory license has expired; 2. The invention patent or utility model patent which is the subject of the compulsory license expires or is invalidated.
Article 32 If, prior to the expiry of the term of the compulsory license specified in the decision to grant the compulsory license, the reasons for granting the compulsory license are eliminated and will not reoccur, the patent right holder may request the State Intellectual Property Office to terminate the compulsory license. Upon requesting the termination of a compulsory license, an application for termination of a compulsory license should be submitted, indicating the following items: 1. The name and address of the patent right holder; 2. The nationality of the patent right holder or the registered country or region thereof 3. The document number of the granted compulsory license that is the subject of the termination request; 4. The reason for requesting the termination of the compulsory license; 5. If authorizing a patent agency, the name and ID thereof, and name, registration number and contact telephone number of the agent specified by the agency; 6. The signature or stamp of the patent right holder; if there is an authorized agency, the stamp of the agency; 7. A list of the attached documents;
8. Any other items that must be stated. The patent right holder shall execute the request and attached documents in two copies.
Article 33 If any of the following cases relating to the request for terminating the compulsory license applies, the request will not be accepted and the petitioner will be notified: 1. The petitioner is not the right holder of the invention patent or utility model patent which is the subject of the compulsory license; 2. The document number of the decision to grant the compulsory license is unclear; 3. The request documents are not in Chinese; 4. It is clear that there is no reason for terminating the compulsory license.
Article 34 If the request documents do not conform to the provisions of Article 32 of these Measures, the petitioner should rectify the documents within 15 days of notification thereof. If rectified documents are not submitted within this period, the request will be deemed as not submitted.
Article 35 If the State Intellectual Property Office accepts a Request for Termination of Compulsory License, it shall send a copy of the Request to the individual or entity who has obtained the compulsory license. Except where specified, the individual or entity who has obtained the compulsory license should state their opinion within 15 days of receiving this notification; however, if no response is made, this will not negatively influence the decision of the State Intellectual Property Office
Article 36 The State Intellectual Property Office shall examine the stated reasons and related evidence submitted by the patent right holder, and the opinion of the individual or entity who has obtained the compulsory license. If an on-site examination is required, it shall dispatch at least two employees to perform the on-site examination.
Article 37 If the patent right holder withdraws their request prior to the decision by the State Intellectual Property Office, the related procedure terminates.
Article 38 If the Examiner has carried out examination and asserts that the reasons for the request to terminate the compulsory license are not valid, the State Intellectual Property Office shall reject the request to terminate the compulsory license. Before the State Intellectual Property Office issues the decision to reject the request for termination of the compulsory license, it shall notify the patent right holder of the intended decision and state the reasons thereof. Except where specified, the patent right holder can submit an opinion within 15 days of receiving said notification.
Article 39
If the Examiner has carried out examination and asserts that the reasons for the request to terminate the compulsory license are valid, the State Intellectual Property Office shall issue a decision to terminate the compulsory license. Before the State Intellectual Property Office issues the decision to terminate the compulsory license, it shall notify the entity or individual who has obtained the compulsory license of the intended decision and state the reasons thereof. Except where specified, the entity or individual who has obtained the compulsory license can submit an opinion within 15 days of receiving said notification. The decision to terminate a compulsory license should clearly indicate the following: 1. The name and address of the patent right holder; 2. The name and address of the individual or entity who has obtained the compulsory license; 3. The name, patent number, date of application and date of grant of the invention patent or utility model patent which is the subject of the granted compulsory license; 4. The document number of the decision to grant the compulsory license; 5. The facts and legal basis for the decision; 6. The stamp of the State Intellectual Property Office and the signature of the responsible persons; 7. The date of the decision; 8. Any other relevant matters. The patent right holder and the entity or individual who has obtained the compulsory license shall be notified of the termination of the compulsory license within 5 days of the decision being made.
Supplementary Provisions
Article 40 Decisions to grant or terminate a compulsory license, or automatic termination thereof, that have come into effect should be registered on the patent register and published in the patent gazette.
Article 41 If a party concerned objects to a decision of the State Intellectual Property Office regarding compulsory licensing, they can file for an administrative review or proceed with administrative litigation in accordance with the law.
Article 42 The responsibility for interpretation of these Measures is vested with the State Intellectual Property Office.
Article 43 These Measures take effect from May 1, 2012. Simultaneously, the “Measures for Implementing Compulsory Licensing” (No. 31) promulgated by the State Intellectual Property Office on June 13, 2003 and the “Measures for Implementing Compulsory Licensing of Patents Relating to Public Health Issues” (No. 37) promulgated by the State Intellectual Property Office on November 29, 2005, each expire.
Note: This is an unofficial translation and is provided for your reference. Please refer to the Chinese original should you have any uncertainties on the law/regulations (http://www.sipo.gov.cn/zwgs/ling/201203/t20120319_654876.html).
《专利实施强制许可办法》(第 64 号)
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
专利实施强制许可办法
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。