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The Measures for Compulsory Licensing of Patent Implementation, which have been deliberated and adopted at the executive meeting, are hereby promulgated and shall come into force on May 1, 2012.

Measures for Compulsory Licensing of Patent Implementation

Chapter I General Provisions

Article 1 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 Detailed Rules for the Implementation of the Patent Law of the People's Republic of the People's Republic of China and the relevant laws and regulations for the purpose of regulating the procedures for the granting, fee adjudication and termination of compulsory licenses for the implementation of invention patents or utility model patents (hereinafter referred to as compulsory licenses).

Article 2 The State Intellectual Property Office shall be responsible for accepting and examining requests for compulsory licensing, requests for adjudication of royalties for compulsory licensing and requests for termination of compulsory licensing and making decisions.

Article 3 The request for the grant of a compulsory license, the request for the adjudication of the royalties of a compulsory license and the request for the termination of a compulsory license shall be handled in writing in Chinese.

If the various certificates and supporting documents submitted in accordance with these measures are in foreign languages, the State intellectual property Office may, when it deems it necessary, require the parties concerned to attach a Chinese translation within a specified period of time; if they are not attached at the expiration of the period, the certificates and supporting documents shall be deemed not to have been submitted.

Article 4 Foreigners, foreign enterprises or other foreign organizations that do not have a habitual residence or business office in China shall entrust a patent agency established in accordance with the law to handle compulsory licensing matters.

Where a party entrusts a patent agency to handle the affairs of compulsory licensing, it shall submit a power of attorney stating the power of entrustment. If a party has more than two patent agencies and has not entrusted them, unless otherwise stated, the first party specified in the written documents submitted shall be the representative of that party.

Chapter II The raising and acceptance of the request for compulsory licensing.

Article 5 If the patentee fails to implement or fully implement his patent without justifiable reasons after 3 years have expired from the date of granting the patent right, and 4 years have expired from the date of filing the patent application, the unit or individual that meets the conditions for implementation may According to the provisions of Item 1 of Article 48 of the Patent Law, request a compulsory license.

Where the exercise of the patent right by the patentee is recognized as a monopoly act according to law, in order to eliminate or reduce the adverse impact of the act on competition, the unit or individual that has the conditions for implementation may, in accordance with the provisions of Article 48, Item 2 of the Patent Law, Request for compulsory licensing.

Article 6 In the event of a state of emergency or extraordinary circumstances, or for the purpose of public interest, the relevant competent department of the State Council may, in accordance with the provisions of Article 49 of the Patent Law, recommend that the State Intellectual Property Office grant it a compulsory license to a unit that meets the conditions for implementation.

Article 7 For the purpose of public health, an entity that meets the conditions for implementation may, in accordance with the provisions of Article 50 of the Patent Law, request the grant of a compulsory license to manufacture and export the patented pharmaceutical to the following countries or regions:

(I) least developed countries or regions;

(II), in accordance with the relevant international treaties, notify the World Trade Organization of its developed or developing members that it wishes to be importers.

Article 8 Where an invention or utility model for which a patent right has been obtained has major technological progress of significant economic significance over an invention or utility model for which a patent right has been obtained before, and its implementation depends on the implementation of the previous invention or utility model, the patentee may request a compulsory license to implement the previous patent in accordance with the provisions of Article 51 of the Patent Law. Where the State Intellectual Property Office grants a compulsory license to implement the former patent, the former patentee may also request a compulsory license to implement the latter patent.

Article 9 Where a request is made for compulsory licensing, a written request for compulsory licensing shall be submitted, stating the following:

The name, address, postal code, contact person and telephone number of the (I) requester;

(II) the nationality of the person requesting or the country or region of registration;

The title, patent number, date of application, date of announcement of authorization, and the name or title of the patentee of the invention patent or utility model for which the (III) requests compulsory licensing;

The reasons, facts and duration of the (IV)'s request for a compulsory license;

If the (V) requestor entrusts a patent agency, the name and code of the entrusted agency, as well as the name, license number and contact number of the agent designated by the agency;

The signature or seal of the person requesting the (VI); if the patent agency is entrusted, it shall also have the seal of the agency;

List of (VII) attached documents;

(VIII) other matters that need to be noted.

The request and its attached documents shall be made in duplicate.

Article 10 Where a request for a compulsory license involves two or more patentees, the petitioner shall submit copies of the request and its additional documents according to the number of patentees.

Article 11 Where a compulsory license is requested in accordance with the provisions of Article 48, paragraph 1 or Article 51 of the Patent Law, the claimant shall provide evidence to prove that it has requested the patentee to license it to implement the patent on reasonable terms, but failed to obtain the license within a reasonable time.

Where a request for a compulsory license is made in accordance with the provisions of Article 48, paragraph 2 of the Patent Law, the claimant shall submit a judgment or decision of the judicial organ or anti-monopoly law enforcement agency that has taken effect in accordance with the law to identify the exercise of the patent right by the patentee as a monopoly act.

Article 12 Where the competent department concerned under the State Council proposes to grant a compulsory license in accordance with Article 49 of the Patent Law, it shall specify the following:

(I) a state of emergency or extraordinary circumstances arise in the country, or a compulsory licence is required for purposes of public interest;

The name, patent number, date of application, date of announcement of authorization, and the name or title of the patentee of the invention patent or utility model for which the (II) proposes to grant a compulsory license;

the period for which the (III) proposes to grant a compulsory licence;

The name, address, postal code, contact person and telephone number of the unit designated by the (IV) to meet the implementation conditions;
　　
(V) other matters that need to be noted.

Article 13 Where a request is made for the grant of a compulsory license in accordance with the provisions of Article 50 of the Patent Law, the requesting party shall provide the importer and the medicines it needs and the relevant information on the grant of the compulsory license.

Article 14 Where a request for compulsory licensing is under any of the following circumstances, it shall not be accepted and the person making the request shall be notified:

(I) the patent number of the invention patent or utility model patent for which a compulsory license is requested is unclear or difficult to determine;

(II) request documents are not in Chinese;

The (III) clearly does not have the grounds for requesting a compulsory license;

(IV) the patent for which a compulsory license is requested has been terminated or invalidated.

Article 15 If the request documents do not comply with the provisions of Articles 4, 9 and 10 of these Measures, the requester shall make a correction within 15 days from the date of receipt of the notice. If no correction is made at the expiration of the time limit, the request shall be deemed not to have been made.

Article 16 Where the State Intellectual Property Office accepts a request for compulsory licensing, it shall promptly send a copy of the request to the patentee. Unless otherwise specified, the patentee shall state its opinions within 15 days from the date of receipt of the notice; if there is no reply within the time limit, it shall not affect the State Intellectual Property Office to make a decision.

Chapter III Examination and Decision on Compulsory Licensing Requests

Article 17 The State Intellectual Property Office shall examine the reasons stated by the requester, the information provided and the relevant supporting documents submitted, as well as the opinions stated by the patentee; if on-site verification is required, two or more staff members shall be assigned to conduct on-site verification.

Article 18 Where the claimant or patentee requests a hearing, the State Intellectual Property Office shall organize the hearing.

The State Intellectual Property Office shall notify the requester, the patentee and other interested parties 7 days before the hearing.

The hearing shall be conducted in public, except where state secrets, commercial secrets or personal privacy are involved.

When a hearing is held, the claimant, the patentee and other interested parties may plead and cross-examination.

When a hearing is held, a transcript of the hearing shall be made and submitted to the hearing participants for signature or seal after confirmation.

Where a compulsory license is proposed or requested in accordance with the provisions of Article 49 or Article 50 of the Patent Law, the hearing procedure shall not apply.

Article 19 If the requester withdraws his request before the State Intellectual Property Office makes a decision, the examination procedure of the compulsory license request shall be terminated.

Before the State Intellectual Property Office makes a decision, if the claimant and the patentee have entered into a patent licensing contract, they shall promptly notify the State Intellectual Property Office and withdraw their request for compulsory licensing.

Article 20 Upon examination, the State Intellectual Property Office shall make a decision to reject the request for compulsory licensing if it considers that the request for compulsory licensing is under any of the following circumstances:

(I) the claimant does not comply with the provisions of Article 4, Article 5, Article 7 or Article 8 of these Measures;

(II) the reasons for requesting compulsory license do not comply with the provisions of Article 48, Article 50 or Article 51 of the Patent Law;

(III) the invention-creation involved in the compulsory license request is a semiconductor technology, the reason does not comply with the provisions of Article 52 of the Patent Law;

(IV) the request for compulsory licensing does not comply with the provisions of Article 11 or Article 13 of these Measures;

The reasons stated by the (V) requester, the information provided or the relevant supporting documents submitted are insufficient or untrue.

Before making a decision to reject a request for compulsory licensing, the State Intellectual Property Office shall notify the requester of the decision to be made and the reasons for it. Unless otherwise specified, the requestor may state its opinions within 15 days from the date of receipt of the notice.

Article 21 If the reasons for requesting a compulsory license are found to be valid after examination, the State Intellectual Property Office shall make a decision to grant a compulsory license. Before the decision to grant a compulsory license is made, the requester and the patentee shall be notified of the decision to be made and the reasons therefor. Unless otherwise specified, the parties may state their opinions within 15 days from the date of receipt of the notice.

Before making a decision to grant a compulsory license in accordance with Article 49 of the Patent Law, the State Intellectual Property Office shall notify the patentee of the decision to be made and the reasons for it.

Article 22 The decision to grant a compulsory license shall state the following:

(I) the name or address of the unit or individual that has obtained the compulsory license;

The name, patent number, application date and authorization announcement date of the invention patent or utility model patent for which the compulsory license is (II) granted;

The scope and duration of the compulsory license granted by the (III);

The reasons, facts and legal basis of the (IV) decision;

(V) the seal of the State Intellectual Property Office and the signature of the person in charge;

the date of the (VI) decision;
　　
(VII) other relevant matters.

The decision to grant a compulsory license shall be notified to the applicant and the patentee within 5 days from the date of making the decision.

Article 23 Where the State Intellectual Property Office makes a decision to grant a compulsory license in accordance with Article 50 of the Patent Law, it shall also specify the following requirements in the decision:

The quantity of drugs manufactured by the (I) under the compulsory license shall not exceed the quantity required by the importing party, and all of them must be exported to the importing party;

(II) a drug manufactured under a compulsory license shall use a specific label or mark clearly stating that the drug is manufactured under a compulsory license; where feasible and will not significantly affect the price of the drug, a special color or shape shall be used for the drug itself, or a special packaging shall be used for the drug;

Before the shipment of a (III) drug, the unit that has obtained a compulsory license shall publish on its website or the relevant website of the World Trade Organization the quantity of the drug shipped to the importer and the drug identification characteristics mentioned in the second paragraph of this article.

Article 24 Where the State Intellectual Property Office makes a decision to grant a compulsory license in accordance with Article 50 of the Patent Law, the relevant competent department of the State Council shall notify the World Trade Organization of the following information:

The name and address of the unit (I) to obtain a compulsory license;

(II) the name and quantity of exported medicines;

Importer of (III);

the duration of the (IV) compulsory license;

(V) the website referred to in Item 3 of Article 23 of these Measures.

Chapter IV Examination and Judgment of the Request for the Adjudication of the Fees for the Use of Compulsory Licensing

Article 25 Where a request is made for the adjudication of the royalties for compulsory licensing, a written request for the adjudication of the royalties for compulsory licensing shall be submitted, stating the following:

The name or title and address of the person requesting the (I);

(II) the nationality of the person requesting or the country or region of registration;

The symbol of the decision of the (III) granting a compulsory licence;

(IV) the name or title and address of the person requested;

The reasons for the (V)'s request for adjudication of the royalties for compulsory licensing;

If the (VI) requestor entrusts a patent agency, the name and code of the entrusted agency, as well as the name, license number and contact number of the agent designated by the agency;

The signature or seal of the person requesting the (VII); if the patent agency is entrusted, it shall also have the seal of the agency;

List of (VIII) attached documents;

(IX) other matters that need to be noted.

The request and its attached documents shall be made in duplicate.

Article 26 If the request for the award of the use fee of the compulsory license is under any of the following circumstances, it shall not be accepted and the claimant shall be notified:

(I) decision to grant compulsory license has not been made;

The (II) claimant is not the patentee or the entity or individual that has obtained the compulsory license;

(III) the parties have not held consultations or have reached an agreement through consultations.

Article 27 Where the State Intellectual Property Office accepts a request for a ruling on the use fee for compulsory licensing, it shall promptly send a copy of the request to the other party. Unless otherwise specified, the other party shall state its opinions within 15 days from the date of receipt of the notice; if no reply is made within the time limit, it shall not affect the decision of the State Intellectual Property Office.

In the process of adjudication of the compulsory license fee, both parties may submit written opinions. The State Intellectual Property Office may hear the oral opinions of both parties according to the needs of the case.

Article 28 If the claimant withdraws his request for adjudication before the State Intellectual Property Office makes a decision, the adjudication procedure shall be terminated.

Article 29 The State Intellectual Property Office shall, within 3 months from the date of receipt of the request, make an adjudication decision on the use fee for compulsory licensing.

Article 30 The following items shall be specified in the adjudication decision on the use fee for compulsory licensing:

(I) the name or address of the unit or individual that has obtained the compulsory license;

The name, patent number, application date and authorization announcement date of the invention patent or utility model patent for which the compulsory license is (II) granted;

The content of the (III) award and its reasons;

(IV) the seal of the State Intellectual Property Office and the signature of the person in charge;

the date of the (V) decision;

(VI) other relevant matters.

The decision on the award of the compulsory license fee shall be notified to the parties within 5 days from the date of making the decision.

Chapter V Examination and Decision on Termination of the Request for Compulsory Licensing

Article 31 Compulsory licensing shall automatically terminate under any of the following circumstances:

The term of the compulsory license stipulated in the decision of the (I) granting the compulsory license expires;

(II) invention patent or utility model patent for which a compulsory license has been granted is terminated or declared invalid.

Article 32 If the reasons for compulsory licensing are eliminated and no longer occur before the period of compulsory licensing stipulated in the decision to grant compulsory licensing expires, the patentee may request the State Intellectual Property Office to make a decision to terminate the compulsory licensing.

A request for termination of a compulsory license shall be submitted, stating the following:

(I) the name or title and address of the patentee;

(II) the nationality of the patentee or the country or region of registration;

The symbol of the decision to grant a compulsory license for which the (III) requests termination;

The reasons and facts of the (IV)'s request for termination of the compulsory license;

If the (V) patentee entrusts a patent agency, the name and code of the entrusted agency, as well as the name, license number and contact number of the agent designated by the agency;

(VI) the signature or seal of the patentee; if a patent agency is entrusted, it shall also have the seal of the patent agency;

List of (VII) attached documents;

(VIII) other matters that need to be noted.

The request and its attached documents shall be made in duplicate.