Patent compulsory licensing approach

    (Released March 15, 2012, State intellectual property office, the 64th since May 1, 2012) Chapter I General provisions

    In order to regulate the implementation of the first compulsory license to exploit the patent for invention or utility model (hereinafter referred to as compulsory licensing), costs award and termination of proceedings, in accordance with the People's Republic of China patent law (hereinafter referred to as patent law), the People's Republic of China implementation rules of the patent law and related laws and regulations, these measures are formulated.

    Article II, State intellectual property office is responsible for receiving and reviewing the compulsory license request, compulsory license fee ruling requests and requests for termination of compulsory licenses and to make a decision.

Article requests for granting a compulsory licence, request a ruling compulsory license fee and request termination of compulsory licenses, you should use the Chinese language in written form.

    Proof of documents submitted in accordance with these measures, is in a foreign language, State intellectual property Office considers it necessary, may request the parties within a specified period comes with Chinese translation is not attached to the expiration, shall be deemed not to submit the documents, supporting documents.

Fourth no habitual residence or business office in China of a foreigner, foreign enterprise or other foreign organization for compulsory licensing services shall entrust's patent agency established by law. Parties appoints a patent Agency to carry out the compulsory license shall submit a power of Attorney, giving delegated authority.

    Party of two or more and has not appointed a patent Agency, unless otherwise indicated, specified in the written document submitted to the first party representative for the party.

    Chapter II compulsory licenses requested and considered

Article fifth patent 3 years from the date of grant of the patent right, and 4 years after the date of the patent application, without any justified reason, is not implemented or not fully implementing its patent, with conditions of units or individuals according to the 48th article of the patent law provides that requests for granting a compulsory licence.

    The patentee behavior is identified as a monopoly of the exercise of patent rights, to eliminate or reduce the adverse effects of the conduct on competition, with conditions of units or individuals according to the 48th article of the patent law provides that requests for granting a compulsory licence.

    Sixth in the State when emergency or exceptional circumstances occur, or where the public interest objective, 49th of the patent law by the relevant authorities under the State Council, recommendations for implementation of the national intellectual property Office granted to the specified conditions of the compulsory license.

Article seventh for public health purposes, and implementation conditions of units according to the 50th of the patent law provides that requests to manufacture patented drugs and export them to the following countries or areas of compulsory licenses:

(A) the least developed countries or regions;

    (B) in accordance with the relevant international treaty notified to the world trade organization hopes the import side of the Group's developed members and developing members. Eighth of a patented invention or utility model patent has been made before the invention or utility model has significant economic importance and significant technological progress, its implementation also depends on the front of an invention or utility model act, the patentee can according to the 51st of the patent law request prior to the implementation of a compulsory license for exploitation of patent.

    The State intellectual property Office granted prior to the implementation of a compulsory license for exploitation of patent, a patent holder can also be requested before after the implementation of a compulsory license for exploitation of patent.

Nineth requests for granting a compulsory licence, compulsory license for exploitation shall submit a letter of request, stated the following:

(A) the claimant's name, address, postal code, contact person and telephone;

(B) requesting registration of a person's nationality or national or region;

(C) requests for granting a compulsory licence the patent for invention or utility model name, number, filing date, for patent license notice, as well as the patentee the name or names;

(D) requests for granting a compulsory licence reasons and facts, the term;

(E) the claimant appointed a patent Agency, the trustee's name, organization code and the authorized agent's name, and license number, contact phone number;

(F) the claimant's signature or seal; appointed a patent Agency, should also have the stamp of the institution;

(G) the list of attached files;

(H) other matters should be marked.

    Request and any additional files should be in duplicate.

    Tenth compulsory license request involves two or more patentees, the request shall be submitted in accordance with the number of patent documents and the additional request copies.

11th according to the 48th article of patent law or the 51st article requests for granting a compulsory licence, the petitioner should provide the evidence proved, to request the authorization of the patentee on reasonable terms to its patent, but not available within a reasonable period of time to obtain a license.

    According to the provisions of patent law article 48th requests for granting a compulsory license, the request shall be submitted to the entry into force of the judiciary or antitrust law enforcement bodies conduct as a monopoly of the exercise of the patent rights of the patentee's decision or decisions.

12th State Council relevant departments in charge according to 49th of the patent law proposal for granting a compulsory licence shall indicate the following:

(A) national emergency or situation occurs, or need to be in the public interest to grant a compulsory license;

(B) recommend the granting of compulsory licenses the patent for invention or utility model name, number, filing date, for patent license notice, as well as the patentee the name or names;

(C) recommend the granting of a compulsory license period; (d) specifies the implementation conditions of company name, address, postal code, contact person and telephone number;

    (E) other matters should be marked.

    13th 50th of the patent law provides for granting a compulsory license, the request shall provide importing Parties and the necessary drugs and information about granting a compulsory licence.

14th compulsory license request any of the following circumstances, inadmissible and notify the requesting person:

(A) requests for granting a compulsory licence the invention patent or utility model patents the patent number is not clear or is difficult to determine;

(B) the requested file does not use Chinese;

(C) does not have the requested a compulsory license for obvious reasons;

    (D) the request to grant a compulsory license of patent rights have been terminated or be declared null and void. 15th fourth requested file does not conform to these measures, the Nineth and tenth article, request shall, from the date of receipt of the notification of correction within the 15th.

    Expiration of the correction is not made, the request is considered to have not been filed. 16th State intellectual property Bureau of compulsory licensing request, and shall promptly send a copy of the written request the patentee.

    Unless otherwise specified, a patentee shall, from the date of receipt of the notification within the 15th presentation; did not reply to the expiry of, does not affect the State intellectual property office to make a decision.

    Chapter III compulsory license requested review and decisions

    17th State intellectual property office shall request one for the reasons stated, providing the information and supporting documents submitted by review and the views presented by the patentee; needs verification in the field, should be assigned more staff on-site.

18th applicant or patentee requests a hearing, the hearing organized by the State intellectual property office.

State intellectual property office notification request before the hearing shall be held in the 7th person, the patentee and any other interested person.

In addition to involve State secrets, business secrets or personal privacy, hearings open to the public.

When the hearing was held, petitioner, patent rights and other interested persons may make representations and cross-examine.

Shall draw up a record of hearing held the hearing, after hearing participants confirm signature or seal.

    Under the provisions of patent law article 49th or 50th suggestions or requests for granting a compulsory licence shall not apply to hearing procedures.

19th the claimant withdraws his request before the State intellectual property Office decision, requesting review of program termination of compulsory licenses.

    Before making a decision in the State intellectual property office, claimant entered into a patent license agreement with the patentee, shall notify the State intellectual property office, and to withdraw his request for a compulsory license.

20th reviews have concluded that compulsory licensing request any of the following circumstances, the State intellectual property office rejected compulsory license request decision should be made: (a) the request does not meet the article fourth, fifth, seventh, or eighth of the rules;

(B) requests for granting a compulsory licence reasons do not comply with the patent law of the 48th, 50th and 51st provisions;

(C) requests relating to semiconductor technology is the invention of compulsory licenses, citing provisions of article does not meet the 52nd of the patent law;

(D) the request does not comply with the compulsory licensing provisions of article 11th or 13th;

(E) the claimant for the reasons stated, the provision of information or supporting documents submitted by insufficient or inaccurate. The State intellectual property office before the decision to reject compulsory license request, it shall notify the applicant the decision to be taken and the reasons for it.

    Unless otherwise specified, a person from the date of receipt of the notification of the request presented their views in the 15th. 21st following a review to consider a request to grant a compulsory license has merit, the State intellectual property office shall make a decision to grant a compulsory license. Before making a decision to grant a compulsory license, it shall notify the applicant and the patentee intended decisions and the reasons for it.

Unless otherwise specified, but from the date of receipt of the notification of the parties presented their views in the 15th.

    State intellectual property office according to the 49th of the patent law before making a decision to grant a compulsory license shall notify the patentee intended decision and the reasons for it.

22nd decision to grant a compulsory license shall specify the following:

(A) obtain compulsory licensing entity or individual's name and address;

(B) be given compulsory license for the patent for invention or utility model names, patent number, filing date and authorized notice date;

(C) the scope and duration of granting a compulsory licence;

(D) the reasons for the decision and the factual and legal basis;

(E) the head of the State intellectual property Office of the seal and signature;

(Vi) date to be determined;

(G) other relevant matters.

    Decision to grant a compulsory license shall be effective as of the date of making the 5th notification request and the patentee.

23rd State intellectual property office in accordance with article 50th of the patent law of the decision to grant a compulsory license, it should be clear in this decision for the following requirements:

(A) according to the compulsory license for manufacturing of drug quantity shall not exceed the number of requirements of the importing party, and must all be exported to the importing party;

(B) according to the compulsory licensing of medicines should be using specific labels or tags clearly indicate whether the drug is manufactured according to the compulsory license; where feasible and does not have a significant impact on drug prices case, medicine should be using a special color or shape, or special packaging for medicines;

    (C) the drug prior to shipment, obtain compulsory licensing entity shall, in its Web site or published on the Web site of the World Trade Organization medicines shipped to the importer number and identifier of the drugs referred to in the second subparagraph of this article, and so on.

24th State intellectual property office in accordance with article 50th of the patent law of the decision to grant a compulsory license shall be formulated by the competent departments the following communications from the World Trade Organization:

(A) obtain compulsory licenses the names and addresses of the units;

(B) the name and quantity of exported drugs;

(C) the importing party;

(D) the duration of compulsory licenses;

    (E) these measures referred to in article 23rd Web site.

    Fourth chapter of compulsory licensing fees ruling request reviews and awards

25th requesting a ruling compulsory license fee shall be submitted to the compulsory license fee ruling request, stated the following:

(A) the name or name and address of the claimant;

(B) requesting registration of a person's nationality or national or region;

(C) the decision to grant a compulsory license number;

(D) the name or name and address of the claimant;

(E) the reasons for requesting a ruling compulsory license fee;

(F) the claimant appointed a patent Agency, the trustee's name, organization code and the authorized agent's name, and license number, contact phone number;

(G) the requestor's signature or stamp; appointed a patent Agency, should also have the stamp of the institution;

(H) the list of attached files;

(IX) other matters required to State.

    Request and any additional files should be in duplicate.

26th compulsory licensing fees ruling request any of the following circumstances, inadmissible and notify the requesting person:

(A) the decision to grant a compulsory license has been made;

(B) the request is not the patentee or units or individuals obtain compulsory licenses;

    (C) the parties have not yet consulted or have reached an agreement through consultation. 27th the State intellectual property Office of compulsory licensing fees ruling request, and shall promptly send a copy of the written request to the other party.

Outside except where otherwise specified, the other party shall, from the date of receipt of the notification within the 15th presentation; did not reply to the expiry of, does not affect the State intellectual property office to make a decision. A compulsory license fee process, parties may submit their views in writing.

    The State intellectual property office needs to listen to the parties ' oral submissions on the merits.

    28th request before making a decision in the State intellectual property office to withdraw the ruling request, the award program termination.

    29th national intellectual property offices should be made within 3 months from the date of receipt of the request for a compulsory license fee award decision.

Article 30th compulsory license fee award decision shall clearly state the following:

(A) obtain compulsory licensing entity or individual's name and address;

(B) be given compulsory license for the patent for invention or utility model names, patent number, filing date and authorized notice date;

(C) the content of the decision and the reasons for it;

(D) the head of the State intellectual property Office of the seal and signature;

(E) the date of decision;

(F) other relevant matters.

    A compulsory license fee within 5th as of the date of the award decision shall notify the parties.

    Fifth chapter terminate the compulsory license requested review and decision

The 31st under any of the following circumstances, automatic termination of compulsory licenses:

(A) the decision to grant a compulsory license provisions of compulsory license expiry;

    (B) be given compulsory licensing of patents or utility model patent terminates or is declared null and void.

Article 32nd in the decision to grant a compulsory license provisions before the expiry of the period of compulsory licensing, compulsory licensing grounds for removal and will not recur, the patent holder may request the State intellectual property Office's decision to end compulsory licensing.

Requesting termination of compulsory licenses shall submit the termination of compulsory licensing request, stated the following:

(A) where the patentee the name or names and addresses;

(B) the registration of a patent holder's nationality or country or region;

(C) request to end a decision on granting a compulsory license number;

(D) requesting termination of compulsory licensing reasons and facts;

(E) where the patentee appoints a patent Agency, the trustee's name, organization code and the authorized agent's name, and license number, contact phone number;

(F) signature or seal of the patentee; appointed a patent Agency, should also have the stamp of the institution;

(G) the list of attached files;

(H) other matters should be marked.

    Request and any additional files should be in duplicate.

33rd request to terminate the compulsory license has any of the following circumstances, inadmissible and notify the requesting person:

(A) the claimant not be given compulsory licensing of patents or utility model patent the patentee;

(B) does not contain the requested termination of the decision on the grant of the compulsory license number;

(C) the requested file does not use Chinese;

    (D) clearly does not have the reason to terminate the compulsory license. Article 34th requested file does not conform to the provisions of article 32nd request shall, from the date of receipt of the notification of correction within the 15th.

    Expiration of the correction is not made, the request is considered to have not been filed. Article 35th of the State intellectual property office to terminate the compulsory license request, compulsory license for exploitation shall promptly send a copy of the written request made by units or individuals.

    Unless otherwise specified, but made compulsory licensing unit or individual shall, from the date of receipt of the notification within the 15th presentation; did not reply to the expiry of, does not affect the State intellectual property office to make a decision.

    36th State intellectual property office the patent holder should be for the reasons stated and submit all supporting documents as well as access to compulsory licensing unit or personal statement review comments; needs verification in the field, should be assigned more staff on-site.

    37th the patentee in the State intellectual property office before making a decision to withdraw its request, termination of the program. The 38th article following a review to consider a request to terminate a compulsory licence be unfounded, dismissed by the State intellectual property Office should be made to terminate the compulsory license decision. Prior to the decision to dismiss the requests for termination of compulsory licenses, shall notify the patentee proposed and the reasons for the decisions taken.

    Unless otherwise specified, a patentee from the date of receipt of the notification within the 15th representations. 39th following a review to consider a request to terminate a compulsory licence has merit, the State intellectual property Office's decision to end compulsory licensing should be made. Prior to the decision to terminate the compulsory license, compulsory license for exploitation shall be notified to make the entity or individual intends to make a decision and the reasons for it.

Unless otherwise specified, but made compulsory licensing of units or individuals presented their views from the date of receipt of the notification in the 15th.

Terminate the compulsory license shall specify the following:

(A) where the patentee the name or names and addresses;

(B) obtain compulsory licensing entity or individual's name and address;

(C) be given compulsory license for the patent for invention or utility model names, patent number, filing date and authorized notice date;

(D) the decision to grant a compulsory license number;

(E) the factual and legal basis of the decision;

(F) the head of the State intellectual property Office of the seal and signature;

(VII) date of decision;

(H) other relevant matters.

    Terminate the compulsory license within 5th as of the date of the decision shall notify the patentee and units or individuals obtain compulsory licenses.

    By-laws

    40th coming into force has been to grant a compulsory license decision and the decision to terminate the compulsory license and compulsory licenses automatically terminate, shall be registered in the patent register and announcement in the Patent Gazette.

    41st party disagrees with the decision of the National Council on compulsory licensing of intellectual property, may apply for administrative reconsideration or bring an administrative suit.

    This approach by the State intellectual property office is responsible for the interpretation of the 42nd article. 43rd these measures come into force May 1, 2012. On June 13, 2003 the State intellectual property office patent issued a compulsory license approach, 31st and November 29, 2005, released by the State intellectual property office, the 37th of the issues relating to public health measures for compulsory license on patent implementation of repealed simultaneously.