The Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) are open for comments

On September 11th, the General Department of the State Drug Administration and the Office of the State Intellectual Property Office issued the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments).
In order to implement the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices, and the Opinions on Strengthening the Protection of Intellectual Property Rights to Explore the Requirements for the Establishment of a Drug Patent Link System, the State Drug Administration and the State Intellectual Property Office have drafted the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments) and are now soliciting opinions from the public.
Annex 1 Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments) Article 1 "Legislative Purposes" These Measures are formulated in order to protect the legitimate rights and interests of drug patent holders, encourage research and promotion of new drugs and promote the development of high-level generic drugs, and establish an early resolution mechanism for drug patent disputes.
article 2 (Patent Information Registration) The drug regulatory department under the State Council shall establish a platform for the registration of patent information for drugs listed in China for the registration of drug-related patent information registered and listed in China by the licensed holders of drugs listed in China, and make it available to the public.
these Measures shall not apply to patent information that has not been registered on the patent information registration platform for drugs listed in China.
3 (Platform Management) The State Drug Review Agency is responsible for establishing and maintaining a platform for the registration of patent information for listed drugs in China.
when the applicant declares the drug for market, he or she registers the drug name, relevant patent number, patent type, patent status, patent owner, license holder, expiration date of patent protection, mailing address, contact person, contact information, etc.
the relevant patents for listed drugs, the holder may supplement the submission of relevant patent information.
the applicant or the drug listing license holder is responsible for the authenticity, accuracy and completeness of the relevant patent information submitted by him.
Article 4 During the drug review period, if the applicant obtains a patent right, he may register the patent information on the patent registration platform of the drug patent information listed in China within 30 days from the date of the announcement of the grant of the patent right, and submit the patent information to the State Drug Review Agency.
the information of registered drug patents is changed, the applicant or the holder of the drug listing license shall make the change registration within 30 days after the change has taken effect.
Article 5 When an applicant for a chemical drug registration submits an application for a drug market license, he may register a patent for a drug-active ingredient compound, a patent for a pharmaceutical composition containing an active ingredient, and a patent for a pharmaceutical use on a drug patent registration platform listed in China.
Article 6 (Patent Statement) When an applicant for a chemical generic drug submits an application for a drug market license, he shall make a declaration against the patent information contained in the patent information registration platform of the drug that has been listed in China, and provide the basis for the declaration of each relevant drug patent of the generic drug. the
statement is divided into four categories: one kind of declaration: no patent information related to generic drugs in the patent information registration platform of listed drugs in China, and two types of declaration: the relevant patents of generic drugs included in the patent registration platform of listed drugs in China have been terminated or declared invalid, and three types of declarations: patent information registration platform of listed drugs in China Contains patents related to generic drugs, generic drug applicants promise not to list generic drugs applied for before the expiration of the patent validity period, four types of statements: China's listed drug patent information registration platform included in the generic drug-related patent rights should be declared invalid, or their generic drugs did not fall within the scope of the relevant patent protection.
applications for generic drugs and corresponding statements are made available to the public on the information platform of the National Drug Review Agency.
Article 7 If the patent right or interested party objects to the patent declaration or declaration on the basis of the patent statement, it may, within 45 days from the date on which the State Drug Review Agency announces the application for a drug listing license, file a suit in a people's court or apply to the patent administrative department under the State Council for an administrative ruling on whether the relevant technical scheme for the application for a listed drug falls within the scope of protection of the relevant patent rights.
If a patente or interested party files a lawsuit or applys for an administrative award within the prescribed time limit, a copy of the acceptance notice shall be submitted to the State Drug Review Institution within 10 days from the date when the people's court or the patent administrative department under the State Council files a case or accepts it.
If the patente or interested party has not filed a lawsuit or applied for an administrative ruling within the prescribed time limit, the drug regulatory department under the State Council may directly make a decision on whether to approve the listing in accordance with the conclusions of the technical review and the declaration submitted by the applicant for generic drugs.
article 8 (Waiting period) From the date when the people's court or the patent administrative department under the State Council files a case or accepts it, the drug regulatory department under the State Council shall set a waiting period of 9 months for the application for registration of chemical generic drugs, and the state drug review institution shall not stop the technical review during the waiting period.
Article 9 (Classification Approval) The drug regulatory department under the State Council shall, on the basis of the conclusions of the technical review, make a decision on whether to approve the listing of an application for registration of chemical generic drugs submitted in the first and second categories of declarations;
Article 10 (Category Approval) Application for registration of chemical generic drugs in the case of filing a category 4 declaration, such as the patente or interested party, shall apply for the relevant technology of the listed drug within 45 days from the date on which the State drug review agency announces the application for a drug listing license. Whether the scheme falls within the scope of protection of the relevant patent rights to bring a suit in a people's court or apply for an administrative ruling with the patent administrative department under the State Council, the patent right or interested party shall, within 10 days of receipt of the judgment or decision, report the judgment or decision to the State drug review institution.
For applications for registration of chemical generics approved by technical review, the State Drug Review Agency shall deal with them accordingly in conjunction with the judgment of the people's court or the administrative decision of the patent administrative department under the State Council: (1) if it is confirmed that it falls within the scope of the protection of the relevant patent rights, the application for the relevant chemical generics shall be transferred to the administrative examination and approval process 20 working days before the expiration of the patent term; In accordance with the procedures, the relevant application for chemical generic drugs shall be transferred to the administrative examination and approval process; (3) if the relevant patent rights are declared invalid, the relevant application for chemical generic drugs shall be transferred to the administrative examination and approval link in accordance with the procedures; (4) if the people's court or the patent administrative department under the State Council has not made an effective judgment or administrative ruling, or if no mediation letter has been issued, the relevant application for chemical generic drugs shall be transferred to the administrative examination and approval link in accordance with the procedure.
(5) If the drug regulatory department under the State Council receives a judgment from a people's court or an administrative ruling of the patent administrative department under the State Council during the period of administrative examination and approval, confirming that it falls within the scope of the protection of the relevant patent rights, the relevant application for chemical generic drugs shall be submitted to the State Drug Review Agency for handling in accordance with the provisions of Paragraph 1 of this Article.
After the drug regulatory department under the State Council has made a decision to suspend approval in accordance with the judgment of the people's court or the administrative decision of the patent administrative department under the State Council, the applicant for generic drugs may apply to the drug regulatory department under the State Council for approval of the listing of generic drugs, and the drug regulatory department under the State Council may make a decision on whether to approve the generic drug in accordance with the conclusions of the technical review and the final judgment of the people's court.
Article 11 "Encouraging Policy" The drug regulatory department under the State Council shall not approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug, and the exclusive period of the market shall not exceed the patent term of the challenged drug.
drug review agencies do not stop technical reviews during the exclusive market period.
application for registration of chemical generic drugs approved by the technical review shall be transferred to the administrative examination and approval process 20 working days before the expiration of the exclusive market period.
Article 12 (Classification Treatment) Applicants for registration of biological products and Chinese medicines for listing shall, in accordance with Articles 2, 3, 4, 6 and 7 of these Measures, register and declare relevant patent information.
can register sequence structure patents, Chinese medicine can register Chinese medicine composition patents, Chinese medicine extract patents, pharmaceutical use patents.
Article 13 (Classification Treatment) For applications for registration of biosynthic drugs and Chinese medicines of the same name, the drug regulatory department under the State Council shall, on the basis of the conclusions of the technical review, directly make a decision on whether to approve the listing.
If the patente or interested party, within 45 days from the date when the State Drug Review Agency announces the application for a drug listing license, brings a suit in a people's court or applys to the patent administrative department under the State Council for whether the relevant technical plan for the drug for listing falls within the scope of protection of the relevant patent rights, and the people's court or the patent administrative department of the State Council confirms that the relevant technical plan falls within the scope of patent protection before the completion of the drug administrative examination and approval procedure, the drug regulatory department under the State Council shall indicate the approval of the listing decision after the expiration of the patent period.
the approval of generic drugs for listing, the patente believes that generic drugs infringe their corresponding patent rights and cause disputes, and the dispute shall be resolved in accordance with the provisions of the Patent Law and other laws and regulations.
the market license of a drug that has been approved in accordance with the law shall not be revoked and shall not affect its effectiveness.
Article 15 (Subject Responsibility) Applicants and their agents who have deliberately submitted false statements and other frauds and deliberately incorporated other unrelated patents into the patent information registration platform for listed drugs in China shall be subject to joint disciplinary action for breach of trust in accordance with the law, and the applicant shall not apply for registration of the species again within one year;
Article 16 (Time of Implementation) These Measures shall come into effect from the date of XX.
Annex 2 Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments) drafted the Measures to protect the legitimate rights and interests of patent holders, reduce the risk of patent infringement of generic drugs, encourage drug research and development innovation, and promote the development of high-quality generic drugs, which were jointly studied and drafted by the State Drug Administration and the State Intellectual Property Office.
the relevant situation is explained as follows: First, the drafting background and process drug patent link system or the early settlement mechanism of drug patent disputes refers to the drug market approval procedures and drug patent dispute resolution procedures linked to the system.
October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug Medical Device Innovation, calling for the exploration of the establishment of a drug patent link system.
November 2019, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Strengthening the Protection of Intellectual Property Rights, once again proposing to explore the establishment of a link system for drug patents.
In order to implement the decision-making and deployment of the CPC Central Committee and the State Council, and promote the establishment of an early settlement mechanism for drug patent disputes in China, the Drug Administration and the Intellectual Property Office, together with relevant departments, have carefully studied the specific system of the early settlement mechanism for drug patent disputes in China, formed the basic framework of the early settlement mechanism for drug patent disputes in China, and organized in-depth discussions between relevant legal experts, experts in the field of patent management and drug management, as well as industry representatives and associations.
II. The main content (1) The drug regulatory department of the State Council establishes the registration platform for the registration of patents of listed drugs in China, which is used by the licensed holders of drugs listed in China to register the relevant information on the core patents of drugs listed in China and make them available to the public as a basis for generic drug applicants to provide a declaration of the status of patent ownership.
these Measures shall not apply to patent information that has not been registered on the patent information registration platform for drugs listed in China.
(2) To clarify the scope of drug patent registration and to clarify the scope of drug patents covered by the early settlement mechanism of drug patent disputes is the basis for establishing an early settlement mechanism for drug patent disputes.
The scope of specific drug patents registered in the China-listed drug patent information registration platform may include: patents for pharmaceutical active ingredient compounds of chemical drugs, patents for pharmaceutical compositions containing active ingredients, patents for pharmaceutical uses, patents for sequence structure of biological products, patents for Chinese medicine compositions, patents for Chinese medicine extracts, patents for pharmaceutical uses.
the applicant or the drug listing license holder is responsible for the authenticity, accuracy and completeness of the relevant patent information submitted.
(3) The patent declaration system of the patent status declaration system for generic drug applicants urges generic applicants to respect the legitimate rights and interests of drug patent holders, and the applicant shall bear the consequences and responsibilities a result of submitting false statements in accordance with the law.
a generic drug applicant submits an application for a generic drug listing license, he shall file a corresponding declaration against the patent information registered on the patent registration platform of a listed drug in China, and the patent status declaration shall be divided into four categories.
and corresponding declarations for the listing of generic drugs shall be made public to the public on the information platform of the national drug review agency.
(4) If the patent right right or interested party has expressed any objection to the patent declaration or declaration of the generic drug applicant within a specified time limit for the patent right or interested party to object, it may, within 45 days from the date of the publication of the application for a generic drug listing license, file a lawsuit with the people's court or apply to the patent administrative department under the State Council for an administrative ruling on whether the relevant technical scheme for the drug to be listed falls within the scope of protection of the relevant patent rights.
the patente or interested party has not raised any objection within the prescribed time limit, the drug regulatory department under the State Council may directly make a decision on whether to approve the listing in accordance with the conclusions of the technical review and the declaration submitted by the applicant for generic drugs.
(5) The waiting period for the examination and approval of chemical drugs shall be balanced between the interests of the patent holder or the original drug listing license holder and the generic drug applicant, taking into account China's judicial and patent administrative protection practice, the patent holder or interested party shall apply within 45 days from the date of publication of the application for a generic drug listing license. If the relevant technical plan for listed drugs falls within the scope of protection of the relevant patent rights to bring a suit in a people's court or apply for an administrative ruling with the patent administrative department under the State Council, the drug regulatory department under the State Council shall set a waiting period of 9 months for the application for a license for the listing of chemical generic drugs from the date on which the people's court or the patent administrative department under the State Council opens a case or accepts the application, and the state drug review institution shall not stop the technical review during the waiting period.
application for registration of biosynthic drugs and Chinese medicines of the same name, the drug regulatory department under the State Council shall, on the basis of the conclusions of the technical review, make a direct decision on whether to approve the listing.
(6) to implement a classification of drug review and approval to deal with the patent status declaration category proposed by the drug regulatory department under the State Council on the basis of applicants for chemical generic drugs