Provisions on patent right in drug registration application

According to China's Measures for the Administration of Drug Registration, drug registration refers to the process that the US Food and Drug Administration systematically evaluates the safety, effectiveness and quality controllability of drugs to be listed according to the application and legal procedures of drug registration applicants, and decides whether to approve their applications. Provisions on Patent Rights in Drug Registration Applications Drug registration applications include applications for new drugs, drugs with national standards, imported drugs and supplementary applications. Domestic applicants apply for drug registration in accordance with the procedures and requirements for new drugs and drugs with existing national standards, and overseas applicants apply for drug registration in accordance with the procedures and requirements for imported drugs. To apply for drug registration, the applicant shall submit it to the local (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government, and submit relevant materials and drug samples; The application for registration of imported drugs shall be submitted directly to the State Food and Drug Administration. When filing an application, the applicant shall provide a description of the patent of the applicant or others in China and the ownership status of the drug applied for registration or the prescription, process and use used; If another person owns a patent in China, the applicant shall submit a statement that the patent of another person does not constitute infringement. For a drug that has been patented by others in China, the applicant may apply for registration within 2 years before the expiration of the patent term of the drug. The State Food and Drug Administration of the United States shall conduct an examination in accordance with these Measures, and if it meets the requirements, it shall issue a drug approval number, an import drug registration certificate or a pharmaceutical product registration certificate after the patent expires. If a patent dispute occurs after the approval of the drug registration application, the parties concerned may settle it through consultation or through the patent administration department or the people's court in accordance with the provisions of relevant laws and regulations. The patentee may apply to the State Food and Drug Administration to revoke the drug approval number of the infringer according to the final ruling of the patent administration department or the effective judgment of the people's court, and the State Food and Drug Administration shall revoke the drug approval number of the infringer accordingly. Note: the applicant for drug registration (hereinafter referred to as the applicant) refers to the institution that applies for drug registration, bears corresponding legal responsibilities, and holds the drug approval certificate after the application is approved. The domestic applicant shall be an institution legally registered in China and able to bear civil liability independently, and the overseas applicant shall be an overseas legal pharmaceutical production enterprise.