Source: China Intellectual Property News
The implementation of the Early Resolution Mechanism for Drug Patent Disputes is accelerated.
Recently, the National Medical Products Administration (NMPA) jointly with the China National Intellectual Property Administration (CNIPA) released the Measures of the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation) (hereinafter referred to as the Measures) and the supporting explanations on the policy. CNIPA subsequently issued the Administrative Ruling Measures of the Early Resolution Mechanism for Drug Patent Disputes. The topic of early resolution for drug patent disputes attracted the public concern rapidly.
Implementation of the Mechanism
The Early Resolution Mechanism for Drug Patent Disputes refers to the mechanism connecting the procedure of approving new drug listed with the procedure of resolving the related drug patent dispute. In order to implement the arrangements of the CPC Central Committee and the State Council, NMPA and CNIPA carried out the Measures after carefully studied the mechanism and learned from the foreign practices based on the comments from the delegates and the experts in the field.
In respect to the channels of early resolving the drug patent disputes, Article 6 of the Measures stipulates that a drug that the applicant requests for a drug marketing license shall act in accordance with the patent information disclosed on the patent information registration platform for drugs marketed in China, and shall make a declaration on each relevant generic drug patent. If the patentee or interested parties have objections, they may, within 45 days from the date of disclosure of the generics application by the NMPA, file a lawsuit before the court (namely the judicial channel) or request the CNIPA to make an administrative ruling (namely the administrative channel) as to whether the relevant technical solutions of the drugs applying for marketing approval fall within the protection scope of the relevant patents.
In respect to the declaration, the Measures stipulates that when the applicants of generic drugs and traditional Chinese medicines with the same name and same formulation submit an application for a drug marketing license, they will make declarations regarding each relevant patent in accordance with the patent information on the registration platform. Within 10 days of acceptance by the People’s Court or CNIPA, the patentee or generic drug applicant must notify the holder of drug marketing license with the declaration. If the declaration does not fall into the protection scope of the relevant patent, it shall be based on the comparison table of technical solution of the generic drugs and the claims of relevant patent, and the relevant technical materials. Besides the written materials, the applicant of generic drug shall send the declaration and the supporting materials to the email of the platform and save the records.
Public Concerns
Following the Measures, CNIPA issued the Administrative Ruling Measures for the Early Resolution Mechanism for Drug Patent Disputes to specify the subject, the conditions, and the files submitted. In the Provisions on Acceptance of Administrative Ruling for the Early Resolution Mechanism for Drug Patent Disputes, the measures and paper work are defined. According to the Notice of Issuing the Administrative Ruling Measures for the Early Resolution Mechanism for Drug Patent Disputes released by NMPA, the China’s listed drug patent information registration platform is officially operated. The Provisions on Several Issues Concerning the Application of Law in Hearing Civil Cases Involving Patent Disputes for Drug Listed for Registration, specifies the court for hearing, the specific causes of action, the materials for suing, and the connection between administrative and judicial procedures, and provides clear guidance for hearing such cases with fairness.
“Such a series of regulations demonstrate that the mechanism for early resolution of drug patent disputes is officially operated in China, as an important part of the drug patent protection system”, said the person in charge of IP department of Bayer (China). The mechanism is conducive to avoid the generic drug going into the market in advance, and encourage the pharmaceutical enterprises to further dedicate to innovations, and provide the relevant infringement information for the enterprises of generic drugs, so as to build a good business environment.
Ms. Mo Huan, attorney of Jia Yuan Law Offices, said, the mechanism of early resolution for drug patent disputes is fully carried out in China with the officially operation of the China’s listed drug patent information registration platform. The mechanism is seeking a balance between China’s innovative drugs and the generic drugs, to contribute the innovations of the pharmaceuticals industry. The mechanism demonstrates the achievement in the reform of China’s drug examination system, but also highlights the IP protection for drugs.
Mr. Zhao Xu, associate professor of Intellectual Property School of East China University of Political Science and Law said, according to the regulations released, the mechanism has drawn on foreign experience based on Chinese characteristics, which is an anticipating exploration. The encouragement for innovations in pharmaceutical industry will safeguard the heath of the public and improve the medical service. The mechanism is anticipated to perform its functions in the further.
Links:
On October 8, 2017, Opinions on Deepening Reform of Examination and Approval System and Encouraging Innovations of Drugs and Medical Devices, issued by General Office of the CPC Central Committee and General Office of the State Council, proposed to build a drug patent linkage system.
On July 3, 2020, Amendments of Patent Law of the People's Republic of China (Second Review Draft) issued by Commission for Legislative Affairs of the NPC Standing Committee, was added with the provisions on the Mechanism of Early Resolution for Drug Patent Disputes.
On July 4, 2021, the Measures of Early Resolution for Drug Patent Disputes (for Trial Implementation) were issued by the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA).
The Notice on the Measures of Early Resolution for Drug Patent Disputes (for Trial Implementation) was issued by the National Medical Products Administration (NMPA).
On July 5, 2021, the Provisions on Several Issues Concerning the Application of Law in Hearing Civil Cases Involving Patent Disputes for Drug Listed for Registration, was issued by the Supreme People’s Court (SPC).
The Administrative Ruling Measures for the Early Resolution Mechanism for Drug Patent Disputes and the Provisions on Acceptance of Administrative Ruling for the Early Resolution Mechanism for Drug Patent Disputes, were issued by the China National Intellectual Property Administration (CNIPA).
