Patent linkage is a system where a country links drug marketing approval of a generic drug to the status of the patents related to the originator’s product. In China, there have been a series of regulations that have been released for public comment which indicate that China will soon be introducing a patent linkage system: on May 12,2017, the China Food and Drug Administration (CFDA) announced for public comment “Policies regarding the Promotion and Protection of Innovators’ Rights in Pharmaceutical Products and Medical Devices” (“Announcement No. 55”); 2) on October 8, the General Office of the CPC (Central Committee) and the General Office of the State Council of the People’s Republic of China published an “Opinion on the Promotion of Reformation regarding Examination and Approval System as well as Innovation of Pharmaceutical Products and Medical Devices” (“Opinion”) for extensive implementation of reforms; and 3) on October 23, the CFDA released for public comment “Administration Regulations for Registered Pharmaceutical Products” (“Proposal for Revision”).
This system hopes to ensure a stable supply of pharmaceutical products by taking the patent term of an original drug into consideration by, for example, negotiating with the original drug manufacturers prior to the approval of generic drugs. Since 2007, generic drug applicants are obliged to declare that their generic drug products do not infringe the patent right of the original drug. However, there is no mention of the punishment or penalty for non-conformance with this obligation. Since the CFDA is not capable of examining whether the generic drug infringes a patent right in response to the approval application for generic drugs, it is highly probable that the CFDA will approve the generic drug without clarifying the possibility of patent infringement. The linkage system will attempt to resolve these issues, but as commented below, the new set of regulations will still be insufficient and advantageous for generics as a whole. Therefore, generic drug manufacturers are expected to mount a more vigorous challenge to original drug manufacturers’ patent rights and original drug manufacturers are expected to file lawsuits in response to these challenges. Thus, disputes regarding patent rights are likely to increase further after introduction of the patent linkage system.