Abstract:
The newly revised
Patent Law of the People’s Republic of China has established an early resolution mechanism for pharmaceutical patent disputes. The waiting period for the marketing approval of generic drugs serves as a supporting system within this early resolution mechanism. The waiting period plays a crucial role in balancing the interests of original drug manufacturers, generic drug manufacturers, and the general public. The current procedural framework of the system for the waiting period lacks systematic design. It is thus necessary to clarify and streamline the procedures governing its actual operation. In practice, the waiting period system still exhibits several deficiencies. These include unreasonable duration settings, a lack of legal safeguards against abuse by original drug manufacturers, and insufficient coordination among relevant departments. The improvement of early resolution mechanism for the pharmaceutical patent should include the establishment of a flexible waiting period. This must be supported by stronger legal regulations against abuse of this period by originator companies and improved functional coordination across departments.