Moving to systematize the settling of patent disputes, Chinese health regulators are testing an online patent linkage system designed to connect the approval for marketing of generic drugs with the expiration of innovative drug patents. The system puts into effect patent linkage measures issued late last year. Under the measures, a generic drug will not be approved until the patent term on its branded equivalent has expired, or until the relevant authority has determined the branded drug’s patent will not be infringed or is invalid.
The regulations cover chemical drugs, biologics, and traditional Chinese medicines. They codify regulatory language and bolster protections rarely enforced by Chinese authorities in the past. Originator drugs must be approved for sales in China in order to be eligible for patent linkage registration.
The test system began operating in mid-May and will be replaced by a permanent registration platform sometime after June 1, when the new patent law takes effect. Applicants who register using the test system can choose to have their registrations transferred to the permanent system when it is launched.