China’s Drug Patent Linkage System

Innovation in China’s patent system: On July 4, 2021, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) published methods for the early resolution of drug patent disputes. Thus,  China now has a system of patent linkage.

The patent linkage system links the market approval of generic drugs to the expiration of patents on innovative drugs. An application for marketing approval of generic drugs must now take into account the patent status of previously marketed drugs to avoid potential patent infringement. This can prevent or resolve patent disputes at an early stage.

Drug approval holders must register the information about their patents on the patent platform for approved drugs in China. When the manufacturer of a generic drug submits an application for marketing approval, it must comment on all relevant drug patents published on the platform and notify the patent holder.

The platform includes three types of drug patents: chemical drugs, biological preparations and traditional Chinese medicines (TCM). If the patent holder disagrees with a generic chemical drug applicant’s declaration, it may file a lawsuit in court or request an administrative procedure with the CNIPA on whether the relevant technical solution of the generic drug application falls within the scope of protection of the relevant patent rights within 45 days after the NMPA discloses the drug marketing authorization application. Then, NMPA orders a 9-month waiting period for the application for registration of the generic chemical product.

If, during the waiting period, the court or CNIPA confirms that the generic drug falls within the scope of protection of the relevant patent, the registration process for the generic chemical drug is postponed until the patent right expires. If, on the other hand, it is confirmed that it does not fall within the scope of protection of the patent in question, or if the parties reach an agreement, the patent in question is declared invalid. If, at the end of the waiting period, no judgment has been rendered or no decision has been reached, the approval procedure continues.

Thus, while the system for linking drug patents can resolve potential disputes and protect the interests of patent holders at an early stage, it also places higher technical demands on manufacturers’ patents. Only high-quality drug patents can withstand patent challenges from generic manufacturers in a hurry.

Picture: Unsplash

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