NMPA and CNIPA Jointly Issued Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Patent Linkage)
Issue Date: 2021-07-04
On July 4, 2021, the NMPA and the CNIPA issued the “Implementation Measures for the Early Settlement Mechanism of Drug Patent Disputes (for Trial Implementation)” (the “Measures”), which aims to provide a mechanism for parties to resolve relevant patent disputes in the drug marketing review and approval process, protect the legitimate rights and interests of drug patent owners, and reduce the risk of patent infringement after the listing of generic drugs. That is, a system for patent linkage.
Key features of the Measures include: construction of an information platform, patent right registration, generic drug patent declaration, bifurcated judicial and administrative proceedings, waiting period for approval, drug review and approval classification and processing system, and first generic drug market exclusivity.
The early resolution mechanism of drug patent disputes refers to the system that connects the drug marketing approval procedures with the drug patent dispute resolution procedures. According to the Measures, parties can obtain an early resolution of drug patent disputes through either the judicial route or administrative route (i.e. the patentee or interested party may file a lawsuit before the court or request an administrative ruling from the CNIPA on whether the relevant technical solution of the drug applied for marketing falls within the scope of protection of the relevant patent right).
The relevant drug patents covered by the early resolution mechanism of drug patent disputes include: API compound patents, pharmaceutical compositions with API patents and medical use patents for chemical drugs (excluding APIs); traditional Chinese medicine (“TCM”) composition patents, TCM extract patents and TCM medical use patents; API sequence patents and medical use patents for biologics. The relevant patents do not include patents on intermediates, metabolites, crystal forms, preparation methods, and detection methods.