China accepts cluster of complaints under new patent linkage law
The China National Intellectual Property Administration (CNIPA) has accepted its first set of drug patent linkage complaints since the introduction of a new patent law in June 2021. The office confirmed the development in a statement released on October 29.
The new law, the “Administrative Adjudication Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes” provides a legal and institutional basis for the early settlement of drug patent disputes.
According to Venable partners Keith Haddaway and Christopher Loh, the updated patent legistlation will see r egistration, review and litigation in China fall in line with established international IP systems.
As of October 27, the office received 23 requests for administrative adjudication of drug patent disputes from patentees or drug marketing license holders, the CNIPA’s statement said.
The office carried out a preliminary review of the requests, and issued acceptance notices for 12 requests that met the acceptance conditions, and the cases were formally filed.
The new law creates a linkage system for patent listing and pre-approval adjudication of patent claims, similar to the Hatch Waxman system in the US, and involving the National Medical Products Administration (NMPA) and CNIPA. The law also creates a patent information platform for marketed drugs, similar to the US orange book, and introduces patent term extension for regulated drugs.
Article 76 of the Patent Law stipulates that the applicant for a drug marketing authorisation and the relevant patentee or interested party may file a dispute with the patent right of the drug for which registration is applied for.
The revised law provides for three new measures, including the introduction of an administrative adjudication committee for the early resolution of drug patent disputes; the second enables an announcement on the acceptance of administrative adjudications of the early resolution of drug patent disputes to clarify such cases.
The third allows for the formulation of relevant case handling regulations to further refine and standardise case trial procedures. The office aims to strengthen information communication and coordination with the State Drug Administration and People's Courts to ensure the smooth implementation of the system, according to the statement.
It also seeks to protect the legitimate rights and interests of drug patent holders, encourage research on new drugs, and reduce the risk of patent infringement after the listing of generic drugs.
