In follow up to the joint National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) release of patent linkage implementation measures, CNIPA has released the Administrative Adjudication Measures for Early Resolution Mechanisms for Drug Patent Disputes (药品专利纠纷早期解决机制行政裁决办法) on July 5, 2021. These Measures provide an alternative dispute mechanism to litigation (see the Supreme People’s Court’s (SPC) litigation provisions also issued July 5, 2021). CNIPA’s administrative adjudication may be the preferable route for patentees as the Administrative Adjudication Measures, unlike the SPC’s provisions, do not appear to provide for a defense of prior use or existing technology.
CNIPA will not accept a request for administrative adjudication if the patent is not registered on Center for Drug Evaluation platform, the claims are declared invalid by CNIPA, or a patent linkage case has been filed with the Beijing Intellectual Property Court previously.
Once accepted by CNIPA, CNIPA will notify the requester and respondent within five working days.
CNIPA may optionally conduct oral hearings and if so, will give the parties at least 5 working days notice.
If some claims in the patent are declared invalid, the CNIPA will still issue an administrative decisions based on the surviving claims.
If a party is dissatisfied with a CNIPA decision, the party may sue at the Beijing Intellectual Property Court.
Also note that like the SPC’s provisions, no deadline to conclude an adjudication is provided in the Administrative Adjudicate Measures despite the 9-month timeline set by the patent linkage implementation measures.
The full text (Chinese only) is available here.