Recently, the China National Intellectual Property Administration (CNIPA) concluded three cases of drug patent disputes resolved through the administrative channel. These are the first batch of cases of the type since the implementation of the revised Patent Law, which, among others, provides for the establishment of an early resolution mechanism in China for drug patent disputes, i.e., the drug patent linkage system.

 

This first batch of cases involves three invention patents (No. 201210135209.X, No. 201510599477.0, and No. 201010151552.4) related to the same original drug of oxycodone hydrochloride prolonged-release tablet. The cases were bought by the patentee against a company seeking marketing authorization of the generic drug, requesting the affirmation that the technical solutions of the generic drug fall within the protection scope of said patents. The CNIPA set up a collegial panel of five members, who all possess patent examination experience in the fields of drug or chemistry, to assist in the evidence collection and trial of the cases. Upon adjudication it was deemed that the technical solutions of the generic drug at issue do not fall within the protection scope of said patents.

 

According to Article 76 of the revised Patent Law, which took effect on 1 June 2021, interested parties in a drug patent dispute may seek remedies by means of litigation or administrative adjudication, wherein the CNIPA is responsible for the administrative route. The said cases were accepted in October 2021 and concluded by the CNIPA within 6 months.