China’s National Intellectual Property Administration Rules in First Batch of Patent Linkage Cases

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On April 26, 2022, the China National Intellectual Property Administration (CNIPA) announced that is concluded the first batch of patent linkage cases related to “Oxycodone Hydrochloride Sustained-Release Tablets” from Purdue Pharmaceuticals.  China’s patent linkage system prevents marketing authorization for a generic prior to the expiration of the patent term on the branded equivalent unless the Beijing IP Court or the China National Intellectual Property Administration (CNIPA) rules that the generic does not fall within the scope of the relevant patent rights or is invalid. In this batch, CNIPA ruled that “the technical solutions related to generic drugs did not fall within the protection scope of the above patent rights.”  The Beijing IP Court recently ruled similarly against a foreign patentee in its first patent linkage case.

FIG. 1 of CN201510599477.0

The invention patents involved were No. 201210135209.X, No. 201510599477.0 and No. 201010151552.4.  Notably, CNIPA, like the first Beijing IP Court patent linkage case, was able to issue a decision within the 9-month moratorium on generic marketing authorization.

CNIPA stated,

The above-mentioned cases are among the first adjudication cases for early resolution of drug patent disputes through administrative channels. The CNIPA attaches great importance to it, and immediately established a five-member collegial panel. All members of the collegial panel have senior patent examination experience in the fields of medicine or chemistry.  During the trial of the case, the collegial panel strictly took facts as the basis and the law as the criterion, obtained relevant evidence from the drug regulatory department, organized multiple rounds of evidence exchange and pretrial conferences between the parties, and conclude the case in a timely manner after oral trial and panel deliberations. The trial period of this batch of cases was only six months, which effectively handled the patent disputes arising from the drug marketing review and approval process, and also accumulated practical experience for the trial of similar cases.

…Up to now, a total of 59 requests for administrative adjudication have been received, and 39 requests that meet the acceptance conditions have been filed.

CNIPA did not release copies of the decisions. The full text of the announcement is available here (Chinese only).

Author: Aaron Wininger

Aaron Wininger is a Senior Attorney and Director of China Intellectual Property at Schwegman Lundberg & Woessner.

Author: Aaron Wininger

Aaron Wininger is a Senior Attorney and Director of China Intellectual Property at Schwegman Lundberg & Woessner.