China Patent Linkage News Flash (III) – CNIPA Administrative Adjudication Measures announced on 5 July 2021

Published

Jul 05 2021

Written By

Partner
China

As a partner in our Intellectual Property Group in Hong Kong and Head of our Life Sciences & Healthcare Sector Group in Asia, I have 24 years' experience in advising clients in the life sciences, healthcare, food & beverage and retail & consumer sectors.

Martoe Xu

Registered Foreign Lawyer
China

I am a Registered Foreign Lawyer in our Intellectual Property Group, based in the Hong Kong office.

The China National Intellectual Property Administration (“CNIPA”) will now officially accept patent linkage cases according to the “Notice on the Acceptance of Patent Linkage Adjudication” (the “Notice”) because the “Administrative Adjudication Measures for Drug Patent Dispute Early Resolution Mechanism” (“Patent Linkage Administrative Adjudication Measures”) was issued and effective on 5 July 2021.

The key provisions in the Patent Linkage Administrative Adjudication Measures are set out as follows.

1. Case filing requirements

The CNIPA has established a Patent Linkage Administrative Adjudication Commission to handle patent linkage administrative adjudication proceedings.

(1) Parties

The Applicant can be the generic drug applicant or patentee/interested party. However, the generic drug applicant can only file a request if the patentee or interested party does not file patent linkage proceedings before the court or CNIPA within the prescribed 45-day timeline, which is in line with the Patent Linkage Implementing Measures.

The interested party can be the patent licensee or the registered drug marketing authorization holder (“MAH”). A MAH or an exclusive patent licensee can file the request on its own i.e. without the patentee, but a patent licensee of a sole licence agreement can only file the request on its own if the patentee does not file it.

If the patent is owned by multiple parties, the request must be filed by all the owners,…