Regulatory

China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results

30 June 2022

China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, […]

China Releases Draft Implementation Guidelines for the Drug Administration Law

2 June 2022

The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval […]

Breaking: China Released New Implementation Measures for the New Patent Linkage System

14 July 2021

On July 4, 2021, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) released details on the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage”), effective July 4, 2021. Below is a summary highlighting key provisions and changes from the draft measures. Creation of an […]

A Detailed Dive into China’s New Patent Term Extension Provisions

11 December 2020

This article is a part of a larger article that highlights the newest draft implementation rules of the new Chinese Patent Law. This particular article takes a detailed dive into the patent term extension/adjustment provisions. One of the biggest and most exciting provisions in the newly amended patent law is patent term extension for delay […]

China Forges Ahead with Draft Measures for New Patent Linkage System

19 October 2020

Update! The finalized Implementation Measures are now out. You can read the details here: Breaking: China Released New Implementation Measures for the New Patent Linkage System Last month September 11, 2020, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued a draft set of measures for public opinion […]

Breaking News: Newest Draft Amendment to the Chinese Patent Law Available for Public Comment

10 July 2020

Finally, after more than a year since the last draft amendment came out in 2019, a new draft has been submitted to the National People’s Congress Standing Committee for deliberation on June 28, 2020. The newest version is now published for public comments until August 16, 2020. As a whole, these proposed changes address a […]

New Policies to Promote Importation of Innovative Drugs

8 November 2018

At the April 12, 2018 executive meeting of the State Council in China, Premier Mr. Li Keqiang indicated the government’s desire to increase China’s access to innovative drugs. To achieve this, the government would encourage importation of innovative drugs into China by streamlining the regulatory pathway, enhancing IP protection, and lowering the cost of medicine. […]