Patent Linkage

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 […]

CHINA: New Patent Examination Guidelines Now Available for Public Comment

4 August 2021

Two months after the new Chinese Patent law came into effect, the CNIPA has released a new set of Patent Examination Guidelines (proposed version) for public comments on Aug 3, 2021. Here are the explanation of the amendments (Chinese only). Here is the full set of proposed amendments (Chinese only). Briefly, the new amendment focuses […]

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 […]

China Releases Details on Patent Term Extension, Deferred Examination and More in the Latest Draft Implementation Rules of the New Chinese Patent Law

11 December 2020

The China National Intellectual Property Administration (CNIPA) is moving forward at breakneck speeds aiming to get all the necessary pieces in place for the June 1, 2021 date when the new 4th Amendment of the Patent Law will come into effect. Most recently, this means a flurry of drafts coming out from CNIPA, including, but […]

How will Civil Cases Work under the Patent Linkage Provision in the New Chinese Patent Law?

20 November 2020

The Supreme People’s Court has just issued draft regulations for comment regarding how new Article 76 will work in conjunction with civil procedure law. The period to submit comments ends December 14, 2020, and the final version will come into force June 1, 2021, together with the new Chinese Patent Law. The Backdrop: New Chinese […]

Breaking News: China passes Fourth Amendment to the Chinese Patent Law

19 October 2020

After 12 years, the Fourth Amendment to the Chinese Patent Law has passed and will be in effect on 1 Jun 2021. After years of multiple draft amendments that moved in various directions, we FINALLY have some clarity on what patent protection is going to look like in China in the coming future. Many of […]

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. […]