The revisions have been issued by the China National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA).

It is thought that the revisions will incentivize drugmakers to enter the Chinese market, by offering greater protection for brand-name products. The revisions also establish a new system for brand-name manufacturers and generics makers to resolve patent disputes.

A Hatch-Waxman-like approach
In resembling the Hatch-Waxman approach, China’s patent law will now provide companies with an early route to challenge generic medicines before they enter the market. This strengthens intellectual property rights of innovator manufacturers. In turn, generics makers have the opportunity to challenge the validity of drug patents during the approval process.

There are some differences in the Chinese and US approach, for example, in China there will be just a nine-month stay on regulatory approval once a lawsuit has been filed, in contrast to a 30-month stay in the US. Questions have been raised over whether it will be possible to solve dispute in this short timeframe. Another difference to the US system is that the first generics maker to successfully challenge a brand-name maker’s patent and obtain regulatory approval will have a 12-month period in which they are protected from competition from other generics, in contrast to a 180-day exclusivity period in the US.

The patent database
The new Chinese system includes both generics and biologicals, unlike the US system which only covers generics.

It will provide a platform for registering patent information. This database allows registration of compound patents, composition patents, and use patents related to small molecules, biologicals and traditional Chinese medicine. Patents related to intermediates, metabolites, crystalline forms, preparation methods, or detection methods are not eligible for registration.

Certifications for generics
When it comes to generics products, drug applicants filing for marketing authorization will be required to make certifications regarding the related brand-name innovator drug patents that are listed on the database. The certification system has four categories and is similar to the US’s Hatch-Waxman framework [1].

Generic drug applicants have 10 days after submitting a marketing approval application, to provide a notice of patent declaration to the marketing approval holder of the relevant innovative drug.

Patent term extensions
The revised Chinese system will now also allow for patent term extensions due to patent office delays. Similar extensions of up to five years are available in the US and Europe.

Related articles
The future of copy biologicals in China

Challenges facing copy biologicals in China

The state-of-play for copy biologicals in China

Copy biological approvals in China compared to the US and EU

China published new patent law amendment

  
Reference
1. GaBI Online - Generics and Biosimilars Initiative. China’s draft measures for patent linkage system [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/policies-legislation/China-s-draft-measures-for-patent-linkage-system

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.