China loosens grip on clinical trials, improves IP protection to boost innovation

To create a more innovation – friendly environment for the pharma industry, the Chinese Food and Drug Administration CFDA) recently released two drafts for public opinion until June 10, reports The Pharma Letter’s China correspondent Wang Fangquing.

On May 12, it released a draft aiming for intellectual property protection. Specifically, China will establish a pharmaceutical patent linkage system. Much like the system in the USA, new drug applications will be required to file with a statement about the status of all the related patents. In the case of any possible patent infringement, the applicant will have to inform the original patent owner within 20 days after filing a New Drug Application (NDA), and the patent owner will also have 20 days after the notice to initiate a infringement litigation and inform the CFDA, which will set an approval waiting period for no longer than 24 months.

The current Chinese patent law does not require applicants to inform original patent owners, and there is no approval waiting period. The infringed party often finds out the violations on its own, goes through lengthy litigation and gets the judicial judgement often after the patent protection is expired.