China to strengthen data and patent protection mechanisms for pharmaceutical industry

Recently, China’s State Council announced that it would strengthen the protection of intellectual property rights of the pharmaceutical industry. The announcement referred to both Data Protection and Patent Term Extensions. As will be discussed below, the measures appear to be especially beneficial towards those companies that take the Chinese market into account early on in the development and marketing.

 

Data protection

 

Soon after the announcement by the State Council, the China Food and Drug Administration provided draft measures for data protection, open for review and comments. Similar to the current situation in the US, those draft measures foresee a period of 6 years of data protection for new chemical entities and a period of 12 years for biologics. Orphan and pediatric drugs would also benefit from 6 years of protection.

 

However, the full protection timeframe would only be available for those cases where clinical trials have been run in China and if there is no delay in requesting marketing authorization in China versus other countries.

 

If the marketing authorization is requested with a delay, only 1 to 5 years of data protection are available. In cases where the marketing authorization is requested in China more than 6 years after a foreign application, no data protection is provided.

 

In addition, if no clinical data on Chinese patients is provided, the data protection duration is reduced by 75%, while 50% remains available if such data are supplied later on.

 

Patent term extension

 

Although no draft measures are available yet, the State Council announcement indicates a patent term extension of up to 5 years to compensate for the approval process. This term is thus similar to the current provisions regarding Europe’s Supplementary Protection Certificates (SPCs) and the US Patent Term Extensions (PTEs). However, different from those systems and in line with the Chinese draft measures on data protection, the announcements states that the patent term extension will be available for innovative drugs for which the marketing authorization is applied for simultaneously in China and abroad.

 

Conclusion

 

At the moment, it remains to be seen if, when and how the measures will come into force. The current indications do show the strongest benefits for which the testing and marketing authorization application are performed timely in China. For drugs for which China will present an important market in the future, pharmaceutical companies might take these indications into account as early on as when discussing clinical trial design. 

 

GEVERS will keep monitoring the further implementation. For the time being, do not hesitate to contact our SPC specialists or China Desk for more information.

 

By Stijn LAGAERT

Senior European Patent Attorney

 

 
     
Stijn LAGAERT   Yi-Han HSIEH
Senior European Patent Attorney  
Patent Engineer
    Chinese Patent Attorney
   

China Desk Expert

 

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