On January 4, China’s National People’s Congress (NPC) released its draft amendments to the Chinese Patent Law, opening a docket for public comments to be submitted by February 3. Significantly, for the first time, the Patent Law would provide up to five years of patent term restoration  for patent term loss due to National Medical Products Administration’s (NMPA, formerly China Food and Drug Administration) regulatory review, but only when a new drug application is concurrently filed both in China and abroad. Under the draft amendments, the total duration for patent rights in China would be 20 years for invention patents and the total effective patent term shall not exceed 14 years after the new drug is launched.

Also under the draft revision, the statutory compensation for patent infringement would be increased from a maximum of 1 million to 5 million RMB Yuan (around 700,000 USD), and 1-5 times punitive damages for willful infringement would be added.

This move comes as China continues developing its “Hatch-Waxman” system to encourage new drug development.  NMPA already published a draft guidance that provided details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. The government is expected to finalize rules on data exclusivity protection for new drugs later this year.

If you have any questions about the amendments or wish to submit comments, please contact us.