Is there a remedy for lack of transparency and expeditious preventive remedy under the current patent linkage provisions?
When the Patent Linkage provisions were first adopted in China, we understood the process to be roughly as follows (no official at SFDA has confirmed the exact procedures which are in place): pioneer company lists patent information in drug registration application; generic company required to complete a patent search through SIPO or agency with access to SIPO data base; patent search report provided to SFDA. However, this process lacked transparency in two important ways: pioneer company has no notice of the name or date of acceptance of second drug registrants application by SFDA for the pioneers product; pioneer company has no access to the patent search report submitted by the generic company. As a result: pioneer company has no access to legal evidence of drug registration application having been filed (because of lack of receipt of notice from generic company and lack of public disclosure of second drug registrants application) which can cause many complications when making appli
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