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China Chemical/Medical Invention Examination Standard Update: Can Experimental Data Be Supplemented to Contest Insufficient-disclosure Rejection?

Scott Lin


Due to the characteristics of chemical/medical inventions, experimental data are usually essential when determining whether the claimed efficacy can be achieved.  In accordance with the previous examination practice of the Chinese Patent Office, experimental data cannot be supplemented to overcome the defect of an invention lacking test data proving the effect thereof described in the specification, in particular for cases wherein the name or example number of the compounds tested is not depicted in the assays provided in the original specification.  Accordingly, a rejection for lacking activity test data to support the effect of an invention is very difficult to overcome. 
 
The above strict examination standard is now changing.  Under current practice of the Chinese Patent Office, supplementary examples/data may be accepted for consideration by the examiner and may be submitted to overcome the defect of an invention lacking test data proving the effect described in the specification.  Nevertheless, for chemical/medical inventions where experimental data are essential to demonstrate the patentability of the claimed inventions, experimental data must be provided in the specification originally filed.  For example, with respect to inventions related to new use of a known compound, which is contrary to the teaching of prior art, a general assertion in the specification is insufficient to convince skilled artisans that the claimed invention indeed has the asserted new use.  Therefore, in such a circumstance, provision of experimental data in the specification originally filed is still necessary.


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