Article 26(3) of China’s Patent Law requires that the specification of an application set forth the invention (or utility model) in a sufficiently clear and complete manner so as to allow a person skilled in the relevant art to be able to carry out the invention.  According to the Guidelines for Examination Part II Chapter 10, sufficient disclosure of a chemical (compound) invention should satisfy the following requirements:  

1. Identify the chemical (compound);

2. Describe how to prepare the chemical (compound); and

3. Describe the use and/or the technical effect of the chemical (compound). 

On December 4, 2013, the Patent Affairs Administration Department (Patent Affairs Department) of the State Intellectual Property Office of China (SIPO) held a “News Briefing on Patent Examination in SIPO” to “clarify” the examination standard involving the sufficiency of disclosure of chemical and medical inventions.  Specifically, the briefing discussed the relationship between the submission of post-filing experimental data and the sufficiency of disclosure during the examination of such applications.  The reason for the briefing was to address the problem of some Chinese Examiners applying a different standard of examination for sufficiency of disclosure than that required by SIPO.  The effective date for the application of the “clarified” standards was October 17, 2013.  These standards apply only to Office Actions issued after this date.  CCPIT Patent and Trademark Office provided a report of the briefing which can be found at the AIPLA web site. 

The briefing reiterated that the sufficiency of disclosure involves determining the technical solution achieved by the claims and whether this solution was achieved as of the filing date of the application.  Generally, in chemical (compound) applications in China, Examiners require the scope of the claims to conform very closely with the examples or specific embodiments described in the application at the time of filing.  Moreover, Chinese Examiners typically will not consider any supplemental data submitted after filing.  However, the briefing clarifies that the submission of post-filing experimental data is permissible in very limited instances, specifically, if being used to confirm that the technical solution has the use or effect asserted by the Applicant in the specification (such as to prove the facts or statements in the original specification are correct).  Nonetheless, submission of post-filing experimental data will not rectify a disclosure that is insufficient at the time of filing.  An example is provided of an application claiming a new use for a known compound, the use of which is contradictory to what is known in the prior art.  According to the briefing, in such an instance, a simple assertion in the specification of the new use will not be deemed sufficient for a person skilled in the art to be “convinced” that the technical solution does in fact have the asserted use.  Rather, the specification must contain experimental data supporting the use in order for the Examiner to find sufficiency of disclosure.  

While the clarification by the SIPO is helpful, it will be interesting to see how Chinese Examiners implement the standard.  It is not entirely clear how Chinese Examiners will differentiate between the permissible (to support that the facts or statements regarding the technical solution) and impermissible use (to establish the technical solution) of post-filing experimental data.