China: SIPO Shifts On Data Disclosure Requirement

Last Updated: 20 January 2016
Article by He Jing and Wu Li

Article 26.3 of the Chinese Patent Law specifies a sufficient disclosure requirement: "the description shall set forth the invention or utility model in a manner sufficiently clear and complete so as to enable a person skilled in the relevant field of technology to carry it out." However, there was a great deal of controversy in Chinese patent practices concerning whether or not the State Intellectual Property Office (SIPO) had correctly interpreted this provision for medical inventions, especially the so-called "compound invention", which is an invention simply directed to a compound itself, not to the potential pharmaceutical usage of the compound.

SIPO had been heavily criticized for insisting that, for all medical inventions including compound inventions, some rather specific experimental data demonstrating the pharmaceutical usage of the invention must be included in the specification, and that no post-filing data is allowed to address the sufficient disclosure rejection under this circumstance. Given the difficulties in selecting the right pharmaceutical compound(s) among thousands of potential candidates during the early R&D stage, and the unavoidable delay in obtaining experimental data on the biological effects of the selected com- pounds, such a unique experimental data requirement substantially impeded applicants in the pharmaceutical industry from timely filing new applications.

According to the criticisms, this unique data requirement of SIPO for medical inventions, especially for compound inventions, is not in line with the patent practices in other major jurisdictions. Several comparative studies, including studies made from the pharmaceutical industry association INTERPAT, were conducted and showed that, for many compound inventions, national stage applications derived from the same PCT. application can be granted in all other major jurisdictions but China, with the rejection merely based on this exact ground – lack of specific experimental data in the specification to demonstrate the pharmaceutical use of the claimed compound.

Although SIPO had long taken a defensive position to address these criticisms, recently there are clear signs that SIPO started to soften its attitude in this regard. On December 4 2013, SIPO held a short news briefing to clarify its official examination standard on disclosure issue, assuring that its examination of disclosure on medical inventions would not simply be based on whether or not the specification contains any experimental data and that post-filing data would not be flatly rejected under this circumstance. More than one and half years have passed and, according to our observation, SIPO's practices indeed have undergone certain changes.

For example, we recently conducted an empirical study based on the published re-examination decisions after January 1, 2014, and found out that, to our surprise, for all those cases concerning pharmaceutical compounds that were rejected under Article 26.3 for allegedly lacking experimental data, the Patent Re-examination Board reversed the rejections and resumed the prosecution procedures in over 90% of the cases, as opposed to a mere 20% reversal rate we observed be- fore 2014.

This is certainly a very promising move, although further concerns also arise. For example, many practitioners have observed that, for medical inventions, rejections based on the inventiveness issue (under Article 22.3 of the Chinese Patent Law) now become outstanding. Some start to worry whether or not this shift on rejection grounds may merely indicate a strategy change in making rejections by SIPO: the application formerly rejected on one ground is now to be rejected on another ground, and the applicant does not really get benefit in protecting his/her invention.

Ironically, under the Chinese Patent Law, an applicant has to fight hard to show that his/her invention is obvious to the skilled artisan during the Article 26.3 battle (for disclosure issue) so as to convince the examiner that certain experimental data should not be required; now, at this battlefield concerning Article 22.3 (for inventiveness issue), those arguments the applicant has so diligently made during the Article 26.3 battle can be handily turned over to use against the applicant himself/herself. This then make the following question even more prominent: will the inventiveness standard be upheld correctly? For the pharmaceutical industry, this kind of doubt better be clarified

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