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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