By: Yu Li (LL.M candidate in Intellectual Property Law,
Boston University School of Law; LL.B, Minzu University of China School of Law.
Yu Li has professional experience at both Chinese IP court and IP law firm in
Beijing, China).
The State Intellectual Property Office (SIPO) of China
announced the decision to amend the Guide
to Patent Examination on March 1, 2017, and the revised guidelines will
come into effect on April 1, 2017. This is the third modification after 2013
and 2014. The changes include those to business model, computer program, experimental
data, and invalid procedure.
The revisions delete the current rule that "examples and experimental data that
are not taken into account after the filing date[1]" and replace it with: "the examiner shall review the experimental data
submitted after the filing date. The technical effect evidenced by the
post-filing experimental data should be obtained by technical person skilled in
the art, from the disclosure of the patent application.[2].”
The revised contents of Section 3.4, Section 3.5 are
as follows:
Section
3.4 - About the Examples
Since the
field of chemistry is an experimental discipline, most inventions need to be
experimentally proven, the specification should generally include examples,
such as the preparation and application of the product. The number of
embodiments in the specification depends on the degree of generalization of the
technical characteristics of the claims. For example, the degree of
generalization of the elements, and the range of values of the data; in the
chemical invention, the specific technical field is different depending on the
nature of the invention. The number of requests is not exactly the same. The
general principle is that, it should be sufficient to understand how the
invention is implemented, and to be able to determine that the effect can be
achieved within the limits defined by the claims. [3]
Section 3.5 -
Experimental data on submissions
Whether the
instructions are of full disclosure, is based on the original description and
the contents of the claims. The examiner shall review the experimental data
submitted after the filing date. The technical effect evidenced by the
post-filing experimental data should be obtained by technical person skilled in
the art, from the disclosure of the patent application. [4]
Before the revised Guide, examples and experimental
data submitted after the filing date were not considered.
The revised Guide clarifies the review criteria: to take
the post-filing experimental data submitted into considerations. At the same
time, SIPO of China emphasizes the first-application principle in the
Guidelines, because all the examinations,
including the disclosure examination, should be based on the original description,
specification and the contents of the claims basis. Therefore, the examination
still follows the provisions of Article 33 of the Chinese Patent Law, that the
effect of all the experimental data should be derived from the disclosure of
the patent application; also, the patent applicant can only use the post-filing
data to reinforce the reliability of technical effects in the patent claims and
specifications, but cannot demonstrate that the technical program has a new
technical effect by submitting experimental data after the filing date.
Different from the U.S. common law system, precedent
is not that important in Court of Chinese law system. Similar to the other
civil law system, Chinese courts will first rely on statute, regulations, judicial
interpretation, guidelines and public documents before stare decisis. Another authentic interpretations offering referential and
comprehensive conclusions is from Hubin Zhou, director of the business
management department in the SIPO of China. Director Zhou one of the officer
who is responsible for drafting amendments and guide to patent examination.
According to Director Zhou’s clarification, the
original meaning of the existing guideline (the one before the revisions)
actually takes experimental data submitted after the filing date
into considerations. The revision is
intended to clarify the examination criteria that, experimental data submitted
after the filing date shall be considered and examined, though it can only be
used to prove technical effects that are obvious to those skilled in the art
from the original disclosure.
Besides, the subject of the judgment is the technical
person in the field, which is similar to the concept of POSITA (person having
ordinary skill in the art) in U.S. patent law. And the object of the judgment
is the technical effect of the supplementary experimental data, rather than the
experimental data itself, thus the examiners will stand by the technical staff
to determine whether the technical effect is consistent with the data or whether the experimental data is consistent with the experimental methods.
In conjunction with the new Guides and Zhou’s clarification,
Guohua Tang, a Chinese patent attorney in Beijing, China, has the following
understanding for further reference.
First, the revision on experimental data is only to clarify that the examiner should review the post-filing experimental data. Here “should
review” means "should consider", but not means “must consider”. That
is to say, it is not definite for the examiner to accept and examine the “late submitted
data”; also it is not for sure that the data and its claimed technical effect
will be directly approved[5].
Second, in patent application practice in China
currently, the applicant may be able to submit experimental data for
examinations by the examiner, as long as the applicant wants to overcome some
defects in utility, disclosure, novelty. Therefore, nothing will change
with the revisions in this part of practice[6].
Third, different licensing terms, application
documents and their own technical areas of the existing technology will bring
different principles of judgment, as to whether the examiner will accept or
endorse the technical results of the test data. It cannot be generalized[7].
To be specific, on one hand, if the original
specification does not have the technical effect recorded, the technical effect
of the experimental data will not be recognized. For technical instructions
that are documented in the specification but are not supported by experimental
data, it is necessary to see if the technical effect is based on the original
application document or the predictability of the inventive mechanism. If there
is little predictability, it will be less possible to accept the experimental
data.
On the other hand, it is necessary to submit
experimental data, to prove that the claimed technical effect can be achieved,
by the need for a description of the inventive mechanism based on the original
specification, and by means of the prior art. For example, an application with
only one example provided for a range of rights, or an application that only
provides a specific compound having a few specific groups for a compound
formula, generally needs the applicants disclose the inventive mechanism, the
common formula group or the general formula, sometimes by reference to the
prior art. Under this circumstance, the post-filing experimental data is
acceptable and necessary.
As far as I am concerned,
chemical enterprise, medical corporations, biopharmaceutical companies in the
Chinese market, as well as the chemistry industry in china, benefits from the SIPO’s
Guide to Patent Examination,
particularly the revision on experimental data after filing date. In either
medicinal development or chemical engineering, the specific parameters are of
great impact on the technical effect. And a series of experiments on that may
take a long time. Without the revision of SIPO’s Guide, the incomplete experimental data or the lack of data may
become a follow-up attack from other parties. Now, chemical patent applications
can be filed appropriately in advance, because the reasonable post-filing
experimental data can be considered.
There are several suggestions
that I can provide based on my practice and my understanding in the new Guides’
experimental data revision. First, companies in chemical industry in the
Chinese market enterprise, like medical corporations, can file the patent
applications with incomplete experimental data. Second, they do not have to
wait until the experimental data is perfect, but the follow-up experimental data submitted
after filing should explain the technical effects, should be in the
original scope of the chemical patent application, and should have a technical
effect of direct or indirect description. Last but not least, if the technical
effect cannot be determined before the experiment, you can try to: (1) describe
the possible technical results as much as possible; or (2) file a few more applications,
respectively, describing the different technical effects, especially when the
potential technical effects would be of mutual contradiction. Then, after
obtaining the experimental data with technical results, submit the experimental
data corresponding patent application.
[1] See the Guide
to Patent Examination (2014), State Intellectual Property Office (SIPO) of
China. The original cited is of Chinese
language version, so I translate it into English.
[2] See the Guide
to Patent Examination (2017), SIPO of China. Website Available at: http://www.sipo.gov.cn/zwgg/jl/201703/t20170302_1308618.html or
The original cited is of Chinese language version, so I
translate it into English.
[3] Id.
[4] Id.
[5] See the online article from attorney Tang (in Chinese
language version), available at: https://mp.weixin.qq.com/s?__biz=MjM5NjQ4NzY5Mg==&mid=2654437195&idx=1&sn=786e48f5e447b0b45c9a68486f1606d0&chksm=bd2ba8288a5c213ea50825814bc96f64b05fa78e891b242938d8c5113cacc78353e61ee9ffcf&mpshare=1&scene=24&srcid=0309DakGJydE96rGtNJPzmZ7&pass_ticket=uqCOUmv6Nf4r%2B7iu%2FBbH3qZF%2FE%2BcEdvw4RtT5klRJySwE30jhzrS3glTy5pned4H#rd
The original cited is of Chinese language version, so I
translate it into English.
[6] Id.
[7] Id.
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