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Tengfei SHI
Junior Partner
Vice Manager of Division II
Chemistry & Biotechnology Department
Patent Attorney
Hello, everyone. It’s a great honor for me to talk about some patent practices in China.
Some background on me. My name is Walker, I’m a chemistry patent attorney at the firm of lindaliu group. I practice in our Beijing head office.
My focus is patent prosecution, which includes the planning of patents and patent portfolios, drafting and patent applications, office action responses, and so on. Also, I do a bit of invalidation and litigation.
I have been working in our Lindaliu Group for 7 years since 2013. Previously, I was a chemistry patent examiner in CNIPA, and I worked in CNIPA for 10 years from 2002 to 2012.
OK, my today’s topic is about the supplementary experimental data, which is very closely related to the chemistry, pharmaceutical, biochemistry and material technical fields. Frankly speaking, this is a quite hot topic in recent years in China. It has attracted much attention from our clients around the world. Most of our clients wonder that how to make the examiners during the examination process or make the judges in the court to accept the supplementary experimental data. Some of our clients had difficulties in providing the appropriate supplementary experimental data.
Actually, this topic has a long story. Previously, the CNIPA put a very strict requirements on the supplementary experimental data, thus the result was that almost every examiners would reject all forms of supplementary experimental data, or even some examiners would never check the contents of the supplementary experimental data.
Why? This was mainly because the supplementary experimental data is actually not described in the original patent description, and it is not a real part of the original description. The examiners often thought that the supplementary experimental data has no basis in the original description, and the examiners couldn’t judge whether the supplementary experimental data is true or false based on the original description.
This was the main reason why most examiners hardly accepted any supplementary experimental data in the past. And every year, many patent applicants suggested the CNIPA to release the requirements on the supplementary experimental data.
In Apr. 1 2017, the newly revised Chinese patent examination guideline put into practice. It specifies that the examiners should consider the supplementary experimental data, rather than hardly considered these datas just like in the past.
So, compared to the past, things become different and things have changed, but it’s still hard to conclude that the examiners will inevitably approve the novelty, inventiveness or sufficiency of disclosure by checking the supplementary experimental data. In other words, although the examiners would check the contents of the supplementary experimental data, it doesn’t mean that the examiners would inevitably accept the data.
You may naturally ask “why”? This is because, actually, there is still a pretty important precondition for the supplementary experimental data in Chinese patent examination guideline. The guideline specifies that, the technical effects which reflected by the supplementary experimental data should be obtained from the original description by the person skilled in the art. Frankly speaking, this precondition is kind of vague, because it’s often hard to judge whether we can obtain the technical effects reflected by the supplementary experimental data from the original description.
In other words, for the patent applicants, a good news is that the examiners will consider the supplementary experimental data, however at the same time, a bad news is that the examiners will not inevitably approve the patentability although we provided the supplementary experimental data.
How about the actual situation in our practical work? You must want to know that what kind of the supplementary experimental data will be more likely to be accepted by the examiners.
OK, today I introduce some tips for you. From our experiences, there are two forms of the supplementary experimental data which often can be more likely to be accepted by the examiners.
As one example, our present application describes a product which has a parameter such as viscosity, while the D1 which is referenced by the examiner, describes another different parameter, for example strength. As we know, it is impossbile to compare the viscosity of the present application to the strength of the D1. When the examiner thought that the present application is not novel or has no inventiveness over the D1, what should we do? What’s the effecient supplementary experimental data we can provide?
OK, We have two good options. One option is that we can repeat the whole process of the example of D1(for example the example 1), and using the same measuring method as in the present application to measure the parameter which is the same as the present application. Then, we can compare the parameter in the present application to the newly measured one of the example of D1. So, we can conclude that whether the present application is novel or has inventiveness over the D1. In the present case, we can measure the viscosity of example of D1, and then compare the viscosity value of the present application to that of the example of D1.
Another option is that we can repeat the example of the present application, using the same measuring method as that of D1 to measure the parameter which is the same as the D1. In the present case, we can measure the strength of the example of the present application, and compare it to that of D1.
The above two forms of the supplementary experimental data have been widely recognized by the examiners. However, it doesn’t mean that other forms of the supplementary experimental data can’t be accepted by the examiners. On the contrary, other forms of the supplementary experimental data are still likely to be accepted.
For example, another form of supplementary experimental data which is commonly used by our clients is that, using a specific component in D1 in place of that of the present application, and repeating the example of the present application by using the specific component in D1, so as to prove that, using the component in D1 can only obtain inferior technical effects to the present application. In our experience, many of these forms of the supplementary experimental data have been accepted by the examiners and thus many patents have been granted.
But here I should emphasize that, for the insuffiency of disclosure issues appeared in the application, currently there is no possibility of eliminating these issues by providing the supplementary experimental data. This is because the CNIPA and the Chinese courts are still very strict on the requirement of suffiency of disclosure. Many judicial cases in China have already demonstrated that the insuffiency of disclosure issues can’t be overcamed by the supplementary experimental data, this is because the supplementary experimental data is inevitably not described in the original description, and it has no basis in the original description. So, it can’t solve the intrinsic defects of the original description.
In summary, Chinese examiners are increasingly accepting the supplementary experimental data, and we can provide these datas as much as possible, it can influence the examiners’ opinions towards to our application and it contributes to the granting of the application.
Now, China and US have signed an economic and trade agreement, and we noticed that the agreement requires that China should allow the pharmaceutical patent applicants to provide the supplementary experimental data, so as to satisfy the requirements of patentability, including the requrements on the inventiveness and suffiency of disclosure.
So, in the near future, the patent practice about the supplementary experimental data in China will probably change in some extent. We also look forward to the new change. If we have any new information, we will tell you in a short time.
OK, thank you for your listening, see you next time! Bye!
