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A Discussion on the Impact of Confirmation of Technical Effect on Criterion of Inventive step in the Field of Chemistry and Pharmacy

31

JUL

2019

In order to discuss the impact of confirmation of technical effect on criterion of inventive step, the Reexamination and Invalidation Department of the Patent Office, CNIPA used one of those Top Ten Patent Review Cases published in 2018 as example. In this specific case, a company filed a request of reexamination regarding its invention of emulsion and mask that contained Chinese native medicine ingredient such as bletilla and tuckachoe. (Please refer to http://reexam.cnipa.gov.cn/alzx/fswxsdaj/21760.htm)

This case especially concerns comprehension of technical effect. When it comes to experimental science, especially relates to chemistry and pharmacy field, compared to other subject areas, the confirmation of technical effect has its own distinctive feature and a high degree of difficulty. In the field of chemistry and pharmacy, even when it comes to the technical effect claimed by the invention, in actual operation, whether it is actually achievable or not depends on qualitative or quantitative experimental verification. Besides experiment, those skilled in the art can make a judgment or confirmation based on their own experience and the prior technical background.

The confirmation of technical effects is first and foremost the confirmation of its credibility, because during the inventive examination, there are no necessity and possibility at all to consider an untrustworthy technical effect. In the case where the specification describes the experimental data to prove the technical effect achieved by the invention, especially when it is claimed that the invention has achieved unexpected technical effects, the confirmation of the technical effect is more important. Regarding to experimental data and conclusion, various factors such as experimental object, experimental condition and experimental data itself needed to be considered in order to confirm the technical effect which the invention attempts to achieve. At this time, it is necessary for a person skilled in the art to reasonably analyze and confirm the general technical effects actually achieved by the invention based on his knowledge and ability, and perform creative evaluation based on this.

Through case studying, this paper aims to shed light on the confirmation of technical effect. The author cites the following case to illustrate from another angle that not only the technical effect of the invention patent itself needs to be reasonably analyzed and confirmed, but also according to this theory, the technical effects claimed by the examiner during examination for the technical solutions in the citations also need to be reasonably analyzed and confirmed. Therefore, it can be clarified whether the citations can be used as the main basis for determining whether the invention patent is not inventive.

Case Background

Application No.: 200980103457.2, which is a PCT Patent application named “The hydrotalcite which provides resin with improved thermostability and its preparation method.” Considering the request of No. 71490 patent reexamination, on 18th August 2014, the Reexamination and Invalidation Department of the Patent Office affirmed the original decision that was made on 1st, March 2013. The applicant refused to accept this decision and lodged a complaint. On 20th, July 2016, Beijing Intellectual Property Court cancelled the decision and a new reexamination decision was required to be made. This patent application was granted on 8th, March 2019.

Technology Solution of the Patent

This patent relates to a hydrotalcite which is generally used as an additive to improve thermoresistance of synthetic resin products and represented by the formula of Mg1-xAlx(OH)2(An-)x/n•{(1-a)(1-3x/2)-a•z/18}H2O, (wherein, An- is an anion selected from the group consisting of CO32-, NO3-, SO42-, OH-, F-, Cl-, Br- and an oxoanion comprising Si, P or B; z is a formula weight of; x is in the range of 0.20 < x ≤ 0.33; a is in the range of 0.015 ≤ a 0.0352).

One of the purposes of this patent is to provide a structurally stable hydrotalcite that contains a minimum amount of crystal water which enhances thermostability of synthetic resin products. By comparing with citations in the examination stage, it became clear that the technical difference lies in the value range of a in hydrotalcite formula. In order to ensure better thermostability, the minimum amount of crystal water should be based on the range of a.

Panel’s Opinion

JP59152941AD1discloses a hydrotalcite. The molecular formula of Mg0.30Al0.70(OH)2(CO3)0.150.55H2O. The distinguishing feature of the patent claim 1 and the D1 is only the range of values of a in the hydrotalcite chemical formula of claim 1 of the patent, i.e., 0.015≤a0.0352. The technical problem to be solved is how to optimize the performance of the hydrotalcite.

D1 discloses that the proportion of crystal water is preferably about 1/3 or more. It is obvious that those skilled in the art can control the value range of a by adjusting dehydration rate. When the dehydration rate is reduced, the value of a decreases. In addition, both the Table 1 and Table 2 in D1 demonstrate the impact of different dehydration rates on thermostability. When the loss of crystallization water increases and the value of a increases, the thermal stability of PVC decreases. Moreover, as the common sense Polyvinyl chloride assistant and tableulation design technology said, there is a need to have a suitable level of dehydration during the dehydration process so as to ensure a proper amount of crystal water, which can improve the thermostability and flame retardancy of PVC. Both D1 and the common technical knowledge in the art show the proportion relationship between stability, heating temperature or crystal water. Evidently, the technical solution of Patent Claim 1 can be obtained through combining D1 and normal technical knowledge in this art.

After summarizing the review opinions of the panel, based on the common knowledge in the art, it has been disclosed in the art that reducing the amount of dehydration, allowing the hydrotalcite to retain an appropriate amount of crystal water, and improving the thermal stability of the resin. On one hand, D1 shows that the value of crystal water can be about 0.4, which is not too different from the value range of a in this patent, which is 0.015≤a0.0352. On the other hand, both Table 1 and Table 2 disclose the impact of different dehydration rates have on the thermostability of PVC. When the loss of crystallization water increases and the value of a increases, the thermal stability of PVC decreases. Based on the combination of D1 and common technical knowledge, it is obvious that the limitation of the range of a can give resin a better thermostability.

Court Opinion

When the patentee filed a lawsuit, we provided an opinion that the panel gave an illogical analysis and reasoning about the technical effect against D1, resulting in the fact that the patent obtained according to this did not have a inventive basis. The court upheld our opinion.

The court held the view that the recognition of inventive step of claim 1 of the patent mainly based on two aspects. The first one is the content disclosed in both Table 1 and Table 2, the effects of the different dehydration rates on thermostability of PVC. When the dehydration rate is 4.6%, 5%, 10%,13%, the thermal stability lasts for 120min, 118min, 115min ,109min respectively. It is evident that when there is a loss of crystal water and an increase of the value of a, the thermostability of PVC decreases. The other aspect is that during the process of dehydration, there is a need to reduce the dehydration, ensuring a proper amount of crystal water so as to improve the thermostability and flame retardancy of PVC.

Through a comprehensive understanding of the technical solution and technical effect of D1, according to Table 1 and Table 2, the court believed that when the dehydration rate is 4.6%, 5%, 10%,13%, the thermal stability lasts for 120min, 118min, 115min ,109min respectively. Based on the above statement, it can be concluded that when there is a loss of crystal water and an increase of the value of a, the thermostability of PVC decreases. The above data is recorded in the examples, at the same time, both Table 1 and Table 2 show the comparative examples. The only difference between examples and comparative examples is that whether or not stearyl alcohol is contained. Stearyl alcohol doesn’t have impact on thermostability of PVC, so it seems that the data recorded in examples can demonstrate that when there is a loss of crystal water, the thermostability of resin decreases. However, if this conclusion is applicable to examples, it should also be applicable to comparative examples, because the only differences between examples and comparative examples doesn’t have impact on thermostability of PVC. According to the comparative exampleswhen the dehydration rate is 0 and 12%, the thermal stability lasts for 120 min, and no change occurs. It can be concluded that the content disclosed in both Table 1 and Table 2 can’t prove that when there is a loss of crystal water, the thermostability of resin decreases. Considering the fact that this conclusion is invalid, it can be said that the conclusion that claim 1 of the patent isn’t inventive is also invalid.

Conclusion

According to one of the top ten cases of patent review in 2018 mentioned in the beginning part of this paper, which concerns the impact of technical effect on inventive step judgment in the field of pharmaceuticals. In this case, the remanding for retrial and the obtainment of patent rely on whether the technical effects of the citations (i.e., patent or patent application document) are logically reasoned and identified by those skilled in the art.

The ruling given by the court also fully demonstrates that in the inventive examination, both the patent invention itself and the citations cited need to logically reason and confirm the technical effects claimed. There is no need and possibility to consider an unreliable technical effect. Especially in the field of Chemistry and Pharmacy, when it comes to experimental data and conclusions, it is necessary to consider various factors such as the experimental object, experimental conditions and experimental data itself in order to confirm the technical effect it intends to prove. Once there is a technical effect claimed by those skilled in the art that cannot be judged and confirmed by logical analysis and reasoning, it can be said that the conclusion determined by this data is invalid. On this occasion, there is an opportunity for the patentee to regain the patent right.

About the Firm

Ge Cheng & Co Ltd.
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Tel 86-10-8518 8598
Fax 86-10-8518 3600
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