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China: Retroactively Submits Experimental Data during Patent Procedures and Relevant Countermeasures

21st March, 2018

In the process of patent application examination, regarding how to consider the embodiment and experimental data submitted after the date of filing, the Guidelines for Chinese Patent Examination have experienced many revisions. In Part II Chapter 10 Section 3 of the Guidelines for Patent Examination of SIPO[1] [2] which is effective since April 1, 2017, a sufficient disclosure of a chemical invention-regarding Embodiment (2) is incorporated into the newly added section 3.5 regarding the embodiment and experimental data submitted after the date of filing, stipulating as follows:

"Whether or not the Description is sufficiently disclosed is judged on the basis of the disclosure contained in the initial Description and Claims.

The examiner should examine the experimental data retroactively submitted after the filing date. The technical effect proved by the retroactively submitted experimental data should be obtained by persons skilled in the art from the contents disclosed by a patent application." 

How should practiioners’ interpret "the technical effect proved by the retroactively submitted experimental data should be obtained by persons skilled in the art from the contents disclosed by a patent application"? This article puts forward thoughts and opinions on this problem, by analyzing two decided cases one before and one after the revision of the Guidelines for Patent Examination.

Case 1
A case of reexamination of the rejected patent application with an application No. 200580023071.2[3]. This case seeks to protect a method for preparing a ketone compound, which differs from the closest prior art in that a composite catalyst used in the preparation method contains a copper compound, and its technical effect is to prepare and obtain the ketone compound in a high yield and a high purity.

What is used in Embodiments 1 and 2 of the Description of the present case is a composite catalyst containing a copper compound, and what is used in Embodiment 3 is a composite catalyst not containing a copper compound (corresponding to the technical solution of the prior art). As calculated based on the experimental results, the yields in either Embodiment 1 or Embodiment 2 is lower than the yield in Embodiment 3. Thus, the experimental data and results disclosed based on the Description are not sufficient to prove that the claimed technical solution possesses inventiveness. Therefore, during the examination, the applicant retroactively submitted experimental data to prove that the claimed technical solution, compared with the prior art, has a faster reaction rate and less by-products. However, the technical effect of having a faster reaction rate and less by-products is not recorded in the Description of the present case.

The dispute focus of the present case lies in whether the experimental data retroactively submitted by the applicant can serve as a basis for evaluating inventiveness of the present case?
The Administrative Ruling (No. 1878 (2016), Administrative Petition, SPC)[4] made by the Supreme People's Court on September 27, 2016 with respect to the present case has provided a clear conclusion: "based on the first-to-file principle in the Chinese Patent Law and the principle of offering a disclosure for a protection, when a patent applicant intends, by submitting comparative experimental data, to prove that the claimed technical solution possesses inventiveness relative to the prior art, the precondition of accepting such data must be aiming at the technical effect clearly recorded in the original application documents.".

That is to say, if the technical effect to be proved by the experimental data retroactively submitted during the examination is not clearly recorded in the original application documents, such retroactively submitted experimental data will not be accepted as a basis for evaluating inventiveness of the present case. This conclusion is also made clear in the gist of the No. 21646 Invalidation Decision[5] with a patent No. 97180299.8, which is one of top ten reexamination invalidation cases in year 2017: "whether a patentee’s assertion that the patent has a certain kind of (or a certain extent of) technical effect by retroactively submitting an experimental evidence can be accepted generally depends on two factors: 1. whether the technical effect intended to be proved can be confirmed by the experimental evidence; 2. whether the technical effect can be confirmed by persons skilled in the art based on the contents disclosed in the original patent documents. If the technical effect proved by the (retroactively submitted) experimental evidence is not recorded in the original patent documents, it will not be considered when judging inventiveness."

Case 2
A Patent invalidation case with a patent No. 201110029600.7[6]. This case seeks to protect a pharmaceutical composition comprising valsartan and NEP inhibitors. Paragraphs [0041-43 and 63] of the Description of the present case disclose the following technical effect: "it has surprisingly been found that, a combination of valsartan and a NEP inhibitor achieves a greater therapeutic effect than the administration of valsartan, ACE inhibitors or NEP inhibitors alone......", and "the obtained results indicate that an unexpected therapeutic effect is achieved by the combination according to the invention". However, the Description of the present case does not record any experimental data verifying the above technical effect.

The present case is listed as the fifth case of "serious cases heard in public" of the Patent Reexamination Board, and one of the dispute focuses is the experimental data submitted after the application date and a synergistic effect of the pharmaceutical composition [7].

On January 3, 2018, the Patent Reexamination Board made the No. 34432 Invalidation Decision[8] for the present case, and the gist of the decision points out "experimental data retroactively submitted after the filing date does not belong to the contents recorded and disclosed by the original application documents of the patent, and these experimental data is not the content of the prior art of the present patent; based on the first-to-file principle and the essence of offering a disclosure for a protection in the patent system, the precondition of accepting such data must be that the technical effect proved by it can be obtained from the original Description."

In the No. 34432 Invalidation Decision, the collegial panel considers that the technical effect recorded in the Description of the present case belongs to an experimental conclusion, and the Description of the present case does not disclose detailed experimental data or results. But the experimental data and results play a decisive role in proving the medical effects, and an experimental conclusion is established on the basis of the statistical analysis results of the experimental data. Under the premise that persons skilled in the art cannot expect a synergistic effect, an experimental conclusion which is not based on the experimental data and results cannot enable persons skilled in the art to confirm the synergistic effect of the pharmaceutical composition.

That is to say, even if the Description records the technical effect of the invention, there is no experimental data to verify this technical effect, and based on the disclosure of the Description of the patent application, persons skilled in the art cannot confirm that the invention achieves the asserted technical effect. In this situation, using the retroactively submitted experimental data to prove this technical effect cannot be accepted.

Relevant Countermeasures
In the patent examination practices in China, an experimental evidence or data retroactively submitted after the filing date can be used to verify or complementally prove a technical effect which has been disclosed by a patent document, while cannot change this factual basis[4].

Then, where the Description has recorded the technical effect of the invention, to what extent this technical effect is disclosed, "the technical effect proved by the retroactively submitted experimental data should be obtained by persons skilled in the art from the contents disclosed by a patent application" stipulated in the Guidelines for Patent Examination can be met?

Next, the author tries to illustrate their thoughts and opinions on this problem through specific examples. The specific examples take the above Case 2 as the basis. For the convenience of description, the valsartan and NEP inhibitor in Case 2 are respectively simplified as A and B.
When drafting the application documents of Case 2, the therapeutic effect data by combining A and B and by giving A or B alone was provided, verifying that a combination of A and B has a synergistic therapeutic effect.

During examination of the present case, a prior art literature which influences inventiveness of the technical solution of combining A and B is found, and the literature discloses that a combination of A' and B' similar to a combination of A and B also has a synergistic therapeutic effect.

If the retroactively submitted experimental data is the therapeutic effect data of a combination of A' and B' obtained by using the experimental method disclosed by the present case, a comparison between the retroactively submitted therapeutic effect data of the combination of A' and B' and the therapeutic effect data of the combination of A and B can prove that the combination of A and B has a more excellent and unpredictable synergistic therapeutic effect. Such retroactively submitted experimental evidence only verifies a current technical solution of combining A' and B', does not change the factual basis of the present case itself, and can be accepted for evaluating inventiveness of the present case relative to the prior art literature.

However, when the therapeutic effect of a combination of A' and B' is equivalent to the therapeutic effect of a combination of A and B, if the retroactively submitted experimental data uses the therapeutic effect data of a specific combination of A1 and B1 in the combination of A and B, and compared with the therapeutic effect data of a combination of A' and B' to prove that the combination of A1 and B1 has a more excellent and unpredictable synergistic therapeutic effect, persons skilled in the art cannot foresee that such specific combination of A1 and B1 has a particularly excellent synergistic effect, because the original application document does not disclose that this specific combination of A1 and B1 has a particularly excellent synergistic therapeutic effect, and such retroactively submitted experimental evidence changes the factual basis of this case and cannot be accepted.

To sum up, although the Guidelines for Patent Examination effective from April 1, 2017 stipulates "the examiner should examine the experimental data retroactively submitted after the filing date ", it also strictly limits the conditions for the retroactively submitted experimental data to be accepted, i.e., "the technical effect proved by the retroactively submitted experimental data should be obtained by persons skilled in the art from the contents disclosed by a patent application". As can be concluded based on the above two cases, a technical effect which can be obtained by persons skilled in the art from the disclosure of a patent application should be clearly recorded in the original Description and be verified by experimental data in the prior art or the Description of the present case.

Cited Literatures:
[1] Guidelines for Patent Examination (version 2010), State Intellectual Property Office of the People's Republic of China, Intellectual Property Publishing House
[2] Guidelines for Patent Examination effective from April 1, 2017 publicized on March 06, 2017 on http://www.sipo.gov.cn/zscqgz/1101305.htm 
[3] Method for producing 1, 2-dihydropyridine-2-one compound by the patent applicant, EISAI R&D MAN CO LTD, invention patent application CN1984890A, publicized on June 20, 2007
[4] Administrative Ruling (No. 1878 (2016), Administrative Petition, SPC)
[5] Fifth case of the top ten reexamination invalidation cases, the case of requesting for invalidation of the patent right of the invention "substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimide and -1-dihydroisoindol and a method for reducing a tumor necrosis factor α", publicized on September 27, 2017, http://www.sipo-reexam.gov.cn/alzx/fswxsdaj/21162.htm
[6] A pharmaceutical composition comprising valsartan and NEP inhibitors, by the Patentee, NOVARTIS AG, Invention patent CN102091330 B, publicized on April 08, 2015
[7] Serious case heard in public, a pharmaceutical composition comprising valsartan and NEP inhibitors, publicized on September 15, 2017, http://www.sipo-reexam.gov.cn/alzx/zdajgksl/21180.htm
[8] No. 34432 Invalidation Decision by the Patent Reexamination Board publicized on January 03, 2018, http://app.sipo-reexam.gov.cn/reexam_out1110/wuxiao/wuxiaolb.jsp


Written by: Xianglan Ding, Beijing Sanyou Intellectual Property Agency Ltd.

Author: Lena Shen

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